For nearly 70 years, food and beverage companies have been able to decide on their own that a new ingredient is safe and put it on the market without informing the Food and Drug Administration (FDA). A new proposal could require that companies notify the agency when they add a new substance to human or animal food.
Currently, companies can self-certify ingredients as "generally recognized as safe" (GRAS). The proposed rule aims to address an information gap that food safety experts have criticized for years but does not require companies to wait for the FDA to determine that an ingredient is safe before selling it.
The proposal is part of Health Secretary Robert F. Kennedy Jr.'s broader "Make America Healthy Again" (MAHA) agenda, which seeks to reshape federal oversight of the nation's food supply.
Peter Lurie, president of the Center for Science in the Public Interest and a former FDA official, stated, "It is something of a step forward, but it is not nearly as significant a step forward as they make it out to be."
The GRAS exemption was created by Congress in 1958 for widely accepted substances, such as salt and vinegar, where a formal FDA review was deemed unnecessary. However, it has been used for a broader range of ingredients than originally intended. An estimated 99% of food chemicals introduced since 1958 have entered the market through the GRAS pathway rather than the FDA's formal food additive approval process, according to a 2025 analysis by the Environmental Working Group.
The lack of knowledge about food ingredients has complicated food safety scenarios. For example, a 2022 foodborne illness outbreak linked to Daily Harvest plant-based crumbles, which hospitalized 133 consumers, was eventually traced to tara flour, an ingredient that the FDA later determined does not meet GRAS standards.
Companies have been able to submit voluntary notifications of their GRAS ingredients, usually involving hiring their own experts to review new ingredients. The FDA's Human Foods Program has logged over 1,300 GRAS notices since it began accepting them in 1997, but these notices have never been required for companies to sell food with a new GRAS ingredient.
While some critics refer to the GRAS exemption as a "loophole," Patricia Zettler, a law professor at Ohio State University and former FDA associate chief counsel, noted that the exemption was created by Congress.
The proposed rule would make the FDA's voluntary GRAS notification program mandatory. Companies introducing a new substance under the GRAS provision would need to notify the FDA of their basis for concluding that the substance is safe for its intended use. Although companies that skip this step would not be automatically barred from selling the substance, the FDA would consider the lack of notification when prioritizing substances for post-market safety review.
Agricultural economist Charles Benbrook stated that while the proposal would provide the FDA with information not consistently received under the current system, it falls short of a full safety review, which involves gathering scientific data and public comment.
The proposal also addresses ingredients already sold based on past "self-affirmed" GRAS determinations. If enacted, companies would have one year to make a streamlined submission identifying the substance and its use, without needing to provide underlying safety data.
Benbrook expressed concern that the FDA requires no data or evidence to support a determination that a food additive poses no risk. Marion Nestle, professor emerita at New York University, questioned whether the FDA has the resources to evaluate all notices, given staff reductions.
The proposal allows companies to market a substance while the FDA considers the GRAS notice, which differs from the formal food additive process that requires scientific evidence evaluation before market approval.
Lurie expressed skepticism about the proposal's enforcement, stating, "The government is depicting this as mandatory, but it really isn't. There is no real enforcement mechanism to assure that the companies will report."
The FDA did not respond to inquiries about potential consequences for non-compliance. The GRAS proposal is part of the Trump administration's MAHA initiative, which emphasizes the role of food additives in the American diet. The Department of Health and Human Services stated the proposal aims to strengthen nutrition science and modernize food supply oversight.
Nestle pointed out that the GRAS rule does not address microbial food safety issues, such as cyclospora or salmonella outbreaks. Lurie noted that focusing on food additives might divert attention from other dietary factors linked to health problems.
The proposal is open for public comment through early December. Zettler remarked that even if a final rule is issued, it could take years to implement. Under the Administrative Procedure Act, the FDA must consider public comments before issuing a final rule, which could lead to changes in the proposal.
Lurie anticipates opposition from both industry stakeholders and those against increased federal regulation. Key issues likely to draw comments include FDA enforcement of the notification requirement and the adequacy of the notification process to address safety concerns. Lurie suggested that a more meaningful overhaul would involve creating a public database of GRAS determinations and independent FDA review of supporting evidence.
The proposal could provide the FDA with a clearer picture of the ingredients companies are using under the GRAS exemption. Lurie stated, "We will know better what's in the food. We will know better whether or not there's a sustainable claim for safety."
Source: PBS NewsHour