The long-anticipated GRAS notification rule outlined by federal regulators is less burdensome than many in the food sector expected, but it could still create significant compliance challenges if under-resourced and is likely to draw courtroom challenges, according to legal and industry experts.
Under the proposal, companies would no longer be permitted to self-affirm substances as Generally Recognized as Safe, and instead would be required to submit a complete GRAS notice to the Food and Drug Administration.
For legacy self-GRAS ingredients already in commerce, the agency proposes a streamlined pathway intended to bring those uses into view without requiring each to undergo a full retrospective GRAS review.
The FDA said the approach would let it prioritize post-market safety evaluations while avoiding unnecessary regulatory burdens.
The proposal will be published in the Federal Register on August 11 and will be open to public comment for 120 days before the agency drafts a final rule. Key elements include:
- From the effective date, GRAS notifications would be mandatory for ingredients not yet marketed. Firms would have to submit a full dossier to the FDA. GRAS substances would remain exempt from premarket approval.
- For self-GRAS substances already on the market before the effective date, firms would have one year to make a streamlined submission identifying the substance and its conditions of use, without submitting the underlying safety dossier. The agency estimates preparation time of about 31.5 hours for streamlined submissions, versus 180 hours for a full GRAS notice, and 11 hours for FDA review.
- The FDA could decide which, if any, streamlined submissions merit deeper scrutiny and may subsequently require a full GRAS notice or a food additive petition.
- Qualifying streamlined submissions would be posted on a public list. Inclusion would not indicate FDA review or endorsement of GRAS status.
- The agency estimates more than 2,000 self-GRAS substances and 1,740 FEMA GRAS substances are already on the market.
- Failure to notify would be treated as a factor in prioritizing substances for post-market review.
- The agency projects the mandatory system would generate about 98 additional GRAS notices per year, on top of the roughly 112 now filed voluntarily.
- The FDA proposes to complete initial evaluations to determine whether to file a submission as a GRAS notice within 45 days.
- Proposed exceptions to mandatory notification include uses covered by an existing “no questions” letter, substances listed as GRAS in FDA regulations, certain historical-use substances, uses reviewed through established consultation processes, threshold-of-regulation exemptions, and uses covered by food-contact notifications.
GRAS notification rule raises questions about prior letters
Because firms are not currently required to inform the agency when they self-affirm GRAS status, regulators may only learn of unsafe uses after a public health issue arises. A mandatory program, the FDA said, would help ensure GRAS conclusions rest on science and proper documentation.
The proposal also clarifies how the agency would determine that a substance is not GRAS. For substances listed or affirmed as GRAS in regulations, the FDA could propose in the Federal Register that a use is not GRAS, seek 60 days of comment, and if evidence is insufficient, amend or repeal the relevant regulation.
A law firm advisory noted the FDA is asserting authority to revisit, update, or rescind prior “no questions” letters if new information undermines a GRAS conclusion.
When could the GRAS notification rule take effect?
An attorney at Akin said there is no firm timetable for a final rule, though pressure to act is likely given the priority placed on GRAS reform in current policy agendas.
He characterized mandatory notification as primarily administrative since properly conducted self-determinations should meet the same substantive scientific standard as formal notices. He also argued that many companies have used self-GRAS appropriately to allow flexibility for iterative process or formulation changes, provided dossiers are maintained.
Firms that cut corners, he cautioned, could face difficulty.
Not all legacy self-GRAS determinations are equal
Some older self-affirmations would probably struggle to meet current standards, said a consultant who has worked on numerous GRAS determinations.
He described legacy decisions made soon after the 1958 law as sometimes thinly documented and signed by individuals without the necessary qualifications.
Resourcing remains a central industry concern
Experts warned that the proposal’s success hinges on staffing and funding. One consultant said the agency has never had the resources to review all ingredients.
Another attorney noted FDA already takes about a year or more to review GRAS notices. A surge in mandatory submissions could lengthen timelines, with knock-on commercial effects, since larger customers often prefer a “no questions” letter before sourcing.
He added that the food program’s reliance on congressional appropriations, rather than user fees, constrains capacity, and filings are already increasing as firms anticipate mandatory notification.
Streamlined path seen as less onerous, but legal fights likely
An advocacy group’s general counsel called the streamlined option far less burdensome than requiring full dossiers for all legacy uses. Still, he predicted litigation given the lack of explicit congressional authorization and the potential for higher industry costs.
He said the change could increase the chance the FDA will refuse GRAS recognition for substances that previously would have proceeded based on self-determination, and it will strain existing resources.
Advice to food companies
A partner at a national law firm advised companies relying solely on self-GRAS conclusions to ensure those determinations are fully documented and defensible and that dossiers could withstand potential scrutiny.
He recommended identifying substances and uses supported by independent GRAS conclusions and confirming when those uses entered interstate commerce to leverage the streamlined pathway, if adopted.
He also cautioned that mandatory submissions are not guaranteed. The legal question remains whether the Food, Drug, and Cosmetic Act authorizes the agency to impose mandatory notification without congressional action.
Another attorney urged close monitoring of congressional efforts to amend the statute, as several major GRAS bills could reshape or supersede the rulemaking.
He also noted state-level activity, pointing to a New York bill that would create a first-of-its-kind state reporting regime for self-affirmed GRAS substances.
CSPI questions enforcement approach under the GRAS notification rule
A health advocacy group welcomed the proposal but urged the FDA to require premarket review of all new food chemicals.
Its president said it is unclear how the agency would enforce a requirement described as mandatory, arguing that without enforcement, mandatory provisions would be ineffective.
*FEMA GRAS refers to determinations by the Flavor and Extract Manufacturers Association.
For broader context on how federal oversight intersects with food production, see reporting from Minnesota on USDA visits and crop outlook.