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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 4:04 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, HHS said.

The FDA maintains a public inventory where all notices,

supporting data, and response letters are available for review.

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.

(Reporting by Bhanvi Satija and Ananya Mariam Rajesh in

Bengaluru; Editing by Arun Koyyur)

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