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A guide to the FDA Modernization Act of 1997.

Author(s) : HUTT P. B.

Type of article: Article

Summary

The Food and Drug Administration (FDA) Modernization Act of 1997 amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the biological products provision in section 351 of the Public Health Services Act (PHS Act). It affects all products regulated by FDA. This analysis summarizes the nine food provisions contained in Title III of the FDA Modernization Act: flexibility for regulations regarding claims; petitions for claims; health claims for food producst; nutrient content claims; referral statements; disclosure of irradiation; irradiation petition; glass and ceramic ware and food contact substances. General provisions cover: approval of supplemental applications for approved products; informal agency statements; FDA mission and annual report; information system; education and training; mutual recognition agreements and global harmonization; environmental impact review; FDA study of mercury compounds in drugs and food; interagency collaboration; contracts for expert review; clarification of seizure authority; interstate commerce and safety report disclaimers.

Details

  • Original title: A guide to the FDA Modernization Act of 1997.
  • Record ID : 1999-0915
  • Languages: English
  • Subject: Regulation
  • Source: J. Food Technol. - vol. 52 - n. 5
  • Publication date: 1998/05
  • Document available for consultation in the library of the IIR headquarters only.

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