E. C. Dewitt & Co., Inc.

Text (OCR of the scan at left; may contain errors)

IN THE MATTER OF E. C. DEWITT & CO. , INC.

ORDER, OPINION , ETC. , IN REGARD TO THE ALLEGED VIOLATION OF THE FEDERAL TRADE COMMISSION ACT Docket 8642. Complaint, Aug, 96.4--Decision, Dec. 16, 1966* Order requiring a New York City manufactu!'er of " Man Zan Pile Ointment" and other pile remedies to cease falsely representing in its advertising that its product wi1 shrink, avoid need for surgical treatment on, heal, cure, or remove hemorrhoids or effect any other cure beyond temporary relief.

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 E. C. De Witt & Co. , Inc., a corporation, hereinafter referred to as respondent has 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 E. C. Dewitt & Co. , Inc., is a corporation, organized, existing and doing business under the laws of the State of New York, with its principal offce and place of business located at 730 Fifth Avenue, in the city of New York, State of New York.

PAR. 2. Respondent E. C. Dewitt & Co. , Inc., is now and has been for more than one year Jast past, engaged in the sale and distribution of three preparations offered for the treatment of piles or hemorrhoids and coming within the classification of drugs as the term "drug" is defined in the Federal Trade Commission Act.

The designations used by respondent E. C. Dewitt & Co. , Inc., for said preparations, the formulas thereof and the directions for use are as follows :

A. Designation: Dewitt' s Stainless Man Zan Pile Ointment." Formula: Active Ingredients: CARBOLIC ACID % % BENZO- CAINE. ZINC OXIDE. ALLANTOIN, EPHEDRIKE HCI. Di1' sections: For palliative relief cleanse affected parts with warm water and toilet soap; dry with soft towel. After gently inserting the ").odif)(-'d on D"c- 15 , 1970 Complaint 70 F.

Stainless Man Zan applicator as faJ' as possible into the rectum, squeeze tube to apply a liberal quantity. Use night and morning, also after stooling when convenient.

CA UTIOX : Avoid using this preparation in case of undue bleeding', since this may indicate a serious condition requiring medical advice. B. Designation: "ll.fan Zan Pile Ointment, Formula: Active Ingredients: Ephedrine HCI Allantoin, Benzocaine Carbolic Acid 0.5 % Menthol, Tannic Acid. Directions: For palliative relief cleanse affected parts with \Varm water and toilet soap; dry with soft towel. After gently inserting the Man Zan applicator as far as possible into the rectum, squeeze tube to apply a liberal quantity. Vse night and morning, also after stooling when convenient.

CAUTION: Avoid using this preparation in case of undue bleeding since this may indicate a condition requiring medical advice. C. Designation: Dewitt' s Stainless I\'1an Zan Suppositories. Formula: Active Ingredients: Benzocaine Zinc Oxide, Phenol 0. Allantoin, Phenylpropanolamine.

Direc6ons: Before using Man Zan Suppositories remove the protective foil wrapping. Vlash affected pal'to: , then insert the suppository as high as possible into the rectum. Use morning' and night and after each bo,..e1 movement. Treatment should be con6nued daily for best results. External discomforts are best treated with Man Zan Pile Ointment-Stainless or Regular.

CA UTION: If reHef is not obtained in a reasonable period of time, and in cases of undue bleeding, consult your physician. PAR. 3. Respondent E. C. Dewitt & Co. , Inc. , causes the said preparations, when sold, to ue transported from its place of business located at 2835 SheffeJd A venue, Chicago 14, Ilinois, to purchasers thereof located in various other States of the United States and in the District of Columbia. Respondent maintains, and at all times mentioned herein has maintained, a course of trade in said preparations in commerce, as "commerce" is defined in the Federal Trade Commission Act. The volume of business in such commerce has been and is substantial. PAR. 4. In the course and conduct of its business, respondent has disseminated, and caused the dissemination of, certain advertisements concerning the preparations referred to in Paragraph Two, above, by various means in commerce, as "commerce " is defined in the Federal Trade Commission Act, including, but not limited to advertisements in newspapers, magazines and other advertising media, for the purpose of inducing and which were likely to induce, directly or indirectly, the purchase of said preparations; and has disseminated, and caused the dissemination of advertisements concerning said preparations by various means , E. C. DEWITT & CO. , INC. 1649 1647 Complaint including but not limited to the aforesaid media for the purpose of inducing and which were likely to induce, directly or indirectly " isthe purchase of said preparations in commerce, as "commerce defined in the Federal Trade Commission Act. PAR. 5. Among and typical of the statements and representations contained in said advertisements disseminated as hereinabove set forth are the following:

Itching and Soreness of hemorrhoid discomfort quickly relieved with De- Witt' s Manzan. Manzan contains Allantoin for healing, benzocaine to ease pain, and a vasoconstrictor to help reduce swelling. For soothing action and fast palliaiive relief, try. . . Manzan ointment or Suppositories HEMORRHOIDS Real Relief . . When simple hemorrhoids cause agony. . .

. . . a special healing agent.

. . . to ease pajn . . . reduce swel1ng. REAL RELIEF FROM HEMORRHOIDS . . now even more effective with Allantoin, a special1 healing agent. PAR. 6. Through the use of said advertisements and others similar thereto not specifically set out herein, respondent has represented and is now representing, directly and by implication that the use of DeWitt's Stainless Man Zan Pile Ointment, Man Zan PiJe Ointment, DeWitt's Stainless Man Zan Suppositories, and each of them, wil:

1. Reduce piles;

2. Heal piles;

3. Be effective in relieving severe or agonizing pain of piles; 4. Relieve alj pain or itching caused by piles. PAR. 7. In truth and in fact the use of DeWitt's Stainless Man Zan Pile Ointment, "Ian Zan Pile Ointment, Dewitt' s Stainless Man Zan Suppositories, or each of them will not: 1. Reduce piles;

2. Heal piles;

3. Be effective in relieving severe or agonizing pain of piles; 4. Relieve al1 pain or itching caused by piles; 5. Afford any relief or have any therapeutic effect upon the condition known as piles, or upon any of the symptoms or manifestations thereof, in excess of affording temporary relief of minor pain or minor itching associated with piles. Therefore, the advertisements referred to in Paragraph Five were and are misleading in material respect and constituted and now constitute false advertisements " as that term is defined in the Federal Trade Commission Act.

16f50 FEDERAL TRADE COMMISSION DECISIONS Opinion 70 F.

