Opinion ID: 599675
Heading Depth: 3
Heading Rank: 2

Heading: federal statutes relevant to vital health's products

Text: 26 The Federal Food, Drug, and Cosmetic Act of 1938 (the Act), 21 U.S.C. § 301, et seq., was designed to protect public health by regulating certain products moving in interstate commerce. United States v. Kordel, 164 F.2d 913 (7th Cir.1947); United States v. Two Bags, Poppy Seeds, 147 F.2d 123 (6th Cir.1945); Barnes v. United States, 142 F.2d 648 (9th Cir.1944). One of the Act's primary purposes was to ensure the safety of food and drugs before they became available to the public. United States v. Wiesenfeld Warehouse Co., 376 U.S. 86 (1964). Section 331 of the Act prohibits the introduction or delivery of a misbranded drug or an unapproved new drug through interstate commerce. 21 U.S.C. §§ 331(a) and (d). 27 A product is a drug for the purposes of the Act if it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals. 21 U.S.C. § 321(g)(1)(B). A new drug is any drug that 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 condition prescribed, recommended, or suggested in the labeling thereof. 21 U.S.C. § 321(p)(1). However, a grandfather clause exists in 21 U.S.C. § 321(p)(1) which exempts a drug from new drug status if it was subject to the Food and Drugs Act of 1906 and its labeling contain[s] the same representations concerning the conditions of its use as it did prior to the Act. 28 The manufacturer of a new drug has two recourses if he wishes to distribute his product in accordance with the Act. First, he may submit an application to the Secretary of Health, Education and Welfare which must contain: 29 (A) full reports of investigations which have been made to show whether or not such drug is safe for use and whether such drug is effective in use; (B) a full list of the articles used as components of such drug; (C) a full statement of the composition of such drug; (D) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug; (E) such samples of such drug and of the articles used as components thereof as the Secretary may require; and (F) specimens of the labeling proposed to be used for such drug. 30 21 U.S.C. § 355(b). Once the application is filed, the Secretary will either approve the application or conduct a hearing on whether the drug should be approved. Grounds for refusing the application include a failure to adequately test the drug, failure to show that it is safe for the uses prescribed, and lack of evidence that the drug will do what it purports to be able to do. 21 U.S.C. § 355(d). 31 If the manufacturer does not wish to go through the trouble and expense of the application, he can claim that his product is not a new drug because it is generally recognized among experts as being safe and effective for its intended uses. 21 U.S.C. § 321(p)(1); United States v. Articles of Drug, 624 F.Supp. 776 (N.D.Ill.1985). Courts have construed 'general recognition' to require a consensus of expert opinion based on the same 'substantial evidence' of effectiveness based on 'adequate and well-controlled investigations' which would be required for approval of a new drug application under 21 U.S.C. § 355(d). United States v. Articles of Drug, 624 F.Supp. at 778, citing Weinberger v. Bentex Pharmaceuticals, Inc., 412 U.S. 645, 653 (1973). 32 A drug may be termed misbranded if there are allegations that its labeling or advertising is misleading. Whether or not a label is misleading is a question of fact. United States v. 47 Bottles, Jenasol RJ Formula '60', 320 F.2d 564 (3rd Cir.1963). In determining whether the drug is actually misbranded, the factfinder may take into account both statements or representations made about the drug and the seller's failure to reveal material facts about consequences which may result from the use of the drug as labeled. 21 U.S.C. § 321(n). Labeling includes all labels and other written, printed, or graphic matters (1) upon any article or any of its containers or wrappers, or (2) accompanying such article. 21 U.S.C. § 321(m). 33 When the drug is a prescription drug, the labeling requirements are not as stringent, since prescription medicines are regulated by other sections of the Act. Title 21 U.S.C. § 353(b)(2) exempts prescription medications from the definition of misbranded, because the burden of providing information to the customer has been shifted from the manufacturer to the prescribing physician. The drug companies provide information to the physician, who must then make the decision whether or not to prescribe the medicine, knowing the risks and benefits associated with it. See United States v. Evers, 643 F.2d 1043, 1052 (5th Cir.1981). However, even prescription drugs' labels must contain directions for use and cautionary statements, if any, [must be] contained in such prescription. 21 U.S.C. § 353(b)(2).