FDA Seeks to End Food Companies’ Ability to Self-Certify Ingredients as Safe

Why It Matters

A recent Congressional Research Service report examines a growing legal and policy fight over how the Food and Drug Administration regulates substances that manufacturers determine are generally recognized as safe, or GRAS. Unlike food additives, GRAS substances are exempt from FDA premarket approval, and current regulations generally allow companies to make their own GRAS determinations without notifying the agency. The report identifies a central legal question for Congress over whether FDA can require those notifications under existing law or whether lawmakers must give the agency clearer authority.

The issue has become more immediate since CRS published the report July 2. On Aug. 10, FDA formally proposed a rule intended to strengthen oversight of substances claimed to be GRAS. The agency says the proposal would enhance transparency and consumer protections, moving forward with an initiative that HHS began in March 2025 when it directed FDA to explore eliminating the self-affirmed GRAS pathway.

The Big Picture

A substance qualifies as GRAS when qualified scientific experts generally recognize its intended use as safe based either on scientific procedures or, for substances used in food before Jan. 1, 1958, experience based on common use. GRAS substances are not considered food additives and are exempt from FDA's premarket review. When a GRAS determination rests on scientific procedures, FDA regulations require the same quantity and quality of scientific evidence needed for approval of a food additive.

Under the 2016 GRAS rule, manufacturers may voluntarily notify FDA that they have concluded a substance is GRAS. FDA generally responds within 180 days and may extend that period by 90 days. But companies may market substances based on their own GRAS determinations without submitting a notice to FDA.

FDA itself has previously questioned how far its statutory authority extends. In the preamble to the 2016 rule, the agency said it lacked express statutory authority to require companies to submit GRAS notices. FDA pointed to Congress' decision to exclude GRAS substances from the statutory definition of food additives and to the Food and Drug Administration Modernization Act of 1997, which expressly created mandatory notifications for food contact substances but not for GRAS substances generally.

That interpretation survived a legal challenge in Center for Food Safety v. Becerra. In 2021, the U.S. District Court for the Southern District of New York upheld the voluntary notification system after applying the Chevron doctrine and concluding that FDA's interpretation of the statute was reasonable. The court also noted Congress' decades of silence on whether GRAS submissions must be mandatory. The plaintiffs did not appeal.

The legal landscape has since changed. In Loper Bright Enterprises v. Raimondo, the Supreme Court overturned Chevron deference in 2024. Courts now independently determine the best reading of ambiguous statutes rather than deferring to a reasonable agency interpretation. CRS notes that Center for Food Safety did not decide whether FDA may require GRAS notices. It addressed whether the law required FDA to mandate them. The unpublished district court opinion also would not bind a future court considering a new FDA rule.

The shift could make FDA's prior statements about its authority important in future litigation. CRS notes that courts may still give agency interpretations persuasive weight under Skidmore, including by considering whether an agency's current interpretation is consistent with its earlier positions. FDA's past statement that it lacks express authority to mandate notices could therefore become part of any challenge to a mandatory notification regime.

The administration has nevertheless moved ahead with rulemaking. FDA said Aug. 10 that it had proposed a rule to strengthen oversight of substances claimed to be GRAS and opened the proposal for public comment. That represents a significant development since CRS published its analysis, when the proposed rule was still undergoing Office of Management and Budget review and its text was not public.

The Bottom Line

Congress is also considering legislation that could directly change the GRAS framework. Rep. Mike Lawler (R-NY) introduced H.R. 7291, the GRAS Oversight and Transparency Act, which would establish a federal board to review certain older GRAS determinations that manufacturers made without submitting them to FDA.

Sen. Ed Markey (D-MA) introduced S. 2341, the Ensuring Safe and Toxic-Free Foods Act of 2025, with Sens. Cory Booker (D-NJ), Elizabeth Warren (D-MA) and Richard Blumenthal (D-CT). The bill would amend the Federal Food, Drug, and Cosmetic Act to impose new requirements on GRAS substances and require FDA to reassess the safety of chemicals added to food.

CRS identifies several paths for lawmakers. Congress could enact legislation changing how GRAS determinations work, expressly clarify whether FDA may mandate GRAS notifications or take no action and allow FDA's rulemaking and subsequent litigation to determine the boundaries of the agency's authority.

The dispute therefore involves more than whether companies should notify FDA when they determine an ingredient is safe. FDA is now seeking to tighten a voluntary system that has existed for decades, while its own previous interpretation of the statute and the Supreme Court's rejection of Chevron deference create uncertainty over whether the agency can accomplish that goal without new legislation.

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