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May 27, 1986



The opinion of the court was delivered by: ELFVIN


The abovenamed corporation and individuals ("the defendants") are charged in a seven-count Indictment with violations of the Food, Drug and Cosmetic Act ("the Act"), 21 U.S.C. § 301 et seq. in connection with the marketing of a substance known as "Gammaprim", and with conspiracy to defraud the government in violation of 18 U.S.C. § 371. Presently pending are motions to dismiss the Indictment by all of the defendants on a number of grounds as well as specific motions to dismiss by defendants Fenicchia and Copia.

 The heart of the matter is the legal tenability of any distinction between "food" and "drug" on the one hand and between "over the counter" and "prescription" drugs on the other, within the terms of the Act. General Nutrition, Incorporated ("GNI") is a corporation "engaged in the production, distribution and sale of nutritional, personal care and related products." Defendants' Summary Memorandum, pp. 2-3. The other defendants are officers and employees of GNI. GNI markets Gammaprim, a substance derived in part from oil of evening primrose. The Indictment charges inter alia that Gammaprim was touted as effective in prevention, mitigation and treatment of certain medical conditions such as hypertension, arthritis and multiple sclerosis by virtue of which it is a drug within the meaning of 21 U.S.C. § 321(g). *fn1" Specifically, Count I of the Indictment alleges conspiracy by GNI, Daum, Walsh and McTurk to defraud the United States in violation of 18 U.S.C. § 371 by participating in the offenses alleged in the remaining counts. Counts II-VII allege identical statutory violations but in different factual settings. GNI, Daum, Walsh and McTurk are named as indictees in all counts. Fenicchia is named as such in Counts II and VII while Copia is so named in Count V. The counts allege that Gammaprim, a drug within the meaning of section 321(g) was "misbranded" -- a prohibited act within the meaning of 21 U.S.C. § 331(k) and one for which a penalty is provided by section 333(a). This misbranding took three different forms according to the Indictment. First, it is alleged that the Gammaprim label violates 21 U.S.C. § 352(f)(1) which provides that a drug shall be deemed misbranded unless its labeling bears adequate directions for use. Second, a violation is alleged of 21 U.S.C. § 353(b)(1)(B) which provides that a drug which,

"because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such drug,"

 must be dispensed by prescription or it will be deemed misbranded. Third, the defendants are said to have violated 21 U.S.C. § 353(b)(4) which provides that drugs coming within section 353(b)(1) will be considered misbranded if they do not bear the statement "Caution; Federal law prohibits dispensing without a prescription." The defendants' main arguments in favor of dismissing the Indictment are that Gammaprim is improperly classified as a prescription drug -- to wit, that it is a food, or at most an over the counter drug --, that the government's failure to adhere to a uniform definition of proscribed conduct under the Act implicates the defendants' due process rights and that, in any event, this prosecution infringes the defendants' First Amendment rights to express opinions regarding Gammaprim's alleged nutritional value.

 The Gammaprim label consists, insofar as is pertinent here, of a listing of contents and the directions "As a food supplement, take up to six capsules per day." The Indictment charges that Gammaprim was promoted in the media and elsewhere for its supposed beneficial health effects. For example, it is alleged that Gammaprim was sold in conjunction with certain "self-help" literature purporting to provide a medical and scientific context to the uses of the substance. *fn2" Brochures that are part of its integrated distribution program can be found to constitute a drug's labeling. United States v. Guardian Chemical Corporation, 410 F.2d 157 (2d Cir. 1969). Thus Gammaprim is said to be a drug within the meaning of 21 U.S.C. § 321(g)(1)(B). Moreover, the government asserts that Gammaprim is a prescription drug under 21 U.S.C. § 353(b)(1)(B) because collateral measures are necessary to its use. Thus the government suggests:

"Collateral measures necessary to the safe use of Gammaprim in the management of hypertension means all those things which a layman, because of his or her lack of education, training, and experience, cannot do to safely manage the disease. These include taking a proper history, doing a physical exam, ordering appropriate laboratory tests, having a knowledge of the diseases that cause hypertension, integrating the results of the history, exam, and tests with this knowledge, making a diagnosis, designing a treatment plan, and carrying the plan through with proper continuing evaluation." Government's December 20, 1985 Memorandum in Opposition to Motion to Dismiss All Counts Based Upon the Prescription Drug Status of Oil of Evening Primrose at p. 5.

