The J. B. Williams Company, Inc.

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IN THE MATTER OF THE J. B. WILLIAMS COMPANY, INC., ET AL.

ORDER, OPINION, ETC. , IN REGARD TO THE ALLEGED VIOLATION OF THE FEDERAL TRADE COMMISSION ACT Docket 8547. Complaint, Dec. 1962-Decision . Sept. , 1965 Order requiring a New York City manufacturer of drug preparations and its advertising agency. to cease misrepresenting the effectiveness of its Geritol" liquid and tablets by falsely representing in television commercials and newspaper advertising that all cases of tiredness, loss of strength, run-down feeling, nervousness and irritability indicate a deficiency of iron and that the common effective remedy for these symptoms is " Geritol"; and also to affirmatively state that in the great majority of cases of tiredness the symptoms are not caused by such iron or vitamin deficiency.

COMPLAINT Pursuant to the provisions of the Federal Trade Commission Act, and by virtue of the authority vested in it by said Act, the Federal Trade Commission, having reason to believe that The J. B. Williams Company, Inc. , a corporation, and Parkson Advertising Agency, Inc. , a corporation, hereinafter referred to as respondents, have violated the provisions of said Act, and it appearing to the Commission that a proceeding by it in respect thereof would be in the public interest, hereby issues its complaint stating its charges in that respect as follows:

PARAGRAPH 1. Respondent The J. B. Williams Company, Inc. is a corporation, organized and existing under the Jaws of the State of New York, with its office and principal place of business Jocated at 400 Park Avenue, in the city of New York, State of New York. Respondent Parkson Advertising Agency, Inc., is a corporation organized and existing under the laws of the State of New York with its office and principal place of business Jocated at 400 Park Avenue, in the city of New York, State of New York. PAR. 2. Respondent The J. B. Williams Company, Inc., is now and has been for some time last past, engaged in the saJe and distribution of preparations containing ingredients which come within the classification of drugs as the term "drug" is defined in the Federal Trade Commission Act.

The designations used by respondent The J. B. Wiliams Company, Inc. , for the said preparations, the formulae thereof and directions for use are as follows:

... .......... ...

Complaint 68 F.

1. Designation: Geritol Liquid"

Formula (Per Oz.):

Thiamine (B, 5 mg. Riboflavin (B 5 mg. Niacinamide 100 mg. Panthenol ... .. 4 mg. Pyridoxine (B 1 mg. Vitamin B" 3 mcg. Methionine 100 mg. Choline Bitartrate 100 mg. Iron (as in iron ammonium citrate) 100 mg. Directions: As a high potency tonic (Iron, Thiamine, Riboflavin. Niacin deficiencies): 1 tablespoonful at each meal or as directed by physician. As a dietary supplement: 1 tablespoon daily at breakfast or any mealtime 2. Designation: Geritol Tablets Formula (One Tablet):

Thiamine (B, 5 mg. Riboflavin (B, 5 mg. Vitamin C 75 mg. Niacinamide 30 mg. Calcium Pantothenate 2 mg. Pyridoxine (Bo 5 mg. Vitamin B,-, 3 mcg. Inositol 20 mg. Methionine 25 mg. Choline Bitartrate 25 mg. Iron 50 mg. Debittered Brewer s Yeast 50 mg. Directions: As a high potency tonic (Thiamine, Riboflavin, Niacin, Vitamin C or Iron deficiencies) :

Three (3) tablets daily - one at each mealtime or as directed by a phy"ician.

As a dietary supplement:

One (1) tablet daily at breakfast or any meal of your choice. PAR. 3. Respondent The J. B. Wiliams Company, Inc. , causes the said preparations, when sold, to be transported from a place of business in the State of New Jersey to purchasers thereof Jocated in various other States of the United States and in the District of Columbia. Respondent maintains, and at ajj times mentioned herein has maintained, a course of trade in said preparations in commerce as "commerce" is defined in the Federal Trade Commission Act. Respondent Parkson Advertising Agency, Inc. , is novv' and for some time last past has been, the advertising agency of The J. B. Wiliams Company, Inc. , and now prepares and places, and for some time last past has prepared and placed, for publication adver- ..

THE J. B. WILLIAMS CO. , INC. , ET AL. 483 481 Complaint tising material, including the advertising hereinafter referred to to promote the sale of the said preparations. In the conduct of its business, at all times mentioned herein, respondent Parks on Advertising Agency, Inc. , has been in substantial competition, in commerce, with other corporations, firms and individuals in the advertising business.

PAR. 4. In the course and conduct of their business, respondents have disseminated, and caused the dissemination of, certain advertisements concerning the preparations referred to in Paragraph Two, above, by the United States mails and by various means in commerce, as "commerce" is defined in the Federal Trade Commission Act, including, but not limited to, advertisements inserted in newspapers and other advertising media, and by means of television broadcasts transmitted by television stations Jocated in various States of the United States and in the District of Columbia, having sufficient power to carry such broadcasts across state lines, for the purpose of inducing and which were likely to induce, directly or indirectly, the purchase of said preparations; and have disseminated and caused the dissemination of, advertisements concerning said preparations by various means, including but not limited to the aforesaid media, for the purpose of inducing and which were Jikely to induce, directly or indirectly, the purchase of said preparations in commerce, as "commerce " is defined in the Federal Trade Commission Act.

PAR. 5. Among and typical, but not all-inclusive thereof, of the statements and representations contained in said advertisements including audio-visual representations in television broadcasts, disseminated as hereinabove set forth, are the following: if you often have that tired and run-down feeling' and if you take vitamins yet stil feel wornout, remember :. your trouble may be due to iron- poor blood. And vitamins alone can t build up iron-poor blood. But GERITOL can! (Television) Here s how to feel stronger fast Especially after a fever, flu, or virus. Have you been feeling tired and rundown more often than usual'? Your trouble may be due to iron-poor blood. And this is often especially true after a fever, the flu or virus. Durjng such an illness you may be on a liquid diet or eat light foods. As a result you may continue to feel a Jack of strength and energy after your illness, because the essential iron in your blood is reduced and your resistence is low. (Newspaper) GERITOL begins to strengthen iron-poor blood in twenty-four hours. Check with your doctor. And if you feel rundown because of iron-poor blood '" especially after a fever, flu or virus take GERITOL every day. You Complaint 68 F.

feel stronger fast * * * in just seven days or your money back from the GERITOL folks. (Television) In onl:y one day GERITOL-iron is in your bloodstream carrying strength and energy to evcry part of your body- (Television) GERITOL "' the high-potency, vitamin iron-rich tonic to help you FEEL STRONGER.' (Television) have you been suffering from the flu, a cold or sore throat? (Television) PROVED BY MEDICAL TESTS Patients diagnosed with iron-deficiency anemia frequently were pale. nervous irritable and easily tired. After patients took GERITOL daily, doctors reported definite clinical improvement-further confirmed by laboratory tests. Remember, ordinary maintenance vitamins can t do it! But the high-potency combination of vitamins plus iron in GERITOL can help you regain your strength and energy. (Newspaper) Vitamins alone can t build up iron-poor blood. But GERITOL can! Because GERITOL contains 7 important vitamins and. in addition, supplies the therapeutic amount of iron needed to build iron-rich rcd blood. Just 2 GERITOL tablets, or 2 tablespoons of GERITOL liquid, contain twice the iron in a pound of calves' liver! It is this rich source of iron, combined with high-potency vitamins, including essential B vitamins in 3 to 5 times the minimum daily requirements, that make GERITOL such an effective strengthbuilding tonic. (Newspaper) I know you II feel stronger fast in just 7 days " or your money back! (Television) PAR. 6. Through the use of the statements in the aforesaid advertisements, and others similar thereto not specifically set out herein respondents have represented, and are now representing, directly and by implication:

L That the use of Geritol Liquid and Geritol Tablets wi1 be of benefit, safe and effective in the treatment and relief of an estab- Jished or existing deficiency of iron and iron deficiency anemia, and tiredness, loss of strength, run-down feeling, nervousness and irritability- 2. That Geritol Liquid and Geritol Tablets, and each of them will increase the strength and energy of every part of the body within 24 hours- 3. That Geritol Liquid and Geritol Tablets, and each of them win promote convalescence from a cold, flu, fever, virus infection sore throat and other winter i1nesses.

THE J. B. WILLIAMS CO. , INC. , ET AL. 485 481 Complaint 4. That the vitamins contained in both Geritol Liquid and Geritol Tablets contribute to the effectiveness of these preparations in the treatment or relief of an established or existing deficiency of iron or iron deficiency anemia.

5. That the purchase price of Geritol liquid and Geritol Tablets wi1 be refunded unconditionally if the purchaser is not satisfied with the product.

PAR. 7. In truth and in fact:

1. Neither Geritol Liquid nor Geritol Tablets wi1 be of benefit in the treatment of tiredness, loss of strength, run-down feeJing, nervousness or irritability except in a small minority of persons whose tiredness, loss of strength, run-down feeling, nervousness Of irritability is due to an established or existing deficiency of one or more of the vitamins provided by these preparations or to an established or existing deficiency of iron or to iron deficiency anemia.

Furthermore, the statements and representations in said advertisements have the capacity and tendency to suggest, and do suggest, to persons viewing or hearing such advertisements that in cases of persons of both sexes and all ages who experience tiredness loss of strength, run-down feeling, nervousness or irritability there is a reasonable probability that these symptoms in such cases wil respond to treatment by the use of these preparations; and have the capacity and tendency to suggest, and do suggest, that in cases of persons of both sexes and all ages who have an established or existing deficiency of iron or who have iron deficiency anemia the preparations can be used safely and effectively in the treatment and relief of an established or existing deficiency of iron or of iron deficiency anemia and their symptoms. In the light of such statements and representations, said advertisements are misleading in a matefial respect and therefore constitute "false advertisements as that term is defined in the Federal Trade Commission Act, because they faiJ to reveal the material facts that in the great majority of persons, or of any age, sex or other group or class thereof, who experience tiredness, loss of strength, run-down feeling, nervousness or irritability, these symptoms are not caused by an established or existing deficiency of one or more of the vitamins provided by Geritol Liquid or Geritol Tablets or by an established or existing deficiency of iron or iron deficiency anemia, and that in such persons the said preparations wi1 be of no benefit; and they are additionally misleading in a material respect because they fail to reveal the material fact, when representing that the preparations wil be effec- 486 FE)),S TRADE COMMISSION DECISIONS Complaint 68 F.

tive in the treatment and relief of an established or existing deficiency of iron or of iron deficiency anemia, in adults, and when ascribing symptoms of tiredness, loss of strength, run-down feeJing, nervousness or irritability, in adults, to an established or existing deficiency of iron or to iron deficiency anemia, that, in women of any age beyond the usual child-bearing age and in men of all ages an established or existing deficiency of iron or iron deficiency anemia is almost invariably due to bleeding from some serious disease or disorder and in the absence of adequate treatment of the underlying cause of the bJeeding the use of the preparations may mask the signs and symptoms and thereby permit the progression of such disease or disorder.

2. Neither Geritol Liquid nor Geritol Tablets wil increase the strength or energy of any part of the body within 24 hours. 3. Neither Geritol Liquid nor Geritol Tablets wil be of benefit in promoting convalescence from a cold, flu, fever, virus infection, sore throat or other winter illnesses.

4. The vitamins supplied in neither Geritol Liquid nor Geritol Tablets are of any benefit in the treatment or relief of an established or existing deficiency of iron or iron deficiency anemia. 5. The purchase price of Geritol Liquid or Geritol Tablets is not refunded unconditionally, but there are terms and conditions which must be complied with by a purchaser in order for him to secure a refund, which terms and conditions are not disclosed in the advertising.

The aforesaid advertisements set forth and referred to in Paragraph Five above were, and are, misleading in material respects and constitute "false advertisements " as that term is defined in the Federal Trade Commission Act.

PAR. 8. The dissemination by the respondents of the false advertisements, as aforesaid, constituted, and now constitutes, unfair and deceptive acts and practices, in commerce, in violation of Sections 5 and 12 of the Federal Trade Commission Act. Mr. Bruce J- Brennan and Mr. Daniel J. Manelli for the Commission.

Mr. Thomas Austern, Mrs. James H. McGlothlin, Mr. George Blow and . Gerry Levenberg, attorneys for respondents Covington Burling, Union Trust Building, Wash. 5, D. . ... . .. ..................,......... . ..... ............ ............................. .. .. . ........... ......... THE J. B. WILLIAMS CO. , INC. , ET AL. 487 481 Initial Decision INITIAL DECISION BY ABNER E. LIPSCOMB, HEARING EXAMINER MAY 8, 1964 INDEX page L The Complaint 488 II. The Answer 489 III. Pre hearing Conferences and Hearings 489 IV. Proposed Findings . 489 V. The Respondents and The Products 490 VI. Issues as to the Content and Meaning of Respondents' Advertisements 491 VII. Statements in Respondents' Advertisements Alleged to be False 498 VIII. Terms Used in Complaint Defined 499 IX. Scientific Witnesses ....... 499 Iron and The Human Body 500 A. Sources of iron 500 B. The amount and location of iron in thc body 501 C. How iron is absorbed .. .. ..... .. 502 D. Utilization and preservation of iron 503 E. How iron is lost 503 XI. Iron Deficiency Anemia and Iron Deficiency; 504 Diagnosis; Symptoms XII. The Charge that In Only a Small :\inority of Persons Is Tiredness, Etc. Due to a Deficiency of One or More of the Vitamins in Geritol or a Deficicncy of Iron. .. ... 507 A. Symptoms due to causes other than vitamin and iron deficiency. .. 508 B. In only a small minority of persons with symptoms of tiredness, etc. are those symptoms due to vitamin or iron deficiency 508 C. Conclusions 512 XIII. The Charge that the Advertisements Are Misleading Because They Fail To Reveal That the Great Majority of Persons of Any Age or Sex Who Suffer Tiredness, Etc. Are Not Suffering From a Deficiency of the Vitamins Provided in Geritol or From a Deficiency of Iron 513 XIV. The Charge that the Advertisements Are Additionally Misleading Because They Fail to Reveal that in Women of Any Age Beyond the Usual Child-Bearing Age, or in Men of All Ages, Iron Deficiency Is "Almost Invariably Due to Bleeding from Some Serious Disease, and In the Absence of Adequate Treatment of the Underlying Causes of the Bleeding, the Use of Geritol May Mask the Signs and Symptoms of Such Disease and Thereby Permit Its Progress 514 A. In women of any age beyond the usual child-bearing age and men of all ages an iron deficiency is almost invariably due to bleeding 514 ... ... .. .. .. .. ....... ....... ...... .... .............. Initial Decision 68 F.

B. In women of any age beyond the usual child-bearing age and in men of all ages the bleeding giving rise to iron deficiency anemia is almost invariably due to a serious disease or disorder 516 C. In the absence of adequate treatment of the underlying cause of bleeding, the use of the Geritol preparations may mask the signs and symptoms thereof and thereby permit the progression of such underlying cause 519 XV. The Charge that Neither Geritol Liquid nor Geritol Tablets \Vil Increase the Strength or Energy of Any Part of the Body Within 24 Hours 522 XVI. The Charge that Neither Geritol Liquid nor Geritol Tablets Will be of Benefit in Promoting Convalescence From a Cold Flu, Fever, Virus Infection, Sore Throat or Other 'Winter Illnesses 523 XVII. The Charge that the vitamins Supplied in Neither Geritol Liquid nor Geritol Tablets Are of Any Benefit in the Treatment or Relief of an Established or Existing Deficiency of Iron or Iron Deficiency Anemia 525 XVIII. The Charge that the Unconditional Guarantee Is Not Observed. 526 XIX. Conclusions 527 XX. Order 528 Appendix I. Scientific Witnesses 529 II. Glossary of Scientific Terms 534 SUPPORTING REFERE:XCES Tr." refers to the official transcript.

CX refers to Commission Exhibits.

RX refers to Respondents' Exhibits.

The references are placed at the end of each paragraph in the order in which the particular statements which they support are made in the paragraph. 1. The Complaint 1. On December 18, 1962, the Federal Trade Commission issued the complaint upon which this proceeding is based charging The J. B. Williams Company, Inc. , a corporation, hereinafter referred to as Wiliams, and Parkson Advertising Agency, Inc., hereinafter referred to as Parkson, with the dissemination of false and misleading advertising of two drug preparations called Geritol Liquid and Geritol Tablets.

2. Respondent Williams is, and has been for a number of years engaged in the interstate saJe and distribution of the two drug preparations named above; and respondent Parkson is, and has been for some time, the advertising agency for Wmiams and is engaged in the preparation and dissemination of advertisements to promote the sale of Geritol Liquid and Geritol Tablets. Respond- THE J. B. WILLIAMS CO. , INC. , ET AL 489 481 Initial Decision ents' advertisements are disseminated by the United States mails and through various means in commerce including newspaper advertising and television broadcasts.

3. The complaint sets forth brief portions of various advertisements of Ceritol Liquid and CeritoJ Tablets which are alleged to be typical of the advertisements of those products. The alleged misrepresentations which are charged as having appeared in respondents' advertisements are alleged to have been disseminated in violation of Sections 5 and 12 of the Federal Trade Commission Act (complaint, answer).

II. The Answer 4. A joint answer to the complaint was submitted by the respondents on January 16, 1963. Respondents' answer makes certain admissions concerning the business of the respondents, but denies the dissemination of any false advertisements and denies any vio- Jation of the Federal Trade Commission Act. III. Prehearing Conferences and Hearings 5. Prehearing conferences were held on February 20 and March , 1963 , at which various agreements and statements were made interpreting or modifying the language used in the complaint which were thereafter incorporated in the hearing examiner s prehearing order.

6. Hearings in support of the case-in-chief were held in New York, New Orleans, Boston, Washington, and St. Louis during the period from March 12 through May 6, 1963. Counsel supporting the complaint called nine witnesses, seven of whom were medical doctors.

7. Hearings on behalf of the respondents were held in Washington, New York, New Orleans, Boston, Philadelphia, Baltimore Atlanta, Portland, San Francisco, and Los Angeles during the period June 3 through October 29, 1963. Respondents called 43 witnesses, of whom 35 were presented as experts in the field of medicine or nutrition.

8. Hearings in rebuttal of respondents' defense were held in Washington, Cincinnati, and Boston during the period of December 3 through December 16, 1963. Counsel supporting the complaint presented four rebuttal witnesses, all of whom were medical doctors. IV. Proposed Findings 9. Opposiing counsel submitted proposed findings as to the facts, proposed conclusions and a proposed order. In addition, they Initial Decision 68 F.

submitted replies to the opposition s proposals. AJJ proposals have been considered by the hearing examiner, and those not incorporated in this initial decision, either verbatim or in substance, are hereby rejected.

V. The Respondents and The Products 10. Wiliams is a New York corporation with its principal place of business at 711 Fifth Avenue, New York, New York. 11. Parkson is also a New York corporation with its principal place of business located at 400 Park Avenue, New York, New York. 12. Wiliams is now and has been for some time engaged in the sale and distribution of two preparations known as Geritol Liquid and Geritol Tablets. The formula of those preparations and the directions for their use, which appear on the Jabels affixed to the containers, are as follows:

Designation: Geritol Liquid"

Formula (Per Oz.).- Thiamine (B, 5 mg. 5 mg. Riboflavin (Eo; 100 mg. NiacinamidePanthcnol 41 mg.mg. Pyridoxine (Eo) 3 mcg. Vitamin B" 100 mg. :.1ethionjne 100 mg. Choline Bitartrate Iron (as in iron ammonium citrate) 100 mg. Plus other Vitamin B Complex factors as found in yeast extract. Directions: As a high potency tonic (Iron, Thiamine, Riboflavin, Niacin deficiencies): 1 tablespoonful at each meal or as directed by physician. As a dietary supplement: 1 tablespoonful daily at breakfast or any mealtime.

2. Designation: Geritol Tablets Formula (One Tablet):

Thiamine (B, 5 mg. Riboflavin (B, 5 mg. Vitamin C 75 mg. N"i8cinamide 30 mg. Calcium Pantothenate 2 mg. Pyridoxine (R) 5 mg. Vitamin B" 3 mcg. Inositol 20 mg. :.1ethionine 25 mg. Choline Bitartrate 25 mg Iron as in Ferrous Sulfate 50 mg. Debittered Brewer s Yeast 50 mg. THE J. B. WILLIAMS CO. , INC. , ET AL 491 481 Initial Decisi;n Directions: As a high potency tonic (Thiamine, Riboflavin, Niacin, Vitamin C or iron deficiencies): Three (3) tablets daily-one at each mealtime or as directed by a physician. As a dietary supplement: One (1) tablet daily at breakfast. (CX 13, 14, 15; Respondents Answer. par. 2, Exhibits A and B) 13. Parkson is the advertising agency for Wmiams. The evidence shows that the advertising done on behalf of Wmiams is a substantial volume and the advertising for Geritol alone amounted in 1962 to approximately $3 500 000. About 95% of Parkson total business is for Wiliams; and in addition, it does some advertising for Liggetts Drug Company. AU of the stock of Parkson is owned by the stockholders of Wmiams, but neither Parkson nor Williams is a subsidiary of the other. The record contains no further evidence concerning Parkson s competitive activities and we are therefore constrained to conclude that there is no substantial evidence that Parkson is in substantial competition in commerce with other corporations, firms, or individuals similarly engaged in tbe advertising business.

