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Exhibit 570

Substances Generally Recognized as Safe, proposed rule (91 FR 51834; Docket FDA-2025-N-3262; RIN 0910-AJ02)

Exhibit 570 · Federal Register proposed rule

Substances Generally Recognized as Safe, proposed rule (91 FR 51834; Docket FDA-2025-N-3262; RIN 0910-AJ02)

Today, an unknown number of substances are being introduced into the market under the GRAS provision of section 201(s) of the FD&C Act.

Proposes to convert the voluntary GRAS notification program to a mandatory one, with exceptions (existing no-questions letters, substances listed in 21 CFR parts 182, 184 and 186, and others) and a one-year streamlined submission for substances already on the market. Effective 60 days after a final rule, with 18 months to comply. Noncompliance would be a factor in FDA's prioritization for post-market review; the rule creates no premarket approval. It grounds authority in sections 409(a), 409(d) and 701(a) and compares today's position to the years before 1958. Comments close 9 December 2026.

Source
U.S. Food and Drug Administration
Date
11 August 2026
Quoted from
91 FR 51838, section I (Executive Summary)
Grade
Primary record
Document
https://www.govinfo.gov/content/pkg/FR-2026-08-11/pdf/2026-16296.pdf
Accessed
2026-11-09
Cited by
Findings citing this exhibit
Note
Other passages read: 51835 ('Under our current regulations, a person who concludes that the use of a substance is GRAS under the conditions of its intended use may, but is not required to, notify FDA of this conclusion.'); 51838 ('we find ourselves in a situation much like the years before the 1958 amendment’s enactment.'); 51842 ('Although we cannot verify the accuracy of these estimates'); 51845-46 (legal authority); 51866 (compliance date); 51870 (PRIA counts).

Cited by

Finding AGR-1.7
Primary record FDA's 2026 economic analysis states that the exact number of substances marketed under independent GRAS conclusions is unknown and assumes 1,000 to 3,000 (primary estimate 2,000), against 1,309 notices filed from February 1998 to March 2025. The proposed rule states that FDA "cannot verify the accuracy of these estimates."
Finding AGR-1.11
Primary record FDA's proposed rule of 11 August 2026 would require GRAS notices for substances purported to be GRAS, with a one-year streamlined submission for substances already on the market. The rule creates no premarket approval, lets companies market a substance before notifying and while FDA reviews the notice, and makes failure to notify "a factor" in FDA's prioritization for post-market review.
Finding AGR-1.16
Open question Whether California's database-based definition of ultraprocessed food reaches additives marketed on independent GRAS conclusions is unanswered. The definition relies on FDA's Substances Added to Food database, and FDA states that it has "little, if any, information on independent conclusions of GRAS status."