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Kennedy asks FDA to revise 'self-affirm' rule for food ingredient safety
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Kennedy asks FDA to revise 'self-affirm' rule for food ingredient safety
Mar 10, 2025 6:06 PM

March 10 (Reuters) - U.S. Secretary of Health and Human Services Robert F. Kennedy Jr.

on Monday directed the Food and Drug Administration to revise safety rules to help eliminate a

provision that allows companies to self-affirm that food ingredients are safe.

This would increase transparency for consumers as well as the FDA's oversight of food

ingredients considered to be safe, Kennedy said.

"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," he said in a statement.

Kennedy has promised to address an epidemic of chronic illness with President Donald Trump's

backing, but his broad agenda from making food healthier to studying vaccines could clash with

government spending cuts.

Currently, the FDA strongly encourages manufacturers to submit notices under a rule known as

Substances Generally Recognized as Safe, but they can also self-affirm the use of a substance

without notifying the FDA.

Eliminating this pathway would make it mandatory for companies that want to introduce new

ingredients in foods to publicly notify the FDA of their intended use and submit underlying

safety data, the HHS said.

The FDA maintains a public inventory where all notices, supporting data and response letters

are available for review.

The Consumer Brands Association, which represents companies such as Coca-Cola and WK

Kellogg, said that they "look forward to continued engagement with the secretary and the

qualified experts within HHS to support public health, build consumer trust and promote consumer

choice."

PepsiCo ( PEP ), General Mills ( GIS ), Kraft Heinz ( KHC ), Hershey, Mondelez ( MDLZ )

and Kellanova ( K ) did not immediately respond to Reuters' requests for comment.

A few months ago, the FDA had set in motion a restructuring of its food division to increase

oversight of food supply and agricultural products under the former commissioner Robert Califf.

In January, it proposed that food companies display nutrition labels on the front of the

packages.

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