Exhibit 561

Substances Generally Recognized as Safe, final rule (81 FR 54960; Docket FDA-1997-N-0020)

Exhibit 561 · Federal Register final rule

Substances Generally Recognized as Safe, final rule (81 FR 54960; Docket FDA-1997-N-0020)

We agree that we lack express statutory authority to require companies to submit GRAS notices.

Finalized the 1997 proposal as a voluntary notification procedure. FDA rejects comments that voluntariness violates the 1958 amendment, says there is no distinction in law between a conclusion submitted as a notice and one kept by its proponent (formerly called a 'self-determination'), and states that it lacks express statutory authority to require submission. It cites its 2010 caffeinated-alcohol letters as an example of enforcement without a notice.

Source: U.S. Food and Drug Administration
Date: 17 August 2016
Quoted from: 81 FR 54981-82 (Comment and Response 28)
Grade: Primary record
Document: https://www.govinfo.gov/content/pkg/FR-2016-08-17/pdf/2016-19164.pdf
Accessed: 2026-11-09
Cited by: Findings citing this exhibit
Note: The quoted sentence runs across the page break between 54981 and 54982. Response 1 (81 FR 54970): 'Although the FD&C Act specifically provides for our review of food additives, it is silent with respect to industry submissions to us on the use of GRAS substances.' Section on terminology (81 FR 54984): 'there would be no distinction between a conclusion of GRAS status submitted to us as a GRAS notice and a conclusion of GRAS status that remains with its proponent as an independent conclusion (formerly referred to as a “self-determination”) of GRAS status.' Effective 17 October 2016.

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-1.2: Primary record FDA's 1997 proposal and 2016 final rule made notification of a GRAS conclusion voluntary. The 2016 rule treats a conclusion kept by its maker the same in law as one submitted to FDA, and it states that FDA lacks express statutory authority to require notices.
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.