Exhibit 571 ยท Agency economic analysis
Substances Generally Recognized as Safe: Preliminary Regulatory Impact Analysis (Docket FDA-2025-N-3262)
Although the exact number of purported GRAS substances currently being used in human and animal foods is unknown, a 2011 study estimated that there were 1,000 substances being used in human food that were the subject of an independent conclusion of GRAS status
FDA's own count and estimate. 1,309 GRAS notices filed from February 1998 to March 2025 (1,234 human food, 75 animal food) by 673 notifiers; of 1,215 not pending, 961 drew a 'no questions' letter, 231 ended at the notifier's request, and 23 drew an insufficient-basis letter. FDA assumes 1,000 to 3,000 substances (primary estimate 2,000) are on the market under independent GRAS conclusions, about 1,028 firms have not filed a notice, and 1,740 substances rest on association expert-panel (FEMA) conclusions. Present value of costs about $89.6 million at 3 percent.
- Source
- U.S. Food and Drug Administration, Office of Economics and Analysis
- Date
- August 2026
- Quoted from
- Section II.D.2 (Independent Conclusions of GRAS Status), PRIA p. 13
- Grade
- Primary record
- Document
- https://www.fda.gov/media/194138/download
- Accessed
- 2026-11-09
- Cited by
- Findings citing this exhibit
- Note
- FDA assumes the 2011 estimate (Neltner et al.) is the low end and sets 3,000 as the high end because of the time since publication.