VI. Issues as to the Content and Meaning of Respondents' Advertisements 14. Since the complaint is predicated upon the aUegations that certain of respondents' advertisements are misleading in a material respect, and since respondents have chaUenged the interpretation placed upon certain of those advertisements, the content and meaning of those advertisements arc critical issues which we must resolve. In this connection respondents have also asserted and Mr. Edward Kletter, president of Parkson, has testified that certain of Wiliams advertisements of Geritol were not typical advertisements because they had been abandoned and that certain other television advertisements were not typical because they were 30second Jength television advertisements and 30-second Jength commercial advertisements were no longer in use. The abandonment of advertisements is, of course, no defense to a charge that it is false. (Henry Spencer Gift, Inc. v. 302 F. 2d 267 (1962)). Furthennore, since the abandoned advertisements are similar to and of the same general type as other of respondents' advertisements, we think that they may be properly caUed "Typical." We think further, however, that fairness to the respondents requires that the entire advertisement, as near as possible, as it was read seen, or heard, be considered in order to determine what reprew sentations were actuaUy made. Accordingly, we quote in fuU number of respondents' advertisements as foUow: . ;

Initial Decision 68 F.

VIDEO AUDIO MS OF BERT PARKS. GERITOL BERT PARKS: Well now, has the DESK UNIT NOT IN VIEW. weather been like this in your part of the country? Snowy '" '" '" blustery '" ,. " cold? FILM CLIP #SF- :14 SOUND: WIND HOWLING: (WINTER SCENE) (USE ONLY : 10) CUT BACK TO BERT PARKS. As a result, have you been in bed with a cold, flu, fever? After such an illness, if you suffer from iron-poor blood you may find that DOLLY BACK REVEAL recovery is slow. To get back your UNIT. normal strength fast, when this is your problem, you should build up iron-poor blood. Now, if you ve been taking vitamins and stil feel tircdremember, vitamins alone can t build up iron-poor blood.

But GERITOL can! BecausePICKS UP BOTTLE OF GERITOL TABLETS.

DOLLY IN TO LOSE UNIT just 2 GERITOL tablets HOLDS UP BOTTLE OF GERl- or 2 tablespoons of GERITOL liquid TOL LIQUID contain 7 vitamins PLUS'" * '"DISSOLVE BOTT SUPER: CARD #G-548R3 "7 VITAMINS +"

(PULL -') twice the iron in a pound of calvesUNDERCUT Batt SUPER: CARD #G- 164R3 liver. TWICE THE IRON IN A POUND OF CALVES' LIVER"

LOSE SUPER. GERITOL begins to strengthen ironpoor blood in twenty- four hours.

Check with your doctor. And if you feel rundown because of iron-poor blood * . ., especially after a fever flu or virus * '" ;. take GERITOL every day.

ll feel stronger fast '" '" inCUT TO CARD #G-574R You DISPLAY Y OF PRODUCT WITH just seven days ** '" or your money MESSAGE "FEEL STRONGER back from the GERITOL folks. FAST"

. . .

THE J. B. WILLIAMS CO. , INC. , ET AL. 493 481 Initial Decision VIDEO AUDIO ART LINKLETTER, The other dayco OF ART LINKLETTER IN COMMERCIAL AREA. I heard a lady say, "1 fecl so tired every night, a team of horses couldn drag me out " If you feel too tired ever, 0;tothatgo outworn-outand havefeelinga littlemayfunbe due to iron-poor blood. And if you been taking vitamins, yet still feel tired, remember vitamins alone can build up iron- poor blood. But GERI- TOL can! Because .

HOLDS UP BOTTLE OF GER!- just 2 GERITOL tablets TOL TABLETS AND PICKS UP BOTTLE OF GERITOL or 2 tablespoons of GERITOL liquid LIQUID. POINTS TO IT.

DISSOLVE BOTTOM SUPER: contain 7 vitamins plus CARD #G-548R3 "7 VITAMINS -1" (PULL +) twice the iron in a pound of calvesUNDERCUT BOTTOM SUPER, CARD #G-164R3 "TWICE THE liver.

IRON IN A POUND OF CALVES' LIVER"

LOSE SUPER In only one day GERITOL-iron is in your bloodstream carrying strength and energy to every part of your body. Check with your doctor and if you ve been feeling worn- out because of iron-poor blood" and especially after a cold, the flu or sore throat take GERITOL every day.TCU OF LINKLETTER. GES. TURES WITH BOTTLES. CLOSE AS POSSIBLE BOTTOM SUPER: CARD #G-283 Feel stronger fast' in just 7 days FEEL STRONGER FAST" or your money back from the GERI- TOL folks. And to save one dollar UNDERCUT BOTTOM SUPER , buy the economy size. #SP.201 "SAVE $1.00 BUY ECON- OMY SIZE"

VIDEO AUDIO IVfACK: Well now, has theECU OF TED MACK BEHIND TED DESK. NO UNIT IN VIEW weather been like this in your part of the country? Snowy, blustery, cold? FILM CLIP OF WINTER SCENE SOUND, WIND HOWLING , . , Initial Decision 68 F.

VIDEO AUDIO CUT BACK TO MACK As a result, have you been suffering from the flu, a cold or sore throat? DOLl.Y BACK TO REVEAL UNIT Remember, the combination of a winter illness and iron-poor blood can drag you down. And I'd like to point out, if you ve been taking vitamins and still DOLL Y IN TO LOSE UNIT feel tired, remember * vitamins alone can t build-up iron-poor blood HOLD UP BOTTLE OF GERITOL But GERITOL can.! Because just 2 TABLETS GERITOL tablet, ' PICKS UP BOTTLE OF GERITOL or 2 tablespoons of GERITOL liquid LIQUID IN RIGHT HAND.

1'011'TS TO IT DISSOLVE BOTTOM SUPER: contain 7 vitamins ", ". plus CARD #8-548R3 "7 VITAMINS +" (PULL +) UNDERCUT BOTTOM SUPER: twice the iron in a pound of calves CAHD #G-164H3 "TWICE THE liver.

IRON IN A POCND OF CALVES' LIVER"

LOSE SUPER In only one day GERITOL-iron is in your bloodstream carrying strength and energy to every part of your body. Check with your doctor. And if you been feeling wornout because of ironpoor blood CUT TO PRODUCT DISPLAY take GERITOL every day. BOTTOM PULL REVEALS Y ou I! feel stronger fast in just #G-131 "FEEL STRONGER 7 days . or your money back FAST" from the GERITOL folks. 15. The issues as to the alleged content and meaning of the above advertisements may be stated in six questions, as follows: 1. Do respondents' advertisements represent directly and by implication that Geritol Liquid and Geritol Tablets wil be of benefit, safe and effective in the treatment and relief of a deficiency of iron or iron deficiency anemia and tiredness, loss of strength run-down feeling, nervousness and irritability? 2, Do respondent's advertisements have the capacity and tendency to suggest, and do they suggest, to persons of both sexes and THE J. B. WILLIAMS CO. , INC. , ET AL. 495 481 Initial Decision all ages who experience tiredness, loss of strength, run-down feeling, nervousness or irritability that there is a reasonahle probability that those symptoms wil respond to the taking of Geritol? 3. Do respondents' advertisements represent that Geritol wil increase the strength and energy of every part of the body within 24 hours 4. Do the respondents' advertisements represent that Geritol Liquid or Tablets wil promote convalescence from a eold, flu fever, virus infection, sore throat and other winter illnesses? 5. Do respondents' advertisements represent that the vitamins contained in Geritol contribute to the efficiency of those preparations in the treatment or relief of a deficiency of iron or iron deficiency anemia? 6. Do respondents' advertisements represent that the purchase price of Geritol will be refunded unconditionally if the purchaser is not satisfied with the product"

That the respondents' advertisements represent the Geritol products are safe and effective in the treatment of iron deficiency and iron deficiency anemia and the symptoms of tiredness, loss of strength, run-down feeling, nervousness or irritability which may accompany such deficiency is unquestioned. As to the other alleged meanings of respondents' advertisements, we do not find the same agreement.

16- A study of respondents' advertisements Jead to the conclusion that they are addressed to all persons regardless of age or sex who may be suffering from tiredness, Joss of strength, rundown feeling, nervousness, or irritability when such symptoms are due to a deficiency of the vitamins in Geritol or to a deficiency of iron. It is true as respondents point out that the various advertisements admonish the consumer who reads, listens, or views the advertisements to "check with your doctor" in order to determine whether the potential consumer is suffering from "iron poor blood with the further admonition that if the consumer is suffering from such a deficiency to take Geritol 17. Respondents' advertisements must be viewed not as a grammarian might parse a sentence, but with a view to the practical realities of life and the probable impression which such advertisements may be reasonably expected to convey to those seeing, reading, or hearing them. Respondents' counsel leJls us that Geritol' s advertising is aimed primarily at women during the childbearing years who have a deficiency of iron " but the advertisements do not so state.

, Initial Decision 68 F.

18. What is the significance of the admonition in the advertisements eheck with your doctor ? Do the respondents really expect the consumers to check with their doctors? There is no evidence in the record to answer that question directly. There is evidence however, which warrants certain conclusions concerning that ad- 19. Respondents' advertising director, Mr. Kletter, testified thatmonition. 90% of respondents' budget is used for television advertising and the remaining 10% for newspaper advertising. The record is silent as to what mayor may not have been expended by the respondents to advertise Geritol to the medical profession- But the interference is warranted that, during the period under consideration, nothing was spent on that type of advertising. If respondents really expected consumers to consult their physicians in reponse to respondents advertisements, it would seem reasonable that respondents would have devoted some of their advertising budget to convince the medical profession of the merits of Geritol. 20. We believe that the consumer upon hearing, viewing, 01' reading respondents' advertisements may reasonably be expected to conclude that his tiredness and run-down feeling will respond to the taking of Geritol, and that he may reasonably conclude that his symptoms are the result of iron deficiency or vitamin deficiency, or both. He may further reasonably be expected to conclude that the heeding of the suggestion "check with your doctor" is unnecessary because there is a clear implication in the advertisement that the symptoms enumerated may well be those of iron deficiency- If he indeed has iron deficiency, he has been told in respondents' advertisement that he can correct that condition by the taking of Geritol. The consumer need merely buy Geritol and wait for the promised improvement in his symptoms. He has been told that his strength and energy wil increase in 24 hours; and further, that jf he does not feel better at the end of the seven days, he may have his money back from the Geritol "folks." From the evidence it is reasonable to expect that the placebo effect of such medication as in the case of other medication, may cause many people at Jeast to believe that their symptoms are relieved and that their health is actually better.

21. The respondents' television advertising does not show peopJe checking with their doctors. To the contrary, it depicts tired people and people who have recovered their strength from taking Geritol. Consider for example the woman depicted in the Commission s Exhibit 9A and B. As the announcer is stating, "in only one day Geritol is in your blood stream carrying strength and , ,, :: . :

THE B. WILLIAMS CO. , INC. , ET AL. 497 481 Initial Decision energy to every part of your body, " the woman jn question js transformed into an energetic, vibrant, happy individual. 22- For the reasons stated, we conclude that respondents' advertisements represent that there is a reasonable probability that the symptoms described in those advertisements wi1 respond to treatment by the use of Geritol.

23. The statement in respondents' advertisements that " in only one day Geritol-iron is in the blood stream carrying strength and energy to every part of your body" clearly represents that the person using Geritol will experience an increase in strength and energy in 24 hours. Such representation holds out the promise of much more in the way of strength and increased energy than a mere microscopic change in an individual' s blood. 24. There is a statement in respondents ' television advertisement, following the sound of heavy wind, that: As a result, have you been in bed with a cold, fJu. fever; after such an ilness. if you suffer from iron-poor blood, you may find that recovery is slow Such statement indicates that there is a reasonable probability that Geritol will promote convalescence from a coJd, flu, fever virus infection, sore throat or other winter illnesses. The further statement in respondents' advertisements that Remember vitamins alone can t build up ironRpoor blood" implies that there js a cooperative action between the vitamin content of Geritol and the iron content thereof; and that the advertisement represents that the vitamins in Geritol aid the iron in that preparation in the building up of iron-poor blood.

25. The statement "feel stronger fast " in just seven days or your money back from the Geritol folks " dearly implies an unconditional guarantee.

26. We conclude that the interpretation placed upon the respondents' advertisements in the complaint are warranted by the exhibits in evidence and by a 10gicaJ interpretation of those exhibits. 27. We have considered the testimony of the three witnesses presented by the respondents as communications specialists and their interpretations of respondents' advertisements and to the extent that their testimony is inconsistent with the above conclusions, their opinion testimony is deemed to be unrealistic and in error (Maynard, Tr. 2839-59; Berlo, Tr. 3652; Smith, Tr. 4061- 77).

Initial Decision 68 F.

VII. Statements in Respcndents Advertisements Alleged to be False 28. Based upon the alleged content and meaning of the respondents' advertisements, which we have found in the preceding section of this opinion to be warranted, the complaint charges that such advertisements are false and misleading in a material respect and that in truth and in fact:

1. Neither Geritol Liquid nor Geritol Tablets will be of benefit in the treatment of tiredness, loss of strength, run-down feeling, nervousness or irritability except in a small minority of persons whose tiredness, loss of strength, run-down feeling, nervousness or irritability is due to an established or existing deficiency of one or more of the vitamins provided by these preparations or to an established or existing deficiency of iron or to iron deficiency anemia.

2. In the light of such statements and representations, said advertisements are misleading in a material respect and therefore constitute " false advertisements " as that term is defined in the Federcl Trade Commission Act because they fail to reveal the material facts that in the great majority of persons, or of any age, sex or other group or class thereof, who experience tiredness, loss of strength, run-down feeling. nervousness or irritability, these symptoms arc not caused by an established or existing deficiency of one or more of the vitamins provided by Geritol Liquid or Geritol Tablets or by an established or existing deficiency of iron or iron deficiency anemia, and that in such persons the said preparations will be of no benefit; ;, 'C. They are additionally misleading in a material respect because 3. they fail to reveal the material fact, when representing that the preparations will bc effective in the treatment and relief of an established or existing deficiency of iron or of iron deficiency anemia, in adults, and when ascribing symptoms of tiredness, loss of strength, run-down feeling, nervousness or irritability, in adults, to an established or existing deficiency of iron or to iron deficiency anemia, that, in women of any age beyond the usual childbearing age and in men of all ages, an established or existing deficiency of iron or iron deficiency anemia is almost invariably due to bleeding from some serious disease or disorder and in the absence of adequate treatment of the underlying cause of the bleeding the use of the preparation may mask the signs and symptoms and thereby permit the progression of such disease or disorder . 1\either Geritol Liquid nor Geritol Tablets will increase the strength or energy of any part of the body within 24 hours. 5. Neither Geritol Liquid nor Geritol Tablets will be of benefit in promoting convalescence from a cold, flu, fever, virus infection, sore throat or other winter illnesses.

6. The vitamins supplied in neither Geritol Liquid nor Geritol Tablets are of any benefit in the treatment or rejief of an established or existing deficiency of iron or iron deficiency anemia. 7. The purchase price of Geritol Liqujd or Geritol Tablets is not refunded uncondjtionally, but there are terms and conditions which must be complied THE J. B. WILLIAMS CO. , INC. , ET AL 499 481 Initial Decision with by a purchaser in order for him to secure a refund, which terms and conditions are not disclosed in the advertising. VIII. Terms Used in Complaint Defined 29. A number of terms used in the complaint were defined by counsel supporting the complaint at the prehearing conference held herein and thereafter formalized in a prehearing order issued by the hearing examiner dated March 4 , 1963.

30. "The term anemia, as it is used in the complaint and generally used in clinical medicine, refers to a reduction below normal in the number of red corpuscles per cubic miJlimeter, the quantity of hemoglobin, and/or the volume of packed red cells per 100 ml. of blood. Iron deficiency anemia as that term is used in this complaint is anemia due to a deficiency of iron of such degree that hemoglobin production is impaired.

31. "The word 'established' as used in the complaint to describe a deficiency of iron, of vitamins, and iron deficiency anemia means existing' and there is no intention of implying from the use of the word 'established' that such a deficiency has been scientifically proven to exist."

32. "The words 'great majority' as used in the complaint mean substantially greater than 50 percent and the words ' the small minority' mean that portion or number which is between the great majority and 100 percent.

33. "The usual child-bearing years of a woman are approximately 18 to 35.

34. "' Men of all ages, as those words are used in the complaint mean males 21 years of age and over.

35. "The words 'almost invariably' as used in Paragraph Seven of the complaint are synonymous with 'always 36. "The words 'signs and symptoms' referred to in Paragraph Seven (1) on page 485 of the complaint mean those signs and symptoms of the anemia which have been caused by a serious disease or disorder.

IX. Seientific Witnesses 37. The seientific and medical problems which are hereinafter discussed in this opinion are based upon the testimony and scientific literature of a distinguished group of medical doctors and experts in the field of nutrition. The testimony of each witness has been considered although the testimony of each may not be cited in support of a particular statement. Counsel supporting the complaint presented 11 medical doctors and the respondents Initial Decision 68 F.

presented 28- All of the witnesses were recognized and received as experts in their particular field of endeavor. Although differences of opinion were expressed about various problems, some of which reflected deep convictions, the testimony of the witnesses as a group was characterized by commendabJe frankness and objectivity. A full discussion of the qualifications and accomplishments of each witness would unduly lengthen this opinion. Accordingly, we include herein, in an appendix, a brief introduction to each of the witnesses. A fuller discussion may be found in the record and in the proposed findings as to the facts of counsel. X. Iron and The Human Body 38. A knowledge of the amounts and the functions of iron in the human body and how it is accumulated and how it is lost is essential to an understanding of the issues of this case and the medical testimony concerning them.

A. Sources of iron 39. The human body does not synthesize iron and accordingly, all iron in the human body must come from outside sources. "Iron requirements, fortunately, are minimized because iron is avidly conserved and reutilized. " (Dr. Carl Moore, CX 43, p. 327). The supply of iron for the body only becomes of critical importance during the growth of the young, because of bleeding, pregnancy, and Jactation. The initial supply in the new- born infant comes from the mother s body and amounts to 245 to 500 miJigrams in the average infant. The adult body will have an average of 2. grams of iron for a very small woman, to six grams of iron for a large adult maJe (Moore, Tr. 1389; Wallerstein, Tr. 1602; Crosby, Tr. 5077- , and others).

40. The increase of the amount of iron in the body from infancy to maturity normally is supplied by food. It is interesting to observe that when a person s body supply of iron is depleted by iron loss in excess of iron intake, the rate of iron absorption will increase from some stage of iron depletion. Coneering this phenomenon Dr. Carl Moore has stated:

The spread of values is so broad and the number of variables so great that it is stil difficult to make a precise estimate of the absorption of food iron. One can say with reasonable assurance, however, that normal subjects retain 5 to 10 per cent, iron- deficient subjects, 10 to 20 per cent of the iron in food. From an average adult diet in this country, providing 12 to 15 mg. of food iron, normal subjects should absorb 0.6 to 1.5 mg. ; iron- deficient patients should retain 2 to 3 mg.

, p.

