CIRS Analyzes FDA Proposal to End Self-GRAS Pathway
CIRS Group has published an analysis of a major U.S. Food and Drug Administration proposal that could significantly change how companies establish Generally Recognized as Safe (GRAS) status for food and functional ingredients.
FDA’s proposed rule, published in the Federal Register on August 11, would replace the current voluntary GRAS notification system with a mandatory notification requirement for certain uses of substances in human and animal food. Currently, companies may independently conclude that an ingredient is GRAS under its intended conditions of use without notifying FDA.
Under the proposal, companies relying on GRAS status would generally be required to submit notices to FDA unless an exception applies. FDA said the change would provide the agency and the public with greater information about substances entering the food supply and allow regulators to evaluate whether GRAS conclusions have an appropriate scientific basis.
CIRS notes that companies should begin reviewing existing ingredients and safety documentation, including identity, manufacturing processes, exposure assessments and supporting scientific data. Companies developing new functional ingredients may also need to reconsider regulatory strategies and determine whether GRAS, New Dietary Ingredient (NDI) notification or another pathway is appropriate for their intended applications.
The proposal is not yet final. FDA is accepting comments through December 9, 2026, meaning the requirements could change before a final rule is issued.
What this means for the dietary supplement industry
The proposed change could have important consequences for functional-ingredient companies, particularly those supplying ingredients for use in conventional foods, beverages and other applications that rely on GRAS status.
Eliminating the ability to rely solely on an independent GRAS conclusion could increase regulatory costs, documentation requirements and development timelines. It could also increase the strategic value of comprehensive safety dossiers and FDA-reviewed GRAS notifications when ingredient companies seek commercial partners.
Dietary supplement companies should also recognize the distinction between GRAS and NDI requirements. GRAS generally addresses intended uses in food, while dietary ingredients used in supplements are subject to a separate regulatory framework. Companies developing ingredients for both food and supplement applications should therefore carefully evaluate which regulatory pathways apply to each intended use.
CIRS Group is an HPA-Global regulatory strategic partner.
(Source: CIRS Group, U.S. FDA & HPA-Global)
If your company is active in the dietary supplement, functional food, ingredient, or health products industry and is not yet a member of HPA-Global, we invite you to consider joining the association. HPA-Global supports members with China and global market intelligence, marketing visibility, industry connections, and access to regulatory support for supplements, ingredients, and related health products in China, the EU, Japan, South Korea, and the U.S. For companies looking to expand internationally and stay ahead of market and regulatory changes, HPA-Global offers one of the best values in the industry. Contact us for more details: info@hpaglobal.org.