Warner'S Renowned Remedies Company

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IN THE MATTER OF WARNER'S RENO,VNED RE:\IEDIES COMPANY CO~!PLAI~T. FINDINGS, AND ORDER IN REGARD TO THE ALLEGED VIOLATION OF SEC. a OF AN 'ACT OF CO~GRESS APPROVED SEPT. 26, 1914 Docket 10li3. Complaint, Mar. IZ, 19W-Decisio·n, Mar. 23, 1912 ·Where a corporation, engaged in interstate sale and di;;tribution, among other medicinal preparations, of its "\Warner's RPnownell Prescription No. 6," "\Varner's Hpnowned Laxative Tablets," and "\Varner';~ Renowned Alkaline Douche 'I'tablets," which were sold sepnratPly and in combination under the designations "Pn,scription Xo. U Complete," "!'prescription No. G 1\lethod," and "Formula No. G 1\fetbocl"; hy menus of advertisPnwnts through the mails, newsvapers and periodicals, and by drcuhH's, leaflets, and other . advertising literature-- (a) Represented that its said preparations were cures or remedies for functional sterility and constituted a competent aud etrectlve treatnwnt thprpfor, and possessed ben~>ticlal properties in relation to the functioning of the female reproducth·e org:ms ;

(b) Uepresented that one of the gPnerul-c!Hlses of Junctional sterility Is lack of proper timiug betwen ovulation and menstruation, and that Its products served to synehrouize such phenouwna .and thereby bring about pregnancy; and that another general cause of functionnl sterility is constriction of the mouth of the wornlJ, whiclJ pren•uts fertilization, causing scanty menstruation and toxic accumulation, and that "\Warner's Renowned Prescription No. 6" would relax the te11sion so that the month <•f the womb would be sufficiently open to permit pregnancy and prevent toxic accumulations; (c) Represented that the alkalizing hot <louche provi<led by "tres<:ription No. fl'' conntPracted an acid condition of the womb, r~>pre:<ented as another general cause of functional sterility, and thereby made fertilization or pregnancy possible; and that use of Its products would tone uv the female organs and relie,·e sluggisluwss, and then•by overc>ome fuuctional sterility; and (d) Represented that Its pre1mratlon would relieve ltclJy, sensitive, tender, and sore brensts n>osocinted with the menstrual period; Tbe facts being that such u"sertions ns to ailments and theil' <·au!.'PS, a11d the functions conti'I'Ue<l, wpre errt•neous; Its said prpparntions would not, either by reason of the theory upon which hnsc>d or thp ingredients therein contained accompli;;h rPsnlts elainwd; thry wer·e not, used either singly or In combination, cures or effective treutnwnts for sterility, functional or otherwi~P. nnd pnsse~SsP<l no benficial properties with relation to the functioning of the fNnnle rPproduetlvc organs; und there was nothing In Its "Pre~cription No. G" or Its eornblnntiou treatment which could In uny wuy ufl' 't the pe<·nlinr Sl.>llilatlous In the brP:tsts us"ol:llltPd with men~truation; Wltll the f'fi'Pct <•f mi~<l<'atliug a snb~tunt ial portion of the purehn.-!ug public Into the Prrmwnus bPiiPf that such falst• r<'pres~>ntatluu~ were true, awl of thereby hulndng It to pnn·hase Its said preparation~: llcld, That snell nets and pruetkes, muiPr the clrcum~tauces ~;<et forth, were all to the pr!.'jndiC'P and lnjur·y of the tmhlic, ami <'Cmstltuted unfair and dPc~>ptlve al·ts un<l Jll'a(·tit•Ps In comnwrce. 892 FEDERAL TRADE COl\fMISSION DECISIONS Complaint 341!'. T. C. Before Mr. Arthwr F. Thomas and Mr. Roberts. Ilall, trial examiners.