PAR. 8. The dissemination by the respondent of the false advertisements, as aforesaid, constit.uted, and now constitutes, unfair Hnd deceptive acts and practices in commerce, in violation of Sections 5 and 12 of the Federal Trade Commission Act. OPINION OF THE COMMISSIO)/ DECEMBER 16 , 1 96 6 BY JO)/ES Commi.ssioner:

The complaint in this matter, issued on August 28 , 1964, charged that respondent violated Sections 5 and 12 of the Federal Trade Commission Act by making false representations in advertising its preparations sold under the names of "Dewitt' s Stainless Man Zan Pile Ointment ::1an Zan Pile Ointment " and "De- Witt's Stainless Man Zan Suppositories " for the treatment of hemorrhoids or piles. ' The complaint aIJegcd and respondent in its answer admitted that it maintained a course of trade in said preparation in commerce within the meaning of the Federal Trade Commission Act.

Paragraph Five of the complaint charged that the following were typical of the statemcnts made by respondent in its advertising:

Itching and Soreness of 11emorrhoid discomfort quickly relieved with De V'litt' s ::anzan. 1Ianzan contains Allantoin for healing, benzocaine to ease pain, and a vasoconstrictor to help reduce swelling. For soothing action and fast palliative relief, try. . . ::lanzan ointment or Suppositories. HEMORRHOIDS Real Relief . Woen simple hemorrhoids cause agony. . .

a special healing agent.

. . . to ease pain. . . reduce swelling. REAL RELIEF FROM HEMORRHOIDS now even more effective with Allantoin, a special healing agent. Paragraph Six of the complaint charged that through the use of these advertisements and others respondent had represented that use of Mandan will: (1) reduce piles; (2) heaJ piles; (3) effective in relieving severe or agonizing pain of piles; and (1) relieve all pain or itching caused by piles. Respondent denied the allegations in this paragraph except insofar as this paragraph alleged that respondent represented " that the use of its prepara- 1 The terms.S "hemorrhoi,h" find "piles " alc synonymous (Finding of Fact 11; and will be used interchangeably herein. HeJ" inafter the l'aragral'hs of the Findings of Fact in thb case wil be referred to as "

E. C. DEWITT & CO. , I:-C. 1651 1647 Opinion tions will be effective in relieving pain of simple piles" (Answer Par. 6).

In Paragraph Seven the representations set forth in Paragraph Six are alleged to be false and it is further alleged that Mandan wi1 not " (a)afford any relief or have any therapeutic effect upon the condition known as piles, or upon any of the symptoms or manifestations thereof, in excess of affording temporary relief of minor pain or minor itching associated with piles. " Therefore, it is concluded in this paragraph that respondent' s advertisements were misleading in material respects and constituted " false advertisements" within the meaning of the Federal Trade Commission Act. Respondent denied the allegations in this paragraph except that it admitted that "the use of respondent's preparations wi1 not relieve all pain or itching caused by piles" (Answer Par. 7) .

The complaint in this matter was issued simultaneously with four other complaints also charging misrepresentations in the advertising of hemorrhoidal preparations, namely: Humphreys Medicine Company)), Incorpomted Docket 8640 (p. 1502 herein), American Home P,'odncis Corporation Docket 8641 (p. 1524 herein), G1've Labomtories, Incorpomted, Docket 8643 (71 F. 822) and The MeJltholrdmn Company)), Docket 8644 (p. 1671 herein). Hearings in the A me?'ican Home Products case took place in April and May 1965, and the initial decision in that case was rendered on October 22, 1965. Complaint counsel appealed. On January 12 , 1966, before argument of his appeal, complaint counsel moved in each of the other four cases to suspend hearings pending the issuance of the Commission s decision in Ame?' ican Home Products.. This motion was denied by the Commission on March , 1966, and respondents in each of these four cases moveQ for reconsideration. On April 26, 1966 (69 F. C. 1179), the Commission entered an order directing the examiner to proceed with the hearings in each of these cases unless the parties desired to enter into a stipulation providing essentially that their cases may be disposed of on the basis of the record and findings in the American Home Products case. On May 25, 1966 respondent and complaint counsel filed a stipulation in accordance with the provisions of the Commission s order of April 26 , 1966. The stipulation provided that the Commission may issue such order as it deems necessary in the public interest on the basis of 2 The terms of this stipulation (hereiIlsfter referred to as "Stip, ) are set forth in full in Opinion 70 F.

the facts stipulated by the parties and that the respondent waived any intervening steps before the hearing examiner. The parties further stipulated that the advertisements in the case had no significantJy different effect upon readers from the effect of the advertisements in A american Home Products.. that the effect of the use of respondent's preparation is not significantly different from the use of American Home Products' preparation; and that, to the extent that respondent's advertisments differ significantly from those in American Home Products, the Commission may, in its order disposing of this proceeding, include appropriate provisions to take into consideration such differences. Attached to this stipulation are the texts of four virtually identical advertisements. The following is the full text of two of these advertisements:

Real Relief from Hemorrhoids. .When simple hemorrhoids cause agony and embarrassing itch, use De"\Vitt's Mandan-now even more effective with Allantoin, a special healing agent. Mandan also contains benzocaine to ease pain, and a vasoconstrictor to help reduce swelling. For soothing action and fast palliativp. relief, try. . . ::fanZan-Ointment or Suppositories. On the basis of the pleadings, the stipulation of the parties and the attached advertisements, together with such portions of the record in American H mne Products as are specified in the attached findings. we conclude that we have jurisdiction over respondent and the subject matter and that respondent was engaged in commerce and accordingly are entering our Findings of Fact and Conclusions in the matter.

