The Mentholatum Company

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IN THE MATTER OF THE MENTHOLATUM COMPANY ORDER, OPI:-ION, ETC., IN REGARD TO THE ALLEGED VIOLATION OF THE FEDERAL TRAm; COMMISSION ACT Docket fW44. Cmnplaint, Aug. :!H, ltlfiJ,-Dccision, Dec. Hi, l. Order requiring a Buffalo, N. , manufacturer of " Mcntholatum pile ointment to cease falsely representing in its advertising that Hs product will shrink, avoid need fol' surgical treatment on, heal, cure, or remove hemorrhoids or effect any other cure beyond temponuy relief. COMPLAINT Pursuant to the provisions of the Federal Trade Commission Act, and by virture of the authority vested in it by said Act, the Federal Trade Commission, having reason to believe that The Mentholatum Company hereinafter refencd 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 The Mentholatum Company is a corporation organized, existing and doing business under and by virtue of the laws of the State of Delaware with its principal offce and place of business located at 1360 Niagara Street in the city of Buffalo, State of New York.

PAR. 2. Respondent The l\Tethoiatum Company is now, and f01' some time Jast past has been, engaged in the sale and distribution of a preparation offered for the treatment of piJes or hemorrhoids and coming within the classification of drugs as the term I'drug is defmed in the Federal Trade Commission Act. The designation used by respondent The !VenthoJatum Company for said preparation, the formula thereof and directions for use are as follows :

Designation: McntrJOlatum :'I. Mt'licrtled Pile Ointment. Fm' mula: The Rctive ingredients for " 1\fentholatull M. Medicated Pile Ointment are as follow Benzocaine; Hexachlorophene; Ephedrine sulfate, lanolin, in an exclusive prescription-type hase that is tcmperature-stable. Directions: Apply freely night and morning and after each bowel movement. L' sf: scientific applicator for internal hemorrhoids. Lubricate before use *Modifled on Dec. 15 . 1970 ::.

Complaint 70 F.

and thoroughly cleanse after. In case of bleeding, a physician should be consulted Keep all medicine out of the reach of children. PAR. 3. Respondent The Mentholatum Company causes the said preparation, when sold, to be transported from its place of business Jocated at 1360 Niagara Street, Buffalo, ;\ew York, to purchasers thereof located in various other States of the Vnited States and in the District of Columbia. Respondent maintains and at all times mentioned herein has maintained, a course of trade in said preparation 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 said business, respondent has disseminated, and caused t.he dissemination of, certain advertisements concerning the said preparation by the United States mails and by various means in commerce, as "commerce " is defined in the Federal Trade Commission Act, including, but not hmited to, advertisements inserted in newspapers, magazines and other advertising media in the District of Columbia, and in various States of the United States, 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 by various means, including but not limited to the aforesaid media fol the purpose of inducing and which were likely to induce, directly or indirectly, the purchase of said preparation in commerce, as commerce" is defmed in the Federal Trade Commission Act. PAR. 0, Among and typical of the statements and representations contained in said advertisements disseminated as hereinabove set forth are the following:

Clinical Progress Report:

NEW PAI:\LESS MEDICATION FOR HO:\E THERAPY OF HEMOR- RHOIDS Ne,v M. O. cornbincs fast-acting: ingredients in a pres('ription-type ointment to shrink pilcs-re1ievc pain and itch. Famous 1\lentJJOlatum Laboratories have drvrIoTJed a modern, home therapy for hemorrhoids that can bring relief "without surgery or injections. New medicated pile ointment-starts relief from pa:n and itching in seconds. This soofhing medication acts to shrink hemorrhoids and promote healing.

In the exact words of the bvo doctors who conducted recent clinical tests of Mentholatum JI.P.O.. they say, "'Ve are quite p;eased with the results. " In rcponing 011 the treatment of an patients, the results were " good to exceI1ent in 25 cases, fair or poor in only 5 who had more severc hemorrhoids. RELIEF STARTS IN SECONDS- he instant you apply M. O. its anes- THE MENTHOLATUM CO. 1673 1671 Complaint thetie and vasa- constrictor start to work. This soothing, painless medication quickly relieves tormenting pain and stops the embarrassing itch. HELPS PRO:"IOTE HEALING-=v. s exclusive temperature-stable ointment concentrates medication right on inflamed tissue-not beyond as suppositories sometimes do. Its Ephedrine Sulfate works quickly to reduce swelling and shrink piles.

FIGHTS INFECTIOXS-Hexachlorophene, the famous germ-kiler used by physicians, acts to relieve bacteria-caused itching and to fight infectious germs.

New ::. O. takes the fear out of hemorrhoid therapy. Don t suffer another day before you try ::cntholatum M. the painless medication that acts to shrink hemorrhoids without cutting or injections. Available without prescription at all drugstores.

Progress Report: ),Tew Formula For Home Therapy of Hemorrhoids New Metholatum M. O. offers a non-surg"ical treatment to reduce hemorrhoids-relieve pain, itch.

Special Formulation shrink piles.

. . promote healing.

. . . TIew development. . . .

O. offers non-surgical Treatment to Shrink Files. . plus Fast-Acting Relief for Pain and Itching.

. works to shrink hemorrhoirls, help clear them up. . Xew M. medicated ointment-actually acts to shrink piles and helJ)s clear them up.

