FDA moves to close GRAS loophole with new food rule

The U.S. Food and Drug Administration (FDA) proposed a new rule to overhaul the GRAS (Generally Recognized as Safe) system for food ingredients, requiring companies to notify the agency instead of relying solely on self-affirmed GRAS determinations. The proposal, which will be published in the Federal Register on August 11, opens a 120-day public comment period and could significantly change how food companies document and market certain ingredients.

The proposal is designed to address what regulators and health advocates describe as the GRAS loophole, under which companies can determine that a substance is generally recognized as safe without formally notifying the FDA.

Under the proposed framework, companies introducing new GRAS substances would have to submit a full GRAS notification to the FDA. The ingredients would remain exempt from traditional premarket approval, but companies would no longer be able to rely solely on a private self-affirmation.

For ingredients already on the market under self-GRAS determinations, the FDA proposes a streamlined notification process. Companies would have one year after the rule becomes effective to identify the substance and its conditions of use without initially submitting the complete underlying safety dossier.

The agency estimates that preparing one of these streamlined submissions would take about 31.5 hours, compared with approximately 180 hours for a full GRAS notification. The FDA estimates its own initial review would require about 11 hours.

The agency would then determine which substances require a more detailed assessment. In some cases, companies could subsequently be required to submit a full GRAS notification or a food additive petition.

The FDA estimates that more than 2,000 self-GRAS substances and 1,740 FEMA GRAS substances are already on the market. The proposed mandatory system would generate roughly 98 additional GRAS notifications per year, on top of the 112 that companies currently submit voluntarily.

The agency also proposes to complete an initial assessment within 45 days to determine whether a submission qualifies for filing as a GRAS notice.

The proposal includes several exceptions to mandatory notifications, including certain uses covered by existing FDA “no questions” letters, substances already listed as GRAS in FDA regulations, some historical-use substances and uses evaluated through established FDA consultation processes.

According to AgFunderNews, experts consider the proposal less burdensome than initially expected, particularly because the FDA did not require every existing self-GRAS ingredient to undergo a complete retrospective review.

Amaru Sanchez, an attorney at Akin, said the change is primarily administrative for companies that have conducted scientifically sound GRAS determinations. He warned, however, that implementation could be difficult without additional FDA resources.

“Without more staffing or funding, this is going to be extremely challenging to implement,” Sanchez said, according to AgFunderNews.

One of the main concerns is the FDA's capacity to process the additional workload. Existing GRAS reviews can already take about a year or longer, according to Sanchez. A substantial increase in submissions could create delays with commercial consequences, particularly for startups that depend on regulatory certainty to secure customers.

George A. Burdock, president of the Burdock Group, also questioned the quality of some legacy self-GRAS determinations. He argued that certain older assessments may not meet current FDA standards because they were prepared without sufficient scientific or regulatory expertise.

The proposal could also affect substances that previously received FDA “no questions” letters. The agency would have greater ability to revisit previous determinations if new scientific information raises questions about their safety.

Legal challenges are another major issue. Jonathan Emord, general counsel at the Alliance for Natural Health, said the proposal could face litigation because of questions about whether the FDA has explicit congressional authority to impose a mandatory notification requirement.

Brian Sylvester, a partner at Morrison Foerster, advised companies that currently rely on self-GRAS determinations to ensure that their documentation and underlying safety dossiers could withstand FDA scrutiny.

The debate also extends to Congress. Sanchez pointed out that lawmakers are considering several bills related to GRAS, any of which could alter or replace the regulatory framework proposed by the FDA.

Health advocacy groups have welcomed the proposal but argue that it does not go far enough. The Center for Science in the Public Interest called for premarket review of all new food chemicals and questioned how the FDA would enforce a notification system described as mandatory.

The proposal therefore represents a significant change to the U.S. food regulatory system, but its final scope remains uncertain. The FDA must first review public comments before deciding whether to issue a final rule, while potential congressional action and legal challenges could further reshape the outcome.

According to AgFunderNews, the proposed overhaul is less restrictive than some industry observers had anticipated, but it could still increase regulatory costs, workload and uncertainty for food companies that rely on GRAS determinations.