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September 27, 1962

60 28-CAPSULE BOTTLES, MORE OR LESS, and 47 7-Capsule Bottles, more or less, of an article of drug LABELED in part: 'UNITROL * * *'

The opinion of the court was delivered by: MEANEY

This action, which arises under the Federal Food, Drug and Cosmetic Act, Title 21 U.S.C. § 301 et seq., was initiated on September 30, 1959 by the filing of a libel of information in the United States District Court for the Eastern District of Michigan. The libel alleged that the Republic Drug Co., Inc., of Buffalo, New York, had shipped in interstate commerce an article of drug labeled in part 'Unitrol -- A True Appetite Depressant,' from Buffalo, New York, to the Hendrickson Pharmacy, Detroit, Michigan, and that this drug was misbranded within the meaning of Title 21 U.S.C. § 352(a) in that its labeling contained false and misleading statements 'which represent and suggest that article is effective as an appetite depressant; and that it will cause one to lose weight without rigid diets; which statements are false and misleading since article is not effective for these purposes.'

Pursuant to the libel samples of the allegedly mislabeled drugs were seized at the Hendrickson Pharmacy, along with all related promotional material, specifically a counter display carton and two window banners, which material is to be considered as part of the labeling within the meaning of Title 21 U.S.C. 321(m).

 In addition to the present action approximately a dozen other seizure actions were instituted against the same drug, phenylpropanolamine hydrochloride, hereinafter referred to as PPA, manufactured by the same concern Nysco Laboratories, Inc., Long Island City, New York, and marketed by different retail concerns under a variety of trade names.

 The manufacturer, Nysco Laboratories, Inc., upon their motion in the various districts where the seizures were made, was substituted in these actions and these cases, including the instant case, were transferred to the District of New Jersey for disposition. Having chosen this case as being representative, the parties agreed at pretrial to hold the remaining cases in abeyance pending the outcome of the present action.

 Also at pretrial the Government was permitted to amend its libel and allege that the seized drug additionally was misbranded in that it claimed in its labeling 'that the article is an adequate and effective treatment for obesity * * *.' Further, the amendment particularized the language of the labeling to which the Government took exception. Samples of this language read as follows: 'LOSE WEIGHT -- look and feel lovely * * * unitrol -- A TRUE APPETITE DEPRESSANT -- Guaranteed Effective; ONE CAPSULE WORKS ALL DAY -- if you want to lose weight * * * curb your appetite the safe, easy Unitrol way -- Guaranteed effective; LOSE WEIGHT -- UP TO 14 LBS. in 14 DAYS -- unitrol * * * that's all -- 1 capsule works all day.'

 The issues before the court as defined in the pretrial stipulation and as argued at the trial are:

 (a) Whether or not phenylpropanolamine hydrochloride 75 mg. is adequate and effective as an appetite depressant for weight control, or is adequate and effective in the treatment, control or management of obesity.

 (b) What does the labeling involved in this case represent and suggest?

 To take the second issue first the Government contends that the Unitrol labeling represents and suggests that claimant's product is all that is needed to carry out successfully a weight-reducing program. Claimant, on the other hand, argues that what the Unitrol labeling truly represents is that the use of that product along with a reduced caloric intake is all that one need do to lose weight, and points to an 1180 calorie chart that the manufacturer has inserted in each bottle of capsules. Although it is true that the insert states that in order to lose weight caloric intake must be reduced and certain types of food avoided, and although it is also true that by virtue of Title 21 U.S.C. § 321(m) the insert is to be considered as 'labeling,' it seems nevertheless that a prospective purchaser is given no hint, by the labeling available to him, that he must diet in order to lose weight and that 'Unitrol -- that's all' is not really all but merely a part of a dietary regimen. The court finds, therefore, that the labeling herein is deceptive in that it fails to inform the public of the nature of the product which it describes until after the product has been purchased.

 The first witness for the Government was Dr. Joseph F. Fazekas, a physician who is board certified in internal medicine and board qualified in neurology. He has been Medical Officer in Medicine at the District of Columbia General Hospital, and for twelve years was the Chief of Staff of this institution. Doctor Fazekas has taught medicine at the New England Center Hospital, George Washington University Hospital, and Georgetown University Hospital; he has taught pharmacology at the Georgetown University Hospital, and neurology at Tufts Medical School. At present Doctor Fazekas is clinical associate professor in neurology at George Washington University Hospital.