THE J. B. WILLIAMS CO. , INC.. ET AL. 501 481 Initial Decision (Carl v. Moore Iron and the Essential Trace Elements CX50 241.) 41. The daily amount of iron in the average American adult diet has been variously estimated at from four to 15 mg_ , seven to 12 mg., 10 to 15 mg. , 12 to 15 mg. (Dameshek, RX 43 , p. 738, RX 213 p- 25; Crosby, Tr. 5086-87; see Carl Moore, RX 48, p. 138). Additional iron over that supplied in food can be furnished the body orally, as iron salts, by injection, or transfusion of whole blood. Of these methods, the taking of iron salts orally is the most common method employed (McHardy, Tr. 1669; Wallerstein, Tr. 1668-69; Goodman and Gilman, RX 49, p- 1465)- B. The amount and location of iron in the body 42. Every tissue in the body contains some iron. The amount normally in the body and in the various tissues is important for the determination of when there is iron deficiency, and when there is iron deficiency anemia. Every red blood cell contains some iron as part of hemoglobin (the red substance in the cell). The muscle tissues contain iron as a part of myoglobin (the red substance in muscle tissue). Stores of iron, not currently employed in metabolism, are Jocated chiefly in the bone marrow, liver and spleen, but are present in lesser amounts in many other organs. Amounts measured in micrograms are present in the plasma (the fluid part of the blood) and in certain of the enzymes (Beulter, RX 60 pp- 20-31; Wallerstein, Tr. 1602; Dameshek, Tr. 709; Krevans, Tr. 872-73; C. Moore, CX 43 , p. 319, CX 50, p- 236). 43. A 70-kiJogram man with hemoglobin Jevel of 16 gm. per 100 cc. would probably have four to six gm. total iron in his body. The actual amount is very difficult to determine. Roughly speaking, 2 % gm. would be in red blood cells as hemoglobin, one gm. in music1e tissue as myogJobin, one to 1.5 gm. in storage, a very small amount in the plasma, and a small amount in enzymes. The normal body iron content of an adult woman is about 3 % gm., of which about one gm. is in stores (Wallerstein, Tr. 1602; Dameshek, Tr. 695; Farquharson, Tr. 1087; Goldsmith, Tr. 402; Krevans, Tr. 872- 73; C. Moore, Tr. 1387- , CX 43 , p. 319; Welch, RX 181 p. 374; Crosby, Tr. 5083; Trobaugh, Tr. 3444-45; Holly, Tr. 3859-60) .

44. From 50 to 70 percent of al1 the iron in the normal adult is in the circulating blood as a component of hemoglobin, the red material in the red blood cells. Each gram of hemoglobin contains 34 gm. of iron (C. Moore, CX 50, p. 236, RX 79, p. 169; Krevans Initial Decision 68 FTC.

Tr. 872; Trobaugh, Tr. 3446; Welch, RX 181 , p. 374; Wallerstein Tr. 1603-04).

45. The body s incessant manufacture of new blood cells involves constant creation of hemoglobin, of which iron is an essential major constituent. Hemoglobin carries oxygen, which is essential for the functioning of cells, from the lungs to tissues throughout the body, and carries carbon dioxide back from the bssues to the lungs (Wal1erstein, Tr. 1631- 32; C. Moore, Tr. 1370; RX 79 , p. 169 CX 50 , p. 236).

46. From 20 to 40 percent of the iron in the body of an ironreplete normal adult is in stores, chiefly in the bone marrow, liver and spleen, but also in other organs. To produce iron deficiency anemia, loss of iron must first exhaust stores, and then continue until the hemogloblin level drops below normal ranges (C. Moore Tr. 1387-89; Trobaugh, Tr. 3444-45; Goodman and Gilman, RX , pp. 1456-58; Holly, Tr. 3862; Wintrobe, RX 282 , pp. 731-32; C. Moore, CX 43 , p. 3J 9; Beutler, Tr. 4817; RX 60 , pp. 20-25; Finch, Tr. 5202; Crosby, Tr. 5083- , 5136 , 5143 , 5147-48; Farquharson, Tr. 1076- 79; Adelson, Tr. 1234). 47. From seven to 20 percent of the total body iron in a normal adult is a constituent of myoglobin. As a part of myoglobin, iron serves a vital function in oxygen transport and cellular respiration and provides a store of essential oxygen for the muscle (BeutJer Tr. 4912- J3; C. Moore, CX 50, p. 236; RX 79 , p. 169; Beutler RX 60 , pp. 26-27; Goodman and Gilman, RX 49 , pp. 1456-58). 48. An enzyme is a chemical substance which facilitates or speeds up chemical reactions in the body without being itself consumed in the reactions. Iron is essential to enzymes in two ways: many contain iron as an integral part; as to others, iron is necessary for the enzymatic reaction even though the enzyme itself does not contain iron (Beutler, Tr. 4913; Wallerstein, Tr. 1775; Beutler, RX 60 , pp. 28- , RX 292, p. 380; RX 295, pp. 205-06; C. Moorc, RX 79, p. 169; Dameshek, Tr. 343- , 709; YIcCawJey, Tr. 4560-61; Rosenthal, Tr. 2985).

C. How iron is absorbed 49. When iron is taken by mouth, either as a part of food or in a medicine, it is absorbed directly into the bloodstream through the wa lls of the stomach and almost any portion of the gastrointestinal tract. Absorption takes place most efficiently through the upper portion of the small bowel (Beutler, RX 60, p- 36; Dameshek, Tr. 708 , 740; C. Moore, RX 80, p. 69; Wintrobe RX 284 , p. 350; Crosby, Tr. 5149).

THE J. B. WILLIAMS CO. , INC. , ET AL. 503 481 Initial Decision 50- Once iron passes through the bowel wall, it enters the bloodstream and is quickly bound chemically to a transport protein. Within one or two hours, the newly absorbed iron has Jeft the plasma, which has delivered some to tissues to supply the iron needs of enzymes and myoglobin, and the Jarger part to bone marrow and liver. Some small part is probably delivered directly by the plasma to developing infant red blood cells (erythrobJasts) (Beutler, RX 60, pp. 48-49; Arrowsmith, Tr. 3198- 99; WaJlerstein Tr. 1608; C. Moore, Tr. 1372; CX 45, p. 554; CX 47, pp. 110 , 120; Trobaugh, Tr. 3455).

51. Within about seven to 10 days after it is swaJlowed, 80 to 90 percent of the iron absorbed by an iron-deficient individual from oral iron therapy will have reached its ultimate destination in the body, either in storage iron, red blood cells, myoglobin or enzymes (Beutler, Tr. 4922-23; C. Moore, CX 50, p. 241). D. Utilization and preservation of iron 52. Much the largest fraction of iron in the body is contained in hemoglobin as part of the red blood cells. The average life of red blood cells in a healthy person is 120 days, at the end of which the cell is destroyed by the Jiver or spleen. This means about 21 mg. of iron a day is needed to manufacture the hemogJobin to replace that in the destroyed cells. The iron in the destroyed cells is not lost, however. It is redelivered to the plasma which delivers it to the bone marrow for manufacture of new red cells (erythropoiesis), or to other tissues (WaJlerstein, Tr. 1609; Beutler RX 60, pp. 52-54; C. Moore, CX 50, p. 241). E. How iron is Jost 53. Although the body does not excrete iron as such, the normal person has a steady daily Joss. Relatively minute quantities of iron are contained in the feces, sweat, hair and urine. The total amount leaving the body each day in this way averages about one mg. or less (Wal1erstein, Tr- 1615; Farquharson, Tr. 1085; Beutler RX 60, p. 52; C. Moore, CX 43, p. 328; CX 50, p. 242; RX 48 pp. 133, 135; Goldsmith, Tr. 402).

54. The net loss of iron to a woman from normal childbirth including both iron supplied the baby and bleeding at delivery, is from 300 mg. to about 550 mg., or an average net loss of about 60 mg. per month of pregnancy. The average requirement for pregnancy is from one mg. to about three mg. of iron absorbed each day (BeutJer, RX 60, p. 68; WaJlerstein, Tr. 1616; C- Moore RX 80, p. 97; Goldsmith, Tr. 403).

Initial Decision 68 F.

55. By far the most important normal Joss of iron is in blood Joss of menses. Normal menses are about 60 to 70 cc- of blood per month, which amounts to an iron loss of an average one mg. per day (about 30 per month). Some women, however, have an average daiJy loss of iron by menses of more than one mg. a day because of excessive menses, and do not realize they are excessive (Wallerstein, Tr. 1615- 16; BeutJer, RX 60, p. 67; Goldsmith, Tr. 403; Beutler, Tr. 4948; Krevans, Tr. 893; McGanity, Tr. 924 1037; C. Moore, RX 79, p. 176).

XI. Iron Deficiency Anemia and Iron Deficiency; Diagnosis; Symptoms 56. Since the charges involve both iron deficiency anemia and iron deficiency, the medical meaning of those terms must be understood. Symptoms and signs of each condition, and the stage at which they develop, have an important relation to the charges. 57. The essential sign of anemia, including iron deficiency anemia, is blood which contains Jess than the normal amount hemoglobin. These normals differ for males and females and are expressed in terms of ranges. Hemoglobin is measured in tenns of grams per 100 mL of blood. A widely recognized range of normal hemoglobin values is 12 to 16 gm. for adult females and 14 to 18 gm. for adult males. Some authorities believe the lower Emit of normal hemoglobin is 12.5 gm. for adult women and 14. 5 gmfor adult men. A person is not regarded as having anemia unless the hemoglobin level is below the normal range for the particular individual. Dr. Finch stated the problem thus: "I regard iron deficiency anemia as a significant reduction in hemoglobin below the individual's normal level, , * "" (Wintrobe, RX 282, p. 105; BeutJer, Tr. 4800-01; RX 297 , p. 18; Briggs, Tr. 2287; Dameshek Tr. 322-23; Ebeling, Tr. 3750; Goldsmith, Tr. 399; McHardy, Tr. 2059; C. Moore, Tr. 1330; Wallerstein, Tr. 1598; Wintrobe, Tr. 4651-52; Finch, Tr. 5205-06; Wintrobe, Tr. 4652-53; Beutler, 4804- 58. Iron deficiency anemia, as distinguished from other anemias05). is anemia in which the fundamental cause is a Jack of sufficient iron for the synthesis of hemoglobin. Because of this lack, thc body s mechanism for producing red blood cells cannot make a sufficient amount of cells full of hemoglobin, and the hemoglobin per unit of blood falls to a subnormal level. The deficiency of iron may be due to a deficiency of intake, a deficiency of aboorbtion an increased loss, or a combination of these (Krevans, Tr. 851 THE J. B. WILLIAMS CO. , INC. , ET AL. 505 481 Initial Decision 875; Friedman, Tr. 4214; Leake, Tr. 4627; Dameshek, Tr. 250 317; Goldsmith, Tr. 395- 96; Wallerstein, Tr. 1598). 59. \Vhen iron deficiency anemia is severe and of longstanding, the blood is page (hypochromic) and the cells abnormally small (microcytic) from a lack of sufficient hemoglobin to color and fjJ them. However, not all iron deficiency anemia is hypochromic and microcytic; when the anemia is mild, no change in color of the blood or cell size can be detected (Arrowsmith, Tr. 3185 , 3215; Beutler, RX 295, pp- 203-04; RX 296, p. 313; Goldsmith, Tr. 418- 19; C. Moore, CX 43, p. 333; CX 50, p. 246; Holly, RX 213 , p. 31; Arrowsmith, Tr- 3215; Beutler, Tr. 4932; RX 291 , pp- 61 , 78; RX 297 , p. 17; Crosby, Tr. 5142-43; Farquharson, Tr. 1080; Finch Tr. 5204; Holly, RX 213, pp. 17, 31 , 40: Wallerstein, Tr. 1674-75; Wintrobc, Tr. 4654-55).

60. When anemia is severe, it can be readily diagnosed as iron deficiency anemia instead of some other ar!emia primarily by a simple examination of the blood that reveals it is hypochromic and microcytic (Arrowsmith, Tr. 3237; Beutler, Tr. 4809- , 4934- 35; RX 295, p. 203; Wallerstein, Tr. 1621). 61. When the anemia is mild, iron deficiency anemia is much more difficult to diagnose, for aJl the red cell indices (such color and size) may faJl within normal ranges. The most reliable test, according to many witnesses, is to extract a sample of the bone marrow and examine it to see if there is any iron in it. In iron deficiency anemia the iron stores have been exhausted and there will be no stainable iron in the marrow, However, the marrow test is painful, requires skil, and would not be done by a general practitioner. Other sophisticated tests for differential diagnosis of mild iron deficiency anemia include determination of the amount of serum iron, and measurement of the capacity of the serum to transport iron; in iron deficiency anemia the amount being transported is usually subnormal, but the capacity to transport is high. These refined tests are not always readily available to most practicing physicians (Beutler, Tr. 4856, 4934-35; RX 297, p. 17; RX 296, p. 313; Crosby, Tr. 5142-43; WaJlerstein, Tr. 1729-30; Beutler RX 291, p. 78; RX 297 , p. 17; Crosby, Tr. 5161-62; Holly, RX 213, p. 21; Trobaugh, Tr. 3424; Wallerstein, Tr. 1684; Trobaugh Tr. 3425-41 (description of bone marrow test); RX 185-201 (pictures of instruments and techniques used in bone n1arrow test); BeutJer, Tr. 4809- 11; Briggs, Tr. 2280; Dameshek, Tr. 711; Friedman, Tr. 4251-53; Reznikoff, Tr. 2418-20; Rosenthal, Tr. 3425-27; Beutler, RX 295, p. 203; Holly, RX 213 , p. 18). p.

Initial Decision 68 F.

62. Many physicians use the pragmatic approach of prescribing oral iron therapy to make or confirm a diagnosis of iron deficiency anemia, when a patient is found to be anemic and the anemia is suspected of being due to a deficiency of iron. By this trial and error technique, if there is adequate response to the taking of oral iron, the anemia may be diagnosed as iron deficiency anemia without further tests. Dr. Krevans stated: If the anemia improves, although this is not a hundred percent proof, it strongly suggests that the anemia was due to iron deficiency. (Tr. 853) (Farquharson, Tr. 1083 , 1108-09; Goldsmith, Tr. 4478; Holly, Tr. 3873; RX 213 , pp. 31 , 39, 40; BeutJer, Tr. 4810; Rosenthal, Tr. 2981; Trobaugh, Tr. 3451- 52; McGanity, Tr. 1526; Reznikoff, Tr. 2421-22.

63. Some symptoms common to a1l anemias are found in iron level ofdeficiency anemia, and presumably reflect the lowered hemoglobin and the consequent inadequate transport of oxygen throughout the body by the red blood cells. These symptoms are weakness, fatigability, pa1lor, shortness of breath on exertion (dyspnea), headaches, and a feeJing of dead tiredness. Dr. Dameshek, referring to the above list of symptoms, testified that: There are far more symptoms from nervous tension, nervous neurasthenia and neurosis. or whatever you \",ant to call it, than from iron deficiency. The great majority of people who have this multiplicity of symptoms that you brought out are, in my experience, suffering from nerves. On the other hand. the great majority of people with iron deficiency anemia don t have any symptoms, and this is the rub, because if the iron deficiency anemia is due to a silent cancer. this can go along without symptom for a length of time. IT,. 279) , p. 739; (C. Moore, ex 43 334; Dameshek, Tr. 279-80; RX 43 Tr. 397-98; Farquharson, Tr. 1125-31; RX 73 , p. 197; Goldsmith, Wintrobe, RX 282, p. 740; HaJpern RX 250, p. 10; Holly, RX 213 , p. 36; F. :voore, Tr. 5313; Reznikoff, Tr. 2417-18; Weich, Tr. 3351; Wa1lerstein, Tr. 1713- 14) 64. Other symptoms (trophic changes) sometimes found in iron deficiency anemia are peculiar to iron deficiency, and apparently are not related to a severely low hemoglobin level. These are: cracks at the corner of the mouth, smooth sore tongue, difficulty in swal1owing, brittle or spoon shaped fingernails, slow nail growth, and a web obstructing the esophagus (Beutler, Tr. 4815-16; RX 60 pp. 30- , 77- , 83- , 118-21; RX 293 , pp. 130-33; RX 297 pp. 16- 17; Dameshek, Tr. 343-44; Farquharson, Tr. 1140-44; ex , pp. 302- 03; Krevans, Tr. 863-64).

)). , pp.

THE B. WILLIAMS CO. , INC" ET AL. 507 4tH Initial Decision 65. Ot.her symptoms somet.times found in severe, prolonged iron deficiency anemia are: flabby wrinkJed skin, tingling of fingers and toes (paresthesias), be1ching, diarrhea or constipation, early graying of hair, marked Joss of weight, swoJ1en feet, dull chest pain palpabJe spleen, and Jow grade fever (Dameshek, Tr. 279- , 331 338- , 728-30; Farquharson, Tr. 1125- , 1162-64; CX 35 306-07; Dameshek, RX 4-6).

66. When iron deficiency anemia develops slowly, as from a combination of poor diet and slight blood loss, generalized symptoms such as fatigue and nervousness are usually not of a degree that impels the person to see a doctor until the anemia is severe in terms of hemoglobin level (C. Moore, CX 43, p. 334; Dameshek Tr. 279; Farquharson, Tr. 1162-64; CX 35, pp. 306 , 314; Goldsmith, Tr. 397-98 (at hemoglobin levels of 50 percent: 6 to 7 gm. McHardy, Tr. 2080; RX 135-L (no symptoms even in severe case); Leake, Tr. 4628 (?to 8 gm. level); :vcGanity, Tr. 941 (no symptoms at 3-4 gm. ); Reznikoff, Tr. 2472- 73; WaJ1erstein, Tr. 1702 (below 10 gm. ); Welch, Tr. 3377-78 (7- 8 gm.

67. The distinction between iron deficiency anemia and iron deficiency is that in the former the hemoglobin level is below normal due to lack of iron and in iron deficiency the person has a normal hemoglobin Jevel but insufficient body iron. Iron deficiency is the state where the body has sufficient iron to produce adequate hemoglobin for aJ1 red cells, but lacks enough iron for stores, for tissues, and perhaps for enzymes. Thus, iron deficiency is a state of the same nature as iron deficiency anemia, but is less severe (BeutJer, Tr. 4806- , 4816- 18; WaJ1erstein, Tr. 1600; C. Moore Tr. 1325, 1377- 78; Crosby, Tr. 5136 , 5147-48; Finch, Tr. 5202; Farquharson, Tr. 1076-79).

XII. The Charge that In Only a SmaJ1 Minority of Persons Is Tiredness, Etc. Due to a Deficiency of One or More of the Vitamins in Geritol or a Deficiency of Iron 68. As previously stated, the complaint forms an issue herein by the allegation that:

Neither Geritol Liquid nor Geritol Tablets wil be of benefit in the treatment of tiredness, loss of strength, run-down feeling, nervousness or irritability except in a small minority of persons whose tiredness, loss of strength run-down feeling, nervousness or irritability is due to an established or existing deficiency of one or more of the vitamins provided by these preparations or to an established or existing deficiency of iron or to iron deficiency anemia.

Initial Decision 68 F.

A. Symptoms due to causes other than vitamin and iron deficiency 69. Counsel agree that if a person has the symptoms of tiredness, loss of strength, run-down feeling, nervousness, or irritability due to causes other than a deficiency of any constituent contained in the Geritol preparations, then in such cases the taking of Geritol will be of no benefit to such persons (Respondents' Reply, p. 18). 70. Despite the agreement above referred to, we call attention to the fact that there is always the Jikelihood when medicine is administered or taken of a placebo effect. Concerning this possibility, Dr. Dameshek when asked if Geritol could relieve the symptoms of tiredness and so forth when they were due to some cause other than iron deficiency testified as follows: It might. This might be on the basis of what we call a placebo effect. which means an effect due to psychological effect due to the taking of nonspecific material. It could be simply the taking of a medicine . (Tr. 269) 71. Dr. McGanity testified that he would expect 25 percent of the patients with the symptoms referred to who did not have organic diseases to experience a placebo effect (Tr. 9422). He also testified that Geritol Liquid, because of its alcoholic content, might have the desirable effect of "about a shot of sherry before Junch" (Tr. 942).

72. Respondents ' witness Dr. Wintrobe, in his book Clinical Hemotology, wrote: "No benefit from iron therapy can be expected if iron deficiency is not present." (RX 282, p. 460). 73- Respondents' witness Dr. Beutler, in his book Clinical Disorders of I ron Metabolism wrote:

It can not be stressed too strongly that iron deficiency is the only disorder which responds to iron administration. The administration of iron to patients with pernicious anemia, acute or chronic hemC'lytic anemia, anemias of chronic renal diseases, the anemia of chronic infection, the anemia of cancer or any other anemia can do no good, may cause harm and can not be condemned too strongly. (RX 60, Chapter 8) B. In only a small minority of persons with symptoms of tiredness, etc. are those symptoms due to vitamin or iron deficiency 74. There appears to be a consensus of the medical experts that the symptoms of tiredness, Joss of strength, run-down feeJing, nervousness or irritability are common manifestations of almost any disease or disorder. Dr. Dameshek testified that about 100 percent of ajj the patients he had seen over the years exhibited those symptoms. He referred to them as nonspecific symptoms occurring in THE J . B. WILLIAMS CO. , INC., ET AL. 509 481 Initial Decision that ofalmost every disorder known to man. He further testified al1 the men in the United States who exhibit these symptoms of tiredness and so forth, only a very small percentage have been due to iron deficiency anemia (Tr. 268-73). 75. Dr. Adelson testified that the commonest cause of tiredness and nervousness are neurosis and anxiety (Tr. 1265). 76. Dr. Farquharson, in the book Clinical Nutrition edited by J ol1iffe, Tisdall & Cannon, wrote:

Iron deficiency anemia is often wrongly diagnosed when symptoms of chronic ill-health and fatigue, the result of overwork. strain and worry, are attributed either to a non-existent anemia or to an anemia too mild to give rise to the presenting symptoms. (p. 316) The views of Dr. Farquharson, as expressed in the above-titled publication, were reaffirmed on the witness stand (Tr. 1061). Dr. Norman Jol1iffe, the co-author of the book cited, developed Geritol. Dr. Farquharson testified further that some people who have iron deficiency anemia may be tired for reasons other than the anemia and may continue to be tired after the anemia has been corrected. 77. Dr. CarJ Moore when asked what percent of the women whom you have seen who are tired, run-clown, nervaus or irritable have these symptoms due to iron deficiency anemia, replied: accurately thank minority of them. I can t define percentage any more that. These symptoms are caused by many factors and usuaUy can be explained on ba."cs other than anemia.

