#1
April 17th, 2015, 08:09 AM
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FDA Food Drug Cosmetic
I am looking for details about United States Federal Food, Drug, and Cosmetic Act (FFDCA) so please provide me the same including its Contents?
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#2
April 17th, 2015, 09:51 AM
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Re: FDA Food Drug Cosmetic
United States Federal Food, Drug, and Cosmetic Act (FFDCA) 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. 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. Contents of FFDCA: 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[6] and Park[7] 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"[8] 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 allow inspections of regulated entities. Inspection results are reported on Form 483. VIII. Imports and Exports IX. Tobacco Products X. Miscellaneous |
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