Food, Drug, Cosmetic, and Device Enforcement Amendments: Hearing Before the Subcommittee on Health and the Environment of the Committee on Energy and Commerce, House of Representatives, One Hundred Second Congress, First Session, on H.R. 2597, a Bill to Amend the Federal Food, Drug, and Cosmetic Act to Enhance the Enforcement Authority of the Food and Drug Administration, July 17, 1991Abstract: This House hearing examines the additional enforcement needed for the requirements of the Federal Food, Drug, and Cosmetic Act. The bill would give the FDA the ability to recall defective and unsafe products, to assess civil penalties, to subpoena witnesses and documents to embargo defective products, and to destroy imported products that pose a danger to public health. |
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AARP additional adulterated Agency Agency's amended approval believe bill Chairman civil money penalty civil penalties Coenzyme Q-10 Commissioner compliance concern CONGRES CONGRESS THE LIBRARY Congressman consumer Controlled Substances Act Cosmetic Act counterfeit drugs criminal DANNEMEYER defendants DINGELL District Court documents Drug Administration DUNKELBERGER effective enforcement action enforcement authority enforcement powers enforcement tools FD&C Act FDA enforcement FDA's FDCA Federal Food food additive Food and Drug gives the FDA HASTERT health and safety hearing Highland Laboratories HOETING HUTT important impose injunction inserting in lieu interstate commerce investigation KESSLER labeling legislation LIBRA LIBRARY OF CONGRESS lieu thereof limited manufacturing manufacturing practices medical devices misbranded nutrient officer problem provisions public health RARY recall authority records regulations require RESS Saul Kent Secretary seizure Sidmak SIKORSKI SMDA statute statutory Subcommittee subpoena authority testimony Thank tion trade secrets United violation Vitamin D vitamins WAXMAN
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Page 241 - Any 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 drug not so recognized shall not be deemed to be a "new drug...
Page 89 - The purposes of this legislation 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.
Page 89 - The Food and Drugs Act of 1906 was an exertion by Congress of its power to keep impure and adulterated food and drugs out of the channels of commerce. By the Act of 1938, Congress extended the range of its control over illicit and noxious articles and stiffened the penalties for disobedience.
Page 135 - ... the methods used in. or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conf onnity with current good manufacturing practice to assure that such drug meets the requirements of this Act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess...
Page 102 - ... not only representations made or suggested by statement, word, design, device, sound or any combination thereof, but also the extent to which the advertisement fails to reveal facts material in the light of such representations or material with respect to consequences which may result from the use of the commodity to which the advertisement relates under the conditions prescribed in said advertisement, or under such conditions as are customary or usual.
Page 87 - ... shall be liable to be proceeded against while in interstate commerce, or at any time thereafter, on libel of information and condemned in any district court of the United States within the jurisdiction of which the article is found...
Page 101 - Each ingredient used in a cosmetic product and each finished cosmetic product shall be adequately substantiated for safety prior to marketing. Any such ingredient or product whose safety is not adequately substantiated prior to marketing is misbranded unless it contains the following conspicuous statement on the principal display panel: Warning— The safety of this product has not been determined.
Page 136 - ... if it has been produced, prepared, packed or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered diseased, unwholesome or injurious to health...
Page 87 - The Secretary of the Treasury shall deliver to the Secretary of Health, Education, and Welfare, upon his request, samples of food, drugs, devices, and cosmetics which are being imported or offered for import into the United States, giving notice thereof to the owner or consignee, who may appear before the Secretary of Health, Education, and Welfare and have the right to introduce testimony.
Page 87 - Any article of food, drug, device, or cosmetic that is adulterated or misbranded when introduced into or while in interstate commerce, or which may not, under the provisions of section 404 or 505, be introduced into interstate commerce, shall be liable to be proceeded against while in interstate commerce...