78. Respondents' witness Dr. Fein testified that most of the , etc. patients he sees who complain of the symptoms of tiredness do not have anemia at al1, that their complaints are usually due to other factors; whereas most of the other patients in which he finds anemia are those which come in for a routine checkup or some other totally unrelated complaints (Tr. 2598-2600). He states: It is true that one may see these symptoms but, in my practice and in my experience, at least, these are not the presenting complaints for which the patient comes and an iron-deficiency anemia is' discovered. (Tr. 2600) 79- From the testimony and exhibits cited and others that might be cited, we are constrained to conclude that the appearance of the symptoms of tiredness, loss of strength, run down feeling, nervousness or irritability are not necessarily indicative of vitamin or iron deficiency or of iron deficiency anemia.

80. Concerning the instance of vitamin deficiency in the United States which might be eliminated by the taking of Geritol, Dr. Goldsmith testified that such vitamin deficiency was very common Initial Decision 68 FTC.

in the South until about 1940 when it began to decrease markedly and that now such deficiency is extremely rare, amounting to a very small fraction of one percent (Tr. 528). She pointed out that articles published on the subject of vitamin deficiency in the 1940' were no longer valid (Tr. 548- 50). On redirect examination, Dr. Goldsmith testiied that vitamin deficiency is quite rare even in pregnant women and in children. She stated that although vitamin B complex deficiency is very common in certain parts of the world it has become uncommon in the United States (p. 616). 81. Dr. Carl 'voore testified that Jess than one percent of the patients he sees have deficiency of the vitamins contained in Geritol. As to the vitamin deficiency of persons suffering with colds, he testified on crossHexamination as follows: Q. And I 8m sure it is your experience" as an internist that persons with colds and that sort of Hling tend to eat somewhat less Justil:;' than the well person, is that so? A. I\Jost of them still manage unless they are very sick to eat aD adequate diet.

Q. I take it your answer is yes, but most of them still eat an adequate diet. is that. correct? A. Yes, Q. To the extent that the diet is inadequate, it wou.ld also be inadequate in vitamins, would it not? A. For that period of time, I think your question is a little unfair though sir, because it ignores the fact that we all have a pretty fair storehouse of vitamins, people in this country do, at any rate, to tide one very handily over a temporary shortage period.

Q. This is true of all vitamins. doctor? A. It is true of all the vitamins that I know of. (Tr. 1416) 82. Respondents' witness Dr. Wallerstein testified that there was much less vitamin deficiency than there was iron deficiency. 83. Respondents' witness Dr . HaJpern testified: '" * * in our own population where there is a great abundance of all foods available, that we don t have even more than the one- third malnutrition that we do have-defining "malnutrition" not as serious nutritional disorders, but as there being an adequate inbke compared to needs. (Tr. 4290) He testified further:

Well, as I stated, since I have a suspicion that quite a larger number of patients have an inadequate intake for their needs, despite the fact that I cannot determine it through my diagnostic examination, c.md since I feel that many of them probably have inadequate store-and I might mention the B Complex and C vitamins are probably not stored at all; there js probably a one- day or hvo-day need-increased needs arise for one reason or another , THE J. B. WILLIAMS CO. , INC. , ET AL. 511 481 Initial Decision When I say "practically all", I mean ninety-nine percent of the patients. I give all patients a vitamin supplement. The other one percent I do not give it to because they ten me that their stomach is irritated by vitamins or probably I would otherwise give it to them, too. (Tr. 4295) 84- Despite Dr. Halpern s belief in the presence of vitamin deficiency in the people of this country, we do not believe that his testimony is a contradiction of the witnesses cited above. 85. Dr. Carl Moore test.ified as to the instances of iron deficiency anemia as a whole as follows:

One can get a reasonable estimate of the maximum number from this kind of observation. During the Second World War when blood was being col. lected for blood donations, a group of Red Cross centers did initial hemoglobin estimations on blood donors, and had to reject 12. G percent of those donors because their hemoglobin values were below 12 or 12. 5 gr. I forget which figure they use. * \Ve conducted a similar study here in St. Louis which took hemoglobin determinations on Lllo consecutive women who presented themselves as potential donors for the first time. I looked up those figures just thi" morning and approximately eight. or nine percent of the women had hemoglobin values below 12 grams. It was approximately five percent who had hemoglobin values below 11 grams.

For the men. there were 560 consecutive donors and the number of men who had hemoglobin levels below 1;2 grams was less than one percent. N ow these represent maximum figures for iron deficiency anemia since quite obviously, other factors could h3\/e produced the H.nemia in these individuals.

(Tr. 1328) 86. The witness emphasized that the,e figures of 12.6 percent (unsegregated as to age and sex) obtained through reierence to blood donation centers; eight or nine percent observed in the women studied; and one percent in the men studied had to be maximuDl values for the incidence of iron deficiency anemia because other kinds of anemia would certainly be interspersed" (Tr. 1329).

87. Dr. Goldsmith testified that of the patients she sees perhaps five to 10 percent have iron deficiency anemia, and that: This would be considerably more than one would see jn the general population because * *' " the patients arc sent to our group frequently because they have anemia for a diagnosis foi the kind of anemia that they have so I see an extra lot of patients with both malnutrition and anemia because of my special interest. (Tr. 375) 88. Dr. Adelson testified that oi the patients he sees who are not referred, but are part of his general practice of internal medi- Initial Decision 68 F_ cine, under one percent, perhaps 0.5 percent, are anemic and about half of his anemic patients have iron deficiency anemia (Tr. 1183). 89. Responde"ts' witness Dr. Arrowsmith testified that in most of the patients which he sees in his selective practice, where the patients are referred to him, about 50 percent have anemia of some sort and between five and 10 percent of those, or about 2.5 to five percent of the total, have iron deficiency anemia (Tr. 3186)- 90. Respondents' witness Dr. Wallerstein testified that he had done a study of the relative incidence of iron defieiency anemia at the San Francisco General Hospital over a five-year period (Tr. 1620). One thousand two hundred and fifty patients were covered by the study. In 800 of these, his group had been called to see the patient because a diagnosis of anemia had been made. Two hundred and six (approximately 16. 5 percent) of the 1 250 had iron deficiency. Of those with anemia, 25 percent had iron deficiency anemia. On transcript page 1621 he testified that "only about seven percent" of his hematology patients had iron deficiency anemia. He does point out that most of these are referred patients having been sereened first by other physicians, so that he would not see all of the uncomplicated cases of iron deficiency anemia. It seems clear from this testimony, however, that this doctor, by the same token, would not see aU those cases wherein iron deficieney was found not to exist.

91. Dr. Dameshek testified that of the Entire population of ajj ages, those who have symptoms due to iron deficiency anemia woulrl be less than one percent (Tr- 281-82). At page 638 of the transcript he further stated that it would be Jess than one percent in men, but more than one percent in women. He was not asked about overall incidence of iron deficiency anemia, but obviously it would be several times higher than this, since mild iron deficiency anemia is more common than severe iron deficiency anemia; and most mild iron deficiency anemia does not produce symptoms. 92. Dr. McGanity testified that the incidence of iron deficiency anemia in the United States as a whole would be Jess than 10 percent for pregnant women, less than five percent for nonpregnant women in the usual child. bearing age, and less than two percent for postmenopausal women (Tr. 929).

C. Conclusions 93. Although a depletion in the human body of the vitamin and iron cOl!tained in Geritol may cause the symptoms of tiredness and so forth, as stated in the respondents' advertisements, those symptoms are common manifestations of almost any disease or THE J . B. WILLIAMS CO., INC. , ET AL. 513 481 Initial Decision disorder. Moreover, iron deficiency and iron deficiency anemia or vitamin deficiency, even when such states exist in the body, do not always cause the symptoms described. Furthermore, only a relatively small minority of persons in the United States have iron and vitamin deficiencies and still fewer have the symptoms of tiredness and so forth due to such deficiencies. AecordingJy, the charge set forth above is sustained that: Neither Geritol Liquid nor Geritol Tablets will be of benefit in the treatment of tiredness, loss of strength, run-down feeling, ncrvousness or irritability except in a small minority of persons whose tiredness, loss of strength, rundown feeling, nervousness or irritability is due to an established or existing deficiency of one or more of the vitamins provided by these preparations or to an established or existing deficiency of iron or to iron deficiency anemia. XIII. The Charge that the Advertisements Are Misleading Because They Fail To Reveal That the Great Majority of Persons of Any Age or Sex Who Suffer Tiredness, Etc. Are Not Suffering From a Deficiency of the Vitamins Provided in Geritol or From a Deficiency of Iron 94.. The complaint creates another issue herein by the allegation that:

In the light of such statements and representations, said advertisements are misleading in a material respect and therefore constitute " false advertisements " as that term is defined in the Federal Trade Commission Act, because they fail to reveal the material facts that in the great majority of persons, or of any age, sex OT other group or class thereof, who experience tiredness, loss of strength, run-down feeling, nervousness or irritability, these symptoms are not caused by an established or existing deficiency of one or more of the vitamins provided by Geritol Liquid or Geritol Tablets or by an established or existing deficiency of iron or iron deficiency anemia. and that in such persons the said preparations will be of no benefit. 95. In the preceding section, XII, the finding was made that in only a small minority of persons with the symptoms of tiredness and so forth were such symptoms due to a deficiency of anything, including iron and vitamins, contained in the Geritol preparations. It follows, therefore, from that finding that in the great majority of persons who do experience such symptoms as tiredness and so forth that such symptoms are not caused by deficiency of a vitamin or mineral in Geritol. The conclusion also follows that the failure of the respondents, in the light uf the affirmative representations ..

Initial Decision 68 F.

made in their advertisements to reveal the material facts is misleading in a material respect:

". 'i in a great majority of persons, or of any age . sex or other group or class thereof, who experience tiredness. loss of strength, run-down feeling, nervousness Of irritability, these symptoms are not caused by an established or existing deficiency of one or more of the vitamins provided by Geritol Liquid or Geritol Tablets, or by an established or existing deficiency of iron or iron deficiency anemia, and that in such persons the said preparation will be of no benefit.

XIV. The Charge that the Advertisements Are Additionally Misleading Beca use They Fail to Reveal that in Women of Any Age Beyond the Usual Child-Bearing Age, or in Men of AJI Ages, Iron Deficiency Is "Almost Invariably" Due to Bleeding from Some Serious Disease, and In the Absence of Adequate Treatment of the Underlying Causes of the BJeeding, the Use of Ceritol May Mask the Signs and Symptoms of Such Disease and Thereby Permit Its Progress 96. The complaint forms another issue by the allegation that: In the light of such statements and representations, said advertisements are misleading in a material respect and therefore constitute " false advertisements " as that term is defined in the Federal Trade Commission Act, because they fail to reveal the material facts that in the great majority of persons, or of any age, sex or other group or class thereof, who experience tiredness, loss of strength, run-down feeling, nervousness or irritability, these symptoms are not caused by an established or existing deficiency of one or more of the vitamins provided by Geritol Liquid or Geritol Tablets or by an estabEshed or existing deficiency of iron or iron deficiency anemia, and that in such persons the said preparations will be of no benefit; A. In women of any age beyond the usual child-bearing age and men of all ages an iron deficiency is almost invariably due to bleeding 97. Finally, and perhaps most important of all, it is not enough to diagnose the anemia as a hypochromic ;ron deficiency anemia and treat it successfully with iron. In men and older women particularly, it is necessary to remember that hemorrhage is almost certainly the primary factor. While the nature of the primary disease may be obvious, it sometimes happens that a hypochromic anemia is the first manifestation of an almost symptomless carcinoma or other gastrointestinal lesion. (Farquharson, ex 35) When one is confronted with a man or a postmenopausal woman who has hypochromic anemia but n() detectable blood loss, the chances are over- , p.

THE J . B. WILLIAMS CO. , INC., ET AL. 515 481 Initi.al Decision whelming that the patient either bleeds intermittently and does not happen to be doing so during the time of examination, or that he is losing small amounts of blood high in the intestinal tract which are not detectable by routine clinical laboratory methods. The only other possibility is that the diet has been deficient or absorption defective over a very long period of time: five to ten years. (C. Moore, CX 43 , jJ. 331) 98. Dr. Krevans testified that in the United States the most common cause of iron deficiency anemia in adult males is gastrointestinal bleeding (Tr. 793- , 1557). 99- Dr. Dameshek testified that iron deficiency anemia in a male is, for all pract.ical purposes synonymous with blood Joss (Tr. 256, 253).

100. Respondents' witness Dr. Briggs stat.ed that he always assumes that an anemia is due to bJeeding (Tr. 2281). 101. Dr. Goldsmith test.ified that in men "the most common cause of iron deficiency anemia is blood loss" (Tr. 3'19). 102. Dr. Adelson stated that the principal causes of iron deficiency anemia in men are gastrointestinal bleeding, ulcer carcinoma or hiatus hernia (Tr. 1184).

103- Respondents' witness Dr. Wintrobe st.ated: My approach to an adult male who is found to have iron deficiency would be that I would consider it very, very probable that he is losing blood somewhere, most probably from the gastrointestinal tract, and if I haven t found the cause in the first examination, I had better go and look again. (Tr. 4696) 104. Respondents' witness Dr. Beutler wrote: The leading cause in adult males and in postmenopausal females is bleeding from the gastrointestinal tract. (RX 60 , p. 69) Dr. Wintrobe stated:

Whenever iron deficiency is found or suspected, careful inquiry concerning possible causes is important. This is especially true if the cause is not obvious since the development of iron deficiency anemia may be the first sign of an occult malignancy, as already stated. If the patient is a man, except when there has been a gastrectomy section lsic: gastric resectionJ, occult blood loss is almost always due to an ulcerative lesion in the gastro-intestinal tract. (Tr. 4700) 105. Dr. Wintrobe, a witness for respondents, testified that he stiJ holds the opinion stated above (Tr. 4700, 4701- , 4696). He wrote:

r. the discovery of iron deficiency anemia in a male patient almost always signifies the presence of an occult source of chronic blood loss, such as peptic ulcer or carcinoma of the ascending colon or stomach. (RX 282 739) Initial Decision 68 F.

106. Respondents' witness Dr. Wal1erstein testified: any subsequent iron deficiencyOnce a patient has reached maturity .1' , as far as I am concerned, always due to blood loss. There are the rarest of exceptions. And I think everyone in his practice has a case to which he can point with pride and takes pictures of an individual who was on a very miserable diet for 20 or 30 years-I have such an individual in mind. But these are support cases, perhaps one is permitted to say. The vast majority bleed. And certainly any physician seeing iron deficiency anemia in aD adult must make the assumption and never let go from this assumption that this anemia is due to blood loss. (Tr. 1634) 107. In 1950 , Dr. Moore wrote in the magazine Blood as follows: According to all available evidence, the human organism has very little ability to rid itself of iron through ordinary excretory channels: its major losses of iron are through hemorrhage and pregnancies. Hence, it follows that once the body has achieved adult size without showing iron deficiency it will not become iron deficient unless it is drained of its iron by repeated pregnancies or chronic hemorrhage. ,. " - But while an inadequatc diet and poor absorption frequently contribute to the pathogenesis of iron deficiency, they do not seem able to precipitate jts development unless iron is also lost from the body. No carefully studied patient has ever been shown to provide an exception to these statements. In our own experience we certainly have seen none even though it has sometimes been necessary to continue observations for months in order to detect intermittent bleeding from the genito-urinary or gastrointestinal tracts. (CX 51) 108. As to postmenopausal women, Dr. AdeJson testified that the cause of iron deficiency anemia is blood Joss. Some of the causes of the bleeding in such women were listed as ulcers, hiatus hernia and carcinoma (Tr. 1185-86).

B. In women of any age beyond the usual child-bearing age and in men of aJl ages the bJeeding giving rise to iron deficiency anemia is almost invariably due to a serious disease or disorder. 109. Counsel supporting the complaint has defined a serious disease as used in the headnote B. as a:

disease or disorder that causes bleeding and which develops or can develop from a less serious to a more serious state, and gave as examples ulcers and cancer (Tr. 27).

110. Respondents' witness Dr. Wintrobe, under redirect examination by respondents' counsel, testified concerning this question of bleeding from a serious disease as follows: Q. Doctor, you ,vcre asked whether the adult male iron deficiency anemia is almost invariably due to blood loss and, of course, you said yes. Let me ask you this: Is it almost invariably due to blood loss of a progressive disease? A. The answer depends on what you call " progressive disease THE J. B. WILLIAMS CO. , INC. , ET AL. 517 481 Initial Decision Q. I wil define it for you. Progressive disease is one which characteristically as a disease progresses from a less serious to a more serious state in the patient.

A. Well. then, I think I would have to say yes, progressive disease. The question in my mind was with Tegard to peptic ulcer. Now, that can be pretty much the same over many years, improving and getting worse, and improving and getting worse. but I suppose in the course of time the changes in the tissues do become such that is it likely to get worse. The probability is progressive rather than complete healing. Q. Would you regard hemorrhoids as characteristic of a progressive disease, Doctor? A. Well, they tend to become more and more nasty and there is more and more blood lost in time.

* Vie have no quarrel on this side of the table with your earlier Q.statement that in the adult male it is almost invariably caused by blood loss, but t.he charge here doesn t say by blood loss, it says by a serious disease or disorder which has been defined as one which characteristically progresses, and that is why I asked the question, and taking the causes that you referred to, I think there is no question, for instance. that a malignancy is characteristically progressive, and that is why I am asking you about these other disorders which we know bleed. A. I would think that with all of the things we have mentioned. esophageal varices, hiatal hernia, peptic ulceration, carcinoma, the scales tip in the direction of progressive rather than not. Q. And you would say this is true of any bleeding, I take it? A. Yes. The disease is likely to progress and become worse . (Tr. 4716 , 4717) 111. Respondents' Exhibit 181 , a paper by Dr. Welch, a witness for respndents, entitled "Anemia Associated with Disease of the Gastrointestinal Tract" lists 17 causes of chronic blood loss which may cause iron deficiency anemia: peptic ulcer, esophagitis, gastritis, bleeding varices, hiatal hernia, hemorrhoids, carcinoma and other neoplasms, ulcerative colitis, polyps, diverticulitis regional ileitis, Peuts-Jeghers syndrome (multiple polyposis), multiple hereditary telangiectases and other vascular Jesions Mallory-Weiss syndrome, Meckel's diverticulum, carcinoid, and hookworm.

112. Dr. Dameshek testified:

In my own particular experience, iron deficiency anemia in males turns out. to be about 50 percent on the basis of a silent cancer somewhere in the bowel or the gastrointestinal tract, and about 50 percent due to more benign causes such as bleeding from an ulcer and things of that sort. (Tr. 254-55) He defined "silent cancer" as one somewhere in the gastrointestinal tract which does not evoke any symptoms of pain or discomfort (Tr- 255).

:

Initial Decision 68 F.

113. Respondents' Dr. Reznikoff Jisted the common causes of iron deficiency anemia in his practice as "ulcers, mostly duodenal; varcies, esophageal varices, most of them secondary to cirrhosis of the liver, excessive menstruation, fibroids, polyps, neoplasms of the gastrointestinal tract, of course" (Tr. 2426). 114. Dr. Krevans testifying as to the causes of iron deficiency anemia in women age 35 to the menopause, said that menstrual irregularities were the most common cause. Other causes would be chronic blood loss (from any source). As to women of the usual child-bearing years, he states that the most common causes were excessive bleeding with the menses, and frequent pregnancies. (AJ lthough again bleeding lesions of the intestinal tract can occur in this age group as well, aithough they are less common. (Tr- 811 , 814).