J.1/r. William L. Taggart for the Commission. Nash & Donnelly, of Washington, D. C., for respondent. Col'trPLAINT 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 'Varner's Renowned Remedies Co., 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. The respondent, Warner's Renowned Remedies Co., is a corporation, organized and doing business under the laws of the State of Minnesota with its principal offke and place of business located at 13 East Twenty-fifth Street and 2451 Nicollet Avenue, Minneapolis, Minn. Said respondent trading under the name '\Varner's Renowned Medicine Co., is now, and for more than 1 year last past has been, engaged in the sale and distribution of various medicinal preparations. Among the preparations sold and distributed by the respondent are "'Varner's Renowned Prescription No. 6" and "'Varner's Renowned Alkaline Douche Tablets."

Respondent causes its products when sold to be shipped from its place of business in Minneapolis, Minn., 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 medicinal preparations in commerce between and among the various States of the United State~ and in the District of Columbia.

PAR. 2. In the course and. conduct of its aforesaid business, the respondent has disseminated and is now disseminating, and has caused and is now causing the dissemination of, false advertisements concerning its said products by the United States mails and by various other means in commerce, as "commerce" is defined in the Federal Trade Commission Act, for the purpose of inducing, and which are likely to induce, directly or indirectly, the purchase of said products; and respondent has also disseminated and is now disseminating and has caused and is now causing the dissemination of, false advertisements concerning its said products, by various means, for the purpostt of inducing, and which are likely to induce, directly or indirectly, the WARNER'S RENOWNED REMEDIES CO. 893 891 Complaint purchase of its said products in commerce as ''commerce" is defined in the Federal Trade Commission Act.

Among and typical of the false, misleading and deceptive statements and representations contained in said false advertisements dis- ~eminated and caused to be disseminated as hereinabove described, by the United Stutes mails, by advertisements inserted in newspapers and periodicals, by circulars, leaflets, and other advertising literature, are the following: .

1. That r!>spondent's pr!'parations are cut·es or remedies for functional sterility and constitute competent and etrectiYe treatment therefor; 2. That rel:lpondent's preparations possess beneficial properties In relation to the functioning of the female reproductive organs; 3. That one of the general causes of functional sterility Is lack of proper timing between ovulation and menstruation and that the Warner products serve to synchronize such phenomena thereby bringing about pregnancy; 4. That another general cause of functional sterility Is constriction or closing of the mouth of the womb which prevents ferUllzaUon causing scanty menstruation and toxic accumulation and that "Warner's Henowned Prescription No. 6" will relax the tension so that the mouth· of the womb wlll be sufficiently opened to permit pregnancy and prevent toxic accumulations; 5. That the alkalizing hot douche provided by ''Prescription No. 6" counteracts an acid condition of the womb which is another general cause of functional sterility and thereby makes fertilization or pregnancy possible; 6. That the use of the Warner products will tone up the female organs and relieve sluggishness and thereby overcome functional sterility; and 7. That respondent's preparations will relieve itchy, sensitive, tender, and sore breasts associated with the menstrual period. PAR. 3. The respondent's aforesaid representations and claims, as well as others of similar import which have not been specifically set out herein, are grossly exaggerated, misleading and untrue. In truth and in fact respondent's preparations have no therapeutic value in the treatment of the female organs or in relieving any form of functional sterility. Said preparations do not constitute cures or remedies for functional sterility and are not competent or effective tre"atments therefor. Said preparations possess no value or beneficial properties in reference to the functioning of the female reproductive organs. Representations to the effect that the use of respondent's preparations will serve to synchronize the phenomena of ovulation and menstruation are false and deceptive in that menstruation is entirely depentlent upon ovulation and there is no lack of synchronization between ovulation and menstruation but they must occur simultaneously. Respond- Ents representations as to the effect of its preparations in relaxing the mouth of the uterus and removing toxic accumulations is false, deceptive and misleading for the reason that whf'n menstruation occurs the <'ervical opening will be sufficient to admit the passage of spermatozoa Findings 34F. T. C.

