Goldberg, Maurice, et al

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

IN THE MATTER OF --THE RENESOL CORPORATION, MAURICE GOLDBERG AND GHARLES GOLDBLATT COMPLAINT, FINDI~GS, AND ORDER IN REGARD TO THE ALLEGED VIOLATION OF SEC. 5 OF AN ACT OF CO:\'GRESS APPROVED SEPT. 26, 1914 Doclcet 3695. Complaint, Jan. 25, 1939-Decision, July 6, 1942 Where a corporation and two Individuals, who controlled aDll dh·ected its affairs and activities, engaged in the interstate sale and distribution of their "Renesol" medicinal preparation for the treatment of PpilepRy- Represented, directly and Indirectly, through advPrtlsempnts disseminated by them that their said product containPu no harmful drugs, was not habit forming, and was safe to use;

The facts being that while phenobarbital-of which each capsule of said product contained a grain-Is recognized by the medical profession as an appropriate treatment for some of the symptoms of epilepsy, the drug is definitely habit forming; and while various individuals have different tolerances therefor, , I there are those to whom the administration of a small dose would be dangerous and, In unusual Instances, fatal; continued use of said drug in exces~lve amounts will, in some cases, affect the comprehension, concentration, memory, and judgment, and may produce toxic psychosis with hallucinations; their recommencled dosage wa~ excessive; ond their product could not be considered safe and harmless; , , With capacity and tendency to mislead and deceive a substantial portion of the plnchaslng public Into the mistaken belief that sulci represent:ltious ";Pre true, thereby causing it to purchase said p1·eparation; whereby injury was _ done to a substantial portion of said public: lleld, 'that such acts and practices, under the circumstances set forth, were all to the prejudice of the public, and constituted unfair and deceptive acts and practices In commerce.

Before Mr. Lewis C. Rui'Jsell and Mr. John L. Ilornor., trial examiners.

Mr. J. W. Brookfield, Jr., for the Commission. L. J. and _G. A. Shapb·o, of Brooklyn, N. Y., for respondents. COMPLAINT ' Pursuant to the provisions of the Federal Trade Commission Act; and by virtue of the authority vested in it by said act, the Federal Trade Commission, having reason to believe that The Renesol Corporation, and Maurice Goldberg and Charles Goldblatt, individnals, hereinafter referred to as respondents, have violated the provisions of the 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 foliows: THE RENESOL CORP. ET AL. 13 12 Complaint PARAGRAPH 1. Respondents, Maurice Goldberg and Charles Goldblatt, are individuals, maintaining their place of business at 551 Fifth A-venue, New York, N.Y., and are now and have been for more than 2 Years last past engaged in the business of offering for sale and selling a medical preparation or compound for the treatment of epilepsy under the brand name "Reuesol."

Respondent, The Renesol Corporation,· was incorporated under the laws of the State of New York in the year 1933, and maintains its Principal office and place of business at 551 Fifth Avenue, New York, N. Y. Respondent, The Renesol Corporation,. is owned, dominated, l controlled, and directed by the individual respondents, Maurice Gold-I berg and Charles Goldblatt, who, since its incorporation, have controlled, managed, and directed and now control, manage, and direct the.I, ~~fl'airs and activities of said respondent, The Renesol Corporation . Said respondent, The Renesol Corporation, under the direction and control of the individual respondents, Maurice Goldberg and Charles ~oldblatt, is now, and for more than 2 years last past, has been engaged 111 advertising, selling, and distributing for use in the treatment of epilepsy, a certain medical preparation designated "Renesol." Said respondents cause and for more than 2 years last past have caused, said Preparation, when sold by them, to be shipped from their place of business in New York, N. Y., to the purchasers thereof located in Various States of the United States other than the State of origin of such shipments, and in the District of Columbia. There is now and has been for more than 2 years last past, a course of trade in said !Jreparation "Renesol" sold and distributed by the respondents in com- Jnerce between and among the various States of the United States~ und in the District of Columbia.

