For nearly 70 years, food and beverage companies have been able to decide on their own that a new ingredient is safe under the "generally recognized as safe" (GRAS) exemption and put it on the market without informing the Food and Drug Administration. The agency has proposed making its voluntary GRAS notification program mandatory, though the proposal stops short of requiring companies to wait for FDA review before selling products containing new ingredients.
The change would be part of Health Secretary Robert F. Kennedy Jr.'s broader "Make America Healthy Again" (MAHA) agenda, an effort to reshape federal oversight of the nation's food supply. Under the proposal, companies introducing a new substance under the GRAS provision would have to notify the FDA of their basis for concluding that the substance is safe for its intended use. The public comment period runs through early December.
What the Right Is Saying
The Department of Health and Human Services has framed the proposal as intended to "strengthen nutrition science, improve transparency and modernize oversight of the food supply." The MAHA initiative has focused heavily on the role of food additives and chemicals in the American diet.
Patricia Zettler, a law professor at Ohio State University and former FDA associate chief counsel, cautioned against referring to the GRAS exemption as a "loophole," saying this can obscure that Congress itself created it. "Maybe the 'generally recognized as safe' pathway is bigger than Congress initially envisioned in 1958," Zettler said, "but it is how Congress designed the statute." She noted that FDA, like any administrative agency, can only do what Congress has authorized it to do by statute.
Agricultural economist Charles Benbrook said the notification would consist of "the company's opinion, based on what the company knows about the product." He contrasted this with the food additive approval process, where before a new additive is approved for use, it must undergo at least a minimal and open scientific evaluation. "The FDA requires no data, no evidence, no explanation of the basis for their determination and confidence that such a food additive poses no risk," Benbrook said.
What the Left Is Saying
Peter Lurie, president of the Center for Science in the Public Interest and a former FDA official, said the proposal represents "something of a step forward, but it is not nearly as significant a step forward as they make it out to be." He questioned whether the word "mandatory" accurately describes the rule. "The government is depicting this as mandatory, but it really isn't," Lurie said. "There is no real enforcement mechanism to assure that the companies will report, and not a lot of reason to think that they would suddenly want to do this, when the old system of not reporting had worked very well for them for decades."
Lurie said the administration has a general suspicion about additives that may draw attention away from other dietary factors with stronger evidence linking to health problems. "Sometimes they're right that a given additive is dangerous, sometimes they aren't, but they have a general suspicion when it comes to additives," he said. "That's where their focus has been, not on things that probably are more likely to kill you, like sodium, added sugar, saturated fat."
Marion Nestle, professor emerita of nutrition, food studies and public health at New York University, questioned whether the proposed rule will make any difference given staffing constraints. "Who's at the FDA who can review these when 20% of the staff has been fired or left?" she said. For a more meaningful overhaul, Lurie said two changes beyond what is in the proposal would be necessary: a public database of companies' GRAS determinations, and independent FDA review of the evidence supporting those determinations.
What the Numbers Show
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 FDA's Human Foods Program has logged more than 1,300 GRAS notices since it first began accepting them in 1997.
A 2022 foodborne illness outbreak tied to Daily Harvest plant-based crumbles hospitalized 133 consumers and was eventually linked to products containing tara flour. The FDA later determined that tara flour in human food doesn't meet GRAS standards and reclassified it as an unapproved additive, illustrating the complications that arise when regulators lack visibility into which ingredients are in use.
Under the proposed rule, companies selling substances based on past self-affirmed GRAS determinations would have one year to make a streamlined submission identifying the substance and its use. The proposal does not require underlying safety data for these submissions. Companies that skip notification entirely would not be automatically barred from selling the substance, but the FDA says it would factor the lack of notification into which substances it prioritizes for post-market safety review.
The Bottom Line
The proposed rule represents an attempt to close an information gap that food safety experts have criticized for years. If implemented, it would give the FDA something it has lacked for decades: a clearer picture of which ingredients companies are putting into the food supply under the GRAS exemption. "We will know better what's in the food," Lurie said. "We will know better whether or not there's a sustainable claim for safety."
What remains unclear is how the rule would be enforced and whether the FDA has sufficient resources to review submissions. The agency did not respond to questions about what consequences companies would face for failing to comply with the notification requirement. Zettler noted that even if a final rule came out in 2027, "that would be pretty fast for one of these rulemakings." Public comments can meaningfully influence agency policy before any final rule is adopted.