Exhibit 569 ยท Agency press release
HHS Secretary Kennedy Directs FDA to Explore Rulemaking to Eliminate Pathway for Companies to Self-Affirm Food Ingredients Are Safe
industry can self-affirm that the use of a substance is GRAS without notifying the FDA
The Secretary directed the acting FDA commissioner to explore rulemaking to revise the GRAS final rule and eliminate the self-affirmed GRAS pathway. The release says industry can self-affirm without notifying FDA, that FDA has completed more than 1,000 GRAS notices and evaluates about 75 a year, and that HHS will work with Congress on legislation.
- Source
- U.S. Department of Health and Human Services
- Date
- 10 March 2025
- Quoted from
- Paragraph 4
- Grade
- Primary record
- Document
- https://www.hhs.gov/press-room/revising-gras-pathway.html
- Archived
- https://web.archive.org/web/20251230114701/https://www.hhs.gov/press-room/revising-gras-pathway.html
- Accessed
- 2026-11-09
- Cited by
- Findings citing this exhibit
- Note
- The Secretary is quoted: 'For far too long, ingredient manufacturers and sponsors have exploited a loophole that has allowed new ingredients and chemicals, often with unknown safety data, to be introduced into the U.S. food supply without notification to the FDA or the public.'