Famous Mentholatum Laboratories have developed a modern, home therapy for hemorrhoids that can bring relief without surgery or injections. New M. O. takes fear out of hemorrhoidal therapy. New Advance in Home Therapy for HcmoYJhoids. . the latest development in the non-surgical reljef of hemorrhoids. acts to shrink hemorrhoids without cutting or injections. . . . quickly relieves tormenting pain. . . . . acts to shrink hemorrhoids and promote healing. . . . PAR. 6. Through the use of said advertisements, and other simi- Jar thereto not specifically set out herein, respondent has represented and is now representing, directly and by implication that the use of "Mentholatum lV. Medicated Pile Ointment will: 1. Reduce or Shrink piles;

2. Eliminate surgery as a treatment for piles; 3. Heal, cure or clear-up piles:

4. Relieve all pain attributed to or caused by piles. 5. Stops itching.

PAR. 7. In truth and in fact the use of ":i1entholatum M. Medicated Pile Ointment wil not:

1. Reduce or shrink piJes;

2. Eliminate surgery as a treatment for piles; , Opinion 70 F. T.

3. Heal, cure or clear-up piles;

4. Relieve all pain attributed to or caused by piles; 5. Stops itching;

6. 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 respects and constituted and now constitute false advertisements " as that term is defined in the Federal Trade Commission Act.

PAR 8. The dissemination by the respondent 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. OPINION OF THE COMMISSION DECEMBER 16 1966 By JONES Commissione,.:

, 1964, The complaint in this matter, issued on August 28 charged that respondent violated Sections 5 and 12 of the Federal Trade Commission Act by making false representations in advertising its ointment, sold under the name of "' Mentholatum O.' Medicated Pile Ointment " for the treatment of hemorrhoids or piles. ' The complaint alleged, 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 set forth a series of statements which were alleged to be typical of the claims made in respondent' s advertisements. Among the statements quoted are the following:

Famous ::entholatum Laborato1'ies have developed a modern, home therapy for hemorrhoids that can bl'ng relief "\vithout surgery or injections. New medicated pile o:ntmcnt- starts relief from pain and itching in seconds. This soothing medication acts to shrink hemorrhoids and promote healing.

1 The tenr.s "hernolThoids " and " piles" arc synonymous (Finding of Fact 11) : ann wil be used interchang-eflbly herein. Hereinafter the parag-raphs of the Findings of Fact in this case wil be referred to as "

THE MENTHOLATVM CO. 1675 1671 Opinion RELIEF STARTS IN SECONDS-the instant you apply M. O. its anesthetic and vasa-constrictor start to work. This soothing, painless medication quickly relieves tormenting pain and stops the embarrassing itch. HELPS PROMOTE HEALI)JG- O.'s exclusive temperature-stable ointment concentrates medication right on inflamed tissue-not beyond as suppositories sometimes do. Its Ephedrine Sulfate works quickly to reduce swelling and shrink piles.

Ncl,Y M. O. takes the fear out of hemorrhoid therapy. Don t suffer another day before you try Mentholatum M. the painless medication that acts to shrink hemorrhoids without cutting or injections. Available without prescription at all drugstores.

Respondent in its answer admitted so much of Paragraph Five of the complaint as alleged that the statements quoted therein were among the statements made by respondents in advertisements but denied that they were typical (Answer, Par. 5). Paragraph Six of the complaint charged that through the use of these advertisements and others respondent had represented that use of M. O. wi1: (1) reduce or shrink piles; (2) eliminate surgery as a treatment for piles; (3) heal, cure or clear up piles; (4) relieve all pain attributed to or caused by piles and (5) stop itching. Respondent denied each allegation in this paragraph (Answer, Par. 6).

In Paragraph Seven the representations set forth in Paragraph Six are alleged to be false and it is further alleged that M. will 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 the complaint concludes that respondent's advertisements were advertise-misleading in material respects and constituted "false ments " within the meaning of the Federal Trade Commission Act. Respondent denied the allegations in this paragraph except that it admitted that M. O. will not eliminate surgery as a treatment for piles and will not relieve all pain attributed to or caused by piles (Answer, Par. 7).

The complaint in this matter was issued simulataneously with four other complaints also charging misrepresentations in the advertising of hemorrhoidal preparations, namely: Hurnph1eys Medicine Cornpal1Y, Inc01'porated Docket 8640 Cp. 1502 herein), Arne,' ican Home Prodl.,ets Corporation Docket 8641 (p, 1524 herein), E. C. Dewitt Co. , Inc" Docket 8642 (p. 1647 herein), and G1'ove Laboratories, Incorporated Docket 8643 (71 F, 822). Hearings in the A meric(L' Home Products case took place ,.

1676 FEDERAL TRADE COMMISSION DECISIOXS Opinion 70 F.

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 A1nericn11 Hom. e Products. This motion was denied by the Commission on March J 6 , 1966 , and respondents in each of these four cases moved for reconsideration. On April 26, 1966 C69 F. C. 11791. 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 ,Tune , 1966, respondent and complaint counsel filed a stipulation in accordance with the provisions of the Commission s order of April 1966.' The stipulation provided that the Commission may issue such order as it deems necessary in the public interest on the basis of the facts stipulated by the parties and that the respondent waived any intervening steps before the hearing cxaminel' The parties further stipulated that the advertisements in the case had no significantly different effect upon the reader from the effeet of the advertisements in Arnericrw Home Produ.cs; that the effect of the use of respondent's preparation is not significantly different from the use of American Home Products' preparations; and that, to the extent that respondent's advertisements differ significantly from those in Anw1'ican H a'!e 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 two similar advertisements, stated in the stipulation to be "representative of respondent' s advertising claims." One oJ these advertisements reads in full as follows:

IIEl\JORRHOIDS? :-fake this 3-day test! ):ew ::. O. must relieve pain faster and Jonger than the preparation you are now using or wc will gladly refund your purchase price in full. If yon sep). 11'01'(' relief than ()U may now be getting', join the tllousands of hemorrhoid (pile) sufrerers now turning- to new M.P.O. Developed by famous :-lentholatum Laboratories, M. O. ,\'orks in these five ways: 1. Hell).' cuse 1)(111 ostf'. You get more medically accepted pain-relieving ingredients than tJ1E preparation you may nth\' be using . to help reduce pain and di::comfort.