DISCUSSION OF ISSUES A. Repl' esentations Made by Respondent in Its Advel.tisements Respondent is charged with representing that its product wil (1) reduce hemorrhoids, (2) heal hemorrhoids, (3) relieve al1 pain and be effective in relieving severe or agonizing pain of hemorrhoids, and (4) relieve al1 itching caused by hemorrhoids. In A american Home Products we found that respondent had represented that its preparation would "reduce or shrink hemorrhoids heal, cure, or remove hemorrhoids, and cause hemorrhoids to cease to be a problem relieve all pain attributed to or caused by hemorrhoids" and "eliminate all itch due to or ascribed to hemorrhoids " (F.8). In Par. 3 of the stipulation executed by the parties, it is provided that the advertisments in the instant case had no significantly different effect upon readers from the effect E. C. DEWITT & CO. , INC. 1653 1647 Opinion of the advertisements in American Home PTod1Wts. Accordingly, on the basis of this provision of the parties' stipulation alone, we could conclude that respondent's advertisements represent that the alleged representations were in fact made by respondent. However, there is no need to rely exclusively on parties' stipulation for this conclusion since the advertisements speak for themselves and our own independent examination of them enables us to determine whether the complaint allegations as to the representations made in these advertisements may be sustained. (J) Respondent's claims respecting shrinkage or reduction of hemorrhoids Respondent' s advertisements state that its products contain " vasoconstrictor to help reduce swelling," Since a "vasoconstrictor is an agent \which causes constriction of blood vessels (Webster s New International Dictionary, Second Edition), the clear implication of this statement is that the hemorrhoids or blood vessels will be reduced and not merely that the overlying tissue will be reduced in size. Furthermore, the only meaning which the reader could ascribe to the claim that a medication for hemorrhoids will help reduce swelling is that jt wi1 reduce or shrink hemorrhoids. Accordingly, we conclude that respondent' claims in its advertising are tantamount to direct representations that its product will shrink hemorrhoids. (2) Respondent's claims respecting hearing of hemorrhoids Respondent' s advertisements state that Mandan contains "AIlantoin, a special healing agent. " Since the only apparent function of a "healing agent" would be to heal, the reference to such an agent necessarily carries with it the implication that respondent' s product heals hemorrhoids. Thus, in our opinion respondent' s claims are tantamount to representations that its product wi1 heal hemorrhoids.

(3) Respondent's claims respecting pain Respondent promises in its advertising that its product wi1 provide "real relief from hemorrhoids" and states that Mandan \vhieh "contains benzocaine to ease pain " should be used when simple hemorrhoids cause agony, " Respondent's claims are unequivocal and do not permit even an inference that the relief actually afforded may be partial or temporary. The reference to the word "benzocaine " a local anesthetic (Webster s New International Dictionary, Second Edition), implies that the preparation .

Opinion 70 F.

wil produce anesthesia or paralysis of the sensory apparatus in the affected area (rd. ) thus effecting a total absence of pain or other feeling. In our opinion a substantial portion of the purchasing public would conclude from these broadly worded statements not merely that severe or agonizing pain will be relieved by Man. Zan, as alleged in Paragraph Six (3) of the complaint, but further that alj pain resulting from hemonhoids wi1 be relieved, as alleged in Paragraph Six (4). Furthermore, the representations pertaining to hearing referred to above would also tend to cause the reader to believe that the symptoms, including pain, would be eliminated after the "healing agent" had acted to heal the hemorrhoid. Accordingly, we conclude that the statements in respondent' s advertisements constitute representations that its product will relieve a1l pain, including severe or agonizing pain, attributed to or caused by hemorrhoids.

(4) Respondent's claims respecting itching Respondent advertises that its product should be used "when simple hemorrhoids cause agony and embarrassing itch " that itching, of hemorrhoid discomfort (isJ quickly relieved with DeWitt's lVanZan" and the product oHers "real relief from hemorrhoids. " In our opinion these statements unquestionably promise complete relief from the itching due to hemorrhoids and that the average reader would be under the impression that if he used Mandan he would have real or entire relief from itching due to hemorrhoids.

B. Deceptive Nature of Respondent' s Claims The parties have stipulated that the facts applicable to this case support the stipulation that the effect of the use of respondent' s preparation is not signiflcantly difierent from the eflect of American Home Products' preparations (Stip. , Par. 4). Accordingly, the findings of fact and conclusions reached in American Home Products with respect to the effcacy of Preparation H drawn from the record and Findings of Fact in that case, are equal1ly applicable to lVIauZan. It is in the light of these findings and conclusions, therefore, that the allegations in Paragraph Seveu must be analyzed. Respondent has admitted in its answer that lVanZan "will not relieve a1l pain or itching" (Answer, Par. 7), Therefore, our discussion will be confined to the remaining issues relating to the effcacy of Mandan.

E. C. DEWITT & CO. , I:-C. 1655 1647 Opinion (1) Ability of Mandan to reduce hemorrhoios Paragraph Seven (1) of the complaint alleges that, contrary to respondent' s representations, Mandan will not reduce hemorrhoids.

Respondent advertises that Mandan contains " a vasoconstrictor to help reduce swellng." We have concluded that this representation amounts to a claim, and wil be understood by the hemorrhoidal sufferer as a claim, that his hemonhoids will be reouced in size. Hemonhoids arc by definition veins located underneath the mucous membrane of the rectum and the skin of the anal canal (F. 10). The evidence in the record is that hemonhoidal preparations such as Mandan may have some effect upon edema or swelling in the tissue overlying hemorrhoids (F. 25(c), 26), but that they cannot reduce the size of the hemorrhoidal veins (F. 25 (b), 26). The recorrl also demonstrates, however, that this product can have no beneficial eflect when the swelling is due to thl'mbosis (F. 25 (c), 26). Thus, even if we were to assume that some reduction of sweIJing is effected by respondent's preparation, not all types of swelling will be aftected in this way, and furthermore the reduction which will occur will not be of the hemorrhoid itself but only of the surrounding area and thus wil not be of the type implicitly promised by respondent's advertising. Accordingly, we fino that )'respondent' s representations with respect to reduction or shrinkage of hemorrhoids are in all respects false and misleading.

(2) Ability of Mandan to heal hemorrhoids Paragraph Seven of the complaint alleges that contrary to respondent' s representations, ManZau wil not heal hemorrhoids, The record applicable to this case demonstrates that sUl'gicaJ removal is the only means by which hemonhoids can be permanently cured (F. 22). Although certain symptoms may be ameliorated by other means (F, 24, 25) and may disappear spontaneously (F, 21), unless the underlying vascular condition corrected, the patient will be subject to recurring episodes of symptoms (F. 21). Since Mandan cannot affect the underlying dilated veins it cannot heal or cure hemorrhoids (F. 25 (a), 26). (3) Ability of Mandan to relieve severe or agonizing pain caused by hemorrhoids It is alleged in subparagraphs (2) and (3) of Paragraph 4 the complaint that Mandan will not "relieve all pain '" '" * caused by piles or be "effective in relieving severe or agonizing pain of 1656 FEDERAL TRADE COM MISSION DECISIONS Opjnion 70 F.

piles." Respondent has admitted that its preparations "wil not relieve alj pain " " * caused by piles " (Answer, Par . 7). Since all pain is agonizing to many, if not most users and since Mandan admittedly cannot relieve alj pain, it therefore follows that it is not capable of relieving "agonizing" pain in a substantial portion of hemorrhoidal sufferers. Furthermore, according to the record opplicabJe to this case, severe pain in hemorrhoids is frequently caused by spasm or strangulation of a prolapsing internal hemorrhoid (F. 16) or by an external thrombotic hemorrhoid (F. 17) and that Mandan will have no effect upon pain when attributable to these causes (F. 25(d), 26). Thus it is clear that respondent' claims implying that it can eliminate all severe or agonizing pain of hemorrhoids are false and misleading. C. Alleged Absence of Othet Thempeutic Benefits of Mandan In addition to the allegations that respondent' s affrmative representations with respect to its product are false, the complaint also alleged that Mandan wi1 not" (aJ afford any relief or have any therapeutic effect upon any of the symptoms or manifestations thereof, in excess of affording temporary relief of minor pain or minor itching associated with piles" (Complaint, Paragraph Seven (5)).

