United States v. 39 CASES, MORE OR LESS, ETC.
| Decision Date | 14 March 1961 |
| Docket Number | Civ. A. No. 20215. |
| Citation | 192 F. Supp. 51 |
| Parties | UNITED STATES of America v. An article of drug consisting of 39 CASES, MORE OR LESS, each containing 48 60-tablet bottles, and 1 case, containing 24 60-tablet bottles, more or less, labeled in part (bottle): "MICH. BRAND KORLEEN TABLETS, Contains: Choline Citrate, Inositol, Methionine, Cysteine, Niacinamide, Thiamin (Vitamin B1) with excipients. 60 tablets * * * Lelord Kordel of Michigan, Detroit * * * 6009", etc. |
| Court | U.S. District Court — Western District of Michigan |
George E. Woods, Jr., U. S. Atty., Jerome A. Moore, Asst. U. S. Atty., Detroit, Mich., for libelant.
Solomon H. Friend, Bass & Friend, New York City, for claimant.
The claimant has filed this motion for partial summary judgment on the ground that the seized "Michigan Brand Korleen Tablets" were not shipped in interstate commerce or held for sale after shipment in interstate commerce and consequently are not subject to the provisions of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C.A. § 301 et seq.
The Government, in the libel of information, alleged that the Korleen Tablets were misbranded while being held for sale after shipment in interstate commerce. 21 U.S.C.A. § 334(a). The Tablets are manufactured in Michigan for distribution only in that state, but the component ingredients are shipped in interstate commerce to the manufacturer. The claimant contends that any misbranding must be with respect to an article which is in itself shipped in interstate commerce or held for sale after shipment in interstate commerce, and not to a product created from ingredients shipped in interstate commerce.
The Government claims that Korleen Tablets are a "drug" within the definition set out in 21 U.S.C.A. § 321(g):
"The term `drug' means (1) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (2) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (3) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (4) articles intended for use as a component of any device specified in clause (1), (2), or (3); but does not include devices or their components, parts, or accessories."
Five of the six active ingredients of Korleen Tablets, choline, inositol, methionine, niacinamide, and thiamine, are "drugs" being listed in the official United States Pharmacopoeia or the official National Formulary. The representations in leaflets circulated in connection with the sale of the product also demonstrate that the Tablets are a "drug" within clauses (2) and (3) of the statutory definition. See United States v. 46 Cartons, More or Less, Containing Fairfax Cigarettes, D.C.N.J.1953, 113 F.Supp. 336.
The claimant argues that the active ingredients...
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...of the final product, or components which lost their identity in the combined product. E. g., United States v. 39 Cases, . . ., 192 F.Supp. 51 (E.D. Mich.1961); United States v. 40 Cases, . . ., 188 F.Supp. 290 (N.D.N.Y. 1960), rev'd, 289 F.2d 343 (2d Cir. 1961); United States v. An Article......
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...Peanut Oil, and Soya Bean Oil Blended With 25% Pure Olive Oil, 2 Cir. 1961, 289 F.2d 343; United States v. 39 Cases, More or Less, Mich. Brand Korleen Tablets, N.D. Mich.1961, 192 F.Supp. 51. (2) The appellant contends that the evidence is insufficient to prove that the defendant "conscious......
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Baker v. U.S.
...case in its own jurisdiction has thrown the result in Gonsertron into doubt. In United States v. 39 Cases ... Michigan Brand Korleen Tablets, 192 F.Supp. 51 (E.D.Mich.1961) the same district judge who wrote Gonsertron held that tablets compounded in Michigan from ingredients that moved in i......
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United States v. Dianovin Pharmaceuticals, Inc.
...Pharmaceuticals did not comply with the law as he has pointed out." 5 See, also United States v. 39 Cases . . . Mich. Brand Korleen Tablets, 192 F.Supp. 51 (E.D.Mich.1961), aff'd sub nom. United States v. Detroit Vital Foods, Inc., 330 F.2d 78 (6th Cir. 1964), cert. den. 379 U.S. 832, 85 S.......