The tf'l'rr:s of thi, stip'Jlatio!1 (hereinafter refe:rcd to as Stip. are set forth iD F. THE MENTHOLATUM CO. 1677 167J Opinion 2. Helps shrink swollen tissues. O. quickly releases the proven vasoconstrictor, Ephedrine Sulfate.

3. Helps Telieve embaTras,,;ing itch s medication is homogenized for faster absorption, faster action.

4. Helps make 1"elief last longer. O.'s more temperature- stable base holds medication in place for prolonged action. 5. Helps .ftght nger in infection. Proven germ-kiler, Hexachlorophene combats bacteria.

Test it yopTself for the next three days. If not satisfied that M. O. helps you more than the preparation you re now using, return unused portion to the Mentholatum Co. , Buffalo, N. , for refund. Available in stainless ointment or suppositories at drug counters.

The other advertisement states in part as follows You get more medically accepted pain-relieving ingredients, including Benzocaine, than in the preparation you may now be using. On the basis of the pleadings, the stipulation of the parties and the attached advertisements, together with such portions of the record in American Home 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 ano accordingly are en12ri, g our Findings of Fact and Conclusions in the matter.

DISCUSSION OF ISSUES A. Representations Made by Respondent i11 Its Advertisements. Respondent is charged with representing that its product will (1) reduce or shrink hemorrhoids, (2) eliminate surgery as a treatment for hemorrhoids; (3) heal, cure or clear up hemorrhoids; (4) relieve alj pain attributed to or caused by hemorrhoids and (5) stop itching.

In evaluating the meaning of respondent's advertisments we wil consider not only the advertisements annexed to the stipulation between the parties but also to the statements quoted in the complaint which respondent has admitted were made by it in its advertisement. Respondent denied that the statements alleged in the complaint were typical. However, we are not compelled to determine whether the ads are typical but only whether they contain false or misleading statements. The advertisements were conceded to have been made, and if they contain false or misleadjng representations, issuance of an order is proper even though Opinion 70 F.

there may have been other advertisements of respondent which did not contain these representations.

In A me1'ican Ham Products we found that respondent had represented" lithatavoiditsthepreparationneed for surgerywould "reduceas a treatmentor shrinkfor hemor-hemor-rhoids rhoids eliminate all itch due to or ascribed to hemorrhoids relieve all pain attributed to or caused by hemorrhoids " and heal, cure or remove hemorrhoids, and cause hemorrhoids to cease to be a pl'bJem. " In Par. 2 (a) of the stipulation executed by the parties, it is provided that the advertisements in the instant case "had no significantly different effect upon the reader from the effect of the advertisements in Ameriwn Home Products. Accordingly, on the basis of this stipulation alone, we could conclude that respondent's advertisements represent that its ointment will shrink hemorrhoids and relieve alj pain. 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, (1) Respondent's claims respecting shrinkage or reduction of hemorrhoids Respondent claims in the advertisements that its preparation acts to shrink hemorrhoids " and that" (ists Ephedrine Sulfate works quickly to reduce swel1ng and shrink piles " thus directly representing, as alleged, that M. O. will reduce or shrink piJes. Other advertising claims made by respondent, while literally specifying only shrinkage of "swollen tissues " also have the effect of creating in the mind of the hemorrhoid suffer' er that his hemorrhoids will be shrunk These advertisements state that respondent' s medication " Helps shrink 8\vo11en tissues" and "quickly releases the proven vaso-constrictor, Ephedrine Sulfate, " Since a vaso-constrictor" is an agent \which causes constriction of blood vessels (Webster s New International Dietionary, Second Edition), the clear implication of this statement is that the hemorrhoids or blood vessels will be shrunk, not merely that the overlying tissue will be reduced in size. Furthermore, in our opinion any member of the public who reads a representation that a hemorrhoidal preparation will help shrink swollen tissue is unlikely to make any technical distinction between this representation and the representation that the product wil shrink hemorrhoids. Ac- ), ; ;

THE MENTIIOLAT1JM CO. 1679 1671 Opinion cordingly we conclude that respondent's claims in its advertising are equivalent to direct representations that jts products will shrink hemorrhoids.