since it is through the cervix that drainage of menstrual discharges must take place. Furthermore, there is no toxic accumulation in the female organs arising from the causes or in the manner described by the respondent in its various advertising materi1tl. Any alkaliza~ion or neutralization of the aciu condition of the vaginal secretions is contrary to nature since the normal reaction of the vagina is acid and consequently there would be no benefit derived from the use of respondent's alkalizing douche. Respondent's preparations have no therapeutic value in toning up the organs and relieving itchy, sensitive, tender or sore breasts associated with the menstrual period. PAR. 4. The use by the respondent of the foregoing false, deceptive, and misleading statements, representations, and advertisements disseminated as aforesaid with respect to its preparations has had and now has a tendency and capacity to anu does mislead a substantial portion of the purchasing public into the erroneous and mistaken belief that such false statements, representations and advertisements are true and induces a substantial portion of the purchasing public because of such erroneous and mistaken belief to purchase respondents' preparations containing drugs. PAR. 5. The aforesaid acts and practices of respondent as herein alleged ar.e all to the prejudice and injury of the public and constitute unfair and deceptive acts ancl practices in commerce within the intent and meaning of the Federal Trade Commission Act. REPORT, FINDINGS AS TO THE FACTs, AND Onder Pursuant to the provisions of the Federal Trade Commission Act, the Federal Trade Commission, on l\Iarch 12 A. D. 1940, issued and subsequently served its complaint upon the respondent, 'Varner's Renowned Remedies Co., a corporation, charging it with the use of unfair and deceptive acts and practices in commerce in violation of the provisions of said a.ct. After issuance of said complaint, testimony, and other evidence in support of said complaint were introduced by ·william L. Taggart, attorney for the Commission and in opposition to the allegations of the complaint by John A. Nash and Horace J. Donnelly, attorneys for the responllent, lx>fore Arthur F. Thomas and Robert S. Hall, trial examiners of the Commisr-ion theretofore duly designate1l by it, and said testimony and other evidence were duly recorded and filed in the office of the Commis..c;ion.

Thereafter, this proceeding regularly came on for final hearinl! before the Commission upon said complaint, testimony and other t>.videnc(l, report of Trial Examiner Arthur F. Thomas upon tlle WARNER'S RENOWNED REMEDIES CO. 895 891 Findings evidence and exceptions filed thereto, and briefs in support of the complaint and in opposition thereto (oral argument not having been requested); and the Commission having duly considered the matter and being now fully advised in the premises, finds that this proceeding is in the interest of the public and makes this its findings as to the facts and its conclusion drawn therefrom: FINDINGS .AS TO THE FACTS P AR.AGR.APH 1. Respondent, \Varner's Renowned Remedies Co., is a corporation organized and doing business under the laws of the State of :Minnesota, with its principal office and pla~e of business located at 2431 Nicollet Avenue; Minneapolis, l\Iinn. Said respondent, trading under the name of "\Varner's Renowned Medicine Co.," is now, and for more than one year last past has been, engaged in the sale and distribution of various medicinal preparations. Among the preparations sold and distributed by the respondent are "\Varner's Renowned Prescription No. 6," "\Varner's Renowned Laxative Tablets," and "\Varner's Renowned Alkaline Douche Tablets," which are sold separately and in combination under the designations "Prescription No. G Complete," "Prescription No. 6 Method," and "Formula No. 6 Method."

Respondent causes its products, when sold, to be transported from its place of business in the State of Minnesota to purchasers thereof located in various other States of the United States and in the District of Columbia. Respondent maintains, and at all times mlntioned herein has maintained, a course of trade in said medicinal preparations in commerce among and between the various States of the United States and in the District of Columbia. PAn. 2. In the course and conduct of its aforesaid business, the respondent has disseminated and is now disseminating, and has caused and is now causing the dissemination of, false advertisements concerning its said preparations, by the United States mails and by various other means in commerce as "commerce" is defined in the Federal Trade Commission Act; and respondent has also disseminated and is now disseminating, and has caused and is now causing the dis!"('mination of, false advertisements conceming- its s:1itl preparations, by various means for the purpose of inducing, and which are likely to induce, directly or indir£>ctly, the purclwse of its !'aid products in comnwrce as "commerce'' is ddined in the Federal Trade Commission Act.

