The FDA wants food companies to stop self-certifying their own ingredients as safe

HHS and the FDA announced two food-policy actions 10 August: a proposed rule that would make it mandatory, rather than voluntary, for manufacturers to notify the FDA when they determine a food ingredient is "Generally Recognized as Safe" (GRAS), and a proposed federal definition of "ultra-processed foods" submitted jointly with the USDA for review [s1].

The loophole this closes, and how big it actually is

Under the current system, a manufacturer that wants to add a new substance to food can conduct its own safety assessment, conclude the substance is GRAS, and start using it — without ever notifying the FDA, since GRAS notification has been voluntary rather than required. The proposed rule would require manufacturers to notify the FDA whenever they reach a GRAS determination for a substance added to human or animal food [s1]. That changes the FDA's role from possibly-informed to formally-informed for every new GRAS ingredient going forward — but it doesn't retroactively re-examine ingredients that were already self-certified as GRAS under the voluntary system before this rule existed, beyond the streamlined pathway described below.

The timeline: a proposal today, enforcement years away

This is a proposed rule, not yet a final one — the FDA is accepting public comments through 9 December 2026 [s1]. If and when a final rule is issued, it would take effect 60 days after publication, with a further 18-month compliance window before the mandatory-notification requirement actually applies [s1]. Substances already on the market before the new regulations take effect would be eligible for a separate, time-limited streamlined submission pathway, rather than being required to go through the same process as brand-new ingredients [s1]. Altogether, the realistic distance between this announcement and mandatory notification actually taking effect is measured in years, not months — a comment period, a final rule, a 60-day delay, and an 18-month compliance runway, in sequence.

The other half of the announcement: defining "ultra-processed"

Separately, HHS and USDA submitted for final review the federal government's first proposed definition of ultra-processed foods, developed with input from what the announcement describes as thousands of stakeholders across industry, research, consumer groups, and the public [s1]. A federal definition matters because "ultra-processed food" has functioned, until now, as a research and public-health term without a single official regulatory meaning in the US — nutrition studies and advocacy groups have used varying definitions, which complicates comparing findings or writing policy around the category. Establishing one federal definition is a prerequisite for any future regulation, labeling requirement, or program (like school meal standards) that might specifically target ultra-processed foods, though the announcement covered here doesn't itself impose any new restriction tied to the definition.

How this fits the administration's broader food agenda

Both actions are explicitly framed as part of the administration's Make America Healthy Again (MAHA) agenda [s1] — a policy program HHS Secretary Robert F. Kennedy Jr. has centered on food-additive and nutrition policy specifically, distinct from the vaccine-policy actions associated with the same agenda elsewhere in his tenure.

What to watch next

Whether the GRAS rule survives the comment period with its 18-month compliance timeline intact, or gets extended or narrowed in response to industry input — and what the finalized ultra-processed food definition actually says, since the announcement covered here confirms a definition was submitted for review but doesn't specify its content.