(2) Respondent's claims respecting elimination of surgery as a treatment of hemorrhoids Respondent advertises that M. O. "can bring relief without surgery or injections." This, in our opinion, clearly constitutes a representation that it wil "eliminate surgery as a treatment for piles" as alleged in Paragraph Six (2) of the complaint. (3) Respondent's claims respecting hearing, curing or clearing up of hemorrhoids Respondent maintains in its advertising that its preparation actually acts to shrink piles and helps clear them up can bring relief without surgery or injections acts to shrink hemorrhoids and promote healing" and "helps promote healing, While the word "healing" is in certain cases coupled with the word "promote " the implication remains that through the use of O. one s hemorrhoids may be healed. An individual with hemorrhoids would undoubtedly assume that if M. O. promoted healing, use of this medication wil within a reasonable period of time Jead to the healing of his hemorrhoids. Therefore, in our opinion, these statements when viewed in the context of the entire advertisement clearly convey the message to the hemorrhoidal sufferer that M. O. will heal hemorrhoids. (4) Respondent's claims respecting pain Respondent promises in its advertising that its product ",ust relieve pain quickly relieves tormenting pain helps ease pain faster" and "contains more pain-relieving ingredients, including Benzocaine, than the preparation you may now be using. Respondent' s claims are unequivocal and do not permit even an inference that the relief actually af!ordec1 may be partial or temporary. The reference to "benzocaine, " a local anesthetic (Webster s Kew International Dictionary, Second Edition), implies that the preparation will produce anesthesia or paralysis of the sensory apparatus in the affected area (I d. thus effecting a total absence of pain or other feeling. Furthermore, the representations pertaining to shrinking and healing referred to above would also tend to cause the reader to believe that the symptoms, including pain, would be eliminated when the hemorrhoid has been reduced Opinion 70 F.

in size and healed. Accordingly, we conclude that the statements in respondent' s advertisements constitute representations that its product will relieve an pain attributed to or caused by hemorrhoids.

(5) Respondent's claims respecting itching In its advertisements respondent states that M. O. "relieves embarrassing itch. " In our opinion this unqualified statement promises complete relief from the itching due to hemorrhoids and that the average reader would be under the impression that if he used JI.P. O. his itching would stop. MOleover, the claims respecting healing and shrinkage and the references to benzocaine, a local anesthetic, imply that entire relief will be afforded from a11 symptoms including itching.

B. Deceptive l'latu'1e of Responrle1li' s Clal1ns 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 significantly different from the effect of American Home Products' preparations (Stip. , Par. 2 (b)). Accordingly, the findings of fact and conclusions reached in A 11e1':cem H 011e P1' oducts with respect to the effcacy of Preparation II drawn from the record and Findings of Fact in that case, are equany applicable to M. O, It is in the light of these findings and conclusions, therefore, that the allegations in Paragraph Seven must be analyzed. In its answer respondent has admitted that O. win not eliminate surgery as a treatment for piles and wil not eliminate an pain attributed to or caused by piles. Therefore, our discussion will be confined to the remaining issues relat ing to the effcacy of M.

(1) Ability of I.P.O. to reduce or shrink hemorrhoids Paragraph Seven (1) of the complaint alleges that, contrary to respondent' s representations, IV. O. will not reduce or shrink hemorrhoids Respondent advertises that C\. O, "acts to shrink piles " and helps shrink swollen tissues." We have concluded that these representations amount to a claim, and win be understood by the hemorrhoidal sufferer as a claim, that his hemorrhoids wil be reduced in size. Hemorrhoids are by definition veins located underneath the mucuous membrane of the rectum and the skin of the 8naJ canal (F. 10). The evidence in the record is that hemorrhoi- THE MENTHOLATUM CO. 1681 1671 Opinion da! preparations such as M. O. may have some effect upon edema or swe1Jing 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 record also demonstrates, however, that this product can have no beneficial effect when the swellng is due thrombosis (F. 25 (c), 26). Thus, even if we were to assume that some reduction of swelling is effected by respondent's preparation, not all types of swelling wi1 be affected in this way, and furthermore, the reduction which wi1 occur wi1 not be of the hemorrhoid itself but only of the surrounding area and thus wi1 not be of the type implicitly promised by respondent's advertising. Accordingly, we find that respondent's representations with respect to shrinkage of hemorrhoids are in alj respects false and misleading.

(2) Ability of M. O. to stop itching It is alleged in Paragraph Seven (5) of the complaint that, in contrast to respondent's claims in its advertising, M. O. wi1 not stop itching. " According to the record applicable to this case itching is not a common symptom of hemorrhoids, and the itching thought to be caused by hemonhoids is usually the result of some other condition (F. 19). Where the itching is caused by hemorrhoids, M. , through the lubricants which it contains, may possibly relieve dryness and surface irritation and thereby provide some temporary relief from some types of itching associated with hemorrhoids (F. 25 (e), 26). However, it cannot eliminate all itching caused by 01' associated with hemo1'holds (F. 25 (e), (f), 26). Therefore, respondent' s claims to this effect are false. (3) Ability of M. O. to heal hemorrhoids Paragraph Seven (3) of the complaint a1Jeges that, contrary to respondent' s representations, M. O. wi1 not heal, cUIe or clear up piles. The record applicable to this case demonstrates that SUlgicaJ removal is the only means by which hemorrhoids 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 is corrected, the patient wi1 be subject to recu1'ing episodes of symptoms (F. 21). Since l.P.O. cannot affect the underlying dilated veins it cannot heal 01' cure hemorrhoids or cause them to be cleared up or cease to be a problem (F. 25 (a), 26). Opinion 70 F. T.

C. Alleged Absence of Other Thempeutic Benefits of M.P. In addition to the allegations that respondent's affrmative representations with respect to its product are false, the complaint also alleged that M. O, wi1 not" La) 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 (6)).

As we have noted it is clear from the record that M. O. cannot heal hemorrhoids. The record is also clear that while :vr.P.O. may in some cases provide some temporary relief from two symptoms of hemorrhoids, namely, pain and itching, it can provide no relief from the symptoms of hemorrhoids and that it can have no other therapeutic effect upon hemorrhoids (F. 25 (f), 26). Accordingly, we conclude that the allegation in Paragraph Seven (6) of the complaint should be sustained.