As we have noted, the record demonstrates that surgical removal is the only means by which hemorrhoids can be permanently cured (F. 22) and that JanZan will not heal, cure or remove hemorrhoids or cause them to cease to be a problem (F. 25 (a), 26). The record also demonstrates that while JVanZan ma)' in some cases provide some temporary relief from two symptoms of hemorrhoids, namely, pain and itching (F. 25(d) and (e), 26), it will not afford any other type of relief or have any other therapeutic effect upon hemorrhoids or its symptoms (F. 25 (e) (0, 26). Accordingly, we conclude that the allegations in Paragraph Seven (5) of the complaint must be sustained. III THE ORDER The parties have stipulated that the Commission may issue such order as it deems necessary in the public interest, taking into consideration any significant differences between respondent' s advertising and those of A1nerican H01ne Prodl!cts (Stip. Pars. 6 and 7).

In determining \vhat order is necessary to ensure that respondent' s misrepresentations respecting the effcacy of its drug E. C. DEWITT & CO. , INC. 1657 1647 Opinion preparation wiJ not occur again, it is of primary importance to consider the segment of the public which is most likely to be particularlyaffected by these representations. Our mandate under the Jaw was graphically expressed by Judge Clark when he emphasized that "the law is not 'made for the protection of experts, but for the public-that vast multitude which includes the ignorant, the unthinking and the credulous.' Charles of the Ritz Distrib,dillg C01'Jomtion v. Federal TT(ule Commission 143 F. 2d 676, 679 (2nd Cir. 1944). The need for protection of the public becomes particularly acute where misrepresentations are made with respect to health claims and the ef1cacy of drugs since the appeal of such representations facts most poignantly on those persons who are in distress frequently the aged and the infirm. Moreover, today, with Medicare a reality, many people may be consulting doctors for the first time in their lives. They wil be learning that aches and pains and discomforts of all kinds may he symptoms of diseases which they had never heard of before or never before associated with their o\vn distress. Consequently, advertised claims of drug- effcacy will have increasing relevance to this segment of our population and will offer hope of relief to milions in our population who may have previously ignored such advertising not realizing their possible application to their own conditions. Acc01'dingly, it becomes of even greater importance today to make sure that representations respecting health claims and relief of distress are absolutely accurate and do not contain promises, impressions, or even highly veiled suggestions of effcacy which are in any sense false or misleading. It is with these basie principles in mind that we must fashion the type of prohibitive provisions which are necessary to be included in the order in this case.

A. P,' oduct Application of the Orde,. The order proposed by complaint counsel provided that it was to be applicable to :VlanZan " or any other preparation of substanfialllf similar composition 01' possessing substantially similar properties (emphasis added). As we noted in our opinion in American Home Products with respect to Preparation H, under such an order the respondent could easily replace the ingredients in its product with those that are not "substantially similar" or which did not possess "substantially simjlar properties " and be exempt from the order even though such substitute product may be equally ineffective in relieving symptoms of hemorrhoids , p.

Opinion 70 F.

(American Home PTod11cts Opinion, pp. 1623-1625)..' And, as we further pointed out in American Home Products determination of whether or not the new ingredients were "substantially similar or possessed "substantially similar properties would be diffcult of enforcement and would only be productive of controversy and probably litigation (American Home Products Opinion 2623). Consequently, we are entering an order in the instant case comparable to that entered in American Horne PToducts which is applicable to all preparations which may be sold by respondent for relief or treatment of hemorrhoids 01' its symptoms regardless of whether they contain the same or different ingredients from those contained in Mandan. Finally, as we pointed out in detail in our opinion in the Amen ca.n Home PTodlJCtS case, this provision in no way hinders respondent from developing a truly effcacious remedy for hemorrhoids which might enable it to make some of the claims which this order now prohibits it from making. In this situation respondent need only apply to the Commission for a modification of the order as specifically provided for in the order which we are entering.

B. Respondent' s Representations Respecting the EffcCLClI of Mandan The order which we are entering prohibits respondent from representing directly or by implication that its product will reduce or shrink hemorrhoids; heaJ hemorrhoids; afford any relief from pain and itching, in exces of providing some temporary relief in some cases of pain and itching; or have any other effect on hemorrhoids or its symptoms. In connection with the prohibition of further representations as to Mandan s alleged ability to heal hemorrhoids we have also prohibited respondent from claiming that surgery may be avoided through the use of its product. Since surgery is the only certain cure for hemorrhoids (F. 22), it is obvious that the use of Mandan cannot obviate surgery where it is needed (F. 25 (a), 2(;). Although respondent makes no speci fie claims to this effect in its present advertising, the Commission is goal." Federalobligated "to close alj roads to the prohibited Tmde Commission v. Ruberoid 343 U. S. 470 (1953). In its advertising respondent stresses that its preparations contain three ingredients: (1) "AIJantoin, a special healing agent "It is llppal'cnt from the nature of the ingredients in respondent s prejlllration (F, 3) that they in aij Jikelihood are repla cable by other inl'Terlients which mi::ht have no different effect on hemorrhoi(ls and yet be wholly outsille the order if it Illlplierl only to M..nZan or other prcpllJ'ations cuntaining similar ingrerlients, E. C. DEWITT & CO. , INC. 1659 1647 Opinion (2) "benzocaine to ease pain" and (3) "a vasoconstrictor to help reduce swening." We are prohibiting respondent from referring to each of these ingredients.

(1) Allantoin Since, as we have found, Mandan cannot heal" hemorrhoids, the so-called "healing agent Allantoin can in fact perform no useful function. It is clear that continued reference by respondent to A11antoin in its advertising would be highly misleading and would imply to the public that the product is capable of healing hemorrhoids, \vhereas, according to the record, it is unable to provide more than some paniative relief. To prohibit respondent from representing that ;VlanZan has any healing characteristics and to permit it to continue to represent that its product contains Anantoin, its purported "healing agent would be to nunify in major part the prohibition respecting the curative properties of its product.

