For 68 years, food companies have been able to add new ingredients to their products without notifying the government. The rule — called GRAS, for "Generally Recognized as Safe" — lets manufacturers convene their own expert panels, declare an ingredient safe, and put it in food with no FDA review required. HHS Secretary Robert F. Kennedy Jr. announced Monday that he is directing the FDA to eliminate that self-affirmation pathway and require companies to submit safety data to the agency before introducing new food ingredients. Kennedy says between 4,000 and 10,000 chemicals may be in the U.S. food supply without government knowledge, calling the loophole "hijacked by the industry." The announcement followed a 60 Minutes encore rebroadcast Sunday in which Kennedy and former FDA Commissioner David Kessler called the ultraprocessed food supply a public health crisis on the scale of tobacco.

Kennedy Says Thousands of Chemicals Got In Without Federal Review

MAHA reformers argue the GRAS system has let food companies self-police for decades — and FDA needs back in the room.

Kennedy says food companies approved their own ingredients. The self-affirmation pathway gave companies a blank check: 22% of GRAS safety assessments were run by company employees, and 64% used expert panels the companies selected themselves. Companies using self-affirmation never had to tell the FDA at all.

Kessler went further: pull existing ingredients, not just block new ones. He petitioned the FDA in August 2025 to strip GRAS status from processed refined carbohydrates already on shelves, arguing they drive obesity and diet-related disease. Former acting FDA Commissioner Stephen Ostroff has been blunter: "GRAS has been abused, and it's ripe for reform."

Kennedy himself has already dialed back expectations. On 60 Minutes Sunday he said: "I'm not saying that we're going to regulate UPFs. Our job is to make sure everybody understands what they're getting." The announcement Monday directed the FDA to "explore potential rulemaking" — meaning a formal rule change would still require years of regulatory process before it takes effect.

The Food Industry Says Reform Would Choke Innovation and Disrupt Supply

Consumer brands and farm groups argue the GRAS system enables product development and that forcing FDA review would make it impossible.

The Consumer Brands Association says the current GRAS system works. Sarah Gallo, the group's senior vice president of product policy and federal affairs, said GRAS "plays an important role in enabling companies to innovate to meet consumer demand." The association represents major packaged food manufacturers and has consistently opposed mandatory premarket FDA review.

Industry groups say the practical costs would be prohibitive. Requiring companies to submit safety data to FDA for each new ingredient would impose millions in compliance costs per product, delay launches, and potentially price smaller producers out of the market entirely. The American Farm Bureau Federation raised the same concerns, warning that stricter oversight could reduce the variety of food products available to consumers.

Industry says FDA-forced reviews would cost more than they fix. They say shifting oversight to a resource-constrained agency would create more disruption than the self-affirmation pathway ever did.

Critics Say the FDA Kennedy Wants to Enforce This Is the FDA Kennedy Gutted

Pragmatists support the goal but argue Kennedy has already eliminated the agency's capacity to do what he is now promising.

Jim Jones quit over the FDA cuts. Jones was the FDA's deputy commissioner for human foods before he resigned, calling the Trump administration's layoffs "indiscriminate." Those cuts eliminated 89 positions from the Human Foods Program, including 10 staffers who reviewed potentially unsafe food ingredients. Jones said rebuilding that capacity is "the hardest place to shore up." The FDA previously tried a comprehensive review of existing GRAS ingredients and abandoned it because of "time and resource constraints" — before the layoffs.

Knulrick: this reform contradicts what Kennedy did to the FDA. Food scientist Jessica Knulrick said Kennedy's proposal to eliminate self-affirmed GRAS status "is fundamentally at odds with Kennedy's ongoing actions to gut the FDA," and that the agency after the layoffs is "unlikely to stringently review new additives."

Pomeranz says the proposal misses the bigger problem. Jennifer Pomeranz, associate professor of public health policy and management at NYU School of Global Public Health, said "Testing GRAS additives is not a bad idea — but it is not going to make a big difference." The proposal only covers new ingredients. The thousands of chemicals FDA has never reviewed are already in the food supply. Scott Faber of the Environmental Working Group made the same point: "Thousands of chemicals are already being used in our food without ever having been reviewed by the FDA."

Where This Lands

Kennedy's announcement makes food safety a live political fight. The reformer and the regulator are the same person. The opposition is an industry that ran under the same rules for 60 years. The skeptics are former FDA insiders watching the agency try to expand while it contracts. The GRAS loophole survived every prior reform attempt because no administration gave the FDA the staff to do it. Kennedy is now betting a smaller FDA can enforce a bigger mandate on thousands of ingredients.

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