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 American Home P,' oducts (Stip. Pars. 4 and 6).

In determining what order is necessary to ensure that respondent' s misrepresentations respecting the effcacy of its drug preparation will not occur again, it is of primary importance to consider the segment of the public which is most Jikely to be particularly affected by these misrepresentations. Our mandate under the law was graphically expressed by Tudge 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 unthinJdng and the crecluJous.' " Charles of the Ritz Dislrib1dillg C01')!Oration v, Fedeml Trade 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 effcacy of drugs since the appeal of such representations fall 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 , p.

THE MENTHOLATUM CO. 1683 1671 Opinion time in their lives. They ",j! be learning that aches and pains and discomforts of all kinds may be symptoms of diseases which they had never heard of before 01' never before associated with their own distress. Consequently, advertised claims of drug effcacy wil have increasing relevance to this segment of our population and wj! offer hope of relief to millions in our population who may have previously ignored such advertising not realizing their possible application to their own conditions. Accordingly, 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 mis- Jeading. It is with these basic principles in mind that we must fashion the type of prohibitive provisions which m'o necessary to be included in the order in this case, A. Product Application of the Order The order proposed by complaint counsel provided that it was to be applicable to M. O. " 01' any other preparation of substantially similar camposition aT passessing substantially similar properties (emphasis added). As we noted in our Opinion in american H O1ne Prod1wts 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 " 01' which did not possess "substantially similar properties" and be exempt from the order even though such substitute product may be equally ineffective in relieving symptoms of hemorrhoids (American Home Products Opinion, pp. 1623-1625). ' And, as we further pointed out in American Hmne 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 (Americau Hom.e P,' educts Opinion 1623). Consequently, we are entering an order in the instant case, comparable to that entered in Amedcon Hom.e PI'educts which is applicable to alj preparations which may be sold by respondent for relief or treatment of hemorrhoids or its symptoms regardless of whether they contain the same or different ingredients from those contained in M. O. Finally, as we pointed out in detail in '1t is apparent frOIT the nature of the ingredients in respondent's preparation (F. 3) that they in aJ! likelihood R!'e replaceable by other ingredients which might have no different effect on hernor"hoirls and yet be wholly outside the order jf it applied only to " O. or other preparations containing sirni:8r ingredients. Opinion 70 F.

our opinion in the American H O?ne Products case, this provision in no way hinders respondent from developing a truly effcacious remedy for hemo1'holds which might enable it to make some of the claims which this order now prohibits it from making. In this situabon respondent need only apply to the Commission for a modification of the order as specifically providcd for in thc order which we are entering.

B. Respondent' s Representations Respecting the Efj.caey of The order which we are entering prohibits respondent from representing directly or by implication that its product wi1 reduce or shrink hemorrhoids; eliminate surgery as a treatment for hemorrhoids; heal, eule or clear up hemorrhoids; afford any relief from pain and itching, in excess of providing some t.temporary relief in some cases of pain and itching; or have any other effect on hemorrhoids or its symptoms. In addition, we are specifically prohibiting respondent from referring to its "proven vaSQ- Coll'strictor, Ephedrine Sulphate " in its advertising. Since reference to the purported vaso-eonstrictOl implies shrinkage of hemorrhoids, its continued use would have the effect of negating the prohibition on claims of shrinkage and therefore must he disallowed. Wc have similarly specifically prohibited respondent from referring in its advertisements to the ingredient "benzocaine which respondent uses to emphasize the purported pain-reli eving qualities of its medication, As we noted above, reference to this term implies total elimination of aJl pain. In view of our findings and conclusions that O. will not relieve aJl pain, any use of this term would therefore be wholly false and misleading. have found that respondent' s product will at best only afford some temporary relief in some cases of pain associated with 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 ue false and misleading. Accordingly, we have prohibited use of this word. Further' mole, in view of thc likelihood that reference to any single ingredient may convey the impression that such ingredient is of special importance THE MENTIIOLA TUM CO. 1685 1671 Findings 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 or any of its symptoms and unless the specific effect thereof is expressly and truthfully set forth.

Respondent lays great stress upon the purported ability of its product to offer greater relief from hemorrhoids and its symptoms than other hemorrhoidal preparations. For example, it claims that ":v. O. m1l8t relieve pain faster and Jonger than the preparation which you are now using, " These representations that M. O. is more effective than other hemorrhoidal preparations on the market contradict the terms of respondent' s stipulation herein in which it has agreed that the effect of use of its product is not significantly difierent from the use of the preparation of American Home Products, one of the major producers of hemorrhoidal preparations. In our opinion there is no possible justification for permitting respondent to continue to represent that its products are more eftective than those of other companies, which would include American Home Products, when it has conceded that such is not the case. Therefore, we have ordered respondent to cease from claiming that its Pl' oduct is more effective in the treatment or relief of hemorrhoids 01' its symptoms than other preparations sold for the treatment or relief of hemorrhoids. If respondent develops a preparation which is in fact more effective than one 01' more other preparations, it may petition the Commission for the modification of the order permitting an accurate comparison vvith such other preparation or pl' eparations.