115. Respondents' Dr. Wintrobe indicated that he considers the undelying causes of iron deficiency anemia in women past the menopause a matter for serious concern (Tr. 4651-52). 116. Dr. Adelson also pointed out that there is no guarantee that a nonprogressive illness is going to stay nonprogressive. He gave as examples, diverticulitis and hiatus hernia (Tr. 1298). 117. Respondents' witness Dr. Briggs was asked the question: Is cancer, in your view, a serious disease or disorder that normally progresses?" He replied:

All disease is serious to me, but if you re giving priority to certain diseases then cancer must be at the top of the list in seriousness In terms of normal progression? Cancer normally progresses and is therefore serious. He testified further as follows:

Iron-deficiency anemia in my practice is due to a group of conditions which have in common the factor of bleeding. There are a few exceptions recorded to the presence of iron-deficiency anemia due to bleeding but, in my practice r always assume that the patient is-that the anemia is due to bleeding and the causes of bleeding in their order of frequency I would list as follows: First, hemorrhoids; secondly, peptic ulcer, in which I include gastric ulcer and duodenal ulcer; thirdly, hiatus hernia; fourthly, what I would describe as an idiopathic hleeding, which I would define as bleeding from a cause which has not :,/ct been determined. And then, aiter that, I would list malignancies of the gastro"intestinal tract or malignancies in general, and benign tumors can be listed with malignant tumors or can be listed separately. (Tr. 2281-82) 118. Dr. Francis Moore testified concerning serious diseases that progress as follows:

in ulcerative colitis you have a classic example of true p!'gression because a small area is involved and after a while, it may be days, weeks or THE J . B, WILLIAMS CO. , INC. , ET AL. 519 481 Initial Decision months, the speed may be and one may have the entire colon essentially destroyed by the disease.

I would like to say as regards diverticulosis that the bleeding often is associated with diverticulosis rather than diverticulitis, that actually diverticulosis as a cause of the chronic slow seepage bleeding as to use Mr. McGlothlin terms is very rare; whereas it does cause acute exsanguinating, lifeendangering hemorrhage; whereas, I don t think either of those two closely linked diseases as being prominent in the causes of anemia in the population as a whole. Other symptoms are more prominent than anemia in the diverticulosis than diverticulitis, though diverticulosis can bleed massively on occasion. (Tr. 5302, 5303) '" * * Polyps get bigger, that is the only thing that happens to them. They don t grow smaller, they grow larger and they bleed more. They later may cause intussusception of the bowel and there are some people feel they do become malignant in which case they are in sharp contrast to the gastric ulcer situation we discussed a moment ago because here is a benign lesion which can indeed progress on to become malignant at least in some cases. (Tr. 5305-06) 119. In view of the testimony of the distinguished doctors of medicine cited above, we conclude that" , * ., the bleeding giving rise to iron deficiency anemia is almost invariably due to a serious disease or disorder."

C. In the absence of adequate treatment of the underlying cause of bleeding, the use of the Geritol preparations may mask the signs and symptoms thereof and thereby permit the progression of such underlying cause 120. The evidence shows that the Geritol preparations, both in tablet and liquid form, have the ability when taken as directed to relieve the symptoms of iron deficiency anemia (Dr. Wintrobe Tr. 4679; Adelson, 1208- 13; C. Moore, 1345-47). Respondents' witness Dr . BeutJer testified: I would say that I would consider it probable that if a patient took ferrous sulfate in the dosage present in the Geritol Tablets for a sufficiently long period of time, that they could mask an occult carcinoma '" 'I' * I am quite sure that it has happened on the basis of physician-administered iron, and I believe that I alluded yesterday to one case in which there was at least a partial response to physician-administered iron in a patient with a cancer of the colon. (Tr. 48. 78) Dr. Goldsmith testiied that if a patient had been feeling tired and had taken Geritol, and that patient had had an iron deficiency anemia and had taken Geri toJ for long enough, this anemia could have been alleviated "temporarily, " or at least improved: (AJnd if I did my studies on this patient I might not find the anemia and therefore I might not look for a cause of anemia. (Tr. 390) Initial Decision 68 F.

121. It is clear that the Geritol preparations wil have no effect on the underlying cause of the bleeding which is causing the anemia (Goldsmith, Tr. 338; McGanity, Tr. 932).

Dr. F. Moore testified:

The danger, however, is that a patient with an ulcerative lesion of the stomach which is bleeding of the seepage type can treat himself either with powders that he buys or things for his anemia, and thus feel well enough so that he doesn t take any additional steps about it and then discovers he actually has an early malignancy. (Tr. 5287) 122. Dr. Wintrobe, a witness for respondents, test.ified, when asked whether the administration of iron to someone with an iron deficiency anemia actually "covers up" or removes or purshes into the background the indications of the anemia: If I understand your question, I would answer yes, but let me explain what I mean by " yes If a patient has-let us say a patient is a male who has an iron deficiency anemia. The iron deficiency anemia is in most instances due to a leak in the gastrointestinal tract. It is the physician s job, first of all, to demonstrate that leak and to take thc appropriate measures to treat that leak, that. is, if it is a cancer of the cecum, that should be removed, that is far more important than giving iron because iron-the use of iron in that situation could be harmful in this way if enough iron is given and if the blood loss is sufficiently small, even though repeated over a long time, conceivably at least the iron given could relieve the anemia leaving both the doctor and the pat.ient in ignorance of the existence of, say, that cancer of the bowel and thereby delaying for some time-perhaps for a long enough time to make it impossible to remove it and cure him.

Do you think this happens? Yes, it certainly does . (Tr. 4707) Dr. Wintrobe was asked what it was that Jead him to believe this masking effect has occurred. He answered: Well, this would be my reason, that an individual might develop an iron deficiency anemia as a result of some disease of the gastrointestinal tract say. If he medicated himself and if he took a preparation which contained enough iron and took enuugh of this, he could correct this anemia, and having corrected this anemia, he would be under the false impression that he is cured instead of his going to a physician, a good phy!'ician, and being investigated as to the cause of his anemia and then if it is a cause which is co:orectable, let' s say, by the removal of a C::rcinoma or whate'/er the case might be. his life might be saved by that; whereas . the self-medication may have delayed the discovery of the cause to the point even that it would no longer be operable. (Tr. 4721) 123. Dr. Damshek described the process of masking thus: I think if a certain disease such as cancer has a certain set of symptoms including anemia due to blood loss, then it is possible to mask such symptoms THE J B. WILLIAMS CO. , INC. , ET AL. 521 481 Initial Decision by the use of iron. . "" '" If a person takes iron, the symptoms of the anemia may well be masked, obliterated, pushed into the background, no longer noted by the patient because of the iron. * " "' The anemia being due to blood loss, which in turn is due to the cancer may be improved by the use of iron. The cancer meanwhile grows merrily along. (Tr. 290) 124. Dr. Dameshek testiied that he has seen many patients over the years who have been treated with either iron as such, or with iron and vitamins, who were Jater found to have cancer which had gone beyond the operative stage (Tr- 283, 266). 125. In ilustration of some of the problems of masking, Dr. Adelson metioned four cases of women in whom iron deficiency anemia was found to be due to a serious condition and in all of whom the adminstration of iron did produce improvement of the anemia (Tr. 1186, 1193, 1199, 1245). The latter was a 31 year old woman with carcinoma of the cecum; the other three were postmenopausal women. One had carcinoma of the stomach as the cause of iron deficiency anemia, one had carcinoma of the cecum, and the third had first a rectal polyp, then hiatus hernia, and finally a diagnosis of carcinoma of the ascending colon. 126. Respondents' witness Dr. Beutler was asked whether it is theoretically possible for masking of the symptoms or anemia due to a maJignancy to occur with the Geritol preparations. He stated: I think that it is theoretically possible, even with both preparations. I think it is theor!:tically less likely, much less likely with the elixir than it is with the tablets. (Tr. 4877) 127. Dr. Briggs testified that iron wil mask melena (the dark stools sometimes characteristic or mild bJeeding from the stomach or colon), and the patient will not be able to distinguish them. (Tr. 2329)- 128. Dr. Krevans testified as to cases ilustrating the fact that iron deficiency anemia is a symptom and one must not be content merely with the elimination thereof. With respect to one of these he stated:

(YJou wil recall he was given iron, and he got better, his anemia was disappearing, he had returned almost to normal by the time we saw him here and had one been satisfied that just improving the anemia was sufficient we could have abandoned investigation at this point, and missed what reaJIy was the most central feature of the case, namely. the underlying disease which caused the gastrointestinal bleeding. (Tr. 729 , 801 , 809) 129. Dr. Farquharson writes:

It is important that the physician should not consider that his responsibility is discharged when the hemoglobin has risen to normal. . 'r. He must 522 FEDERAL TRADE COMMISSION DECISIOr. Initial Decision 68 F.

search for a bleeding lesion in all cases and especially in all men and older women and, having found its site give effective therapy if possible. (CX 35 p. 325) 130. It is interesting to observe that the above quotation is from a textbook entitled Clinical Nutrition edited by Dr. Norman JoUiffe. Respondents have made a point (see respondents' answer) of aUeging that Dr. JoUiffe was the "developer" of their product. Yet in a book edited by Dr. JoUiffe, Dr. JoUiffe exhorts physicians to observe great care in the administration of iron, and not to rest until the cause of the iron deficiency anemia is Jocated. Respondents' advertising, on the other hand, is silent concerning the danger of masking.

131. As has been shown by the above-cited testimony, both the witnesses caUed by the counsel supporting the complaint as weU as witnesses caUed by the respondents show that there is a real danger of masking the signs and symptoms of iron deficiency or iron deficiency anemia by the taking of iron in general and by the taking of Geritol preparations in particular and thereby permitting the progression of the underlying causes of such bleeding. XV. The Charge that Neither Geritol Liquid nor Geritol Tablets Wiu Increase the Strength or Energy of Any Part of the Body Within 24 Hours 132. Dr. Carl Moore, when asked whether Geritol Liquid or Geritol Tablets would increase the strength or energy of any part of a person s body within 24 hours, testified as foUows: , no.The strength or energy which an individual is able to appreciate If you are talking about something that happens at a microscopic level, there would be a change, but anything that an individual would be able to appreciate . no. (Tr. 1364) He also testified that a man with symptoms of tiredness and irritability due to a moderately severe iron deficiency anemia ought to have improvement but not necessarily entire disappearance of those symptoms within a period of a week to 10 days. " (Tr. 1364 1343).

133. Dr. Dameshek testified:

If a person has iron deficiency and has symptoms and is given iron, the first manifestations of improvement are not noted for at least a week to ten days. (Tr. :J03) 134. Dr. Goldsmith testified:

With the dosage that is given here, it is an adequate therapeutic dose with three tablespoons a day of the liquid, and with adequate iron dosage in , THE J. B. WILLIAMS CO. , INC" ET AL. 523 481 Initial Decision someone who has symptoms due to iron deficiency anemia one would expect improvement in about ten days to two weeks. She made a similar statement with respect to Geritol Tablets (Tr. 384).

135. Respondents' witness Dr. Arrowsmith testified that in adults the reponse is "seldom very dramatic" (Tr. 3223). 136. Respondents' witness Dr. Wallerstein testified that with iron therapy "within a week many patients will feel better" and others may take a JittJe longer, yes. But actually, some seem to notice an improvement in two or three days" err. 1633). 137. Respondents' witness Dr. Trobaugh testified that when a patient begins to feeJ better within a few hours Obviously, this is the placebo effect. " (Tr. 3459).

138. Respondents' witness Dr. Wintrobe testiied that when iron is injected there may be a subjective response within 24 to 72 hours but that "with oral therapy the response is somewhat slower and " Say, within a week." (Tr. 4684-85). 139. Respondents' witness Dr. Dern testiied at Jength about a study which he had performed on behalf of The J. B. Wiliams Company, Inc. to determine whether or not the iron contained in Geritol Tablets and Geritol Liquid does get into the red cells within 24 hours (RX 206, 207). These studies do show that a very small percentage (varying from one hundredth of one percent to 2.4 percent) of the dose administered to each of ten individuals did appear in the red blood cells in 24 hours, within the limits of error of the techniques (Tr. 3569-85).

140. With respect to the significance of these findings, Dr. Dern testified as follows:

Q. Do you feel that there are any other conclusions INhich can be drawn from the study which you performed? And by any other conclusions I mean other than the conclusion as to the original question as to whether or not Geritol iron appeared in the blood within 24 hours. A. I don t believe there are any other conclusions that I can draw from , to be honest with you. (Tr. 3561-62) 141. Accordingly, we conclude that neither Geritol Liquid nor Geritol Tablets wi1 increase the strength or energy of the body within 24 hours.

XVI. The Charge that Neither Geritol Liquid nor Geritol Tablets WiJI Be of Benefit in Promoting Convalescence From a Cold, FJu, Fever, Virus Infection, Sore Throat or Other Winter Ilnesses 142. Dr. Dameshek, Dr. Goldsmith, and Dr. Carl Moore all Initial Decision 68 F.

testified to the effect that neither Geritol Liquid nor Geritol Tablets wi1 be of benefit in promoting convalescence from a coJd fJu, fever, virus infection, sore throat or other winter i1nesses (Tr. 304, 386, 1363).

143. Respondents' witness Dr. Friedman testified that: Concerning a short cold, it will take seven days to recover without added vitamins, and a week to recover with added vitamins. I mean that is a possibility. (Tr. 4273) 144. Dr. Goldsmith was cross-examined concerning statements made by her in some of her earlier writings, particularly one published in 1946. This article is to the general effect that nutritive requirements are increased by psychological stress and in many diseased states. In particular, her statement was quoted: Deficiency syndromes are often seen after trivial illnesses in areas of the country where the dietary habits are poor and food intake borders on inadequacy.

Dr. Goldsmith explained that while the quoted statement was probably correct in 1946, she did not consider it correct as of the present time- She stated that:

I certainly haven seen any deficiency syndromes after trivial illnesses for many, many years. As a matter of fact, I see few deficiency syndromes any more. (Tr. 472) 145. Dr. Carl Moore testified that people with colds and similar ailments sometimes tend to eat less than a well person but that most people still manage to eat an adequate diet. He also added that:

we a11 have a pretty fair storehouse of vitamins, people in this country do at any rate, to tide one over handily over a temporary shortage. This is true of all the vitamins that I know of. (Tr. 1417) 146. The record contains no evidence to show that colds, fJu fever, virus infection and other winter illnesses produce in and of themselves a deficiency of any of the vitamins in Geritol. Respondents' advertisements, however, represent dearly that the Geritol preparations are designed for convalescence after or following a coJd, with the principal emphasis on the iron content of the preparations. For example, Commission Exhibit No. 2 reads, in part, as follows:

Have you been feeling tired and run-down more frequently lately? Your trouble may be due to iron-poor blood, and this is often especially true after a fever, the flu or virus.

, THE . WILLIAMS CO. , INC. , ET AL. 525 481 Initial Decision 147. The record shows that dietary deficiency of iron must be continued for a considerable length of time before it produces an iron deficiency anemia. The respondents' representations, however are to the effect that because of a possible lessened intake of food during the time a person has a coJd, virus and so forth he may very well experience "iron-poor blood.

148. We conclude from the evidence in the record that Geritol preparations will be of no practical benefit in promoting convaJescence foJ1owing a cold or the other related disorders referred to in respondents' advertising.

XVII. The Charge that the Vitamins Supplied in Neither Geritol Liquid nor Geritol Tablets Are of Any Benefit in the Treatment or Relief of an Established or Existing Deficiency of Iron or Iron Deficiency Anemia 149. Dr- Dameshek testified that there is no synergistic effect between iron and vitamins; that the efficiency and effectiveness is not promoted by combining them with vitamins. He testified specifically that "Vitamins are of no value unless there is a specific vitamin deficiency." He testified further It has been adequately demonstrated that there is no synergistic effect. " (Tr. 270) 150. Dr. CarJ Moore Jikewise testified that he knew of no synergistic result of combining vitamins with iron. He has stated however, in a reprint from the Harvey Lectures, respondents Exhibit No- 80, page 78, that:

The addition of a large amount of ascorbic acid (0.25 to 1 g. ) to foods causes absorption of iron to be considerably increase. Dr. Moore was writing about the absorption of food iron and not about the absorption of iron in the form presented in Geritol. 151. Respondents' witness Dr. Wintrobe when asked whether iron in Geritol Liquid would be absorbed any faster than iron given alone, answered:

I don t know off hand any basis for saying that the absorption of iron ammonium citrate from this mixture would be any different from the absorption from iron ammonium citrate given alone.

152. With specific reference to Geritol, Dr. Wintrobe testified that:

My objection is that one is given a lot of things that the patient may not need and, therefore, he is being asked to spend a lot more money and further- Initial Decision 68 F.

more, if he had mothcr kind of abnormality or deficiency. this could even cover that up * '" * (CX 2; Tr. 4705-06). 153. Respondents' witness Dr . Beutler, in a book entitled Clinical Disorders of Iron Metabolism Respondents ' Exhibit No. 60 page 179, makes a forceful statement concerning our present problem as follows:

Iron with Other Hematinics Of the commercially available iron preparations, by far the majority are preparations in which iron is combined with one or several additional hematopoietic factors. These proprietary combination hematinics are promoted with great vigor and great success for the management of a surprising array of unrelated conditions. That this promotional effort has been ovr:rwheJmingJy successful is seen in Table 3- , and yet there is little that can be said about these preparations, except to condemn them. Perhaps one reason for the acceptance of these preparations by some segments of the medical profession is the tempting implication, inherent in the slogan "for all treatable anemias that one may treat any anemia with such preparations without searching out the cause. It is not enough to observe that such irrational and costly combinations may impose an undue burden on the patient's pocket.book, or that they may compound the difficulty of subsequent diagnostic efforts. There is ample reason to believe that they may actually be deleterious in refmctOlY anemias, and in pernicious anemia, 154. Dr. Finch, in Respondents ' Exhibit No. 312 , page 341 makes a similar statement to the one quoted above, concluding that: It is quite clear that the recovery of the patient with uncomplicated iron deficiency anemia is not helped by vitamin supplements or minerals, and if there are other deficiencies, it is important to identify them rather Lhan to obscure their presence with multiple therapy. 155. Although respondents present a number of witnesses who testify that there is a synergistic effect produced by the addition of vitamins to an iron preparation, we believe that the more persuasive evidence indicates the contrary. Accordingly, we find that the vitamins in the Ceritol preparations are. not of benefit in the treatment or relief of an established or existing deficiency of iron or iron deficiency anemia.

XVIII. The Charge that the Unconditional Guarantee Is Not Observed 156. The complaint alleges that:

*- oJ, the purchase price of Geritol Liquid is not refunded unconditionally but there are terms and conditions which must be complied with by a purchaser in order for him to secure a refund, which terms and conditions are not disclosed in the advertisements.

THE J. B. WILLIAMS CO. , INC. , ET AL. 527 481 Initial Decision 157. In response to a Commission order dated March 11 , 1963 counsel supporting the complaint specified that the terms and conditions referred to in Paragraph Five of the complaint which must be complied with by the purchaser in order for him to secure a refund and which are not disclosed in the respondents' advertisements are as follows:

1. That the purchaser must return the product or a part of it before Wiliams wil fuJfil its guarantee.

2. That the price of only one unit of Geritol wil be refunded regardless of the number of units purchased. 3. That the offer to refund is terminated seven days after commencement of the use of Geritol.

158. The uncontradicted evidence shows:

L That the return of ajj or part of the Geritol unit which was purchased is not required but that some showing by the purchaser that a purchase of Geritol was actually made is required. 2. That requests for refunds for more than one bottle of Geritol are de minimis but that they are sometimes paid. 3. That the purchaser s claim for refund need not be made within seven days and that no claims have been denied for that reason (Fitzgerald, Tr. 217, 219 , 221 , 228 , 231 , 235). 159. We believe that a guarantee of "your money back" necessarily implies that the claimant spent money in purchasing the product upon which he seeks a refund and, therefore, necessarily also implies that some indication of proof of purchase may be necessary. We believe that an advertisement is not false merely because it fails to state such obvious facts. Accordingly, we conclude that the evidence fails to support the above stated charge and that so much of the complaint as involves the charge relative to that unconditional guarantee should be dismissed. XIX. Conclusions 1. The Federal Trade Commission has jurisdiction of the subject matter of this proceeding and of the respondents. 2. The complaint herein states a cause of action and this proceeding is in the public interest.

3. The dissemination by the respondents of the false advertisements as herein found constituted, and now constitutes, unfair and deceptive acts and practices in commerce, in violation of Sections 5 and 12 of the Federal Trade Commission Aet. Initial Decision 68 F.

