HHS Moves to End Self-Affirmed GRAS Pathway for Food Ingredients

What the Push to Eliminate Self-Affirmed GRAS Would Change

The Department of Health and Human Services has directed the acting FDA commissioner to begin exploring a rule change that would end a long-standing practice allowing food companies to declare new ingredients safe on their own authority. Under the current framework, companies can self-affirm that a substance is Generally Recognized as Safe — or GRAS — without notifying the FDA or publishing the safety data behind that conclusion.

HHS Secretary Robert F. Kennedy Jr. framed the move as a response to a loophole that he says has let new ingredients and chemicals enter the U.S. food supply without meaningful oversight. If the agency proceeds with rulemaking, companies seeking to introduce new ingredients would need to notify the FDA publicly and submit supporting safety data before the products reach store shelves.

The FDA already runs a voluntary GRAS Notification Program, under which it has completed and published more than 1,000 notices and evaluates an average of 75 per year. The agency's public inventory contains the filings, supporting data and final agency response letters. But participation is not mandatory, and that gap is what the proposed change targets.

HHS also said it will work with Congress on legislation to close the GRAS route entirely, a separate track that could complement the FDA's administrative rulemaking. Acting FDA Commissioner Sara Brenner said the agency is committed to ensuring appropriate review of ingredients and substances that come into contact with food.

How the GRAS Loophole Developed and Who Is Affected

Why GRAS Exists and How It Became Controversial

The GRAS concept is embedded in U.S. food law: certain substances are exempt from the FDA's pre-market approval requirement because they are widely recognized by qualified experts as safe under the conditions of intended use. The 1958 Food Additives Amendment created the exemption, and a 1997 proposed rule formalized the self-affirming path, allowing companies to determine GRAS status internally and skip FDA notification altogether. Critics have long argued that the system rests on an honor code, since the FDA may never see the underlying evidence for ingredients entering the food supply.

What the Numbers Show About Current Oversight

The FDA publishes roughly 1,000 completed GRAS notices and fields about 75 new notices per year — a figure that reflects only the companies that choose to participate. The scale of self-affirmed substances is not tracked publicly, and that unknown is central to the HHS argument. Without mandatory notification, regulators cannot easily quantify how many new ingredients reach consumers annually or how many of those have limited safety data.

Who Would Win and Lose If the Pathway Is Eliminated

Consumer advocacy groups and public health researchers would likely gain better visibility into what is in food, since companies would be required to submit safety data before market entry. Ingredient manufacturers currently relying on self-affirmation would face new compliance costs, longer pre-market timelines and the risk of FDA objections. Smaller specialty ingredient firms, which may lack the legal and regulatory staff to navigate a formal notification process, could be most exposed. Established companies with large regulatory teams would likely adapt more easily, though they too would see added lead times.

What Comes Next

The directive is the beginning of a long process. The FDA must draft a proposed rule, publish it for public comment, review submissions and then issue a final rule — a timeline that often stretches years and can be interrupted by litigation or changes in administration. Any successful regulation would also need to define how existing GRAS substances are treated, whether a transition period applies and what evidence standard companies must meet. Congressional action could accelerate or reshape the outcome, but legislation carries its own political uncertainty.

What to Watch as FDA Rulemaking Moves Forward

• Food companies and ingredient suppliers: Audit any ingredients currently marketed as self-affirmed GRAS. If a formal notification would be required going forward, identify which substances would need new safety dossiers and begin compiling published scientific evidence and expert panel documentation.
• Investors in ingredient and specialty food companies: Watch for the FDA's public agenda and any draft proposed rule. The longer the timeline, the more time smaller suppliers have to adapt; a fast-tracked rule could hit pre-market approval costs sooner.
• Consumer goods brands: Check which ingredients in your supply chain rely on self-affirmed GRAS status. Public pressure on this issue could make disclosure a purchasing decision if the rule changes.
• Anyone tracking the process: FDA rulemaking typically opens a public comment period once a proposed rule is published. Filing comments with data on safety evidence, cost impacts and small-business effects is the most direct way to influence the final text.