The US Food and Drug Administration (FDA) has proposed making notifications for Generally Recognized as Safe (GRAS) substances mandatory, marking a significant shift in how food ingredients are overseen in the US.

The proposed rule, announced by the US Department of Health and Human Services (HHS), would require manufacturers to notify the FDA whenever they conclude that a substance added to human or animal food meets the criteria for GRAS status.

The proposal would replace the current voluntary notification framework under which companies can independently determine that an ingredient is GRAS without informing the FDA.

HHS said the changes are intended to increase transparency and give the FDA greater visibility into substances entering the US food supply.

Kyle Diamantas, acting FDA commissioner, said: “By proposing mandatory GRAS notifications, we are closing critical information gaps and giving the FDA greater visibility into substances entering the food supply.”

The GRAS exemption was established by Congress in 1958 and allows substances whose safety is generally recognised by qualified experts to be exempt from the food additive approval process.

While the FDA has operated a voluntary GRAS notification programme for years, manufacturers have not previously been required to submit a notification when making an independent GRAS determination.

Under the proposed rules, any party introducing a substance into interstate commerce under the GRAS provision would have to notify the FDA of the basis for its conclusion. However, the proposal would not introduce a requirement for pre-market approval. Companies would still be able to market a substance before submitting a GRAS notice, during FDA review and after submission, provided the substance meets the statutory GRAS criteria.

The FDA has proposed that failure to submit a notification would be considered when prioritising substances for post-market review. However, non-notification alone would not automatically mean that a substance is adulterated or that the FDA has determined it is not GRAS.

The proposed framework would also establish a streamlined route for substances already on the market based on independent GRAS conclusions.

Manufacturers would have a limited period to provide the FDA with information about existing uses. Under the proposal, the streamlined submission window would remain open for one year after the final rule takes effect.

The FDA would initially require identifying information rather than the full underlying safety dossier through this pathway. However, the agency would retain the ability to subsequently require a full GRAS notification or a food additive petition.

The proposal includes several exceptions for human food, including certain substances covered by existing FDA ‘no questions’ letters, substances already listed or affirmed as GRAS in FDA regulations, some historical-use substances and uses reviewed through established FDA consultation processes.

The FDA is also proposing the ability to revisit, update or rescind previous ‘no questions’ letters where new information raises questions about the underlying GRAS conclusion.

The proposed mandatory system could significantly increase the regulatory and administrative burden for food and ingredient manufacturers, particularly companies with large portfolios of substances that have historically relied on independent GRAS determinations. This includes food-tech start-ups launching ingredients made via advanced fermentation, like precision fermentation, and other novel alternative protein ingredients.

Legal firm Venable said the proposal means manufacturers should begin reviewing their existing GRAS uses and assessing whether they fall within any of the proposed exceptions.

It also advised companies to preserve evidence documenting when independently concluded GRAS uses entered interstate commerce, which could become important when using the proposed streamlined pathway.

The proposed rule is scheduled for publication in the Federal Register today (11 August 2026), with the FDA proposing a 120-day consultation period with comments expected to be due in December.

If finalised the mandatory notification provisions would have a compliance date of 18 months after the effective date of the final rule. The final rule would itself take effect 60 days after publication.

The proposed changes form part of the Trump administration’s Make America Healthy Again agenda, which is also behind efforts to establish a federal definition of ultra-processed foods.

HHS and the US Department of Agriculture have separately submitted the federal government’s first proposed definition of UPFs for final review.

HHS Secretary Robert F Kennedy Jr said the measures would bring “greater transparency to what’s in our food,” and strengthen the scientific basis of federal nutrition policy.