Exhibit 562 · GAO report
Food Safety: FDA Should Strengthen Its Oversight of Food Ingredients Determined to Be Generally Recognized as Safe (GRAS) (GAO-10-246)
FDA only reviews those GRAS determinations that companies submit to the agency’s voluntary notification program—the agency generally does not have information about other GRAS determinations companies have made because companies are not required to inform FDA of them.
Found that FDA reviews only the GRAS determinations companies submit and generally has no information about the rest, that FDA had issued no conflict-of-interest guidance for company expert panels, that FDA had not finalized its 1997 proposal, and that FDA had not systematically reconsidered GRAS substances since the 1980s. Recommended six actions, the first a strategy to require any company making a GRAS determination to give FDA basic information about it. FDA generally agreed and raised concerns about parts of several recommendations.
- Source
- U.S. Government Accountability Office
- Date
- February 2010
- Quoted from
- Highlights, 'What GAO Found'
- Grade
- Primary record
- Document
- https://files.gao.gov/assets/gao-10-246.pdf
- Accessed
- 2026-11-09
- Cited by
- Findings citing this exhibit
- Note
- Other passages read: p. 12 ('officials representing one international marketer of food indicated the company makes about 5 GRAS determinations each year without notifying FDA'); p. 13 (about 180 companies notified FDA from 1998 through 2008; FDA cannot estimate the number of determinations it was not told of); pp. 14-15 (conflicts of interest); p. 34 (recommendations); pp. 36-37 (FDA's response). The cover date is February 2010; FDA's 2026 rule cites it as March 2010.