Under a proposed new rule from the Food and Drug Administration (FDA), the voluntary self-affirmed Generally Recognized as Safe (GRAS) notification program would be converted into a mandatory pre-market notification requirement for certain dietary supplement and functional food ingredients. The proposal could improve ingredient transparency, but mandatory GRAS review may also delay product launches, discourage innovation, and reduce consumer choice.
Key Proposal Details
Under the proposal, manufacturers could no longer rely solely on self-determined GRAS status. They would first have to notify the FDA about new ingredients, although the agency says companies could continue marketing substances before and during its review.
The proposal’s definition of “new” ingredients may be broad enough to encompass substances already on the market rather than only truly novel ingredients. The agency says companies may still market substances before and during the notification review process.
Products already on the market would receive a one-year window to use a streamlined submission process rather than being required to file a full GRAS notice immediately. For consumers, the shift from a voluntary pathway to mandatory notification presents a tradeoff between greater transparency and potentially slower access to new products.
Greater Transparency and Informed Choices for Consumers
Companies currently introduce novel food ingredients through “self-affirmed” GRAS pathways supported by rigorous scientific evidence, without a pre-market reporting requirement, though many brands do so voluntarily. The FDA says mandatory pre-market GRAS notification would give consumers greater confidence in product safety.
The proposal would also create a centralized consumer database using information submitted by companies, giving consumers greater visibility into new food technologies and distinctive additives.
Although the proposed rule may help label-conscious consumers, its reporting requirements could strain FDA resources. A high volume of submissions could delay agency reviews and responses, slowing product launches and reducing consumer choice.
The added regulatory hurdle could delay the path from laboratory development to retail launch, particularly for products tied to niche health trends or emerging innovations. The proposal’s practical effect will depend on how the FDA defines covered ingredients, manages submissions, and applies the notification process to products already on the market.
The GRAS proposal’s comment period is open through December 6, 2026.
Act now! Say no to the pre-market GRAS proposal. Tell the FDA this proposal has the potential to do more harm than good — limiting product innovation and slowing time to market for product launches and ultimately reducing consumer choice.