(2) Benzocaine As we have noted, the reference in respondenes advertising to "benzocaine," a local anesthetic, is equivalent to a direct claim that entire relief from pain in the affected area wil be achieved. In view of our findings and conclusions that Mandan wil not relieve an pain, any use of this term would therefore be wholly false and misleading. We have found that respondent' s product win at best only afford some temporary relief in some cases of pain associated \vjth some types of hemorrhoids. If this temporary relief is due to benzocaine, it would be redundant to permit respondent to single this ingredient out for special mention in its advertisement in addition to making the permitted disclosure respecting temporary relief for some cases of pain and would serve only to confuse and mislead the reader or hearer. To the extent singling such an ingredient out for special emphasis conveyed an impression different from this disclosure, it would bc false and misleading. Accordingly, we have prohibited use of this word.

(3) "Vasoconstrictor As we have pointed out, ;VlanZan is not capable of reducing the size of hemorrhoids. Since, as we have further found, the word "vasoconstrictor " (literany (bloodJ vessel constrictor) implies that the hemorrhoid win be shrunk, the further reference by respondent to this ingredient can only have the effect of emphasizing that which Mandan is incapable of achieving: the shrinkage of hemorrhoids. To avoid the deception inherent in the use of this word we have ordered that respondent discontinue its use.

Finally, in view of the likelihood that reference to any single Findings 70 F. T.

ingredient may convey the impression that such ingredient is of special importance in the treatment or relief of hemorrhoids, we have provided that respondent may not refer to any other ingredient either singly or in combination unless each such ingredient is effective in the treatment or relief of hemorrhoids 01 any of its symptoms and unless the specific effect thereof is expressly and truthfully set forth.

FINDINGS OF FACT, Conclusions AND ORDER FINDINGS OF FACT A. Respondent and its PTOd1lcts 1. Respondent E. C. Dewitt & Co. , Inc. , is a corporation, organized, existing and doing business under the laws of the State of Kew York, with its principal offce and place of business located at 730 Fifth Avenue, in the city of Kew York, State of Kew York (Complaint, Par. 1; Answer, Par. 1).

2. Respondent E. C. Dewitt & Co. , Inc., is now and has been for more than one year last past, engaged in the sale and distribution of three preparations coming within the classification of drugs as the term "drug" is defined in the Federal Trade Commission Act (Complaint, Par. 2; Answer, Par. 2). 3. The designations used by respondent E . C. Dewitt & Co. Inc. , for said preparations, the formulas thereof and the directions for use are as follows:

A. Desi gnotion: DcVolU' s Stainless Man Zan Pile Ointment." Formula: Active Ingredients: CARBOLIC ACID % BENZO- CAINE , ZINC OXIDE. ALLA:\TOI:\, EPHEDRINE HCI. !J1:recti()ns: For palliative relief cleanse affected parts with warm water and toilet soap; dry with soft towel. After gently inserting the Stainless Man Zan applicator as far as possible into the rcctum, squeeze tube to apply a liberal quantity. Use night and morning, also after stooling when convenient.

CAVTIOX: Avoid using this preparation in case of undue bleeding:. since this may indicate a seJ' ious condition requiring medical advice. B. Designa.tio"r1: Man ZRn Pile Ointment. F01'ilulo: Active ingredients: Ephedrine HCI Allantoin, Benzocaine Carbolic Acid. 0. 5 (/(- Menthol, Tannic Acid, Dircctio1i8: For palliative relief clt'ansf' affected parts with \Va1111 \vater and toilet soap; dry with soft towel. After gently inserting the Man Zan applicator as far as possible into the rectun, squeeze tube to apply a liberal quantity. "Cse nig-ht and morning, also after stooJing \vhen convenient.

CA UTION: Avoid using this preparation in case of 'Jndue bleeding since this may indicate a condition requiring medical advice. E. C. DEWITT & CO., INC. 1661 1647 Findings C. Designation: Dewitt' s Stainless Man Zan Suppositories, Fonnula: Active Ingredients: Benzocaine Zinc Oxide, Phenol 0. Allantoin, Phenylpropanolamine.

Directions: Before using 1an Zan Suppositories remove the protective foil wrapping. Wash affected parts, t.hen insert the suppository as high as possible into the rectum. Use morning and night and after each bowel movement. Treatment should be continued daily for best results. Exter nal discomforts are best treated "wjth Man Zan Pile Ointment-Stainless or Regular.

CA etion: If relief is not obtained in a reasonable period of time, and in cases of undue bleeding, consult your physician. 4. Respondent E. C. Dewitt & Co. Inc., causes the said preparations, when sold, to be transported from its place of business located at 2835 Sheffeld Avenue, Chicago 14, Ilinois, to purchasers thereof located in various other States of the United States and in the District of Columbia. Respondent maintains, and at aU times mentioned herein has majntained, a course of trade in said preparations in commerce, as "commerce" is defined in the Federal Trade Commission Act (Complaint, Par. 3; Answer, Par. 3). B. Stipulation Entered Into By Parnes Hereto 5. The parties hereto entered into a Stipulation, filed on May , 1966, providing as follows:

1. This proceeding may and shall be submitted to the Commission for disposition on the basis of record in Docket 8641 American Home Products CorporntJon and such otner stipulatior:.s and records as are provided for herein. 2. The advertisemcmts attached to and made a part of this stipulation are representative of respondent's advertising claims for its product :JanZan and are to be included in the record of these proceedings- 3. The advertisements in this case had no significantly different effect upon readers from the effect of the advertisements in American Home Products and tht' facts applicable to this case support this stipulation. 4. The eflect of the use of respondent's preparation, Man Zan, is not significant1y different from the use of Am.erican Home Products preparation kno\vn as " Preparation H " and the facts applicable to this case support this s.tipulation.

5. The respondent waives any further intervening procedural steps before the Hear ng Examiner.

6. Thro Commission may, on the basis of this stipulation, the attached advertisements and the record in Ame1-ican Home Products issue such order as it dcems necessary to the public interest. 7. To the extent that the respondent s advertisements differ significantly to those in Aii):Ticu/I Home Products, the Commissjon may, in its order disposing of the proceedings, include appropriate provisions to take into consideration such differences- 8. The Commission is to issue its order disposing of these proceedings COTI- Findings 70 F.

currently with the order setting forth its final decision in Ame?'ican Home Products.