Among and typical of tht> fals£>, misl£>ading, and dec£>ptive statenwnts and represrntations contain('d in said false advPrti!'em£>nts dis- Findings 34F.T.C.

seminated and caused to be disseminated as hereinabove described, by United States mails, by advertisements inserted in newspapers and periodicals, and by circulars, leaflets, and other advertising literature, are the following: · 1. That respondent's preparations are cures or remedies for functional sterility and constitute a competent and effective treatment therefor;

2. That respondent's preparations possess beneficial properties in relation to the functioning of the female reproductive organs; 3. That one of the general causes of functional sterility is lack of proper tirhing between ovulation and menstruation, and that the \Warner products serve to synchronize such phenomena, thereby bringing about pregnancy;

4. That another general cause of functional sterility is constrictiop or closing of the mouth of the womb, which prevents fertilization, causing scanty menstruation and toxic accumulation, and that \Varner's Renowned Prescription No.6 will relax the tension so that the mouth of the womb will be sufficiently open to permit pregnancy and prevent toxic accumulation;

5. That the alkalizing hot douche provided by Prescription No. 6 counteracts an acid condition of the womb, which is another general cause of functional sterility, and thereby makes fertilization or pregnancy possible;

6. That the use of \Varner's prollucts will tone up the female organs and relieve sluggishness, and thereby overcome functional sterility; and 7. That respondent's preparation will relieve itchy, sensitive, tender, and sore breasts associated with the menstrual period. PAR. 3. From examination of the testimony in this case, it appears that it is the respondent's contention that the general health of a woman has a direct bearing upon sterility and that the administration of the various tonics combined in respondent's preparation tones up the general health, with a favorable reaction upon the female organs, causing them to function properly and permit conception to occur. For the purpose of accomplishing this tonic effect, the respondent has developed its combination treatment, which consists of its preparations "'Varner's RE'nowned Prescription No. 6," "\VarnE'r's Renowned Laxative Tablets," and ""\YarnE'r's Renowned Alkaline Douche Tablets." PAR. 4. Responde"nt's tablet preparation "\Varner's Renowned Prescription No.6'' is designed for use as a tonic and contains three ingredients: Ferrous sulfate, gentian, and nux vomica, which are designed ns tonics to tone up the general health. Ferrous sulfate is an iron preparation effective in cases of anemia; gentian is a drug, the use of which WARNER'S RENOWNED REMEDIES CO. 897 891 Findings in modern medicine has, to a great extent, been discontinued, and which was formerly used as a stomachic, with perhaps some tonic value; and nux -vomica is the original organic substance from which strichnine is obtained, which has been used considerably in the past as a tonic but less in recent years, and has a stimulating effect upon gastric secretions .and is a nerve stimulant which tends to relax the nerve endings.

In addition to the above ingredients used for general tonic effect, there are other ingredients contained in this tablet which are designed to tone up the female organs and directly affect sterility. Thesa ingredients are viburnum pruniflorous, a drug formerly used as a uterine tonic or sedative, which, since the use of more specific medication, has been largely discontinued and is now thought to be relatively inert; ovarian substance, a preparation made from whole ovary, which is considered to be inert and of no value when administered orally, particularly in quantities provided in respondent's preparation; and wheat germ oil, which contains vitamin E, sometimes referred to as a sterility vitamin. The value of vitamin E as affecting pregnancy or sterility in women has not been definitely determined. In tests upon rats it has been found to be effective in preventing repeated abortions, the minimum dose required being a half gram a day. If the ordinary pharmacological scale is used, it would require the use of a minimum of one hundred of respondent's pills, three times daily, to provide a comparable dose of this vitamin for human beings. Respondent's laxative tablets designated "Warner's Renowned Laxative Tablets" are designed to assist in beneficially affecting sterility by toning up the system, relieving sluggishness, and eliminating constipation. This preparation consists of three drugs: Cascarin, podophyllin, and aloin, which combination constitutes a harsh laxative, the value of which is limited to the temporary relief of constipation and is of no value in the treatment of sterility. Respondent's third preparation in its combination treatment is a. douche tablet designated "Warner's Renowned Alkaline Douche Tablets" containing ten grains soda bicarbonate. The use of this douche in combination with the other preparations hereinabove described, is designed to assist in toning up the female organs by removing toxic accumulations and particularly the thickened mucous secretion forming a cervical plug or barrier against the entry of male spermatozoa, and by neutralizing the acid condition of the Yagina, considered to be unfavorable to the spermatozoa.