XX. Order It is ordered That respondents The J. B. Wiliams Company, Inc. , a corporation, and Parkson Advertising Agency, Inc. , a corporation, and their officers, and respondents' representatives, agents and employees, directly or through any corporate or other device in connection with the offering for sale, saJe or distribution of the preparation designated Geritol Liquid or the preparation designated Geritol Tablets, or any other preparation of substantially similar composition or possessing substantially similar properties, under whatever name or names sold, do forthwith cease and desist from directly or indirectly:

1. Disseminating or causing to be disseminated by means of the United States mails or by any means in commerce, as commerce" is defined in the Federal Trade Commission Act any advertisement which represents directly or by implication: (a) That the use of such preparation wil be of benefit in the treatment or relief of tiredness, loss of strength, rundown feeling, nervousness or irritability unless such adtisement expressly Jimits the effectiveness of the preparation to those persons whose symptoms are due to an established or existing deficiency of one or more of the vitamins provided by the preparation, or to an established or existing deficiency of iron or to iron deficiency anemia and, further, unless the advertisement clearly and conspicuously reveals the fact that in the great majority of persons, or of any age, sex or other group or class thereof who experience such symptoms, these symptoms are due to conditions other than those which may respond to treatment by the use of the preparation, and that in such persons the preparation wiJ not be of benefit. (b) That the use of such preparation wil be of benefit in the treatment or relief of tiredness, loss of strength run-down feeling, nervousness or irritability due to an established or existing deficiency of iron, or to iron deficicncy anemia, in adults other than women in the usual childbearing age group, unless such advertisement, in addition to the requirements of paragraph (a) hereof, dearly and conspicuously reveals the fact that an established or existing deficiency of iron, or iron deficiency anemia, in such adults, or in any age, sex or other group or class thereof, is almost invaria.bly due to bleeding from some serious disease or disorder and that, in the absence of THE . B. WILLIAMS CO., INC., ET AL. 529 481 Initial Decision adequate treatment of the underlying cause the use of the preparation in such adults may mask the signs and symptoms and thereby permit the progression of such disease or disorder.

(c) That the use of such preparation wiJ be of benefit in the treatment or relief of an established or existing deficiency of iron, or of iron deficiency anemia, in adults other than women in the usual childbearing age group, unless such advertisement clearly and conspicuously revears the fact that an established or existing deficiency of iron, or iron deficiency anemia, in such adults, or in any age, sex or other group or class thereof, is almost invariably due to bJeeding from some serious disease or disorder and that, in the absence of adequate treatment of the underlying cause the use of the preparation in such adults may mask the signs and symptoms and thereby permit the progression of such disease or disorder. (d) That the use of such preparation wiJ increase the strength or energy of any part of the body within 24 hours. (e) That the use of such preparation wiu promote convalescence from a cold, flu, fever, virus infection, sore throat or other winter illnesses.

(1) That the vitamins supplied in such preparation are of any benefit in the treatment or relief of an established or existing deficiency of iron or iron deficiency anemla.

2. Disseminating, or causing to be disseminated, by any means, for the purpose of inducing, or which is likely to induce, directly or indirectly, the purchase of any such preparation, in commerce, as "commerce" is defined in the Federal Trade Commission Act, any advertisement which contains any of the representations prohibited in, or which fails to comply with the affirmative requirements of, Paragraph 1 , hereof. It is further ordered That so much of the complaint as charged that the purchase price of Geritol Liquid or Geritol Tablets is not refunded unconditionally if the purchaser is not satisfied with the product be, and the same hereby is, dismissed. APPENDIX 1. Scientific Witnesses The following are the witnesses who testified at the request Initial Decision 68 F.

of counsel supporting the complaint in the above-entitled proceeding, primarily in the field of hematology: 1. Adelson, Edward, AI. magna cum laude, Tufts Medical School, 1947. Post graduate training at Mt. Sinai Hospital, New York City and Boston City Hospital. Currently director of Blood Research Laboratory, George Vlashington University Medical School; Assistant CJinical Professor of Medicine. George Washington University Medical School. Diplomate of the American Board of Medicil e. Primarily engaged in the' private practice of internal mcdicine and hematology, \Vashingt.on, D, C. (Tr. 1178) 2. Crcsby, Col. William ll. . Ai. D. at U. of Pennsylvania, 1940. Post graduate training at Brooke General Hospital, Pratt Diagnostic Hospital Boston, Mass. Medical Specialist at Queen Alexandra Military Hospital London. Chief, Department of Hematology, Walter Reed Army Institute of Research since 1951. Chief Cancer Chemothen:Jpy Program, Walter Reed general Hospital since 1960. Editorial Boards uf Blood since 1953; Transfwn:on since 1960; American Journal of Digestive Disl:.:ases since 1961. (Tr. 49(7) 3. Domeshek. WilliOlH. .. presently Professor of Medicine at Tufts University School of Medicine, BostOJJ , Mass. Senior Physician and Chief of Hematology, Pmtt Clinic, New England Center Hospital and Blood Research Laboratory; Hematologist-in- Chief. Boston Floating Hospital and Boston Dispensary; founder and editor-in- chief of Blood, The Journal of Hematology. Past President of the International Society of Hematology, Boston, Mass. (T!'240) 4. Farquharson . Ray Fletcher, M D. D. University of Toronto, 1922; Pellow in pathology and bacteriology, University or Toronto, 1922- 23; Post graduate work at Toronto General Hospital, 1923- 26; Fellow in :vedicine L'university of Toronto, and research fellow at the ass. General Hospital and Harvard University cdjcal School. Assistant Professor of Medicine and Head of Department of Therapeutics . University of Toronto. (Tr. 1050) 5 Finch, Clement A. , j\1.D.. M. D. University of Rochester :vledical School: post graduate trClining, Pf'er Bent Brigham Hospital. Boston, Mass. Research Fellow in hematology under Dr. Joseph Ross; Evans Memorial. Former instructor at Harvard medical School. Presently Professor of ::edicine University of VVashington School of Medicine, Seattle, \\lash. Member of American Federation of Clinical Research, International Society of Hematology, Society of Nuclear I\ledicine and many other medical organizations. iT, 5165) 13. Krevans. Julius. R. , Ai. D. New York University. Post graduate work in pathology, Queens General Hospital, New York. Fellow in hematology. Johns Hopkins. Full time faculty member. Johns Hopkins University School of :vedicine since 1953 to present. Consultant in hematology, Baltimore City Hospital. (Tr. 791) 7. lvIcGanity, William J. , !.11. ?-1.D. University of Toronto Medical School. Post graduate training, Toronto General Hospital. Research Fellow in utrition with Vanderbilt School of Medicine, Nashville, Tenn. Associate Professor in Obstetrics and Gynecology, Vanderbilt University. Fellow, Royal College of Surgeons of Canada. Present position is Professor and Chairman of the Department of Obstetrics and Gynecology. Cniversity or Texas. Galveston. Texas. (Tr. 910.) THE J . B. WILLIAMS CO. , INC. , ET AL. 531 481 Initial Decision 8. Moore, Carl v., M. D. Washington University School of Medicine. Post graduate training, National Research Counsel Fellow at Ohio State University. Currently Professor of Medicine, Washington University; Head of the Departments of Medicine and Physician in Chief, Barnes Hospital. (Tr. 1318) The following are the witnesses who testified at tbe request counsel supporting the complaint primarily in the field of nutrition:

9. Goldsmith, Grace A. , kI. D., D. Cniversity of Minnesota, 1936. Post graduate training, Touro Infirmary, New Orleans, La. Fellow, Internal Medicine, Mayo Clinic. Diplomate, American Board of Internal Medicine; American Board of Nutrition. Chairman, Food and Nutrition Board of the National Research Council. Currently Professor of Medicine. Tulane University, New Orleans, La. (Tr. 369) 10. Vilter. Richard William. 1\1. D.. :\1.D. Harvard University, 1937 . Post graduate work at Cincinnati General Hospital. Past pre"ident of the American Society of CJinicial Nutrition. (Tr. 5221) The following surgeon testified at the request of the counsel supporting the complaint during the rebuttal case: 11. l1.oore, Francis D.. M. D. Harvard medical School Post graduate work at Mass. General Hospital. Research Fellow, Medical Sciences, National Research Council. Presently Surgeon-in-Chief, Peter Bent Brigham Hospital Boston, Mass., and Mosely Professor of Surgery, Harvard Medical School (Tr. 5273) The following are the scientific witnesses who testified at the request of the respondents:

12. Albanese, Anthony August, Ph. Ph.D. Columbia University, 1940. Director of Research at St. Lukes Hospital, New York, N.Y. and Greenwich Conn., Director of the Nutrition and Metabolic Research Division of the Burke Foundation and Rehabilitation Center. Associate Editor of the New York State Journal of 1edicine. Member of American Society of Clinical Nutrition. (Tr. 4082) 13. Alton. Edward William, Ed. Doctor of Education University of Maryland, 1955. On July 31 , 1963. became Director of the Cooperative Extension Service for the State of Maryland, a position at the U. of Maryland in which he is in charge of the educational work done off campus with people all over the State relating to agriculture, home economics and related subjects. (Tr. 3927) 14. Arrowsmith, William R.. .l\l. D. Ohio State University, 1938. Research Fellow Washington University Medical School of St. Louis, 1939-42. Currently Professor of Clinical Medicine at Tulane University. Head of the Departments of Hematology and Internal Medicine at the Ochsner Clinic in New Orleans. Consultant in Hematology, U. S. Public Health Marine Hospital in New Orleans and on the visiting staff in other hospitals in that city. Diplomate of American Board of Internal Medicine . (Tr. 3176) 15. Benson, Ezra Taft, M.8c. Bachelors degree from Utah State Agricultural College. M. Sc. in Agricultural Economics, Iowa State College . Post Initial Decision 68 F.

graduate work University of California. Former U.S. Secretary of Agriculture (Tr. 4489) 16. Beutler, Ernest, III. D. University of Chicago, 1950. Taught in the Dept. of Medicine and the Argonne Cancer Research Hospital, 1955-60. Associate Clinical Professor of Medicine of the University of Southern California. Diplomate in Internal Medicine. Fellow of the American College of Physicians. Member of the American and International Societies of Hematology. On Editorial Board of Blood; co-author of Clinical Disorders of Irun Metabolism. (Tr. 4782) . Borsook, Henry, Ph. Ph.D. in biochemistry in 1924 at University of Toronto. Asst. Professor and Professor, California Institute of Technology in Pasadena, 1929-63. Consultant Huntington Memorial Hospital. Nutritional consultant Mt. Zion Hospital, Hollywood. Author Nutritional Status of Aircraft Worhers in Southern California. (Tr. 4738) 18. Briggs, Donald K.. AI. D. University of Cambridge, England 1946. Adjunct Physician in hematology, Lenox Hil Hospital. New York. Member American Society of Hematology, the Society for the Study of Blood, and other professional organizations. (Tr. 2276) 19. Cattell, ftlcKeen, Ph. . JVl.D.. A.M., Ph. . M.D. Harvard University. Se. Universidad de Antioquia in Colombia, 1948. Head of the Pharmacology Dept. , Cornell University :\1edieal College, 1937- 59. (Tr. 2932) 20. Chow, Bacon, F. , Ph. D.. Ph.D. in Chemistry, Harvard University. Worked two years Rockefeller Hospital Taught biochemistry Peking Gnion :Medical College in Peking until 1938. Associate Professor of Biochemistry, Johns Hopkins University School of Hygiene, 1949- present. (Tr. 3970) 21. Clark. Faith, Ph. B. Wooster College, Wooster, Ohio. Master and Ph.D. University of Chicago, Director, Consumer and Food Economics Research Division, Agricultural Research Service, U. S. Dept. of Agriculture since June 1957. (Tr. 2932) 22. Craighead, Claude E. , JVI. D. L. D. School of Medicine, 1939. Diplomate of the American Board of Surgery. Clinical Associate Professor of Surgery, L.S.U. School of Medicine. Senior Visiting Surgeon, Charity Hospital, New Orleans. Senior Surgeon. TauI' Infirmary, New Orleans. (Tr. 3245) 23. Dem, Haymond J., Ph. , lo,. Ph. D. in physiology, University of Rochester School of Medicine, 1946; M.D. from same. Professor of Medicine Stritch School of Medicine of Loyola, Chicago. Attending Physician, Cook County Hospital, Chicago. (Tr. 3530) 24. Ebeling, William Carl, M. D. University of Maryland, 1944. Diplomate of the American Board of Internal Medicine. Currently Associate Professor of Medicine, University of I'v1maryland Hospital. Fellow of the American College of Physicians. (Tr. 3701) 25. Fein, Harry David, ftl. D. New York University, 1936. Currently Asst. Professor of Clinical Medicine at N. U. School of Medicine. Diplomate of the American Board of Internal Medicine. efr. 2574) 26. Friedman, Gerald J., M. D. New York University College of Medicine . 1937. Currently Associate Clinical Professor, Dept. of Physicial Medicine and Rehabilitation. National Medical Director for the United THE J . B. WILLIAMS CO. , INC. , ET AL. 533 481 Initial Decision Parcel Service. Diplomate of the American Board of Internal Medicine and Fellow of the American College of Physicians. (Tr. 4193) 27. Gold, Harry, III. D. Cornell University Medical College, 1922. Currently Professor of Clinical Pharmacology, Cornell. Head of the Cardio- Vascular Research Unit, Beth Israel Hospital. Fellow New York Academy of Sciences, AMA , American Association for the Advancement of Science. (Tr. 4447) 28. Gyorgy, Paul, AI. D. University of Budapest. 1915. Professor of Pediatrics, University of Heidelberg, 1927-33. Research Fellow. Nutritional L"boratory. Cambridge University, England, 1933-35. Professor of Clinical Pediatrics, University of Pennsylvania School of Medicine; currently teaches graduate course in nutrition there. Pediatrician-in-Chief of Philadelphia General Hospital. (Tr. 221.5) 29. Halpern, Seymour Linnel, AI. D. New York University. Currently Asst. Clinical Professor of Medicine, New York Medical College. Diplomate of the American Board of Internal Medicine. President of the Planning Board of the Food and Nutrition Council of Greater New York. ITr. 4280) 30. Hod. Charles W. , Ai. D. Duke University, 1941. Practicing gastroenterologist with 18 yrs. experience in Augusta, Ga, Presently an Associate Clinical Professor of Medicine in Gastroenterology at the Medical College of Augusta. (Tr. 3020) 31. Hully, Roy Groves, M. , Ph. D. Universtiy of Minnesota. Ph. Seme, Professor of Obstetrics and Gynecology, 1954-61. Chief cif the Obstetric and Gynecologic Service, University of Nebraska, Dean of the Graduate School, Nebraska, 1961. Vice Chancellor of the University. Nebraska, 1962, P!'esident of the Association of Professors of Gynecology and Obstetrics, :\1member, American Hematology Society. (Tr. 3853) 32. Leahe, Chauncey D. , Ph, Ph,D. University of \Visconsin, 1923, Professor of Pharmacology, Director of the Medical Branch, University of Texas, 1942. Currently lecturing in pharmacology, University of California. Past President of the American Association for the Advancement of Science. Past Chairman of the Section for Pharmacology and Therapeutics of the AMA. (Tr. 4592) 33. J;IcCawley, Elton L., Ph. Ph, D. University of California School of ::1edicine, 1942. Currently Professor in the Medical School of the University of Oregon. Asst. Coroner, City of San Franci co. Director of the Oregon Control Center for Poisons in the Physicians Reference Center. Acting as the County Coroner s Toxicologist in Portland, Ore. (Tr. 4529) 34, McGavack, Thomas Hodge, M. D. Hahnemann College in Philadelphia, 1923. Professor of Clinical Medicine, New York Medical College. Director of the Geriatrics Research Laboratory, V.A. Center, Martinsburg, Va, Diplomate of the American Board of Internal Medicine, (Tr. 3790) 35, McHardy, George Gordon, M, D" D. Tulane University, 1936. Currently President of the American Gastroenterological Association, Currently Clinical Professor of Medicine, Louisiana State University School of Medicine. Senior Visiting Physician, Charity Hospital, New Orleans. Diplomate American Board of Internal ::edicine. (Tr. 1935) 36. McLau.ghlin, Blaine E. , l\1.D., D. University of the State of New ..

Initial Decision 68 F.

Yark. Presently Professor and Director of the Dept. of Psychiatry at Women :'vledical College in Philadelphia. Member of the AMA. (Tr. 3755) 37. Reznihoff, Paul, j\I. D. Cornell University Medical College, 1920. Teaching staff Cornell University Medical College, 1924. Emeritus Clinical Professor in Medicine, 1961. Charter member, American Society of Ht-!matology and the Society for the Study of Blood . ('fl'. 2403) 38. Rosenthal, Robert, .J'y. D. Columbia College of Physicians and Surgeons, 1946. Past 12 yrs. engaged ill project supported by National Heart Institute. (1'1'. 2976) 39. Shapiro, Shepard, . , rv1.D Bellevuc Hospital Medical College 1919. Research, Goldwater University Hospital, Kew York. 1942. Member American and lntt:mational Societies of Hematology. (Tr. 2754) 40. Spindler, Evelyn B.. Ph Ph.D. University of Iowa in nutrition. Nutrition Specialist with the Federal Extension Service, U.S. A. Instructor University of California at Davis. (Tr. 3945) 41. Trobollffh. Frank E.. J.U. D.. D. Harvard Medical School. 1943. Associate Professor of Medicine in Hematology, University of Illinois Medical School. Since 1960, Director of Hematology in Clinical Laboratories and Blood Bank, Presbyterian St. Luke s Hospital, Chicago, Ill. Diplomate of the American Board of Internal Medicine . (Tr. 3404) 42. Wallerstein, Ralph 0. , M. D. University of California, 1915. Presently Associate CJinical Professor of Medicine at the University of California. Chief of the Hematology Service and Director of the blood bank. Chief of the Hematology Research Laboratory, Children s Hospital, San Francisco. Diplomate of the American Board of Internal Mediciilc. (Tr. 1591) 43. Welch, George E. , I\.f.D.. D. Tulane University, 1945. Clinical FellO\v, Cardiology and the Hematology Divisions, L'university of Vlashington Medical School, 1950-52. Currently Asst. Professor of Medicine, Tulane University. Director of the Louisiana Health Association. (Tr. 3333) 44. Wintrobe, 1\.fa:nL'eli Jolyer, AI. , Ph. Ph.D. Tulane, 1929; M. University of Manitoba, Can. , 1927. Now Professor and Head of the Dept. of Medicine, University of Utah College of Medicine. Chief Consultant, Salt Lake Veterans Hospital. Physician-in-Chief. Salt Lake General Hospital. Past President of the \Vestern Association of Physicians. (Tr. 4641) II. Glossary of Scientific Terms 1. Anemia-a condition in which the blood is deficient either in quantity (oligemia) or in quality. The deficiency in quality may consist in diminution of the amount of hemoglobin (oligochromemia) or in diminution of the number of red blood corpuscles (oligocythemia) or both. 2. Anoxia-oxygen deficiency 3. Ascorbic acid-vitamin C 4. e.e. cubic centimeter 5. Carcinoid-epithelial tumor resembling a malignant carcinoma but following a bcnign cuurse clinically 6. Cirrhosis-a degenerative disease of the liver, unless otherwise specified 7. Diverticulitis-inflammation of a diverticulum. Diverticulitis is a complication of diverticulosis.

THE J. B. WILLIAMS CO., INC. , ET AL. 535 481 Initial Decision 8. Diverticulosis-the presence of a number of diverticula (offshooting cul-dc- sacs) of the intestines 9. Enzyme-an organic compound, frequently a protein, capable of accelerating or producing by catalytic action some change in its substrate for which it is often specific 10. Fibroids-a fibrous. non-malignant tumor of the uterus unless otherwise specified 11. Gm. abbreviation for gram 12. Hematocrit-a measurement of the volume of the red blood cells, in term of percentage of volume of the blood 13. Hematology--study of disease of the blood; a sub-specialty of internal medicine 14. Hemoglobin-an iron-containing protein; the coloring matter of the blood. It is contained in the red blood cells and functions as the carrier of oxygen to the cells of the body 15. Hemorrhage-bleeding, a flow of blood especially if it is very profuse 16. Hiatus hernia-a herniation of the stomach through the diaphragm into the chest. Also termed hiatal hernia and diaphragmatic hernia. 17 Hypochromic- under colored" ; having less than the normal hemoglobin content, as applied to red blood cells 18. IJeitis-infiammation of the ileum, the terminal portion of the small intestine 19. Intussusception-the slipping of one part of the intestine into an adjacent part, often resulting in obstruction of the bowel 20. Jejunum-second section of the small intestine 21. Mg. or mgm. abbreviations fat milligram 22. MI.-abbreviation for miJliliter. Used interchangeably for c. c. or cubic centimeter, although technically they are identical only under standard conditions of temperature, pressure, etc. For all practical purposes they are identical 23. Mallory-Weiss Syndrome-a syndrome that occurs in the chronic alcoholic in which the stress of vomiting tears blood vessels near the gastroesophageal junction, producing hcmorrhage which is often fatal 24. Meckle s Diverticulum-a diverticulum of the jejunum or ileum, normally present at birth. which usually but not always disappears a few weeks after birth. II it persists it may cause strangulation or intussusception. 25. Melena-dark stools due to the presence of blooc1 26. Menopause-permanent cessation of the menses; termination of the menstrual life 27. Menorrhagia-excessively profuse menstruation 28. Metrorragia-abnormal uterine bleeding between menstrual periods 29. Microcytic-abnormally small 30. Myoglobin-the red substance in muscle tissue 31. Neoplasm- new growth". as any kind of tumor, benign or malignant. Cancer is frequently referred to as a neoplasm or neoplastic disease. 32. Niacin-or nicotine acid; one of the B Complex vitamins Opinion 68 F.