FIJ\DI:\GS OF FACT , CONCLUSIONS AND ORDER FINDINGS OF FACT A. Res)Jondent (wd Its P1'od1lct 1. Respondent The Mentholatllm Company is a corporation organized, existing and doing business under and by virtue of the Jaws of the State of Delaware with its prineipal offce and place of business located at 1360 Niagara Street in the city of BufIa10 State of New York (Complaint, Par. 1 ; Answer, Par. 1). 2. Respondent The Mentholatum Company is now, and for some time last past has been, engaged in the sale and distribution of a preparation offered for the treatment of piles or hemor- J686 FEDERAL TRADE COMMISSION DECISIONS Findings 70 F.

rhoids and 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 designation used by respondent The Mentholatum Company for said pJ'eparation, the formula thereof and directions for use are as follows:

Designation: Mcntholatum M. " Medicated Pile Ointment. Formula.: The active ingredients for " Mcntholatum ::VLP. " Medicated Pile Ointment are as follo\vs:

Benzocaine; Hexachlorophene; Ephedrine sulfate, lanolin, in an exclusive prescription-type base that is temperature-stable. Directions: Apply freely night and morning and after each bowel movement. Use scientific applicator for internal hemorrhoids. Lubl"icate before use and thoroughly cleanse after. In case of bleeding", a physician should be consulted. Keep all medicine out of the reach of children. (Complaint, Par. 2; Answer, Par. 2.

4. Respondent The Mentholatum Company causes the said preparation, when sold, to be transported from its place of business located at 1360 )liagara Street, Buffalo, New YOlk, to purchasers thereof located in various other States of the United States and in the District of Columbia. Respondent maintains, and at al1 times mentioned herein has maintained, a course of trade in said preparation in commerce, as "commerce" is defined in the Federal Trade Commission Act. The volume of business in such commerce has been and is substantial (Complaint, Par. 3; Answer, Par. 3).

B, Stipulation Entend Into b1J Parties He)'eto 5. The parties hereto enter' into a Stipulation, filed on June J 7, 1966, providing as follows:

1. The proceedings are herein submitted to the Commission fol' disposition on the basis of the record in the Aillericol/ Home Products CO)'lJOmLio'i Docket No. 8641, and sucn other fads and records as provided for herein; and 2. IT IS FURTHER STIPVLATED (a) That the Advertising: of The :\Jentholatum Company has no significantly different effect upon the reader than the effect of the advertisments in the American Home Products case.

(b) The effect of the use of Respo :dent' s preparation is not significantly different from the use of the preparation of American Home Products. 3. Attached hereto is copy representative of ReslJOndent ", advertisingclaims for inclusion in the record.

4. To the extent that the Hcspondent's advertisements differ significantly to tho",e in IIniccw HOlle PJ'clucts, the Commission may, in its order dispos- THE MENTHOLATUM CO. 1687 1671 Findings ing of the proceedings, include appropriate provisions to take into consideration such differences.

5. The undersigned waive any further intervening procedures before the Hearing Examiner.

6. The Commission may, on the basis of the Stipulation, the attached advertisements and the record in American Home Products, issue such Order as it deems necessary to the Public interest. 7. The Commission is to issue its Order disposing of such proceeding concurrently with the Order setting forth its final decision in American Home Products.

8. The record on which the Commission is to make its disposition of such proceeding and for the purpose of judicial review is limited to the record at the time the Stipulation is filed, the Stipulation with the attached advertisements and the record in American Home Products. Attached to this stipulation (hereinafter referred to as "Stip. are copies of two advertisements.

C. Representations Made 6. In the course and conduct of its said business, respondent has disseminated, and caused the dissemination of, certain advertisements concerning the said preparation 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, magazines and other advertising media in the District of Columbia, and in various States of the United States, 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 by various means, including but not limited to the aforesaid media for the purpose of inducing and which were 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).

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

Famous Mentholatum Laboratories have developed a modern, home therapy for hemorrhoids that can bring relief without surgery or injections. New -medicated pile ointment-starts relief from pain and itching in seconds. This soothing medication acts to shrink hemorrhoids and promote healing RELIEF STARTS IN SECONDS-the instant you apply M. O. its anesthetic and vasa-constrictor start to work. This soothing, painless medication quickly relieves tormenting pain and stops ihe embarrassing itch. 1688 FEDERAL TRADE COMMISSIOK DECISIONS Findings 70 F.

HELPS PROMOTE HEALING- O.'s exclusive temperatnre-stable ointment concentrates medication rignt on inflamed tissne-not beyond as suppositories sometimes do. Its Ephedrine Sulfaie ,yorks quickly to reduce swelling and shrink piles.

New M. O. takes the fear out of hemorrhoid therapy. Don t suffer another day before you try Mentholatum :.LP. the painless medication tllat acts to shrink hemorrboids \vithaut cutting or injections. Available without prescription at a11 drugstores.

HE;lIORRHOIDS? MAKE THIS 3-DAY TEST' NEW M. O. MUST RELIEVE PAIN FASTER AND LOXGER THAN THE PREPARATIO" YO\: ARE NOW USING OR WE WILL GLADLY REFUND YO\:R PURCHASE PRICE 1)/ FULL.

If you seek more relief than you may nov be getting, join the thousands of hemorrhoid (pile) sufferers now turning to new IVJ.P.O. Developed by famous Mentholatum Laboratories, - O. ..yorks in these five ways: 1. Helps ease pain faster. M. O. contains more medically accepted pain-relieving ingredients than the preparation yon may now bc using. to help reduce pain and discomfort.

2. Helps shrink s..\' o11en tissues. M. O. quickly releases the proven vasoconstrictor, Ephedrine Sulfate.

3. Helps relicve embarrassing' itch. 1J. s medication is homogenized for faster absorption, faster action.

4. Helps make relief last longer . M. s mol';' temperature- stable base holds mcdication in place for prolonged action. 5. Helps fight danger of infection. Proycn germ-l,illcr, Hexachloropljenc combats bacteria.

