The Department of Health and Human Services announced the policy Monday, framing it as an effort to catalog substances that entered the market through the “generally recognized as safe,” or GRAS, pathway. Under the new rule, manufacturers adding a new substance to human or animal food must notify the FDA and explain how they concluded it was safe. Companies with GRAS additives already on shelves must also come forward, disclosing how each additive is used.
How the GRAS loophole grew
The GRAS designation dates to 1958, when Congress exempted common ingredients like vinegar and salt from full FDA review. Over time, food companies exploited that exemption to self-certify novel chemicals — from emulsifiers to preservatives — without telling regulators. A 2013 policy shift formalized a voluntary notification system, but participation was optional, and most manufacturers skipped it.
Public health researchers have estimated that more than 10,000 chemicals are allowed in U.S. food, with the FDA lacking data on a large share of them. Advocacy groups including the Center for Science in the Public Interest and the Environmental Working Group have pressed successive administrations to force disclosure, arguing the public has a right to know what it is eating.
What the new rule requires
Going forward, any company seeking to add a substance to food must submit a notice to the FDA describing how it determined the additive was GRAS. For additives already on the market, manufacturers must report how the substance is used and at what levels. That information will be compiled into a public database, giving consumers, researchers, and state regulators a window into the food supply they have never had.
Notably, the rule stops short of requiring companies to prove existing additives are safe. Advocates had pushed for a mandatory safety re-review of chemicals already in circulation, particularly those linked in some studies to metabolic disruption, endocrine effects, or behavioral concerns. HHS officials did not commit to that step Monday
— Aisha Mensah, health desk, AXO News