Lexology March 11, 2025
Keller and Heckman LLP

  • On March 10, 2025, the Department of Health & Human Services (HHS) Secretary Robert F. Kennedy Jr. announced that he is directing the U.S. Food & Drug Administration (FDA) “to explore potential rulemaking to revise its Substances Generally Recognized as Safe (GRAS) Final Rule and related guidance to eliminate the self-affirmed GRAS pathway.”
  • This self-affirmation process is built into the 1958 Food Additive Amendments, which amended the definition of a “food additive” and allows certain substances to be exempt from premarket review if they are GRAS based on scientific procedures or history of use...

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Topics: FDA, Govt Agencies, HHS
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