This year, many in Congress have been working on bills to reform the Generally Recognized As Safe (GRAS) protocols for food ingredients.
In the past week, this included Sen. Roger Marshall’s Better Food Disclosure Act (The Better FDA), to change the Food and Drug Administration’s oversight of ingredient disclosures and reviews. It would also and require food companies to report the ingredients they put in their products to the agency.
Several other Congressional proposals to reform the alleged GRAS loophole include the Grocery Reform and Safety Act (H.R.4958), the Ensuring Safe and Toxic-Free Foods Act (S.2341), and the Toxic Free Food Act (H.R.9817).
All of this Congressional interest raises the question about where the FDA is on the issue.
In March, Health and Human Services Secretary Robert F. Kennedy Jr. directed the FDA to explore rulemaking that would end companies’ ability to “self-affirm” ingredients as safe without oversight.
As part of Kennedy’s “Make America Healthy Again” (MAHA) mission, he called for “radical transparency” for consumers.
But exploring is about all the FDA is doing this year on its GRAS reform assignment. Actual engagement in rule-making change is not going to happen until at least 2026. The FDA added GRAS to its spring 2026 agenda in mid-September.
Currently, companies self-affirm the safety of the ingredients they use in food and voluntarily share research with the FDA, hoping for a “no questions” letter from the agency affirming their GRAS status.
Under Kennedy, HHS ordered FDA to find a “pathway” to eliminate self-affirmed GRAS status for food and beverage ingredients.
The FDA’s GRAS inventory currently includes more than 1,200 substances. Those would likely all be grandfathered in by a new rule. A 2013 Pew Charitable Trusts study estimated that 3,000 GRAS substances have evaded FDA review,
Currently, the FDA has voluntary GRAS notices — handling about 75 annually and publishing more than 1,000 since the program began, according to HHS. Self-affirmation keeps many ingredients off the agency’s radar, with no public disclosure required.
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