FDA to reconsider GRAS standards and designations

CHICAGO, March 12, 2025 — The U.S. Food and Drug Administration (FDA) is reconsidering its longstanding policy of allowing food manufacturers to add ingredients generally recognized as safe (GRAS) without a cumbersome review process. 
On the same day the FDA was directed to review the practice, U.S. Health and Human Services (HHS) Secretary Robert F. Kennedy reportedly alerted several major food companies that ending the use of artificial dyes in their products will be one of his key priorities. The FDA is part of HHS. 

Both moves are part of a drive Kennedy has dubbed MAHA, or Making America Healthy Again. The unconventional means he’s championed for pursuing that goal made him one of President Donald Trump’s most controversial picks for a cabinet post. 

Tighter controls on ingredient changes could prove a significant complication for some food and beverage manufacturers. The practice of allowing processors to self-designate a new or reformulated product as safe can slash the time needed to get an item to market. The manufacturer essentially self-determines that the new or revised food poses no health danger to the public, usually because the added ingredient is already in widespread use, like vinegar or salt. 

The process has been allowed for decades.

But some manufacturers have abused the policy, extending the GRAS designation to undeserving products for the sake of expediency, according to Kennedy. 

“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,” the former environmental lawyer said in directing the FDA to consider new rules.  “Eliminating this loophole will provide transparency.”  

The secretary’s opposition to the use of artificial dyes in food is well-known. He delivered the warning about eliminating them was delivered to such major food companies as PepsiCo, General Mills and WK Kellogg, according to a story this week in The New York Times.

According to the article, Kennedy said he was willing to work with the manufacturers on developing a removal process but stressed that the dyes would be removed one way or another.

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