P.AR, 2. In the course and oonduct of their aforesaid business, the respondents have disseminated ang are now disseminating and have caused and are now causing the dissemination of false advertisements concerning their said product by .United States mails, by insertion m n_newspapers and periodicals having a general circulation and also in Circulars and other printed or written matter, all of which are distributed in commerce among and between the various States of the ~united States and by 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 their said product; and have disseminated and are now disseminating and have caused and are now causing the dissemination of false advertisements concerning their said product by various means for the pur- Pose of inducing and which are likely to induce directly or indirectly the purchase of their said product in commerce as commerce is defined 509749'"-43-vol. 35-4 14 FEDERAL TRADE COMMISSION DE<CISIONS Complaint 35F.T.C.

in the Federal Trade, Commission Act. Among and typical of the false statements ai1d representations contained in .said advertisements disseminated, and caused to be disseminated as aforesaid, are the following:

Renesol DOES NOT CONTAIN Any BROMIDES OR any other HARMFUL or HABIT-FORMING DRUGS and Is absolutely safe for use by both children and adults.

Renesoi Is not habit fo1·mlng making it perfectly safe to use. Renesolls not hnrmful-either to stomach, kidney or skin. l\lost Important RENESOL DOES NOT CONTAIN HABIT-FORMING OR HARMFUL DRUGS OF ANY KIND. It is absolutely safe to use for children us well us adults.

It is safe and harmless-so safe that even a child can take it. The greatest gift that has ever been bestowed upon mankind Is unquestionably HEALTH AND HAPPINESS. You who have suffpred much will fully Appreciate the normal, happy and healthy life which the RENESOL treatment assures you. Your RENESOL treatment will make you realize as it has for countless others who have. been relieved of suffering and misery that a NEW LIFE OF JOYOUS FREEDOM FROI\1 THE ILLS AND EMBARRASSMENTS OF EPILEPSY AWAIT YOU! Through the use of the stateinents and representations hereinabove set forth, and others similar thereto not specifically set out herein, all of which purport to be descriptive of the remedial, curative, or therapeutic properties of respondents' product, and of the ingredients contained therein, respondents have represented and do now represent, directly and indirectly, that respondents' preparation "H.enesoP' will assure to the user a normal, happy, and healthy life; that it contains no harmful drugs, that it is not habit forming; and that it is safe to use.

PAR. 3. The aforesaid representations and claims made by the respondents as hereinabove described are grossly exaggerated, misleading, and untrue, and constitute false advertising. In truth and in fact, respondents' preparation ''Renesol" will not assure the user a normal, happy, and healthy life. It does contain harmful drugs and may be habit forming. It cannot be used indiscriminately with safety. Said advertisements of respondents are also false in that they fail to reveal that the use of this preparation, under the conditions prescribed in said advertisements and under ~ch conditions as are customary and usual, may result" in serious illness as well as nervous and mental disorders.

PAR. 4. The use by the respondents of the foregoing false, deceptive, and misleading statements, representations, and advertisements, disseminated as aforesaid with respect to said, medicinal preparation, has had and now has· the capacity and tendency to and does mislead and deceive a substantial portion of the purchasing public into the errone- I.

THE RENESOL CORP. ET AL, 15l 12 Findings ous and mistaken belief that respondents' said preparation does not in fact contain any harmful drugs, is not habit forming, is safe to use, and that its use will assure the user a normal, happy, and healthy life, and causes a portion of the purchasing public, because of said erroneous and mistaken belief so engendered, to purchase respondents' said preparation. As a result thereof, injury has been and is now being done by respondents to a substantial portion of the purchasing public in the various States of the United States and in the District of Columbia. . PAR. 5. The aforesaid acts and practices of the respondents, as herein alleged, are all to the prejudice of the public and constitute unfair and deceptive acts and practices in commerce within the intent and meaning of the Federal Trade Commission Act.II. REPORT, FINDINGS AS TO THE FACTS, AND ORDER Pursuant to the provisions of the Federal Trade Commission Act, the Federal Trade Commh;sion on January 25, 1939, issued and subsequently served its complaint in this proceeding upon the respondents named in the caption hereof, charging them with the use of unfair and deceptive acts and practices in commerce in violation of the provisions of said act. .After the issuance of said complaint and the filing of l"respondents' answe~ thereto, certain facts agreed upon were read into the rf'cord, and testimony and other evidence in support of and in opposition to the allegations of the complaint were introduced before t'Xaminers of the Commission theretofore duly designated by it, and said agreed facts, testimony, and other evidence~ were duly recorded and filed in the office of the Commission. Thereafter, the proceeding regularly came on for final hearing before the Commission on the said complaint, the answer thereto, the agreed facts, testimony and other evidence, report of the trial examiners and exceptions thereto, and briefs in support of und in opposition to the complaint (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 PARAGRAPH 1. Respondent, The Rcnesol Corporation, is a corporation organized and existing under the laws of the State of New York nnd having its principal office a~d place of business at 551 Fifth Avenue, New York, N.Y. Respondents, Maurice Goldberg, an individual, and Charles Goldblatt, an individual, control, mamlge, and direct the Findings 35F. T.C.

affairs and activities of the corporate respondent, and have since its organization in ·1933 controlled, managed, and directed said affairs and activities.

