Food, Drug and Cosmetic Act | Wikipedia audio article
Channel: wikipedia tts
Date: 12/12/2018

This is an audio version of the Wikipedia Article:
Food, Drug and Cosmetic Act


00:01:11 1 Contents
00:03:02 2 Food coloring
00:03:57 2.1 Certifiable colors
00:04:07 3 Food additives
00:04:35 3.1 Definition of food additive
00:05:20 4 Homeopathic medications
00:06:13 5 Bottled water
00:06:37 6 Cosmetics
00:07:26 7 Medical devices
00:09:00 7.1 Premarket notification (510(k), PMN)
00:11:25 7.2 Premarket approval (PMA)
00:12:12 7.3 Automatic Class III Designation (De Novo classification)
00:12:51 8 Related legislation
00:13:13 9 Significant amendments and related laws
00:19:53 10 Comparison to state laws
00:20:06 11 See also



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SUMMARY
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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, medical devices, and cosmetics. A principal author of this law was Royal S. Copeland, a three-term U.S. Senator from New York. 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. 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(see elixir sulfanilamide disaster). It replaced the earlier Pure Food and Drug Act of 1906.