 The defendants argue that this definition of collateral measures improperly focuses on "disease" rather than the nature of the alleged drug itself. The government, they add, has not pointed out any harmful characteristic of Gammaprim per se. Any number of over the counter drugs are "labeled and marketed for diseases commonly considered to require physician diagnosis and management." Memorandum in Support of Defendants' Motion to Dismiss All Counts Based upon the Prescription Drug Status of Oil of Evening Primrose, p. 13. The defendants assert that the government's approach to "collateral measures" is so expansive that it would encompass commonly used substances, both food and drug, that might arguably require physician supervision in relation to certain diseases. *fn3" They cite United States v. Article Of Drug Labeled Decholin, 264 F. Supp. 473 (E.D.Mich. 1967), wherein a "theoretical potential for harm" was not accepted as a basis or reason for assigning a product to the category of a prescriptive drug. Id. at 480.

 The government argues, tenably, that the inherent characteristics of a drug are targeted by those facets of 21 U.S.C. § 353(b)(1)(B) which cover drugs possessing "toxicity or other potentiality for harmful effect." The defendants' assertion of redundancy for the "collateral measures necessary to its use" language would effectively read it out of the statute.

 The simplest answer to the defendants' arguments here, and to some extent elsewhere, is that the statute is intended to be broad. As the government asserts, subsection (B) is a catchall provision designed to cover drugs which merit prescription-status scrutiny, but do not fit within the more precise specifications of the subsection. Safety legislation must be liberally construed to effectuate the congressional purpose. Whirlpool Corp. v. Marshall, 445 U.S. 1, 13, 63 L. Ed. 2d 154, 100 S. Ct. 883 (1980). The Supreme Court elsewhere has stated:

"The purposes [of the Food, Drug and Cosmetic Act] thus touch phases of the lives and health of people which, in the circumstances of modern industrialism, are largely beyond self-protection. Regard for these purposes should infuse construction of the legislation if it is to be treated as a working instrument of government and not merely as a collection of English words." United States v. Dotterweich, 320 U.S. 277, 280 (1943).

 The holding in United States v. Article of Drug Labeled Decholin, supra, is not as inflexible as the defendants would have it. Therein it was noted:

"While [the intervenor-claimant] is probably correct in saying that the distribution of a drug was not intended by Congress to be restricted just because it will not serve as a cure in all instances in which it may be taken by a person following the manufacturer's recommendations, the fact that a particular product may be an ineffectual remedy under some circumstances could certainly be a substantial consideration in finding that it is unsafe for self-medication. Conversely, a showing that a drug has a tendency to cause laymen to delay seeking help in determining the natures of their illnesses is not per se sufficient to warrant removing it from the over-the-counter market." Id. at 482.

 That court, after an analysis of the underlying legislative history, thus proceeded to set forth certain factors bearing on the question of the point where the balance shifts from over-the-counter to prescription drug status. Major considerations, in its view, would be the extent of information and warning carried on a given label. See, id. at 483. *fn4" Significantly for present purposes, Gammaprim did not carry any warning or advice concerning consultation of a physician or symptomology. Also significantly, the various drugs listed by the defendants -- see note 3, supra -- concededly contained some degree of medical instruction or caution on their labels. Thus assuming Gammaprim is classified as a drug, any potential dangerous effects will be magnified by the complete absence of medical and cautionary information to the consumer. This absence of information is clearly not contemplated by the Act and it is disingenuous to suggest ...

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