Test it yoursclf for t1H next thrcc days. If not c:atisTIctJ tlnlt IvLP. O. helps you more than the prepal. ation you re now using, etl1rn lill,lSec1 portion to the fenth01atum Co. , Buffalo. N. , for refund. Available in st.aiJd02ss ointment or suppositories Dt drug counters.

You get more medically accepted pain-rclieving ingredients, including Ben.. zocaine, than the pJ eparation you may no,\, be using. (Complaint, Par. 5; Answei', Par. 5; Stip. (attachments). lr/meaning of Respondc/lt's Representations 8. In American JI01ne Products Co/'poi'atioil Docket 8641 , vve found that through the use of American Home Products Corporation s advertisements, sajd respondent has represented and is now representing, directly and by impJicatiou, that the use of Preparation H Ointment and SuppositOl'ics, and each of them, will: (a) Reduce or shrink hemorrhoids; , (b) Avoid the need for surgery as a treatment for hemorrhoids;

(c) Eliminate all itch due to or ascribed to hemorrhoids; "The words "hemorrhoids " and "piles " are synonymo' IS (See Finrlin,,: 11 i11fra) and wii I"" used inter hang;€lib\y herein.

THE MENTHOLATUM CO. 1689 1671 Findings (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.

(American Home Products Cm'poration 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, direcUy and by implication, that the use of Mentholatum M. Medicated Pile Ointment wiu:

(a) Reduce or shrink hemorrhoids;

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

(c) Eliminate a1l 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. 2(a).

E. GenerILI Medical Frwts Pertaining to Hemor?'holds and Their TreILtment 10. "Hemorrhoids" are masses of dilated weak-wa1led veins located 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. H.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. "External hemorrhoids" are hemorrhoids occurring below the pectinate line and are covered by skin (A. 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 clot under the surface of the skin located in the immediate vicinity of the anal opening (A.H.P. Tr. 117). It is also referred to as an "anal hematoma " (A. P. Tl'. 719) oj' a " perianal thrombosis " (A. Tr. 549).

14. A "prolapse" 01' "prolalJsing hemorrhoid" is an internal The para aphs of the I'i11dings of Fact in Amer;can Home Products are hereinafter refer e(l cO as " P. - .

3 The referer.ces are to the transcript in American HQme J'roduds. Findipgs 70 F.

hemorrhoid which, due to laxity of the rectum is enabled to fall outside the anal canal and protrudes to the surface (A. 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 hemorrhoidal vein. The hemorrhoidal veins do not have valves to support the weight of this column of blood. The resulting pressure causes the hemorrhoidal 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 abnormany Jong periods of standing, straining, diffculty with bowel movement, impacted stool, pregnancy and cirrhosis of the liver (A. P. Tr. 231-232, 144).

16. The most common symptom of internal hemorrhoids is bleeding (A. P. Tl". 256, 393, 479). The other principal symptom of internal hemorrhoids is prolapse (A. P. Tr. 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 sensory 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 stranguJation caused by prolapse or as the result of the involvement of tissues beyond the pectinate line (A. H.P. Tr. 342, 415, 631-632, 723).

17. The most common symptoms of external hemorrhoids are pain and swellng (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, sweIJing 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. P. Tr. 315).

18. SweIJing, as distinguished from the dilation of the hemorrhoidal veins, may be a symptom of hemorrhoids as well as a possible cause of pain in external hemorrhoids. Swelling usual11y results either from a blood cJot or thrombosis, which causes distension in the tissue overlying the hemorrhoid, or from edema which is the accumulation of serous fluid in the interfibrilar spaces in such tissue (A. P. Tr. 144, 550). THE MENTHOLATUM CO. 1691 1671 Findings 19. Itching is not a common symptom of internal or external hemorrhoids (A. P. Tr. 129, 265, 618-619), 727). The itching thought to be caused by hemorrhoids is usually 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. Tr. 318, 425, 618-619), or healing of an external hemorrhoid (A. P. Tr. 265, 502). 20. The symptoms of hemorrhoids can be confused with other conditions such as fissure, fistula, peri-anal or peri-rectal abcess hypertrophic papillae, papilitus, cryptitis, poJyps, proctitis, uJeerative 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 J 613). However, the underlying pathology, namely, the vascular dilation, wil persist unless corrected and will be subj ect to recurring episodes of symptoms (A. H.P. Tr. 516, 214). 22. Surgical removal is the only means by which hemorrhoids can be permanently cured (A. P. Tr. 118-119 , J 95, 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 outweight the possible benefits to be derived (A. Tr. 226). Surgery is also not advisable for a simple, uncomplicated hemorrhoid (A.H.P. Tr. 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 medical reasons, can go through life without having his hemorrhoids removed (A.H.P. Tr. J35).

23. The symptoms of simple, uncomplicated, internal hemorrhoids of small size can frequently be ameliorated by injectional therapy. This consists of the injection of a schlerosing solution into the hemorrhoid itself which causes scar tissue to form which cuts 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 Conclusions 70 F. T, whereby a ligature of rubber is placed around internal hemorrhoids as another means of cutting oft 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 Hconservative" 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, avoidance 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. Tl' 203-204, 279 , 313 , 355, 358 362-363, 525 , 555, 557) .