9. The record on which the Commission is to make its disposition of the proceeding and for the purposes of judicial review, is limited to the record at the time this stipulation is filed, this stipulation "with the attached advertisements and the record in American Home Products. Attached to this stipulation (hereinafter referred to as "Stip. are copies of four of respondent' s advertisements. C. Representations I'l ade 6. In the course and conduct of its said business, respondent has disseminated, and caused the dissemination of, certain advertisements concerning the said preparation in commerce, as "commerce" is defined in the Federal Trade Commission Act, for the purpose of inducing and which were likely to induce, directly or indirectly, the purchase of said preparation; and has disseminated, and caused the dissemination of, advertisements concerning said preparation for the purpose of inrlucing and which \V€l'€ likely to induce, directly or indirectly, the purchase of said preparation in commerce, as "commerce" is defined in the Federal Trade Commission Act (Complaint, Par. 4; Answer, Par. 4; Stip. Par. 2).

7. Among the statements and representations contained in said advertisements disseminated as hereinabove set forth are the following:

Real l'Clief from Hemorrhoids. \Vhen simple hemorrhoids cause ag-ony and embarrassing" itch, use DeWitt's Mandan-now even more effective with AI- 1antoin, a special hearing agent. Mandan also contains benzocaine io case pain, and a vasoconstrictor to help reduce swelling. For soothing action and fast palliative relief, try. . . 1\IANZAN Ointment or suppositories. Itching and soreness of hemorrhoid discomfort quickly relieved with De- "Vitt' s Mandan. 1'v1anZan contains Ailantoin for healing, benzocaine to case pain, and a vasoconshictor to help reduce swellng. For soothing action and fast palliative relief, try. . . MANZAN Ointment OJ' Suppositories. (Stip. (attachmentsJ).

D. Meaning of Respondent' s Representations 8. In A mericnn Home Products Corpomtion Docket 8641 (p. 1524 hereina, we found that through the use of American Home Products Corporation s advertisements, said respondent has represented and is now representing, directly and by implication, that the use of Preparation H Ointment and Suppositories and each of them, wiJ :

.

E. C. DEWITT & CO. , INC. 1663 1647 Findings (a) Reduce or shrink hemorrhoids; , (b) A void the need for surgery as a treatment for hemorrhoids;

(c) Eliminate al1 itch due to or ascribed to hemorrhoids; (d) ReHeve a11 pain attributed to or caused by hemorrhoids; (e) Heal, cure or remove hemorrhoids, and cause hemorrhoids to cease to be a problem.

(American Home Products Corpomtion Docket 8641, Finding of Fact 7.

9, Through the use of the advertisements set forth in paragraph 7 hereof, and others similar thereto not specifically set out therein, respondent has represented and is now representing, directly and by impHcation, that the use of Mandan Ointment or Suppositories wil :

(a) Reduce or shrink hemorrhoids;

(b) Avoid the need for surgery as a treatment for hemorrhoids;

(c) EJiminate al1 itch due to or ascribed to hemorrhoids; (d) Relieve all pain attributed to or caused by hemorrhoids; (e) Heal, cure or remove hemorrhoids, and cause hemorrhoids to cease to be a problem.

(Stip. , Par. 3.

E. Gener(11 Mediwl Facts Pertaining to Hemorrhoids and Their Treatment 10. "Hemorrhoids" are masses of di!ated weak-wal1ed veins Jocated underneath the mucous membrane of the lower portions of the rectum and under the skin of the anal canal and the peri-anal area (A, P. Tr. 193, 255, 340, 413-414, 478, 543, 606, 709, 817 838 867, 892) .

11. The terms "hemorrhoids" and "piles" are synonymous (A. P. Tr, 117 193 255 340 414, 478-479, 543 607 and 709). 12. "Internal hemorrhoids " are hemorrhoids occurring above the pectinate line and are covered by mucosa. HExternal hemorrhoids " are hemorrhoids occurring below the pectinate line and are covered by skin (A. H.P. Tr. 193, 199, 232, 236, 255-257, 262 342 420, 421, 486 548 549 608, 609 817, 838 867 and 892). 13. An "external thrombotic hemorrhoid" is a blood cJot under 1 The \\ord hemonhoids " find "lJileg" are synonymous (See Fimling II infra) and wil be used intc!'chanl'eabJy hercil'.

"The rnuClg'" aphs of the Findings of Fact in imen:can Home. Frod1lcta are hereinafter referred to as " P. - 3 The references are to the transcript in American Home PToducts. Findings 70 F.

the surface of the skin Jocated in the immediate vicinity of the anal opening (A.H.P. Tr. 117). It is also referred to as an "anal hematoma " (A. P. Tr. 719) or a "perianal thrombosis " (A. Tr. 549).

14. A "prolapse" or "prolapsing hemorrhoid" is an internal hemorrhoid which, due to laxity of the rectum is enabled to fall outside the anal canal and protrudes to the surface (A.H.P. Tr. 199) .

15, Hemorrhoids develop in a human being largely because of the fact that he stands in an upright position. In such a position a column of blood is formed from the splenic to the superior hemorrhoidaJ vein. The hemorrhoidal veins do not have valves to support the weight of this column of blood. The resulting pressure causes the hemol'hoidal veins to dilate (A. P. Tr. 594, 231). Hemorrhoids tend to be hereditary (A. P. Tr. 144, 231). Other factors leading to the development of hemorrhoids are abnormally long periods of standing, straining, diffculty with bowel movement, impacted stool, pregnancy and cirrhosis of the Jiver (A. P, Tr. 231-232, 144).

16. The most common symptom of internal hemorrhoids is bleeding (A, P. Tr, 256, 393 479). The other principal symptom of internal hemorrhoids is prolapse (A. P, 1'1' 256). Pain rarely occurs in internal hemorrhoids since the sympathetic nervous system which services the region above the pectinate line where hemorrhoids are located does not contain sensury nerve fibers (A, P. 266, 294, 342-343). Pain, however, may occur in infrequent cases of severe complicated internal hemorrhoids as the result of spasm or strangulation caused by proJapse or as the result of the involvement of tissues beyond the pectinate line (A. Tr, 342, 415, 631-632, 723).

17, The most common symptoms of external hemorrhoids are pain and swelling (A.H. P. Tr. 256, 742). Pain in external hemorrhoids is frequently caused by an external thrombotic hemorrhoid (A. P. Tr. 503). Other causes of pain in external hemorrhoids are inflammation, swelling and ulceration (A. P. Tr. 174 , 267, 358, 519). Pain may also result from infection. However, this cause of pain is a relatively infrequent occurrence since the rectal and anal area is relatively highly resistant to infection (A. Tr. 520) and thus infection occurs very rarely as a symptom of hemorrhoids (A.H.P. Tr. 315).

