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Food, Drug, and Cosmetic Act (FD&C Act)

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The Federal FD&C Act of 1938 gives FDA authority over cosmetics and medical devices as well as food and drugs. The 1938 Act was adopted to correct the imperfections of the 1906 Act and to respond to change in technology and in societal demands from consumers who demanded ever‐increasing information about food products. In particular, the 1938 Act enacted a comprehensive set of standards by which food safety could be regulated.

Further amendments and revisions to the act after 1938 extended the coverage of the FD&C Act or enlarged FDA’s authority over certain products. However, a few amendments have narrowed FDA’s authority.

Many states have adopted the Uniform State Food, Drug, and Cosmetics Bill recommended by the AFDO, which bears many similarities to the federal FD&C Act. Adoption of this model law is voluntary, but most states have primary food laws that are largely the same as the federal law.


FIGURE 1.2 Overlapping statutory authority.

Food Regulation

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