FDA’s Proposed Self-GRAS Rule May Take Ingredients Off the Table

The Food and Drug Administration is expected to propose a rule that could upend the food and beverage industry by overhauling the available pathways to market certain substances.

It would eliminate a regulatory pathway that allows companies to independently determine that a substance is GRAS—generally recognized as safe—for its intended use without pre-market authorization or FDA review.

If adopted, the expected rule would, for the first time, require companies to submit mandatory GRAS notices to the FDA. This would foreclose a decades-old pathway to market available to industry for substances used in or in contact with food and beverage products.

Proposed Rule

Health and Human Services Secretary Robert F. Kennedy Jr. directed the FDA in March 2025 to explore eliminating the self-GRAS pathway, a move he described as a “crucial step” to “Make America Healthy Again.” He said a future rule could “enhance the FDA’s oversight of ingredients considered to be GRAS and bring transparency to American consumers.”

The full text of the proposed rule hasn’t been published yet, but the FDA submitted a draft proposed rule to the White House’s Office of Management and Budget.

The abstract states that, if finalized, in addition to eliminating the self-GRAS pathway, the rule would require the FDA to maintain a public-facing inventory of GRAS notices and “clarify the process under which FDA would determine that a substance is not GRAS.”

Some commentators have suggested that FDA lacks the authority to eliminate the self-GRAS pathway by rulemaking, such that Congress would need to amend the Federal Food, Drug, and Cosmetic Act to eliminate the self-GRAS pathway.

A federal court in 2021 upheld the FDA’s then-interpretation that GRAS notices were intended to be voluntary under the Federal Food, Drug, and Cosmetic Act. That holding applied the now-obsolete Chevron doctrine, so a re-examination of the self-GRAS pathway in court today could yield a different result.

Federal Legislation

Two proposals in Congress have taken aim at the self-GRAS pathway:

The Ensuring Safe and Toxic-Free Foods Act of 2025 is pending in the current legislative session. If passed, it would eliminate the self-GRAS pathway by deeming substances that rely on a self-GRAS determination unsafe and therefore prohibited.

The FDA would have to post submitted GRAS notices, along with supporting documentation, on its website and provide a minimum public comment period of 60 days. Substances that weren’t marketed for use in foods in the US prior to the legislation’s enactment date would be excluded from eligibility to be considered GRAS.

The Better Food Disclosure Act of 2025, which also is pending, would eliminate the self-GRAS pathway by requiring that GRAS notices be submitted to the FDA and requiring the FDA to maintain a public inventory of GRAS substances.

Both proposals provide industry with a two-year grace period in which to submit GRAS notices for eligible substances that are used in or in contact with food or beverages. Companies could continue to use these substances legally while any such GRAS notices were pending review.

State Legislation

Bills introduced in New Jersey, New York, and Pennsylvania would require companies to notify the state of any substances used in or in contact with food or beverage products based on a self-GRAS determination, and for the state to maintain a publicly accessible database of GRAS substances.

Federal action could be informed by approaches taken at the state level, or state actions could augment changes made at the federal level. It’s uncertain whether the FDA’s expected rule would preempt any such state-specific requirements.

Act Now

Even if the FDA can’t eliminate the self-GRAS pathway through rulemaking, federal or state legislation may restrict this pathway to market for substances used in and in contact with food and beverage products.

Companies can prepare for potential federal and state actions that could affect the self-GRAS pathway by:

• Creating an inventory of all substances used in or in contact with food and beverage products sold in the US, and documenting the regulatory status of each substance in the inventory (such as whether the use is authorized by regulation, the subject of a Food Contact Notification, etc.).
• Evaluating whether evidence on file is enough to support any self-GRAS determinations and updating or supplementing that evidence as necessary.
• Discussing potential options if there are changes that affect substances that are being used based on a self-GRAS determination (such as potential replacements with an alternative substance or submission of a GRAS notice to the FDA).
• Preparing for potential delays in bringing new ingredients and packaging materials to market.

Companies also should continue tracking federal and state developments that could affect substances designated as GRAS, including notices of proposed rulemaking and opportunities for input from industry. Whether implemented at the federal or state level, the food and beverage industry should expect changes to the self-GRAS pathway in 2026.

This article does not necessarily reflect the opinion of Bloomberg Industry Group, Inc., the publisher of Bloomberg Law, Bloomberg Tax, and Bloomberg Government, or its owners.

Author Information

Sam Jockel is partner and co-leader of Alston & Bird’s Food & Beverage industry team, based in Washington, DC.

Ashley Yull and Ben James are senior associates on the team, also based in Washington, DC.

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