18. Swelling, as distinguished from the dilation of the hemorrhoidal veins, may be a symptom of hemorrhoids as well as a E. C. DEWITT & CO., I/'C. 1665 1647 Findings possible cause of pain in external hemorrhoids. SweUing usually results either from a blood clot or thrombosis, which causes distension in the tissue overlying the hemorrhoid, or from edema which is the accumulation of serous fluid in the interfibri1ar spaces in such tissue (A.H.P. Tr. 144, 550). 19. Itching is not a common symptom of internal or external hemorrhoids (A. H.P. Tr. 129 , 265, 618-619, 727). The itching thought to be caused by hemorrhoids is usuaUy the result of some other condition such as fungus infection or idiopathic pruritis (A. P. Tr. 326, 502, 504, 347, 618-619, 727). The itching which is caused by hemorrhoids is usually the result of discharge from a prolapsed internal hemorrhoid (A.H.P. '1r. 318 , 425, 618-619), or healing of an external hemorrhoid (A. H.P. T1' 265, 502). 20. The symptoms of hemorrhoids can be confused with other conditions such as fissure, fistula, peri-anal or peri-rectal abscess, hypertrophic papi1ae, papiUitus, cryptitis, polyps, proctitis, uJcerative colitis, pruritis ani and carcinoma (cancer). Any of these conditions can co-exist with hemorrhoids and it is not uncommon to find such a situation (A. P. Tr. 114-115, 196-197 , 205 259-260 347-349 483-484 545-546, 612-613, 714-715) . 21. The symptoms of hemorrhoids often disappear spontaneously within short periods of time, which may range from several days to two weeks (A. P. Tr. 119, 264, 324, 355 , 361 , 424, 875 1613). However, the underlying pathology, namely, the vascular dilation, will persist unless corrected and will be subject to recurring episodes of symptoms (A. P. Tr. 516, 214). 22. Surgical removal is the only means by which hemorrhoids can be permanently cured (A.H.P. Tr. 118-119 , 195, 200-202 262-263 , 352 , 422 , 487 , 550 , 554, 623, 719-723, 830). However surgery does not effect a complete cure in every case (A. P. Tr. 150). Surgery may not be advisable or necessary in every case. Surgery may be contra-indicated in cases in which the patient' general medical condition is such that the danger of anesthesia and surgery outweigh the possible benefits to be derived (A. Tr. 226). Surgery is also not advisablc for a simple, uncomplicated hemorrhoid (A. P. '11' 169). Although hemorrhoids may be uncomfortable they are rarely a very serious medical problem so that a patient, if he chooses to avoid surgery or should avoid it for medica! reasons, can go through life without having his hemorrhoids removed (A. P. Tr. 135).

23. The symptoms of simple, uncomplicated, internal hemorrhoids of small size can frequently be ameliorated by injectional Findings 70 F.

therapy. This consists of the injection of a schJerosing solution into the hemorrhoid itself which causes scar tissue to form which euts off the blood vessel feeding the hemorrhoid (A, P. Tr. 145 200, 262-263 , 353). A further treatment which has been used within the last several years is the baron ligation method whereby a ligature of rubber is placed around internal hemor rhoids as another means of cutting off blood circulation to the hemorrhoid (A. P. Tr. 200-201 , 488).

24. In cases on which surgery, injectional therapy or the baron ligation method are not used, a so-called "conservative course of treatment may be prescribed. The measures used in such a course of treatment include cleanliness, altering of the diet to eliminate irritative foodstuffs, control of the bowels to ensure a smooth, soft stool, warm baths, witch hazel, boric acid, local anesthetic, ointments, suppositories, a voidance of standing and manual reinsertion of prolapse (A. P. Tr. 120, 202, 306, 356-357 684-686). Ointments and suppositories contain lubricants which may protect the anal and rectal canal against the passage of hard dry stool. Such lubricants may also serve to relieve dryness and soften the skin as well as provide a psychological advantage; many people derive mental relief from the fact that some sort of treatment is applied (A. P. Tr. 203-204, 279, 313, 355, 358, 362- 363, 525 , 555, 557).

Conclusions re Effect of Mandan Oirltment and Suppositories 25. In A meTican Home Products we reached the following conclusions with respect to the effect of Preparation H Ointment and Suppositories on hemorrhoids and its symptoms based on citations set forth below:

(a) Preparation H will not avoid the need for surgery where jt is indicated, or heal, cure or remove hemorrhoids, or cause hemorrhoids to cease to be a problem (A. P. 25 , 26 , 28 , 29; A, Initial Decision, p. 1602; conceded by respondent on appeal (A. 31)), (b) Preparation H cannot reduce the size of hemorrhoidal veins (A. H.P. Tr. 128-129 , 173-174, 212-213 , 276, 369-370 436-437 500 563-564, 629-630 740 1497 1668) (A. P. 32). (c) Preparation H may possibly, through the lubricants which it contains, temporarily protect inflamed surface areas from the passage of hard, dry stool and thereby have some effect upon edema or sweIJing in the tissue overlying hemorrhoids (A.I-I.P. Tr. 202, 1471 , 1570, 1668. But d. Tr. 128-129, 463, 684, 742-743). E. C. DEWITT & CO. INC. 1667 1647 Conclusions However, where swelling is due to thrombosis (A. H.P. Tr. 264), it wil have no beneficial effect (A. P. Tr. 503, (A. P. 33). (d) Preparation H may in some cases afford some temporary relief against some types of pain associated with hemorrhoids (A. P. Tr. 131 , 207, 279, 372-373. 439-440, 503 , 566, 632-633, 744). Through the lubricants which it contains, this medication may protect inflamed surface areas against the passage of hard, dry stool and thereby temporarily relieve some pain caused by ulceration or from edema or swelling resulting from such inflammation (A. P. Tr. 174 , 212-213 , 358 , 493 , 525, But of. Tr. 128-129, 463 , 684, 742-743). Preparation H can, however, have no effect upon pain due to thl'mbosis (A. H.P. Tr. 295, 358, 503) or due to spasm or strangulation caused by prolapsing internal hemorrhoids (A. P. Tr. 631-632) (A. P. 34). (e) Through the lubricants which it contains, Preparation H may possibly relieve dryness and surface irritation and thereby provide some temporary relief from some types of itching associated with hemorrhoids (A. P. Tr. 131, 215, 279-280, 373-374, 439-440 503-504 566 633-634 741) (A. P. 35). (f) Except for the effects set forth in A. P. 33, 34, 35, as well as possible psychological effects (see A. P. 28), Preparation H will not have any beneficial effect in the treatment or relief of hemorrhoids or any of its symptoms (A. H.P. Tr. 131 , 215 , 279, 315-316, 372-373, 424, 439-440, 503-504, 566, 632-633, 682-683 '744; Answer, Par. 3) (A.H.P. 36).

