The issue is whether the Cleanflo was sent to the hospital is a drug or not within the meaning of 21 U.S.C § 321 (p) of the act.
According to 21 U.S.C § 321 (p), the term new drug means “(a) any drug (except a new animal drug or an animal feed bearing or containing a new animal drug) the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof, except that such a drug not so recognized shall not be deemed to be a “new drug” if at any time prior to June 25, 1938, it was subject to the Food and Drugs Act …show more content…
§ 321 (m) the term “labeling means all labels and other written, printed, or graphic matter upon any article or any of its containers or wrappers, or accompanying such article.” Section 502(a) of the Federal Food, Drug and Cosmetic Act (FFDCA) or 21 U.S. Code § 352 declares that a drug or device is misbranded if its labeling proves false or misleading in any particular.
As held in the “United States v. Dotterweich, 320 U.S. 277, 64 S.Ct. 134, 88 L.Ed. 48 (1943), company that purchased drugs from a manufacturer, shipped, and repacked them with a new label, in interstate commerce. Under the FD&C act of 1906 Dotterweich was convicted of a misdemeanor, which prohibits the shipment of misbranded and adulterated drugs in interstate commerce. The Supreme Court upheld Dotterweich's conviction even though he did not directly participate in the proscribed shipments.” Also in the “United States v. Balint, 258 U.S. 250, 42 S.Ct. 301, 66 L.Ed. 604 (1922), Balint charged with unlawfully selling a derivative of a certain amount of a derivative of opium and coca leaves. …show more content…
The Horizon chemical company discovered that its product (Cleanflo), sold for the purpose of cleaning dairy apparatus, also was extremely effective in dissolving the calcium deposits, which clogged catheters that had been removed from the body. Consequently, the Horizon prepared and distributed brochures to the physicians and hospitals to promote the product, for these purposes. The FDA argued that Cleanflo was a drug and that the bottle and brochures were misbranded because they did not contain the label and labeling information required by the law. According to the section 301 (d) of the Food, Drug, and Cosmetic Act, 21 U.S.C. § 331 (d), prohibits the introduction in to interstate commerce of any section 505 of the FDCA, 21 U.S.C. § 355. Section 505 (a), in turn, prohibits any person from introducing or delivering for introduction into interstate commerce any “new drug” unless the FDA has approved the
According to 21 U.S.C § 321 (p), the term new drug means “(a) any drug (except a new animal drug or an animal feed bearing or containing a new animal drug) the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof, except that such a drug not so recognized shall not be deemed to be a “new drug” if at any time prior to June 25, 1938, it was subject to the Food and Drugs Act …show more content…
§ 321 (m) the term “labeling means all labels and other written, printed, or graphic matter upon any article or any of its containers or wrappers, or accompanying such article.” Section 502(a) of the Federal Food, Drug and Cosmetic Act (FFDCA) or 21 U.S. Code § 352 declares that a drug or device is misbranded if its labeling proves false or misleading in any particular.
As held in the “United States v. Dotterweich, 320 U.S. 277, 64 S.Ct. 134, 88 L.Ed. 48 (1943), company that purchased drugs from a manufacturer, shipped, and repacked them with a new label, in interstate commerce. Under the FD&C act of 1906 Dotterweich was convicted of a misdemeanor, which prohibits the shipment of misbranded and adulterated drugs in interstate commerce. The Supreme Court upheld Dotterweich's conviction even though he did not directly participate in the proscribed shipments.” Also in the “United States v. Balint, 258 U.S. 250, 42 S.Ct. 301, 66 L.Ed. 604 (1922), Balint charged with unlawfully selling a derivative of a certain amount of a derivative of opium and coca leaves. …show more content…
The Horizon chemical company discovered that its product (Cleanflo), sold for the purpose of cleaning dairy apparatus, also was extremely effective in dissolving the calcium deposits, which clogged catheters that had been removed from the body. Consequently, the Horizon prepared and distributed brochures to the physicians and hospitals to promote the product, for these purposes. The FDA argued that Cleanflo was a drug and that the bottle and brochures were misbranded because they did not contain the label and labeling information required by the law. According to the section 301 (d) of the Food, Drug, and Cosmetic Act, 21 U.S.C. § 331 (d), prohibits the introduction in to interstate commerce of any section 505 of the FDCA, 21 U.S.C. § 355. Section 505 (a), in turn, prohibits any person from introducing or delivering for introduction into interstate commerce any “new drug” unless the FDA has approved the