 Doctor Fazekas has contributed 204 articles to the medical literature, most of them dealing with metabolic disturbances. He defined metabolic as alterations in the 'biological or biochemical activity of various cells under various conditions' and related it to the translation of ingested food into the make-up of the body.

 At the request of the Federal Food and Drug Administration Doctor Fazekas designed and supervised an 'experiment to determine the therapeutic efficacy of PPA.' The test subjects were 81 institutionalized mentally deficient patients whose mental deficiency, that is, low intelligence, was classified as 'idiopathic' because it had no known cause. The 81 patients were divided into four groups of approximately 20 each. For six weeks each group was given, one hour before meals, one of the following: A placebo (a medication with no medical but possible psychological effect); 25 mg. PPA three times a day; 50 mg. PPA three times a day; and 5 mg. three times a day of dextro amphetamine, an acknowledged potent anorexigenic agent. The identity and dosage of the administered drugs were unknown to both the subjects and the administrators of the tests. In the study there was no attempt made to restrict food intake and the known caloric diet was at least 3000 calories per day and more was given if requested. The choice of mentally deficient subjects was made in order to eliminate as much as possible the many psychological factors such as the 'placebo effect' and the doctor-patient relationship that are known to influence weight reduction in the mentally alert population. Doctor Fazekas testified that idiopathic mentally deficient subjects were valid subjects for his study because in his opinion, 'in primary mental deficiency there is no basic disturbance in the hunger and appetite centers * * *.'

 The 'Summary and Conclusions' section of the Fazekas report, as published in the July 1959 issue of the Journal of the American Medical Association, contains the following statement:

 'the results failed to demonstrate a significant reduction in weight in the groups of subjects receiving 25 and 50 mg. of phenylpropanolamine three times a day and those given a physically indistinguishable placebo. In the group of subjects receiving 5 mg. of dextro amphetamine three times a day over a similar period of time, there was a statistically significant reduction weight. Although related chemically to dextro amphetamine and retaining certain of its peripheral properties, phenylpropanolamine, as indicated by this study, differs in that it does not possess significant anorexigenic potency.'

 The second witness for the Government was Dr. Jean Mayer, a nutritionist and physiological chemist who holds the degrees of Bachelor of Letters, Bachelor of Science and Master of Science from the University of Paris, the degree of Doctor of Philosophy in the medical sciences from Yale University, and the degree of Doctor of Science from the Sorbonne. Doctor Mayer is presently an associate professor of nutrition at Harvard University where he teaches at the medical school and the school of public health. He has been a nutrition officer of the United Nations, a consultant in nutrition to the Food and Agriculture Organization and the World Health Organization, and a member of the First International Committee on Protein Requirements and the Second International Committee on Calorie Requirements.

 Doctor Mayer has been associate editor of Nutrition Review, nutrition editor of Postgraduate Medicine, and presently he is on the editorial boards of the American Journal of Physiology and the Journal of Applied Physiology. He is also a member of the panel on nutrition of the Committee on the Revision of the United States Pharmacopeia. Doctor Mayer has lectured on nutrition, by invitation, in Canada, Holland, Switzerland, Sweden and Scotland and was vice-president of the International Nutrition Congress held in Amsterdam in 1954. He is a consultant in nutrition at a Boston hospital and continues to advise the United Nations and the Health Departments of Massachusetts, New York, California and New Jersey in nutritional matters. In addition he has published approximately 250 articles on nutrition with a concentration during the past twelve years upon appetite satiety and obesity in experimental animals and in man.

 Doctor Mayer testified that he knew of no drug that could be defined as a 'true' appetite depressant, which he defined as a substance that 'could be used for long periods of time to depress appetite and thus treat obesity successfully * * *.' (Emphasis added.) He stated that he had found no difference in the reaction to nutritional treatment or drugs between mentally deficient patients and normal subects because the amphetamines, to which class PPA and dextro amphetamine belong, 'act at levels of the central nervous system way below those at which differences in mental ability would make a difference.' Doctor Mayer further testified that the Fazekas study was 'as good a study as any I have ever seen of the efficacy of a given drug in the treatment ...

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