PAn. 2. Respondent, The Renesol Corporation, under the direction and control of the individual respondents, l\Iaurice Goldberg and Charles Goldblatt, is now, and for a number of years last past, has been engaged in advertising, selling, and distributing a medical preparation designated "Renesol' for use in the treatment of epilepsy. Said respondents cause, and for a number of years last past have caused, said preparation, when sold by them, to be shipped from their place of business in New York, N. Y., to purchasers thereof located in various States of the United States other than the State of New York and in the District of Columbia, and maintain and have maintained a course of trade in said preparation in commerce between and among the various States of the United States and in the District of Columbia.

PAR. 3. In the course and cond~1ct of their aforesaid business respondents, by means of the United States mails and by various means in commerce, as "commerce" is defined in the Federal Trade Commission Act, have disseminated and are now disseminating, and have caused and are now cuusing the dissemination of, false advertisements concerning their said medicinal preparation, and respol1den.ts by various means have also disseminated and are now disseminating, and have caused and are now causing the dissemination of, false advertisements for the purpose of inducing, and which are likely to induce, directly or indirectly, the purchase of said medicinal preparation in commerce, as "commerce" is defined in the Federal Trade Commission Act.

Among and typical of the false representations contained in the advertisements disseminated and caused to be disseminated as aforesaid are the following:

Renesol DOES NOT CONTAIN ANY BROMIDES O£t any other IIAR~IFUL or HABIT-FOR::\IING DRUGS and Is absolutely safe for use by both children and adults.

Renesolls not habit forming, making it perfectly safe to use. Renesolls not harmful-either to stomach, kidney, or skin. 1\Iost Important, ltENESOL DOES NOT CONTAIN HAB~T-FORMING OR HARMFUL DRUGS OF ANY KIND. It is absolutely safe to use for children as well as adults.

It Is safe and harmlesft-so safe that even a child can take it. PAR. 4. Through the use of the statements and representations hereinabove set forth and others similar thereto not specifically set out herein, all of which purport to be descriptive of the therapeutic properties of respondents' product and of the ingredients contained therein, · THE RENESOL CORP. ET AL. 17 12 Findings respondents have represented and now represent, directly or indirectly, that respondents' preparation "Renesol" contains no harmful drugs, that it is not habit fortning, and that it is safe to use. PAn. 5. Respondents' product, "Renesol," is sold to members of the Public in capsule form, and each capsule contains one grain of phenobarbital and some biearbonate of soda. Respondents furnish to pur- . chasers of "Renesol" directions for the administration thereof, which lead in part:

Three (3) capsules are taken with a glass ot water twice a day, once after breakfast, and again one hom· before going to bed at night. This is continued until the patient begins to feel DROWSY AND DIZZY. If at the end ot the thit·d day, drowsiness has not occurred, then continue to take three (3) capsules twice a day for two more days, but NO 1\IORE. This Initial dosage Is tor the purpose of placing putlent"fully under the influ- ~llce of the treatment.

As soon as the drowsinP~s bPglns to oceur, or at the end ot the fifth day, EVEN IF Tile DROWSINESS lias NOT YET llEGUN, the patient begins to take two (2) capsules ONCE A DAY before going to bed at night. After having taken two (2) capsules once a day for three days, in the majority of the cases th(' symptoms of the disease are CONTROLLED and there Is no longer any drowsiness. Then two (2) capsules a day is the proper dose to continue to take before going to bed.

