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1962 Kefauver-Harris Amendments

Explain the following governmental actions that were crafted to make drugs safe for consumption:
-1938 Food, Drug and Cosmetics Act
-1962 Kefauver-Harris Amendments (to the 1938 Food, Drug and Cosmetics Act)
-FDA Modernization Act of 1997
-The Best Pharmaceuticals For Children Act of 2002

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1. The 1938 Food, Drug, and Cosmetic Act

Directly from FDA website:
Pioneered policies designed to protect the pocketbooks of consumers, and food standards were enacted to ensure the 'value expected' by consumers.[1] The 1938 Act eliminated the 'distinctive name proviso' and required instead that the label of a food 'bear its common or usual name'. The food would be misbranded if it represented itself as a standardised food unless it conformed to that standard. The law provided for three kinds of food standards: 1) standards (definitions) of identity, 2) standards of quality, and 3) standards regulating the fill of container. Regulators had the discretionary authority to set standards 'whenever in the judgment of the Secretary such action will promote honesty and fair dealing in the interests of consumers'.[2]
[1]Legislative History, vol. 2, p. 93.
[2]Pub. L. No. 75-717, 52 Stat. 1040 (1938)

To summarize the above, the 1938 act basically stated that foods, cosmetics, and drugs were required to meet certain standards in order to protect consumers. The purpose of this was to defend the rights of consumers buying these products such that they could trust what they were buying. These standards included identity (for example, something claiming to be ...

Solution Summary

1962 Kefauver-Harris Amendments and other legal actions are summarized.