FDA Moves to Mandate Notification of GRAS Ingredients

On Monday, the U.S. Department of Health and Human Services announced a proposed rule that would require food manufacturers to notify the Food and Drug Administration (FDA) whenever they determine an ingredient is “Generally Recognized as Safe” (GRAS). Companies would also submit data on existing GRAS ingredients. The notification would be public, and the FDA would have 45 days for an initial decision and up to 180 days for a substantive safety review.

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The GRAS exemption was created in 1958 to let common substances such as flour, baking soda and standard spices bypass pre-market approval. In 1997 the FDA added a self-affirmation pathway that lets manufacturers rely on internal expert panels rather than filing a formal petition. Critics say the voluntary system has become a loophole, allowing many novel chemicals to enter the U.S. food supply without regulatory oversight.

The Hill

• Industry analysts estimate at least 1,000 new substances have been introduced through the GRAS pathway without FDA review.

The Hill

• A March study identified 111 substances of unknown safety added to foods, drinks and supplements.

NBC News

Health Secretary Robert F. Kennedy Jr. framed the proposal as a response to a “decades-old information gap,” saying the public and regulators need a complete picture of what is in the food supply. He noted statutory limits on the FDA’s authority and said the agency is working with Congress on legislative options to strengthen the GRAS process.

The Hill

Food-policy advocates argue that mandatory notification alone is insufficient. Melanie Benesh, vice-president for government affairs at the Environmental Working Group, called the move “a positive first step” but warned that “true GRAS reform requires more than mandatory notification.” Todd Harrison, a food-and-drug attorney at Venable, said without congressional action the agency “fundamentally… can’t do anything.” The Food Industry Association’s Stephanie Harris urged Congress to enact a “nationally uniform, science-based framework” to give the FDA clear authority and avoid a fragmented state-by-state patchwork.

The Hill

• Authority: Legal analysts note uncertainty about whether the FDA can compel notifications without new legislation, citing a 2021 federal court decision that limited the agency’s power to impose mandatory reporting.

FoodDive

• Enforcement: The proposal does not specify penalties or a mandatory timeline for submissions, leaving open the possibility that companies could self-affirm safety and notify the FDA after the fact.

FoodDive

• Scope: While the rule would cover new GRAS determinations, it provides only a “streamlined submission pathway” for existing ingredients, without a clear mechanism for the FDA to reject a notification or require additional data.

FoodDive

• “We don’t even know exactly how many chemicals are in the food that Americans eat every day, and the food industry continues to develop novel compounds and chemical combinations that do not exist in nature,” — Robert F. Kennedy Jr.

New York Times

• “This new notification system does not establish a pre-market review program.” — Kyle Diamantas, acting FDA commissioner

The Hill

• “True GRAS reform requires more than mandatory notification,” — Melanie Benesh

The Hill

• “If finalized, this rule would formally transition the Gras framework from a voluntary program to a mandatory notification system,” — Kyle Diamantas

The Guardian