The directim1s further provide that in certain contingencies the dosage he increased to the amount of the initial dosage, and provision is also lllade that in other contingencies a gradual reduction in dosage be lllude. Various suggestions are also made "'ith respect to diet, regulation of bowels. and avoidance of excitement. Phenobarbitai in proper dosage under adequate direction and supervision is recognized by the medical profession as an appropriate treatlllent for some of the symptoms of epilepsy. It is a. seclative and tends to ameliorate the violence of epileptic seizures. It is sometimes administered separately and sometimes in conjunction with bromidr.s. Through continued use of phenobarbital, a craving for it may be developed, and the denial of it to a patient who has become habituated to its use may result in the patient developing the usual symptoms of vlithdrawal of the drug. It is definitely a habit-forming drug, not to the extent that mo~phine is, but to a greater degree than some ()ther drugs which are recognized as habit-forming. Various indi- · Viduals have different tolerances for phenobarbital. Some indi-' Viduals are exceedingly sensitive to it, some less so, and others may have more than the normal or average tolerance for it. There are,' however, individuals to whom the administration o£ what might be considered a small dose would be dangerous and could, in unusualI . conditions) result in death.l'· l I 18 FEDERAL TRADE COMMISSION DEGSIO~S Order 35F.T.C.

The dosage recommended by respondents is excessive. This fact was evidently recognized by respondents, and before the conclusion of the trial of this case they revised the directions furnished to pur· chasers and substantially reduced the dosage recommended therein. The continued use of phenobarbital in excessive amounts will, in some . cases, affect the comprehension, concentration, memory, and judg- · ment of an individual, and may produce toxic psychosis with hallucinations.

In view of the fact that phenobarbital is habit-forming, and of the varying degrees of sensitivity to the drug among individuals, as well as the effects which may result from the use of doses not usually considered excessive, the' Commission concludes that respondents' product is not a safe and harmless one.

PAR. 6. The use by respondents of the false, deceptive, and mis· leading statements, representations, and advertisements with respect to "Renesol," disseminated as aforesaid, has had and now has the capacity and tendency to mislead and deceive a substantial portion of the purchasing public into the erroneous and mistaken belief that respondents' said preparation does not contain any harmful drugs, is not habit forming, and is safe to use, and causes a portion of the purchasing public because of such erroneous and mistaken belief to purchase respondents' said preparation. As a result thereof, injury has been and is now being done by respondents to a substantial portion of the purchasing public in the various States of the United States and in the District of Columbia.

CONCLUSION The aforesaid acts and practices of the respondents are all to the prejudice of the public and constitute unfair and deceptive acts and practices in commerce within the intent and meaning of the Federal Trade Commission Act.

ORDER TO CEASE AND DESIST This proceeding having been heard by the Federal Trade Commission upon the complaint of the Commission and the answer of restlondents, certain agreed facts, testimony, and other evidence in support of and in opposition to the allegations of the complaint taken before examiners of the Commission theretofore duly designated by it, report 'of the trial examiners and exceptions thereto, and briefs in support of and in opposition to the complaint, and the Commission having made its findings as to the facts and its conclusion that said respondents have violated the provisions of the Federal Trade Commission Act. THE RENESOL CORP. ET AL. 19 12 Order 1 tis ordered, That respondent, The Rencsol Corporation, its officers, agents, representatives, and employees, and respondents, Maurice Goldberg, and Charles Goldblatt, individuals, their representatives, agents, and employees, jointly or severally, directly or through any corporate or other device, in connection with the offering for sale, sale, and distribution of the medicinal preparation designated "Renesol," or any other medicinal preparation which is substantially similar in composition or possesses substantially similar properties, whether sold Under the same name or any other name, do forthwith cease and desist from 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, or 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 such commerce of the medicinal Preparation designated ''Renesol," which advertisement: 1. Represents, directly or through inference, that said preparation is not habit forming, or that it is safe or harmless. 2. Fails to reveal that the use of said preparation in excessive doses may result in serious injury to the physical and mental health of the user: provided, further, that such advertisement need contain only the statement, "CAUTION: Use only as directed," if and when the directions for use, wherever they appear on the label, in the labeling or both, contain a warning to the above effect; and provided further, that such directions for use do not recommend dosage of said preparation in excess of that recommended in respondents' directions as revised during the trial of this case.

It is furthe~ ordered, That the respondents shall, within 60 d<tys ~after service upon them of this order, file with the Commission a report lll writing setting forth in detail the manner and form in which they have complied with this order.

FEDE~AL TRADE COMMISSION DE1CISIONS20 Complaint 35F.T.C.

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