The Food and Drug Administration will soon require food manufacturers to notify the agency about additives in their products, marking the first U.S. government effort to catalog chemicals Americans consume through food.
The new rule, announced Monday by the Department of Health and Human Services, addresses the “generally recognized as safe” (GRAS) system. This process has allowed companies to introduce thousands of additives into the food supply without federal review. Under the proposal, companies must inform the FDA when adding a new substance to human or animal food and provide safety determination details. Manufacturers will also need to disclose existing GRAS additives already in use, with the information published in a public database.
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While the rule does not require pre-market approval, officials said it would close a long-standing information gap. Acting FDA Commissioner Kyle Diamantas called the proposal a move toward transparency and oversight of the U.S. food supply. He noted it respects the limits of the FDA’s authority under the 1938 Food, Drug, and Cosmetic Act.
After a company submits a notification, the FDA will conduct an initial review within 45 days to verify legal requirements. A more detailed review will follow within 180 days, during which the agency may request additional information or reject the application if it fails to meet GRAS criteria.
Consumer advocates have long criticized the GRAS system for lacking accountability. Jennifer Pomeranz, a public health lawyer at NYU, said the proposal represents an important change that could protect consumers. Without mandatory reporting, the FDA cannot track additives companies self-certify as safe, as this information is not disclosed on food labels or to regulators.
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Critics argue the rule falls short. Peter Lurie, president of the Center for Science in the Public Interest, called the policy mandatory without enforcement, noting companies can still sell products before submitting notices.
Reactions to the announcement varied. Vani Hari, an adviser to the administration on food policy, praised the move as a major step toward transparency. HHS Secretary Robert F. Kennedy Jr. celebrated the proposal at a Monday event, calling it an effort to close the loophole.
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The GRAS proposal will be published in the Federal Register this week and open for public comment until early December. The estimated annual cost of implementation is $10.5 million, most of which would fall on companies.
The rule will not force companies to prove existing additives are safe, a demand advocates have made for years. Instead, it will create a record of what’s already in the food supply, allowing researchers and regulators to assess potential risks. Some see this as sufficient. Others view it as only the beginning of a longer effort.