GRAS no more? Kennedy moves to end self-affirmed food additives

Health and Human Services Secretary Robert F. Kennedy Jr. took aim at a long-criticized food safety loophole on March 10, directing the Food and Drug Administration to explore rulemaking that would end companies’ ability to “self-affirm” ingredients as safe without oversight.

The move, part of Kennedy’s “Make America Healthy Again” (MAHA) mission, promises “radical transparency” for consumers — but faces a steep climb against industry resistance and agency limits.

Kennedy’s order targets the FDA’s Substances Generally Recognized as Safe (GRAS) rule, which lets manufacturers deem ingredients safe by using internal data, often skipping FDA notification.

“For far too long, ingredient manufacturers and sponsors have exploited a loophole that has allowed new ingredients and chemicals, often with unknown safety data, to be introduced into the U.S. food supply without notification to the FDA or the public,” Kennedy said in a March 10 HHS news release. Closing it, he argued, will “help get our nation’s food supply back on track.”

A 2013 Pew Charitable Trusts study estimated 3,000 GRAS substances have evaded FDA review, a figure cited in The Guardian’s 2024 additive coverage and likely fueling Kennedy’s push. Currently, the FDA encourages voluntary GRAS notices — handling about 75 annually and publishing more than 1,000 since the program began, according to the HHS news release. But self-affirmation keeps many ingredients off the agency’s radar, with no public disclosure required. The new regulation would mandate companies notify the FDA with safety data before market entry.

The Consumer Brands Association, representing firms like PepsiCo, met with Kennedy Monday and signaled wariness.

“We look forward to continued engagement,” the group told Reuters, echoing 2024 U.S. News reports of trade groups defending GRAS as efficient. Mandatory reviews, they warn, could slow innovation — a tension Kennedy dismissed in his Fox News-reported industry talks.

The FDA’s plate is already full. Acting Commissioner Sara Brenner pledged to “further safeguard the food supply” in the HHS release, but with a food budget near $1 billion — tiny against the $2 trillion industry — enforcement doubts linger, as described in TIME’s 2024 analysis. HHS also vowed to push Congress for legislation to seal the loophole permanently, hinting rulemaking alone might not suffice.

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