F. Conclusion., Te E(fect of Melltholatum M. O. Medicated Pile Ointment 25. In American 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 it is indicated, or heaJ , 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 responent 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.H.P. 32), (c) Preparation II 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 swelling in the tissue overlying hemorrhoids (A. Tl' 20 1471 , 1570, 1668. But c Tr, 128-129, 463, 68 742-743). However, where swelling is due to thrombosis (A. P, Tr. 264), it wil have no beneflcial effect (A,H.P. Tr. 503) (A. P. 33). (d) Preparation II may in some cases afford some temporary relief against some types of pain associated with hemorrhoids THE MENTHOLATUM CO. 1693 1671 Conel usions (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 s\velling resulting from such inflammation (A. P. Tl' 174 , 212-213 , 358 , 493, 525. But d. Tr. 128-129, 463, 684, 742-743). Preparation H can, however, have no effect upon pain due to thrombosis (A. P. Tr. 295, 358 , 503) or due to spasm or strangulation caused by prolapsing internal hemorrhoids (A. P. TJ' 631-632) (A.ILP. 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. H.P. 35). (f) Except for the euects set forth in A. P. B3, 34, 35, as well as possible psychological effects (see A. P. 28), Preparation H will not have any beneficial enect in the treatment or relief of hemorrhoids or any of its symptoms (A. P. Tr . 131 , 215 , 279 315--B16, 372-373, 424 , 439-410, 503-504, 566, 632-633, 682-683 744; Answer, Par. 3) (A. P. 36).

26. We hereby enter findings with respect to the effect of Mentholatum M. O. Medicated Pile Ointment on hemorrhoids and its symptoms and manifestations identical to the findings with respect to Preparation H set forth in puagraph 25 hereof (Stip. Par. 2 (b) ; Answer, Pal'. 7).

CONCLUSION:'S RE ALLEGATIONS IN COMFLAI"T 1. The Federal Trade Commission has jurisdiction of the subject matter of this proceeding and of respondent. 2. 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 implication, that the use of Mentholatum M. Medicated Pile Ointment, will:

(a) Reduce or shrinl, hemorrhoids;

(b) Avoid the need for SU1'g-ey 8. S a treatment for hemorrhoids;

(e) Eliminate al! itch due to or ascribed to hemorrhoids; (d) Relieve a1I pain attributed to or caused by hemorrhoids; (e) Heal, cure OJ' remove hemorrhoids, and cause hemorrhoids to cease to be a problem.

Order 70 F.

3. Mentholatum M. O. Medicated Pile Ointment wiu not: (a) Reduce or shrink hemorrhoids;

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

(c) HeaJ, cure or remove hemorrhoids and cause hemorrhoids to cease to be a problem;

(d) Eliminate al1 itch or 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 (e) Afford any other type of relief or have any other therapeutic effect upon hemorrhoids 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 advertisements" as that term 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 The Mentholatum Company, a corporation, and its offcers, representatives, agents and employees, directly or through any corporate or other device, do forthwith cease and desist from disseminating or causing the dissemination of any advertisement by means of the United States mails or by any means in commerce, as "commerce" is defined in the Federal Trade Commission Act:

A. In connection with the offering for sale, sale or distribution of Mentholatum M. O. Medicated Pile Ointment or any other product offered for saJe for the treatment or relief of hemorrhoids or piJes or any of its symptoms which: 1. Represents directly or by implication that the use of such product wiu:

(a) Reduce or shrink hemorrhoids or hemorrhoidal tissue or membranes or reduce or shrink sweIJing associated with hemorrhoids;

(b) Avoid the need for surgery as a treatment for hemorrhoids or hemorrhoidal symptoms: THE MENTHOLATUM CO. 1695 1671 Order (c) Heal, cure, remove or clear up hemorrhoids; (d) 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 or upon any of the symptoms or manifestations thereof.

2. Contains any reference (a) to the words " Ephedrine Sulphate " or to any word such as "vasa-constrictor " which implies that said product wil shrink or reduce hemorrhoids; or (b) to the word "benzocaine" or to any other word such as "anesthetic" which implies that said product will provide relief from pain or itching associated with hemorrhoids in excess of affording some temporary relief in Rome cases of pain and itching associated with some types of 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. 4. Makes any claim that said product is more effective in the treatment or relief of hemorrhoids or any of its symptoms than other preparations sold for the treatment or relief of hemorrhoids.

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 preparations, 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 1696 FEDERAL TRADE C02\MISSION DECISIONS Final Order 70 F.

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 be amended. It is furthe,. orcle;'ecl 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. FI:-AL ORDER The parties having entered into a stipulation fied on June 17 1966 , providing, inte,. alia that: the case was submitted to the Commission on the record in Docket 8641 American Home Prod- ?'cts Corporation (p. 1524 hereina and such other facts and records as provided for in said stipulation; that the advertisements in the case had no significantly different effect upon the reader from the effect of the advertisements in America.n Honw 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 American H01ne P'rocl1,wts the Commission may, in its 01'181' disposing of this proceeding, h1clude appropriate provisions to take into consideration such differences; that respondent waives any intervening steps before the hearing eXRminel'; that the Commission may, on the basis of this stipulation, the advertisements attached thereto and the record in A1nerican Bonze Prod-gets issue such order as it deems necessary in 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 filed; and the Commission having rendered its decision and issued its Opinion herein; :;ow therefore, on the basis of said stipulation and attachments, the pleadings herein and the record in Docket 8641 American H01ne pj' odncts Corporation LP. 1624 herein), it is hereby Onle1'ed That the attached Findings of Fact, Conclusions and Order be and they hereby are entered and issued by the Commission in fmal disposition of this proceeding. TIT!;S PACIFIC CORPORATION ET AL. 1697 Complaint