Exhibit 572

Food Additives and GRAS Substances: A Legal Framework (CRS Legal Sidebar LSB11445)

Exhibit 572 · CRS report

Food Additives and GRAS Substances: A Legal Framework (CRS Legal Sidebar LSB11445)

The preamble to the proposed regulations indicates that FDA would consider the failure to submit a GRAS notice as “a factor” in FDA’s prioritization of food substances for post-market review, and therefore marketed substances that are not the subject of a GRAS notice may face increased scrutiny from FDA.

Explains the statutory framework, FDA's 2016 statement that it lacks express authority to require notices, the unsuccessful challenge to the 2016 rule by the Center for Food Safety and the Environmental Defense Fund in the Southern District of New York (decided under Chevron, not appealed), the 2026 proposal, and how Loper Bright could change review of a final rule. Lists four pending bills.

Source: Congressional Research Service
Date: 5 October 2026
Quoted from: p. 4
Grade: Primary record
Document: https://www.everycrsreport.com/files/2026-10-05_LSB11445_224683c645df03271d453db38ec195f31490e3cf.pdf
Accessed: 2026-11-09
Cited by: Findings citing this exhibit
Note: Also p. 3-4: companies 'would be able to market products containing GRAS substances before submitting the notice and while FDA is reviewing the notice.' The Southern District case is named Center for Food Safety v. Becerra; docket number and decision date are not given in the Sidebar.

Cited by

Finding AGR-1.3: Reported The Center for Food Safety and the Environmental Defense Fund challenged FDA's 2016 GRAS rule in the Southern District of New York. According to the Congressional Research Service, the court granted summary judgment to FDA because FDA's reading of the Act was reasonable, and the plaintiffs did not appeal.
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.