33. Occult bleeding-hidden bleeding; that which is not recognized as such by the patient 34. Pellagra-a deficiency disease, due to a deficiency of niacin (nicotinic acid) 35. Peptic ulcer-an ulcer caused by action of the peptic or stomach juices on the lining of the gastrointestinal tract. A gastric ulcer is a peptic ulcer in the stomach. A duodenal ulcer is a peptic ulcer in the duodenum. An esophageal ulcer is peptic ulcer in the esophagus. 36. Plasma-the fluid part of the blood 37. Synergism--the joint action of agents so that their combined effect is greater than the sum of their effects acting independently. Synergistic: enhancing the effect of another f01ce or agent. 38. Telangiectases-usually telangiectasia, hereditary. A local vascular abnormality, hereditary in nature.

39. Thiamine-Vitamin B, 40. Varices-dilated veins OPINION OF THE COMMISSION SEPTEMBER 28, 1965 By DIXON Commissioner:

The complaint in this matter charges respondents with disseminating false advertisements in promoting the sale of two drug preparations, Geritol Liquid and Geritol Tablets,' in violation of Sections 5 and 12 of the Federal Trade Commission Act. The hearing examiner held that the alleged misrepresentations as to the effectiveness and safety Qf the products were sustained by the evidence and ordered respondents to cease and desist from these practices. Respondents have appealed from these findings and order. Counsel supporting the complaint has not appealed from the examiner s holding that respondents have not misrepresented the terms of their refund agreement.

A basic issue presented by respondents' appeal is the interpretation to be accorded to their advertising. In particular, respondents contend that the hearing examiner failed to give suffcient weight to the testimony of their expert witnesses as to the meaning of the 1 While the formula for these two preparations differ, these differences are not generally significant in decidi.'lg the issues in this case. The two products whi sometimes be referred to collectively as " Geritol" in this opinion The hearing examiner\; urder is directed against The J. B. Viili"ms Company, Inc. , which sells and distributes Geritol. and against Porkson Advertising Agency, Inc. Parkson was founded by \\'illiams in 1957. Although technically it is not a subsidiary, in practicality it is Wilioms advertising division. Parkson is completely ovmed hy the stockholders of Williams and advertising Geritol is 95 percent of its business. The president of Park. on is also the vice-president and advertising directur of Williams. His testimony est"blishes that Porkson prepares the advertisements for Geritol "nd that he approves their dissemination in his joint capacity ::S an officer in both corporations.

THE J . B. WILLIAMS CO. , INC. , ET AL. 537 481 Opinion advertising claims challenged in the complaint. To the extent that this argument implies that in the absence of other testimony, the examiner was bound by the testimony of respondents' witnesses it is obviously erroneous.

The examiner has set forth his reasons in support of his interpretation of respondents' advertising and for his rejection of the testimony of respondents' witnesses. Moreover, we have the advertising before us and we are not persuaded by the testimony of these witnesses. ' It is, of course, well settled that the Commission has the authority to draw upon its own experiences in interpreting advertising. Stauffer Laboratories, Inc. v. Federal Trade Commission 343 F. 2d 75 (9th Cir. 1965); . F. Drew Co. v. Federal Trade Commission 235 F. 2d 735 (2d Cir. 1956). As more fuUy developed in our discussion of each issue, the best that can be said for respondents' arguments as to the meaning of their advertising, as supported by the testimony of their witnesses, is that their claims may be susceptible of two interpretations. The courts have made it clear that, if one of two possible interpretations is misleading, the claims wil be construed against the advertiser. Murray Space Shoe Corp. v. Federal Trade Commission 304 F- 2d 270 (2d Cir. 1962). Two of the charges sustained by the examiner reJa te to respondents' alleged failure to reveal material facts in their advertising. Respondents' appeal is devoted chiefly to these issues. However, respondents have also takell exception to the examiner s findings as to what they characterize as "three comparatively minor charges in the complaint. We wil first consider these charges since the primary issue with respect to all three involves a determination as to the meaning of the chaUenged representations. The first of these charges is that respondents have falsely represented that Geritol wil increase the strength and energy of every part of the body within 24 hours- In this regard, respondents' advertising claims that " In only one day GERITOL-iron is in your bloodstream carrying strength and energy to every part of your body. " (CX 6, emphasis in original.) Since the evidence establishes that 1/100 of 1 percent to 2.4 percent of Geritol' s iron wil be distributed throughout the body in 24 hours, respondents argue that their claim is true. This is aU, respondents aUege, that the advertisement promises. The examiner, however, found that respondents are assuring relief noticeable to the consumer within 24 hours in that the ad "holds out the promise of much more in the way of strength 3 Cert.':lin of respondents' advertisements in issue are set forth in full text as an addendum to this upinion , Opinion 68 F, and increased energy than a mere rl1icroscopic change in an individual' s blood.

One such television ad in which the claim appears depicts a husband who is "just too tired to budge." He takes Geritol and then is shown dancing with his wife. While the man is dancing, the announcer is saying " In only .one day GERITOL iron is in your bloodstream carrying strength and energy " .. .. to every part of your body. " (Emphasis added. ) There can be no doubt as to the meaning of the representation in this context, and we are in complete accord with the hearing examiner s interpretation. We find no substance in respondents' contention that the examiner failed to consider the further statement in this same advertisement that" (you I1J feel stronger fast ,;, within seven days , .. or money back." (Emphasis in original.) This stah,ment is made two scenes after the "one day" claim, and the reference to seven days " obviously does not detract from the viewer impression of relief within 24 hours. In fact, the conspicuous emphasis of the two time sequences is that, within one day after taking Geritol you will experience a noticeable increase in strength and energy, and if such physical phenomena doesn t occur within seven days your money wi1 be refunded.

The undisputed evidence establishes that with persons suffering from iron deficiency, the time lapse between taking Geritol and any appreciable increase in strength and energy is substantially longer than 24 hours. Estimates by several medical witnesses placed the interval as high as 10 days to 2 weeks. Respondents' own witness who conducted a study to show that the iron in Geritol appears in the red blood cells in very small percentages within 24 hours, testified that no other conclusions could be drawn from his study. Information that a small percentage of iron from Geritol enters the bloodstream within one day is of no consequence to a tired person unless he also believes that his strength and energy wil increase within that time. Respondents ' advertising conveys that belief. Such advertising is misleading and deceptive, and respondents' appeal on this issue is denied. Although we find no error in the hearing examiner s ruling on this issue, we are of the opinion that the provision in his order as to this practice is too Jimited. Specifically, the examiner s order only bars respondents from representing that Geritol wi1 increase strength or energy "within 24 hours." Obviously, 24 hours is of no significance other than that it is the time period respondents have elected to use in their advertising claims, Basically, of course, the THE .1. B. WILLIAMS CO., INC. , ET AL. 539 481 Opinion practice at which the complaint is directed, and which has been established on this record, is that of misrepresenting the length of time within which Geritol wil provide relief. The hearing examiner s order wil be amended to fully prohibit that practice. We next consider the charge that respondents have falsely represented that Geritol will promote convalescence from winter ilnesses. Following a fim clip of a winter scene and the sound of howJing wind, there is the statement in several Geritol television advertisements that:

As a result (of winter weatherJ, have you been in bed with a cold, flu, fever? After such an illness, if you suffer from iron-poor blood you may find that recovery is slow To get back your normal strength fast, when this is your problem, you should build up iron-poor blood. (CX 3. In the hearing examiner s view, this statement indicates that there is a reasonable probability that Geritol will promote convalescence from these winter illnesses. Respondents, however, contend that these advertisements are directed only toward iron or vitamin deficient individuals who also happen to be recuperating from a winter illness.

As the courts have held, the important criterion in determining whether an advertisement is false and misleading is the net impression which it is likely to make upon the general population. We have no doubt that insofar as the viewing public is concerned respondents ' interpretation is too restrictive. The advertising is worded so as to apply to a person suffering from iron poor blood after a winter ilness. The obvious implication is that winter ilnesses may cause iron poor blood from iron or vitamin deficiencies and that Geritol wil speed recovery by curing these deficiencies. The hearing examiner in reaching his conclusion as to the meaning of respondents' claim, relied, in part, on an excerpt from another advertisement. Respondents point out that the advertisement is not produced in full in the initial decision- Their failure to explain how the full text of the advertisement is of any benefit to them is understandable. The pertinent part of the advertisement in fuJl text, reads:

Have you been feeling tired and rundown more often than usual? Your trouble may be due to iron-poor blood. And this is often especially true after . In their appeal on this issue, respondents state that If an iron-deficient person gets a cold or the flu the combined symptoms will be more oppressive than a simple cold or flu. In such cases, Geritol wil help. " (Emphasis added. "Charles of the Ritz Distributors Corp. v. Federal Trade Commission 143 F. 2d 676 (2d Cir. 1944). Murray Space Shoe Corp. v. Federal Trade Commission, supra. Aronberg v. Federal Trade Commission 132 F. 2d 165 (7th Cir. 1942). Opinion 68 F.

a fever, the flu or virus. During such an ilness you may be on a liquid diet or eat light foods. As a result, you may continue to feel a lack of strength and energy after your illness because the essential iron in you.r blood is reduced and your resistance is low. (CX 2, emphasis added. The evidence establishes and respondents do not contend otherwise on this appeal, that winter ilnesses such as a coJd, fJu or fever wil not cause iron poor blood. Respondents ' advertising which tends to create that impression is misleading. The appeal on this issue is likewise denied.

Respondents are further charged with falsely representing that the vitamins contained in Geritol contribute to the effectiveness of the products in the treatment or relief of an existing deficiency of iron or iron deficiency anemia.

Respondents advertise that:

Vitamins alone can t build up iron- poor blood. But GERITOL can! Because GERITOL not only contains 7 important vitamins but, in addition, supplies the therapeutic amount of iron needed to build iron-rich red blood. Just 2 GERITOL tablets, or 2 tablespoons of GERITOL liquid, contain twice the iron in a pound of calves' liver! It is this rich source of iron . in combination with high-potency vitamins that makes GERITOL such an effective strengthbuilding tonic. (CX 7, emphasis in original.) In a two-pronged defense, respondents first deny the examiner finding that this type of advertisement represents that the vitamins in Geritol wil contribute to its effectiveness in the treatment of iron deficiency. They contend further, however, that even if the examiner s interpretation is correct, the evidence establishes that the vitamins in Geritol actually do assist the treatment of an iron deficiency.

This claim of respondents, after stating that vitamins "alone can t build up iron-poor blood, emphasizes the addition of " 7 important vitamins" to Geritol and extoJs GeritoJ's strength-building effectiveness through its source of iron "in combination with highpotency vitamins. " The fact that the remainder of the advertisement talks about the amount of iron supplied by Geritol does not detract from the obvious impression that the vitamins in Geritol make it a better remedy for iron deficiency than a preparation containing only iron. If, as respondents contend, the advertisement is designed to say that only an iron preparation wil benefit deficiencies of iron, the stress laid upon the addition of vitamins is at least confusing and hence misleading.

As regards their second defense, the respondents contend that the evidence establishes that certain vitamins in fact contribute to the body s ability to absorb iron- The examiner relied on the THE J . B. WILLIAMS CO. , INC., ET AL. 541 481 Opinion direct testimony of medical experts that there is no synergistic effect between iron and vitamins and that the vitamins in CeritoJ do not affect or help iron deficiency.

We have reviewed the evidence relied upon by respondents and find that, at best, it establishes that Vitamin C may facilitate the absorption of iron. Respondents, however, have added Vitamin C only to CeritoJ Tablets, not to CeritoJ Liquid. Moreover, the reference to vitamins in their advertising is not limited to Vitamin C but falsely represents that all seven "important vitamins" in CeritoJ contribute to its effectiveness in relieving iron deficiency. We find no error in the examiner s ruling on this charge. We turn next to one of the two issues which, in addition to requiring an interpretation of respondents ' advertising, also involves a determination as to possible deception through a failure to disclose material facts- The hearing examiner found that, as charged in the complaint respondents have falsely represented that there is a reasonable probability that aU persons with the symptoms described in respondents' advertisements tiredness, loss of strength, rundown feeling, nervousness and irritability," wil respond to treatment by the use of CeritoI. Respondents strongly dispute this finding, contending first that it is based on an erroneous interpretation of their advertising. It is respondents' position that their advertisements are directed only to those persons in whom these symptoms are due to iron deficiency.

The fonowing are typical of the statements in respondents advertising:

'" if you often have that tired and run-down feeling * and if you take vitamins yet still feel wornout, remember 'I ," ,. your trouble may be due to iron- poor blood. And vitamins alone can t build up iron-poor blood. But GERITOL can! (CX 1 , emphasis in original. They say there s a reason for everything. Now, if you ve been feeling tired and run-down, the reason may be iron-poor blood. And that's why, even though you take vitamins, you may stil feel tired. For vitamins alone can build up iron-poor blood. But GERITOL can! Medical tests prove it (CX 12 emphasis in original.) Patients diagnosed with iron-deficiency anemia frequently were pale, nervous, irritable and easily tired. After patients took GERITOL daily, doctors reported definitc clinical improvement. Remember, ordinary maintenance vitamins can t do it! But the high-potency combination of vitamins plus iron in GERITOL can help you regain your strength and energy. So when you feel tired and this is your problem, take fast-acting GERITOL every day. (CX 7, emphasis in original) "These symptoms wil hereinafter be referred to as the " tiredness symptoms. " They were treated as a group throughout the testimony in this case. Opinion 88 F.

In addition to similar statements, other Geritol television commericals portray men and women who appear exhausted (such as a woman tidying up a boy s room) with whom viewers can readily identiy themselves.

These advertisements, appearing mostly on television or in newspapers, are viewed, heard or read by the general population, including all persons with tiredness symptoms from whatever cause. In substance, these people are told that "the reason" they feel tired and worn-out "may be iron-poor blood " and that Geritol "can help" them regain their strength and energy. This is an obvious invitation to any person with tiredness symptoms to seh-diagnose his trouble as a deficiency of iron-and take Geritol. In other words, respondents, by constantly telling all tired people that their trouble may be iron deficiency, thereby imply that iron deficiency is a common affiction, such as a cold or a headache, and that their tiredness generally indicates this condition. Moreover, the alleged reference to iron deficiency in certain of respondents' advertising is so vague as to be meaningless. This is particularly apparent in the newspaper advertisement quoted above (CX 7), where the claim is made "So when you feel tired and this is your problem take fast- acting GERITOL every day. While respondents contend that the phrase "and this is your problem" refers to iron deficiency, we think that, insofar as the impression upon the mind of the reader seeking relief from tiredness is concerned, this phrase may as well be omitted from the sentence. Despite respondents' argument to the contrary, we find that the implication in their advertising that a person can self-diagnose a deficiency of iron from his tiredness symptoms, is not dispelled by the phrase "check with your doctor. " In the first place the word check" suggests that the viewer go to the doctor only to verify a condition that he is quite capable of drawing himself. Moreover this phrase is usually followed by another statement which completely obscures its meaning, such as "Check with your doctor. And if you ve been feeling wornout because of iron-poor blood-take GERITOL. " On the interpretation most favorable to respondents, this advertising suggests that the tired viewer have his condition diagnosed by a doctor and then treat himself according to a teJevision statement. We fail to see how this unlikely suggestion c1arifies the meaning of the advertisement. We find no error in the examiner s interpretation of respondents advertising. We have carefully examined this advertising and it is our opinion that its meaning is clear. It says, in effect, that any THE J. B. WILLIAMS CO. , INC. , ET AL. 543 481 Opinion member of the general population feeJing tired and worn. out may reasonably conclude that his symptoms indicate a deficiency of iron and that the common, effective remedy for these symptoms is Geritol.

It is clearly estabEshed on this record that tiredness is not a generally reliable indication of iron deficiency. As found by the examiner, it is the testimony of both complaint counsel's and respondents' medical experts that the tiredness symptoms are common to many diseases and disorders. Certain of these witnesses relying on their experience, further testified that the commonest causes of these symptoms are nenrosis and anxiety. Moreover, there is substantial evidence that most mild iron deficiency does not produce any symptoms.

In substance, the evidence establishes that there is Jittle reJationship between the tiredness symptoms and iron deficieney. Not only is it clear that a person cannot rely on the tiredness symptom as an indication of a deficieney of iron but it is also well estabEshed on this record that a medical test under the supervision of a physician is generally required to determine such deficiency- There is the unrefuted testimony of several medical experts that a person cannot diagnose for himseJ! whether he has an iron deficieney. These medical experts testified at Jength as to the tests which they are required to perform to make this determination. These tests are fully described by the hearing examiner in his initial decision.

We find, therefore, that the representation implicit in respondents' advertising, that a person can determine the presence of iron deficiency or iron deficiency anemia from his tiredness symptoms is misleading in a material respect. Our order wiu include a prohibition against this practice.

The next issue raised by respondents' appeaJ is whether the examiner erred in finding that only a small minority of persons having the tiredness symptoms have a deficiency of iron or one or more of the vitamins in Geritol.

In support of this finding, the examiner relied in part upon testimony as to the incidences of iron and vitamin deficiency in the general population. The consensus of the medical experts, including respondents, is that less than 10% of the general population has iron deficiency. As to vitamin deficiency, three experts 7 Even with respect to severe iron deficiency, the record discloses that the primary symptoms are .not those for which Geritol is advertised. For example, they include such symptoms as cracks at the corner of the mouth; smooth, sore tongue, brittle or spoon-shaped fingernails; and early greyiog of hair.

Opinion 68 F.T.

weU qualified in the field of nutrition, testiied that such deficiency is extremely rare in this country, and aU three were of the opinion that, of the total population, less than 1 % has vitamin deficiency. While not seriously disputing the 10% figure as to iron deficiency, respondents contend that the incidence of vitamin defieiency is higher than 1 % . We have reviewed the evidence relied upon by respondents in support of their contention and we are not persuaded- In substance, much of this evidence is the testimony of respondents' medical experts that certain groups have symptoms which could be caused by vitamin deficiency; that a "not negligible percentage of persons examined in a particular study had some form of nutritional defieiency; that old people living alone tend to have poor diets and are thus prone to vitamin deficiency; that high school girls may not eat enough because they worry about weight; and that vitamins can be lost from food through cooking or storage. In contrast to this testimony, the medical experts relied upon by the examiner based their testimony upon actual incidences of vitamin deficiency which they have observed in dealing with the general population.

Respondents also contend that a survey by the Department of Agriculture showed that nearJy 50 % of American families had food supplies that provided inadequate nutrients. This survey, which was conducted in 1955 , involved interviews with householders to determine the food they had used during a week's period. The vitamin and mineral content of this food was ascertained and a comparison made with the Recommended Dietary Allowances of the National Research Council for 1953. While this survey showed that a number of people did not consume the recommended dietary allowances, the evidence establishes that the recommended allowances included a safety factor of 50% to 100% over average needs. Included in a report of this survey is a statement by the Department of Agriculture that "This does not prove that aU of those families were poorly fed or subject to malnutrition; the recommended aUowances provide a considerable margin of safety over average needs. " Obviously, this survey is of little value in establishing incidences of actual vitamin deficiency. Although contesting the examiner s findings as to the incidence of vitamin deficiency, respondents' basic argument on this issue is that the percentage of iron and vitamin deficiency in the general population is of no consequence in determining the proportion of the population with tiredness symptoms who wil benefit from taking Geritol. In substance, they contend that, in the absence of THE J. B. WILLIAMS CO., INC. , ET AL. 545 481 Opinion evidence of controlled studies of tired persons to determine how many of them have iron or vitamin deficiency, there is no valid basis on this record for concluding that in only a small minority of persons is tiredness due to a deficiency of iron or one or more of the vitamins in Geritol We do not regard the lack of controlled studies as the determining factor on this issue. As we have found, respondents' advertising is directed to the entire population of whom less than 10% have iron deficiency and Jess than 1 % are deficient in vitamins. Most of this group who exeperienee tiredness do not do so as a result of their deficiencies since mild cases produce no symptoms. The inescapable conclusion is that the number of people in the total population who are tired because of iron or vitamin deficiency is infinitesimally small Unless, therefore, this small group of people or a majority of them, are the only ones in the entire population who experience tiredness symptoms, respondents' argument must fail.

The overwhelming weight of the evidence is to the contrary. As we have previously found, the testimony of medical experts, as set forth in the initial decision, establishes that the tiredness symptoms are common manifestations of almost any disease or disorder and t.hat the commonest causes of tiredness are neurosis and anxiety. Included among the witnesses testifying to this effect are two of respondents' experts, Dr. Arrowsmith and Dr. Fein, both of whom stated that the majority of persons with tiredness symptoms do not have iron deficiency.

