Exhibit 564 ยท Peer-reviewed study
Navigating the U.S. Food Additive Regulatory Program (Comprehensive Reviews in Food Science and Food Safety 10(6):342-368)
assigning the more than 10000 substances currently allowed in human food to those categories
Source of the estimate, based on interviews with food-industry staff and review of public GRAS notices and reports, that as of January 2011 more than 10,000 additives were in use, including about 1,000 human-food substances whose makers had concluded GRAS status without telling FDA. FDA's 2026 economic analysis adopts it as the low end of its own range. The estimate excludes flavors in the FEMA library and substances in common use before 1958.
- Source
- Neltner TG, Kulkarni NR, Alger HM, Maffini MV, Bongard ED, Fortin ND, Olson ED (Pew Health Group)
- Date
- 25 October 2011
- Quoted from
- Abstract, Compr. Rev. Food Sci. Food Saf. 10(6), Nov. 2011 (Wayback snapshot of the journal page, 2023-01-09)
- Grade
- Peer-reviewed
- Document
- https://ift.onlinelibrary.wiley.com/doi/full/10.1111/j.1541-4337.2011.00166.x
- Accessed
- 2026-11-09
- Cited by
- Findings citing this exhibit
- Note
- Not opened. Known through the JAMA paper (which restates the estimate), FDA's 2026 proposed rule (refs. 6-7) and FDA's 2026 PRIA (ref. 4, footnote 2).