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The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C), is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics. A principal author of this law was Royal S. Copeland, a three-term U.S. Senator from New York.〔(Homeopathic Drugs, Royal Copeland, and Federal Drug Regulation )〕 In 1968, the Electronic Product Radiation Control provisions were added to the FD&C. Also in that year the FDA formed the Drug Efficacy Study Implementation (DESI) to incorporate into FD&C regulations the recommendations from a National Academy of Sciences investigation of effectiveness of previously marketed drugs.〔(CDER – Time Line )〕 The act has been amended many times, most recently to add requirements about bioterrorism preparations. The introduction of this act was influenced by the death of more than 100 patients due to a sulfanilamide medication where diethylene glycol was used to dissolve the drug and make a liquid form.〔(ASHP Website : News Article )〕 See Elixir Sulfanilamide disaster. It replaced the earlier Pure Food and Drug Act of 1906. == Contents == The FDC Act has ten chapters:〔(Federal Food, Drug, and Cosmetics Act Table of Contents )〕 :I. Short Title :II. Definitions :: * 201(f) is the definition for a food, which explicitly includes chewing gum :: * 201(g) is the definition for a drug :: * 201(h) is the definition for a medical device :: * 201(s) is the definition of a food additive :: * 201(ff) is the definition of a dietary supplement :III. Prohibited Acts and Penalties ::This section contains both civil law and criminal law clauses. Most violations under the act are civil, though repeated, intentional, and fraudulent violations are covered as criminal law. All violations of the FD&C Act require interstate commerce because of the commerce clause, but this is often interpreted broadly and few products other than raw produce are considered outside of the scope of the act. ::Notably, the FD&C Act uses strict liability due to the Dotterweich〔(United States v. Dotterweich, 320 U.S. 277 (1943) )〕 and Park〔(UNITED STATES V. PARK, 421 U. S. 658 (1975) – US Supreme Court Cases from Justia & Oyez )〕 Supreme Court cases. It is one of a very small number of criminal statutes that does. :IV. Food ::There is a distinction in food adulteration between those that are added and those that are naturally present. Substances that are added are held to a stricter "may render (it) injurious to health" standard, whereas substances that are naturally present need only be at a level that "does not ordinarily render it injurious to health"〔(FD&C Act Chapter IV )〕 :V. Drugs and Devices :: * 505 is the description of the drug approval process :: * 510(k) is the section that allows for clearance of class II medical devices :: * 515 is the description of the (class III) device approval process :VI. Cosmetics :VII. General Authority :: * 704 allows inspections of regulated entities. Inspection results are reported on Form 483. :VIII. Imports and Exports :IX. Tobacco Products :X. Miscellaneous 抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』 ■ウィキペディアで「Federal Food, Drug, and Cosmetic Act」の詳細全文を読む スポンサード リンク
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