l,AR. 5. Based upon the medical testimony, the Commission finds that there are a large number of causes for sterility in women, many 460500m--42--vol.S4----~7 Findings 34F.T.C.

of which are unknown to the medical profession. The term "functional sterility" as used by the respondent is a misnomer and incorrect. By "functional" is meant that the organs are normally functioning, that the ovaries, tubes, uterus, and vagina are all normally developed and functioning within the normal realm, as contrasted to "pathological," where they would be improperly developed or where disease process has taken place. The conditions under which respondent asserts that sterility takes place are, by their nature, pathological and require specific treatment.

It is an established medical fact that women suffering from anemia, tuberculosis, and other debilitating diseases have become pregnant and the toning up of the general health of the individual will not in itself, overcome sterility, which may be due to many various causes of a pathological nature. . The lack of proper timing between ovulation and menstruation is not generally considered as a cause of sterility. In any event, there is nothing in respondent's ''Prescription No. 6" or its combination treatment which will in any way effect the timing between ovulation and menstruation or serve to synchronize such phenomena. The statements made by the respondent with refer!'nce to the constriction or closing of the mouth of the womb as being a general cause of functional sterility, are false and misleading. The mouth of the womb is never closed unless there is a congenital condition requiring surgery. Menstrual fluid is not normally held within the uterus due to constriction of the uterine outlet, and in event the uterine outlet should remain closed and the menstrual fluid accumulate, a very acute illness would undoubtedly result. It is normal between the periods of menstruation for a small amount of mucus to be present in the cervix or mouth of the womb. The presences of such mucous material is not generally considered as an obstruction to pregnancy, as the spermatozoa are able to penetrate this mucous, which is normally present. None of respondent's said preparations, used either singly or in combination will have the effect of relaxing the womb, so that the mouth of the womb will be sufficiently open to permit pregnancy or have any value in the prevention of so-called toxic accumulations. • The normal condition of the vagina is acid, and such acidity is essential for normal functioning. The U!'e of the preparations contained in respondent's combination treatment, with the exception of the douche tabl!'ts, has no effect upon the acid condition of the vagina. The use of the bicarbonate of soda douche as provided in this prescription might have a tendency to temporarily neutralize WARNER.'S RENOWNED REMEDIES CO. 899 891 Order the acid condition of the vagina. This, however, is contrary to the normal process of the vagina and has no value in favorably affecting sterility.

Respondent's preparations, tu;ed either singly or in combination us provided in "Prescription No. 6 Complete," "Prescription No. 6 Method," or "Formula No. 6 :Method," are not cures or remedies for 1':-terility, functional or otherwise, and do not constitute competent ,or effective treatments for sterility and· possess no beneficial properties "·which have any value in promoting or aiding the functioning of the female reproductive organs. The use of said preparations will not tone up the female organs, relieve sluggishness, or in any way overcome sterility. Increased sensitivity of the breasts at or about the time of menstruation is considered to be physiological and normal in a gr~at many women. There is nothing in respondent's "Prescription No.6" or its combination treatment which can in any way affect the peculiar sensations in the breasts associated with menstruation, described by the respondent as itchy, sensitive, tender, and sore breasts. PAR. 6. The use by the respondent of the foregoing false, deceptive, and misleading statements, repre!:ientations, and advertisements, disseminated as aforesaid, with respect to its preparations, has had, and now has, the tendency and capacity to, and does, mislead a substantial portion of the purchasing public into the erroneous and mistaken belief that such false statements, representations, and advertisements are true, and induces a substantial portion of the purchasing public, because of such erroneous and mistaken belief, to purchase respondent's vreparations containing drugs.