26. We hereby enter findings with respect to the effect of Man- Zan Ointment and Suppositories on hemorrhoids and its symptoms and manifestations identical to the findings with respect to Preparation H set forth in paragraph 25 hereof (Stip., Par. 4; Answer, Par. 7).

CONCL(;SIONS RE ALLEGA TIO:'S IN COMPLAINT 1. The Federal Trade Commission has jurisdiction of the subject matter of this proceeding- and of respondent. 2. Through the use of the advertisments set forth in paragraph 7 hereof and other similar thereto not specifically set out therein respondent has represented and is no\\' representing, directly and by implication, that the use of :IanZan Ointment and Suppositories, wil:

(a) Reduce hemorrhoids:

(b) Relieve all itch and all pain, including severe or agonizing pain, associated with hemorrhoids;

Order 70 F.

(c) Heal hemorrhoids;

3. Mandan Ointment and Suppositories wiu not: (a) Reduce hemorrhoids;

(b) Heal hemorrhoids;

(c) Eliminate a11 itch or pain or alj severe or agonizing pain due to or ascribed to hemorrhoids or afford any relief from pain or itching associated with hemorrhoids in excess of affording some temporary relief in some cases of pain and itching associated with some types of hemorrhoids; or (d) Afford any other type of relief or have any other therapeutic effect upon hemonhoids or upon any of the symptoms or manifestations thereof, 4. Therefore, the advertisements referred to in paragraph 7 hereof were and are misleading in material respects and constituted and now constitute "false advertisments" as that tel'm is defined in the Federal Trade Commission Act; and the dissemination of said false advertisements constituted, and now constitutes unfair and deceptive practices in commerce, in violation of Sections 5 and 12 of the Federal Trade Commission Act. ORDER 1. It 'is ordered That respondent E. C. Dewitt & Co., Inc., a cororation, and its officers, representatives, agents and employees directly or through any corporate 01' other device, do forthwith cease and dee;ist from disseminating or causing the dissemination of any advertisement by means of the l;united States ll1ails or by any means in commerce, as "commerce" is dei-ined in the Federal Trade Commission Act:

A. In connection with the offering for sale, sale or distribution of DeWitt's Stainless Mandan Pile Ointment, Mandan Pile Ointment, De\Vitt's Stainless l\TanZan Suppositories, or any other product offered fm' sale fol the treatment or relief of hemorrhoids or piles or any of its SY111ptoms which: 1. Represents directly or by implication that the use of such product will :

(a) Reduce OJ' shrink hemorrhoids OJ' hemorrhoidal tissue or membranes 01' reduce or shrink swelling associated \with hemorrhoids;

(b) Avoid the need for surgery as a treatment for hemorrhoids or hemorrhoidal symptoms; (c) Heal or cure hemorrhoids;

(d) Relieve agonizing or severe pain of hemor- E. C. DEWITT & CO. INC. 1669 1647 Order rhoids or afford any relief from pain Or itching attributed to or caused by hemorrhoids in excess of affording some temporary relief in some cases of pain and itching associated with some types of hemorrhoids;

(e) Afford any other type of relief or have any other therapeutic effect upon the condition known as hemorrhoids 01' upon any of the symptoms or manifestations thereof.

2. Contains any reference (a) to the word "AIJantain; (b) to the word "benzocaine" or to any word such as "anesthetic" which implies that said product wil provide relief from pain or itching associated with hemorrhoids in excess of affording some temporary relief in some cases of pain and itching associated with some types of hemorrhoids; or (c) to any word such as "vasoconstrictor" which implies that said product will shrink hemorrhoids.

3. Contains any reference to any other ingredient either singly or in combination unless each such ingredient is effective in the treatment or relief of hemorrhoids or any of its symptoms and unless the specific effect thereof is expressly and truthfully set forth. B. 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 respondent' preparation or preparabons, in commerce, as "commerce " is defined in the Federal Trade Commission Act, any advertisement which contains any of the representations prohibited in Paragraph I (A) hereof.

II. In the event that respondent at any time in the future markets any preparation for the treatment or relief of hemorrhoids or any of its symptoms for which it desires to make any of the representations now prohibited under Paragraph I (A) of this order, it may petition the Commission for a modification of the order. Such petition shall be accompanied by a showing that the representation is not false or misleading within the meaning of the Federal Trade Commission Act, and, if such has been the case, that the specific representation has been approved by the Secretary of the Department of Health, Education and Welfare under the provisions of the Federal Food, Drug and Cosmetic Act as it is presently constituted or as it may hereafter bc amended. Order 70 F.

It is further ordered That respondent shah, within sixty (60) days after service upon it of this order, file with the Commission a report, in writing, setting forth in detail the manner and form in which it has complied with this order to cease and desist. FINAL ORDER The parties having entered into a stipulation filed on May 25, 1966 , providing, 'inte?' alia that: the case would be submitted to the Commission on the record in Docket 8641 A me1"ican Home Products C01' pomtion (p. 1524 herein), and such other facts and records as provided for in said stipulation; that the advertisements in the case had no significantly different effect upon readers from the effect of the advertisements in American Home Products.. that the effect of the use of respondent' s preparation is not significantly different from the use of American Home Products ' preparation; that to the extent that respondent' s advertisements differ significantly from those in AnwTican Home PToducts the Commission may, in its order disposing of this proceeding, include appropriate provisions to take into consideration such differences; that respondent waives any further intervening steps before the hearing examiner; that the Commission may, on the basis of this stipulation, the advertisements attached thereto and the record in A1nerica-n HOllIe Products issue such order as it deems necessary to the public interest and that the record on which the Commission is to make its disposition of this proceeding is limited to the record at the time this stipulation is flied; and the Commission having rendered its decision and issued its Opinion herein;

Kow therefore, on the basis of said stipulation and attachments, the pleadings herein and the record in Docket 8641 America11 Home P1' oducts C01')omtio11 (p. 1524 hereina, it is hereby Ordered That the attached Findings of Fact, Conclusions and Order be and they hereby are entered and issued by the Commission in final disposition of this proceeding, %(j THE MENTHOLATUYI CO. 1671 Complaint