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Exhibit 559

FDA's Approach to the GRAS Provision: A History of Processes

Exhibit 559 ยท Agency web page

FDA's Approach to the GRAS Provision: A History of Processes

We believe only those chemicals should be automatically exempted from the new law which are recognized among competent experts as safe for their intended use. This would make it unnecessary, for example, to do studies on table salt, but would not approve the continued use, without proof of safety, of the synthetic emulsifiers now widely used in some fabricated foods.

FDA poster by CFSAN staff presented at the April 2006 FDA Science Forum. It gives FDA's own timeline of the GRAS provision, from the 9 December 1958 GRAS list to the 1969 removal of cyclamate and the 1997 proposal, and excerpts 1958 congressional testimony by FDA Commissioner Larrick.

Source
U.S. Food and Drug Administration, Office of Food Additive Safety
Date
2006 (poster; page accessed 2026)
Quoted from
Section 'Excerpts from Legislative History', from Commissioner Larrick's opening remarks
Grade
Primary record
Document
https://www.fda.gov/food/generally-recognized-safe-gras/fdas-approach-gras-provision-history-processes
Accessed
2026-11-09
Cited by
Findings citing this exhibit
Note
The page excerpts the testimony but does not cite the hearing volume.

Cited by

Finding AGR-1.1
Primary record The Food Additives Amendment of 1958 makes a food additive unsafe unless an FDA regulation or exemption covers it, and it excludes from the definition of food additive any substance generally recognized, among experts qualified by scientific training and experience, as safe for its intended use. The statute does not say who the experts are or that a company must tell FDA of its conclusion.
Finding AGR-1.8
Primary record FDA's regulation says general recognition of safety through scientific procedures requires the same quantity and quality of scientific evidence as an additive approval. FDA removed cyclamate salts from the GRAS list in 1969, and in 2010 it sent warning letters to makers of caffeinated alcoholic beverages that had made no GRAS determination.