CONCLUSION The aforesaid acts and practices of the respondent, as herein found, are all to the prejudice and injury of the public, and constitute unfair and deceptive acts and. practices in commerce within the intent nnd meaning of the Federal Trade Commission Act. ORDER TO CEASE .AND DESIST This prof'eeding having been heard by the Federal Trade Commission upon the complaint of the Commis:-:ion, answer of the respondent, testimony, and other Pvide:nce taken before Arthur F. Thomas and Robert S. Hall, trial examiners of the Commission tlm·etofore duly designated by it, in support of the allegations of said complaint and in vpposition thereto, report of Trial Examiner Arthur F. Thomas upon the e,·idence and exceptions filed thereto, and Order 3-!F.T.C.

briefs in support of the complaint and in opposition thereto; and the Commission having made its findings as to the facts and its conclusion that said respondent has violated the provisions of the Federal Trade Commission Act;

It is ordered, That the respondent, Warner's Renowned Remedies Co., a corporation, trading as Warner's Renowned Medicine Co., or under any other trade name, and its officers, representatives, agents, and employees, directly or through any corporate or other device, in connection with the offering for sale, sale, or distribution of its preparations designated "'Varner's Renowned Prescription No. 6," "Warner's Renowned Laxative Tablets," and "Warner's Renowned Alkaline Douche Tablets," either singly or in combination under the designations "Prescription No. 6 Complete," "Prescription No. 6 Method," or "Formula No. 6 Method," or any other products of substantially similar composition or possessing substantially similar properties, whether sold under the same names or under any other name or names, do forthwith cease and desist from: 1. Disseminating, or causing to be disseminated, 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, which advertisement represents, directly or through inference, (a) That respondent's preparations, either singly or in combination, are cures or remedies for, or constitute competent or effective treatments for, functional sterility.

(b) That respondent's preparations, either singly or in combination, have any therapeutic value in the treatment of any form of sterility.

(c) That respondent's preparations, either singly or in combination, possess any properties which have any value in promoting or aiding the functioning of the female reproductive organs. (d) That respondent's preparations, either singly or in combination, possess· any properties which will in any way affect the timing between ovulation and menstruation, or serve to synchronize such phenomena.

(e) That the use of said preparations, either singly or in combination, will be effective in relaxing the womb, cause the mouth of the womb to be sufficiently open to permit pregnancy, or prevent toxic accumulations. . (/) That the use of respondent's preparation "'Varner's Renowned Alkaline Douche Tablets" has any value in the treatment of sterility by neutralizing the Reid condition of the vagina, or that the use of said preparation will remove toxic accumulations or any barrier in WARNER'S RENOWNED REMEDIES CO. 901 891 Order the cervix, or in any way affect sterility or make fertilization and pregnancy possible.

(g) That the use of said preparations, either singly or in combination, will tone up the female organs, relieve sluggishness, or overcome sterility.

(h) That the use of said preparations, either singly or in combination, can in any way affect the sensations of the breasts associated with menstruation or that said preparations have any therapeutic value in the treatment of itchy, sensitive, tender, or sore breasts associated with the menstrual period.

2. Disseminating, or causing to be disseminated, any advertisement, by any means, for the purpose of inducing, or which is likely to induce, directly or indirectly, the purchase in commerce as "commerce" is defined in the Federal Trade Commission Act of respondent's preparations, which advertisement contains any of the representations prohibited in paragraph 1 hereof and the respective subdivisions thereof. · It is further ordered, That the respondent shall, within 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.

COMMISSIO~ DECIStOKS902 FEDERAL TRADE Syllabus 34 F.T.C.