FDA Mandates First-Ever Food Additive Disclosure
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- HHS announced Monday a new rule requiring companies adding substances to human or animal foods to notify the FDA and detail how they deemed each additive "generally recognized as safe" (GRAS)
- Manufacturers with GRAS substances already on the market must disclose to the FDA how each additive is used, with that information compiled into a public database for the first time
- The rule stops short of pre-market approval — the goal of Kennedy's MAHA movement — meaning companies still self-certify safety without independent FDA vetting
- Under the proposal, the FDA would complete an initial review of new ingredient notices within 45 days and a substantive review within 180 days
- An unpublished version of the regulation estimates the rule will cost $10.5 million per year on average, with the bulk of compliance costs falling on companies
- Former FDA Commissioner David Kessler told STAT the rule fails to address refined carbohydrates and sweeteners in ultra-processed foods that drive metabolic disease, saying the agency "isn't even tackling what's in the food supply today"
- Alongside the GRAS proposal, HHS and the Department of Agriculture submitted for final review the federal government's first-ever definition of ultra-processed food, based on new dietary guidelines
Why it matters: For decades, companies self-certified additives as GRAS without ever notifying the FDA — the agency literally didn't know what was in the food supply. This rule finally forces disclosure, but Kessler argues it sidesteps the real drivers of chronic disease (refined carbs and sweeteners). With $10.5M/year in compliance costs landing on industry and comment open through early December, this is a transparency starting point, not the GRAS overhaul RFK has demanded.
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