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The US Food and Drug Administration (FDA)’s proposal to update the Generally Recognized as Safe (GRAS) process is likely to change significantly before being finalised, according to an FDA official.
"We really do anticipate that the plan will look different than the proposal based on comments," Mark Hartman, director of the FDA’s Office of Food Chemical Safety, Dietary Supplements and Innovation, said at a recent symposium.
Speaking at Keller & Heckman’s DC Food Packaging Law Seminar on 27 October, Hartman gave insight into the FDA’s plan to mandate GRAS notifications and indicated some of the agency’s other priorities for 2027 (see box).
"This is a very significant change," Hartman said of the GRAS rule. "We recognise that, and we also recognise we’re not going to solve all those nuances in a proposal."
Hartman acknowledged there are "a lot of unanswered questions" about the GRAS rule and said the FDA is considering feedback from "both sides of the spectrum".
FDA seeks practical feedback
Hartman encouraged stakeholders to provide the FDA with commentary about "what would actually work – whether it's timing, whether it's due diligence ... I think that's important commentary for us to have".
The FDA has already received hundreds of comments from consumer advocates and industry stakeholders about the GRAS proposal, according to the public docket. Some commentators have argued that the proposal lacks enforceability and creates loopholes, while others worry that a mandatory notification requirement would overburden the FDA’s resources.
Hartman acknowledged that the proposed rule would place additional demands on the FDA and manufacturers, particularly regarding Food Contact Notifications (FCNs), the proposal’s recommended route for food contact substances (FCSs).
"We anticipate that there would be an increase in that workload" for FCNs "along with the workload for general GRAS notifications," he said.
Already seeing impact
Although the proposal has yet to be finalised, it has already prompted an estimated 90% increase in voluntary GRAS notifications to the FDA, Hartman said.
"Even the idea of [the FDA] looking into GRAS has created a sort of impetus in the stakeholder community," he said.
Comments on the proposal are due by 9 December.
Ongoing assessments and other priorities
Hartman also outlined other FDA priorities for fiscal year (FY) 2027, including work on assessments of various food substances.
He said FDA will release "a bunch of" draft assessments "soon", and he encouraged industry to submit information about chemicals under review to help each draft assessment "look as close to the final one as it possibly can".
Earlier this year, the FDA initiated post-market assessments of butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT) and azodicarbonamide (ADA) and requested relevant information from industry.
The information received in response to requests for information (RFIs) on those substances did not meet the agency’s expectations, Hartman said
He indicated the agency had some flexibility in its prioritisation tool for post-market review of food substances, which he called "a living document".
Hartman said: "We are test driving it right now, and I would expect, as we continue to develop assessment[s] and go through the risk management process, we'll continue to refine that new process."
Among other priorities for 2027, Hartman indicated that the FDA is "pretty far along" in reviewing BHA, phthalates and 4-methylimidazole, with the latter "closest to being completed". The next step for phthalates is to "move forward with a risk assessment", he added
PFAS contamination also remains a "high-level concern for the current administration", Hartman said, with work ongoing to advance a possible rule on PFAS levels in bottled water. He expects the agency will consider whether the data it has collected could support a national rule addressing PFAS in foods like shellfish.
Finally, Hartman said the FDA is improving guidance for the food contact sector, including "actively working on updating" its chemical guidance.