United States v. General Nutrition, Inc.
Decision Date | 27 May 1986 |
Docket Number | No. CR-84-174E.,CR-84-174E. |
Citation | 638 F. Supp. 556 |
Parties | The UNITED STATES of America v. GENERAL NUTRITION, INCORPORATED, Gary A. Daum, David E. Walsh, George E. McTurk, Ilene M. Fenicchia and Jessie M. Copia. |
Court | U.S. District Court — Western District of New York |
Joseph M. Guerra, III, Asst. U.S. Atty., Buffalo, N.Y., Anita Johnson, Washington, D.C., and Donald E. Segal, Rockville, Md. for plaintiff.
Joseph V. Sedita, Michael Brady, Buffalo, N.Y., Robert B. Fiske, Jr., Pamela R. Chepiga, Charles A. Stillman, New York City, Joseph Sbarbati, Niagara Falls, N.Y., Peter Fleming, Jr., Milton Bass, New York City, for defendants.
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.
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.2 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:
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.3 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, 100 S.Ct. 883, 891, 63 L.Ed.2d 154 (1980). The Supreme Court elsewhere has stated:
United States v. Dotterweich, 320 U.S. 277, 280, 64 S.Ct. 134, 136, 88 L.Ed. 48 (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:
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