Contrary to respondents ' contentions, we conclude that the charge in the complaint that Geritol will benefit only a small minority of persons with tiredness symptoms, is supported by substantial evidence in this record.

This Jeads to the charge, sustained by the examiner, that respondents ' advertising is misleading because it fails to reveal the material fact that in the great majority of persons, or of any age sex or other group or class thereof, who experience the tiredness symptoms, these symptoms are not caused by an existing deficiency of iron or one or more of the vitamins contained in Geritol, and that in such persons Geritol wiJ be of no benefit. Section 15 of the Federal Trade Commission Act expressly provides that in determining whether an advertisement of a drug preparation is misleading, there shall be taken into account the extent to which the advertisement fails to reveal facts material in Opinion 68 F.

the light of the representations made or suggested in such advertisements.

We have previously discussed the representations in the Ceritol advertising. The issue first presented is whether it is material in the Jight of such representations that Ceritol wi1 not be of benefit in relieving tiredness in the great majority of persons having such symptoms. The next issue is whether an affirmative disclosure of this fact, if it is material, is necessary to prevent the public from being misJed by the claims in the Ceritol advertising. We have found that respondents' advertising is directed to the entire population and represents that Ceritol is a generally effective remedy for tiredness. All people with tiredness symptoms are told that their problem may be iron deficiency. This advertising clearly suggests to a tired person the reasonable probability that his tiredness symptoms are the result of a condition that wil respond to the taking of CeritoJ, namely, iron or vitamin deficiency. The evidence establishes, however, that in only a small minority of cases are tiredness symptoms due to a deficiency of iron or one or more of the vitamins in Cerito1. It establishes further that in a1l other cases Ceritol wil be of no benefit whatever in relieving these symptoms. In the light of the representations with respect to the effectiveness of CeritoJ on tiredness symptoms which dominate the CeritoJ advertisements, these limitations on its actual effectiveness are highly material. Respondents' advertisements do not disclose these Jimitations. The result is that the claims of beneficial effects made in such advertisements are clearly misleading and constitute "false advertisements" within the meaning of Section 15. We think it clear that the deception inherent in the advertising can be fully prevented only (1) by omitting from such advertising a1l reference to the effectiveness of CeritoJ on tiredness symptoms or (2) if claims of effectiveness of Ceritol on such symptoms are made, by an express statement of the limitations of such effectiveness.

This record discloses that there are numerous causes of the tiredness symptoms other than a deficiency of iron or vitamins, and that these symptoms are common manifestations of almost any disease or disorder. Physicians, of course, are generally aware of the true facts concerning the relative frequency of tiredness symptoms from conditions other than iron or vitamin deficiency. Members of the public, to whom Ceritol advertising is directed, are not so informed. It is only through a diagnosis by a physician that the presence of a deficiency of iron or vitamins ean be determined. Thus THE J . B. WILLIAMS CO., INC. , ET AL. 547 481 Opinion even advertisements which offer Geritol for relief of tiredness caused only by a deficiency of iron are not sufficiently informative to a member of the public who cannot determine for himself whether his tiredness is due to such cause or to one of many other causes. Before the Jikelihood of deception can be dispelJed from such advertising, the prospective purchaser must be fully informed as to the relative frequency of the occurrence of tiredness as a result of conditions other than a deficiency of iron or vitamins, and of the further fact that Geritol wil not relieve tiredness caused by such other conditions.

This affirmative disclosure is necessary in every instance in which Geritol is advertised as a treatment for the relief of the tiredness symptoms. The purpose of such disclosure is to remove the likelihood of deception inherent in any claim of effectiveness for Geritol on the tiredness symptoms, even though such claim be limited to tiredness symptoms due to iron or vitamin deficiency. It seems obvious, however, that the Jikelihood of the public being deceived in to believing that other than a small minority of tired persons wil find relief for these symptoms by taking Geritol wil continue to exist if in any advertisement the other representations are inconsistent with the facts affirmatively disclosed." Such other claims can only serve to confuse and thereby deceive, thus nullifying the purpose of the required disclosure. Therefore, in advertising in which an affirmative disclosure is required, respondents may make no representations, directly or by implication, which in any way negate or contradict the facts which are affirmatively disclosed. In other words, if despite the affirmative disclosure, any advertising conveys the impression that Geritol wil be of benefit in relieving tiredness generally or in other than a small minority of persons with such symptoms, such advertising wil be deceptive and in violation of tbe order to be entered herein. We agree with respondents, however, that the provision in the hearing examiner s order relating to the affirmative disclosure too broad in scnlJ8- Specifically, evidence introduced by respondents discloses that there are certain small groups of persons in the entire population in which iron or vitamin deficiencies may be significant. While this evidence is not sufficient to overcome the substantial In the Matter of Keeie Hair Scalp Sptcialists, Inc. 55 F. C. 1840 (1959) "Under this order. as under similar orders requiring afiirmative disclosure of facts necessary to prevent an otherwise unqualified claim from being false or misleading, the disclosure must be made in immediate or close proximity with the claim and with equal prominence. The advertisement, regarded as a whole. should r:ot leave any impression negating or obscuring the necessary affirmative disclosure. for otherwise the order would be renclered nugatory. Opinion 68 FTC.

evidence as to the minor incidences of iron and vitamin deficiencies in the general population, it does negate a finding that a majority of tired persons in these smaU groups does not suffer from iron or vitamin deficiency and would not respond to Geritol. To the extent that the requirement for an affirmative disclosure in the examiner order extends to these groups, it is in error and wi1 be amended. Respondents' argument that the court' s ruling in the Alberty case precludes the Commission from requiring an affirmative statement in their advertising is without substance. In the first place, it is weU settled that where deception of the public has been found, the choice of a remedy is particularly within the discretion of the Commission." The authority of the Commission to require an affirmative disclosure where necessary to prevent such deception has Jong been recognized,"

In the Alberty case, the court ruled that merely informative disclosure cannot be required. The court referred to the definition of a false advertisement in Section 15 of the Federal Trade Commission Act, and held that the Commission must make certain findings before it can require affirmative disclosure. The court set aside the Commission s order requiring a disclosure on the grounds that no such finding had been made.

One of the things which the court in the Alberty case held would support an affirmative statement in advertising is a finding "that failure to make such statement is misleading because of things claimed in the advertisement.

In the case before us, the complaint charges that respondents failure to make an affirmative disclosure in their advertising in the light of the representations therein is in itself a cause of deception. The evidence of record, as previously discussed herein, fuUy supports that charge and we have so found. We think it clear on this record that an affirmative disclosure is required to dispel the otherwise misleading representations in respondents' advertising. Where, as here, the facts support the finding prescribed in the Alberty case, the courts have consistently upheld the Commission order. In particular, in several cases involving the advertising of preparations for preventing baldness, the courts have expressly ruled that the Alberty decision is no bar to an order requiring affirmative disclosure. In those cases, the Commission s order 10 Alberty v. Federal Trade Commission 182 F. 2d 36 (D. C. Cir. 19150). 11 Federal Trade Commission v. Mandel Bros. , Inc. 359 U. S. 385 (1959). 12 L. Heller Son, Inc. V. Federal Trade Commission 191 F. 2d 954 (7th Cir. 1951); Haske/ite Manufacturing Co. v. Federal Trade Commission 127 F. 2d 765 (7th Cir. 1942). 13 Ward Laboratories, Inc. V. Federal Trade Commission 276 F. 2d 952 (2d Cir. 1960); Keele Hair Scalp Specialists, Inc. v. Federal Trade Commission 275 F. 2d 18 (5th Cir. 1960). THE J. B. WILLIAMS CO. , INC. , ET AL. 549 481 Opinion required the advertisers to limit their claims for prevention of baldness to those cases not of the male pattern variety and to disclose that nearJy aU cases of baldness fall within that category and that in such cases the preparations would be of no value- These orders were based on a finding that the companies had represented that their preparations would cure aU causes of baldness and the further finding that most baldness is of the male pattern type on which the preparations would have no effect, and that the failure to affirmatively disclose this fact in advertising was misleading. Particularly appropriate to the Geritol advertising is the comment by the court in one of these cases H that "petitioners' own advertising requires the antidote" because it gave the impression that the condition for which the preparations were offered was largely caused by something which the preparations could cure. The unsoundness of respondents ' argument that the Alberty case bars the Commission from entering an order requiring an affirmative disclosure is further reflected in the fact that the same circuit which decided the Alberty case, in a subsequent decision upheld a Commission order containing such a requirement. The remaining issue before us involved the "masking" charge. In substance, the complaint charges that respondents ' advertisements are "misleading in a material respect because they fail reveal the material fact ':' " .; that, in women of any age beyond the usual child-bearing age and in men of aU ages, an established or existing deficiency of iron or iron deficiency anemia is almost invariably due to bleeding from some serious disease or disorder and in the absence of adequate treatment of the underlying cause of the bleeding the use of the preparations may mask the signs and symptoms and thereby permit the progression of such disease or disorder.

The hearing examiner sustained the charge, concluding from the evidence that there is a "real danger" of masking the signs and symptoms of iron deficiency anemia by the taking of Geritol. While in effect conceding that a theoretical possibiliJty of such masking exists, respondents contend that this record establishes that the combination of circumstances that would in theory permit masking to occur is almost never present.

Of primary importance in deciding this issue is the meaning given to certain of the terms used in the complaint. In particular, the validity of this charge depends to a great extent upon the intended Ward Laboratories . Inc. v. Federal Trade Commission, supra at 955. 15 Theodore Kogen Corp. v. Federal Trade Commission 283 F. 2d 371 (D. C. Cir. 1960). 550 FEDFR.\ TRADE COMMISSION DECISIONS Opinion 68 F. T.

meaning of the assertion that iron deficiency is "almost invariably due to bleeding from some " serious disease or disorder. As found by the examiner, the term "almost invariably" was defined by counsel supporting the complaint at a pretrial hearing as being synonymous with "always. " Although not mentioned by the examiner, it also appears that at the pretrial hearings, respondents were informed by complaint counsel that the words "serious disease or disorder" meant "one which causes bleeding and which normally progresses from a less serious to a more serious state. As thus defined and tried, the charge has not been established. In the first place, the evidence primarily relied upon by the examiner is the testimony of medical experts to the effect that, if they found iron deficiency anemia in a patient, they would suspect that it was caused by bleeding and would look for the cause. However, we believe that the examiner erred in concluding from this testimony that iron deficiency anemia is always caused by bleeding. While the primary concern of a doctor may be bJeeding, in our view this falls short of establishing that other causes or iron deficiency anemia do not exist.

Additionally, we are not convinced that on this record complaint counsel has established that, in cases of iron deficiency anemia due to bleeding, the bleeding is always caused by a disease or disorder which normally progresses from a less serious to a more serious state. For example, certain of the testimony quoted by the examiner, and other evidence of record, indicate that hemorrhoids are a frequent cause of iron deficiency anemia. However, we do not believe that the evidence is sufficient to support a finding that hemorrhoids is a serious disease or disorder which normally progresses.

We also note that at a prehearing conference, complaint counsel stated that the masking charge does not apply to a situation which the person has a sign or symptom of the underlying disease other than the tiredness symptoms. However, it appears from this record that most of the serious diseases which cause bJeeding, cited by the examiner, have additional symptoms which Geritol wil not relieve. We cannot conclude from this record that any relief from tiredness symptoms provided by Geritol wil cause a person with additional symptoms to delay treatment of the disease. Under the foregoing circumstances, respondents' appeaJ is granted in part and denied in part. As modified in accordance with this opinion, the initial decision is adopted as the decision of the Commission. An appropriate order will be entered. THE J . B. WILLIAMS CO. , INC. , ET AL. 551 481 Opinion VIDEO AUDIO BERT PARKS: Wen now, has theMS OF BERT PARKS, GERITOL DESK UNIT NOT IN VIEW, weather been like this in your part of the country? Snowy " * * blustery '" * * cold? FILM CLIP #SF- :14 SOUND: WIND HOWLING: (WINTER SCENE) (USE ONLY :10) CUT BACK TO BERT PARKS. As a result, have you been in bed with a cold. flu, fever? After such an ilness, if you suffer from iron-poor DOLLY BACK REVEAL blood you may find that recovery is bac.k your normalUNIT. slow. To get strength fast. when this is your problem, you should build up ironpoor blood. Now, if you ve been taking vitamins and still feel tiredremember, vitamins alone can t build up iron-poor blood.

But GERITOL can! BecausePICKS UP BOTTLE OF GERITOL TABLETS, DOLLY IN TO LOSE UNIT just 2 GERlTOL tablets HOLDS UP BOTTLE OF GERI- or 2 tablespoons of GERITOL liquid TOL LIQUID DISSOLVE BOTT SUPER: CARD contain 7 vitamins * plus * #G-548R3 "7 VITAMINS +"

(PULL -i) twice the iron in a pound of calvesUNDERCUT BOTT SUPER: CARD #G-164R3 liver. TWICE THE IRON IN A POUND OF CALVES' LIVER"

LOSE SUPER. GERITOL begins to strengthen ironpoor blood in twenty-four hours.

Check with your doctor. And if you feel rundown because of iron-poor blood * * * especially after a fever flu or virus * * * take GERITOL every day.

ll feel stronger fast * * * in CUT TO CARD #G-574R Y Qu just seven days * * * or your money DISPLAY OF PRODUCT WITH MESSAGE "FEEL STRONGER back from the GERITOL folks. FAST"

;) Opinion 68 F.

VIDEO AUDIO MS OF ART LINKLETTER IN ART LINKLETTER: The other COMMERCIAL AREA. day I heard a lady say, " I feel so tired every night, a team of horses couldn t drag me out!" If you feel e' * that worn-out tooa littletired funeven to go out and have feeling may be due to iron-poor blood. And if you ve been taking vitamins, yet still feel tired. remember vitamins alone can t build up iron-poor blood. But GERITOL can! Because *' * * HOLDS UP BOTTLE OF GER!- just 2 GERITOL tablets TOL TABLETS AND PICKS UP BOTTLE OF GER!- or 2 tablespoons of GERITOL liquid TOL LIQUID. POINTS TO IT.

DISSOLVE BOTTOM SUPER: contain 7 vitamins * plus CARD #G-548R3 "7 VITAMINS +" (PULL UNDERCGT BOTTOM SUPER twice the iron in a pound of calves CARD #G-164R3 "TWICE THE liver.

IRON IN A POUND OF CALVES' LIVER"

LOSE SUPER inin onlyyourone daybloodstreamGERITOL-ironcarryingis strength and energy to every part of your body. Check with your doc- * and if you ve been feeling tor worn-out because of iron- poor blood TCU OF LINKLETTER. GES- "' and especially after a cold, the TURES WITH BOTTLES. CLOSE flu or sore throat "' , *' take GERI- AS POSSIBLE TOL every day. Feel stronger fast, in just 7BOTTOM SUPER: CARD #G-283 FEEL STRONGER FAST" days or your money back from the GERITOL folks. And to save one UNDERCUT BOTTOM SUPER dollar ' * * buy the economy size. #SP-201 "SAVE $1.00 BUY ECON- OMY SIZE"

VIDEO AUDIO FE Lld MEDIUM SHOT, MOTHER IN LUCILLE STREAT: (RE- BOYS' ROOM STRAIGHTEN- FLECTIVE VOICE OVER) ING UP ROOM. feel so tired and run-down lately. THE J . B. WILLIAMS CO. , INC. , ET AL. 553 481 Final Order VIDEO AUDIO 2. MOVE INTO: CLOSE SHOT . I wonder what the trouble is? AS WOMAN STOPS TIDYING BOB SHEPARD: (VOICE PUTS HAND TO HEAD, EX- OVER) Your trouble may be HAUSTED. due to iron deficiency anemia. 3. ANIMATE ON GERITOL REC- 3. We call it '" * * TIRED BLOOD. TANGLE AROUND HER HEAD, POP ON WORDS TIRED BLOOD"

4. CROSS-DISSOLVE TO GERI- 4. Check with your doctor. And to TOL LABEL WITHIN OUT- feel stronger fast LINE. 5. DISSOLVE IN BOTTLE BE- 5. '" * * take GERITOL * * * the HIND LABEL. high potency tonic. 6. SAME WOMAN AND HER 6. In only one day GERITOL iron HUSBAND COMING IN FROM is in your bloodstream carrying GARDEN. CARRYING FLOW- strength and energy * ERS.

7. MOVE IN TO CD - SHE' 7. * * '" to every part of your body. HAPPY. ENERGETIC AND VIBRANT.

8. 2 GERITOL BOTTLES. WIPE 8. Take GERITOL "* liquid or ON "LIQUID" AND THEN tablets '" * every day. TABLETS". DISSOLVE OFF SUPER AND WIPE ON:

9. "FEEL STRONGER FAST" 9. Feel stronger fast within seven days '" or money back FINAL ORDER This matter baving been heard by the Commission upon respondents' appeal from the initial decision and upon briefs in support of and in opposition to said appeal; and The Commission having determined, for the reasons appearing in the accompanying opinion, that respondents' appeal should be granted in part and denied in part, and having further determined that the initial decision should be modified in certain respects: It is ordered That the hearing examiner s findings of fact numbered 96 through 131 in the initial decision, be, and they hereby are, rejected.

I t is further ordered That the initial decision be modified by striking the order to cease and desist and substituting therefor the following:

It is ordered That respondents, The J. B. Wiliams Company, Inc. , a corporation, and Parkson Advertising Agency, Inc. , a cor- Final Order 68 F.

poration, and their officers, and respondents' representatives agents and employees, directly or through any corporate or other device, in connection with the offering for saJe, sale or distribution of the preparation designated Geritol Liquid or the preparation designated Geritol Tablets, or any other preparation of substantially similar composition or possessing' substantially similar properties, under whatever name or names sold, do forthwith cease and desist from:

1. Disseminating or causing to be disseminated by means of the United States mails or by any means in commerce, as commerce" is defined in the Federal Trade Commission Act any advertisement:

(a) Which represents directly or by implication and without qualification that the preparation is an effective remedy for tiredness, Joss of strength, run-down feeJing, nervousness or irritability;

(b) Which represents directly or by implication that the preparation is a generally effective remedy for tiredness, Joss of strength, run-down feeling, nervousness or irritability;

(c) Which represents directly or by implication that the preparation is an effective remedy for tiredness, Joss of strength, run-down feeling, nervousness or irritability in more than a small minority of persons experiencing such symptoms;

(d) Which represents directly or by implication that the use of such preparation will be beneficial in the treatment or relief of tiredness, Joss of strength, run-down feeling, nervousness or irritability, unless such advertisement expressly limits the claim of effectiveness of the preparation to those persons whose symptoms are due to an existing deficiency of one or more of the vitamins contained in the preparation, or to an existing deficiency of iron or to iron deficiency anemia, and, further, unless the advertisement also discloses clearly and conspicuously that: (1) in the great majority of persons who experience such symptoms, these symptoms are not caused by a deficiency of one or more of the vitamins contained in the pre para tion or by iron deficiency or iron deficiency anemia; and (2) for such persons the preparation wil be of no benefit;

THE J. B. WILLIAMS CO. , INC. , ET AL. 555 481 Final Order (e) Which represents directly or by implication that tiredness, loss of strength, run-do"W feeling, nervousness or irritability are generally reliable indications of iron deficiency or iron deficiency anemia;

(1) Which represents directly or by implication that the presence of iron deficiency or iron deficiency anemia can be seJ! diagnosed or that either can generally be determined without a medical test conducted by or under the supervision of a physician;

(g) Which represents directly or by implication that the use of such preparation wil increase the strength or energy of any part of the body in any amount of time Jess than that in which the consumer may actually experience improvement;

(h) Which represents directly or by implication that the use of such preparation will promote convalescence from a cold, flu, fever, virus infection, sore throat or any other winter illnesses;

(i) Which represent directly or by implication that the vitamins supplied in such p:reparatibn are of any benefit in the trea tmen t or relief of an existing deficiency of iron or iron deficiency anemia.

2. Disseminating, or causing to be disseminated, by any means, for the purpose of inducing, or which is Jikely to induce directly or indirectly, the purchase of any such preparation in commerce, as "commerce" is defined in the Federal Trade Commission Act, any advertisement which contains any of the representations prohibited in, or which fails to comply with the affirmative requirements of, paragraph 1 hereof. It is further ordered That the hearing examiner s initial decision as modified and as supplemented by the findings and conclusions embodied in the accompanying opinion, be, and it hereby is adopted as the decision of the Commission- It is further ordered That respondents shall, within sixty (60) days after service upon them of this order, fiJe with the Commission a report, in writing, setting forth in detail the manner and form in which they have complied with the order to cease and desist set forth herein- Complaint 68 F.