FDA to Mandate Safety Review for All New Food Additives, Ending Decades-Old Voluntary 'GRAS' System

The U.S. Food and Drug Administration is preparing to close one of the most consequential regulatory loopholes in the American food supply. For decades, food and supplement manufacturers have been able to introduce new chemical additives into the market without mandatory federal safety reviews or public disclosure.[2][4]

This practice, known as "self-affirmation" under the Generally Recognized as Safe (GRAS) exemption, has allowed thousands of novel ingredients to bypass direct federal scrutiny. Now, under a sweeping overhaul of the agency's Human Foods Program, the FDA is moving to mandate premarket notification and safety reviews for all new food substances claimed to be GRAS.[1][3]

The upcoming regulatory shift, scheduled for a formal proposed rule in December 2026, marks a fundamental transformation in how the United States regulates food chemistry. It shifts the burden of proof back to manufacturers, ensuring that the safety of new additives is verified by federal scientists before they reach grocery store shelves.[3][4][6]

To understand the magnitude of this change, it is necessary to look back at the 1958 Food Additives Amendment. Congress established that any new food additive must undergo a rigorous premarket review by the FDA. However, lawmakers carved out an exemption for ingredients that were "generally recognized as safe" by qualified experts—a provision originally intended for common, historically used ingredients like salt, pepper, and vinegar.[4]

Over time, the interpretation of the GRAS exemption expanded dramatically. In 1997, citing a lack of resources to handle a backlog of petitions that could take years to process, the FDA introduced a voluntary notification program. This allowed companies to convene their own panels of experts to declare a new chemical additive safe, without ever being required to notify the FDA or the public.[2]

Public health advocates and consumer groups have long criticized this voluntary system as a loophole that effectively privatized food safety. Because companies were not required to submit their safety dossiers to the FDA, the agency often had no record of what new chemicals were entering the food supply, let alone the data to independently verify their safety.[2][4]

The push to close the GRAS loophole gained definitive momentum in early 2025 under the Department of Health and Human Services. HHS leadership directed the FDA to explore rulemaking that would eliminate the self-affirmation pathway, citing the urgent need to prevent chemicals with unknown safety profiles from being introduced into consumer products.[2]

The FDA's 2026 Unified Regulatory Agenda confirms that the agency is drafting a proposed rule to mandate premarket notification for substances determined to be GRAS. Crucially, the agenda indicates that the FDA will presume any covered food substance is not GRAS—and is therefore an unapproved, illegal food additive—unless the mandatory notification requirement has been fully satisfied.[3][6]

This presumption of non-GRAS status effectively reverses decades of industry reliance on self-affirmation. Manufacturers will no longer be able to quietly launch new functional ingredients, preservatives, or synthetic compounds based solely on internal consensus. Instead, they will have to submit their scientific evidence to the FDA for formal review and public listing.[3][4][6]

The regulatory overhaul is not limited to new ingredients. The FDA has also launched a Systematic Post-Market Assessment program to reevaluate the safety of chemicals that are already widely used in the food supply. This marks a significant departure from the agency's historical approach, which rarely revisited the safety of approved additives unless prompted by external petitions.[1][5]

Under Acting FDA Commissioner Kyle Diamantas, the agency has finalized the framework for this post-market review process. The program uses a risk-based prioritization tool to identify chemicals that warrant fresh scrutiny based on new scientific evidence regarding toxicity and consumer exposure levels.[1][5]

The first targets of this post-market reassessment include butylated hydroxytoluene (BHT) and azodicarbonamide (ADA)—chemical additives commonly used to prevent oxidation in cereals and condition dough in baked goods. The FDA has issued requests for information on these substances, signaling a willingness to restrict or ban ingredients if modern science no longer supports their safety.[1][5]

For the food and supplement industries, the end of the voluntary GRAS system presents significant operational challenges. Companies that previously leveraged self-affirmation to accelerate product development and reduce compliance costs will now face longer timelines and higher regulatory hurdles to bring novel ingredients to market.[6]

Legal experts anticipate that the FDA's proposed rule will face intense scrutiny and potential litigation. Industry groups and legal analysts may challenge the agency's statutory authority to mandate GRAS notifications, arguing that the Federal Food, Drug, and Cosmetic Act explicitly exempts GRAS substances from premarket approval requirements.[3]

Despite the looming legal battles, the FDA's actions align with a growing national demand for food transparency. At the state level, legislatures in California, New York, and elsewhere have already begun banning specific food additives that are permitted by the FDA but prohibited in Europe due to health concerns, increasing the pressure for federal action.[3]

The FDA's dual approach—mandating reviews for new GRAS substances and systematically reassessing existing chemicals—aims to restore public confidence in the federal oversight of the food supply. By closing the self-affirmation loophole, the agency is taking a decisive step toward ensuring that the convenience of food innovation does not outpace the rigorous science of food safety.[1][4]