FDA Proposes Mandatory GRAS Notification Rule, Reassesses Common Food Preservative

Congress also considers multiple bills to reform the GRAS process amid growing scrutiny of long-standing food chemical approvals.

Published on Feb. 20, 2026

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The U.S. Food and Drug Administration (FDA) has proposed a rule to require mandatory submission of GRAS (generally recognized as safe) notices for human and animal food substances, signaling a potential shift in the longstanding GRAS framework. This comes as FDA launches a comprehensive reassessment of the food preservative butylated hydroxyanisole (BHA), which has had a GRAS listing since 1958. Meanwhile, Congress is considering several bills that would reform various aspects of the GRAS process, including establishing mandatory notification requirements, tightening eligibility criteria, and requiring periodic reassessment of GRAS substances.

Why it matters

The proposed changes to the GRAS process have broad implications across multiple regulated industries, as many dietary supplements, food additives, and other products rely on GRAS substances. The heightened scrutiny of long-standing GRAS determinations could lead to reformulation decisions, new regulatory strategies, and supply chain shifts for companies. The outcome of these reform efforts will shape the future landscape for food and supplement ingredients.

The details

The FDA's proposed mandatory GRAS notification rule, currently under review by the Office of Management and Budget, would require companies to submit notices to the agency before using a substance deemed GRAS. This marks a potential departure from the current self-affirmed GRAS pathway. Separately, the FDA announced it is launching a comprehensive reassessment of BHA, a common food preservative that has had a GRAS listing since 1958, to evaluate its safety based on the latest scientific evidence. This review is part of a broader FDA effort to expand post-market oversight of GRAS substances and revisit long-standing determinations.

  • In December 2025, the Office of Management and Budget began reviewing the FDA's proposed mandatory GRAS notification rule.
  • On February 10, 2026, the FDA announced it is launching a reassessment of the food preservative BHA, which has had a GRAS listing since 1958.

The players

U.S. Food and Drug Administration (FDA)

The federal agency responsible for regulating food, drugs, and other products in the United States.

Office of Management and Budget (OMB)

The Executive Office of the President that oversees the administration's regulatory agenda, including reviewing proposed rules from federal agencies.

Make America Healthy Again Commission

A government commission that has prioritized expanding post-market review of food chemicals, including GRAS substances, and revisiting long-standing approvals.

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What they’re saying

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