What’s the Latest on FDA GRAS in the United States?

Brian Sylvester authored an article, “What’s the Latest on FDA GRAS in the United States?” published in the ATOVA’s Spring Newsletter on pages 24–25. On March 10, 2025, U.S. Secretary of Health and Human Services (HHS) Robert F. Kennedy, Jr. directed FDA to “take steps to explore potential rulemaking” to eliminate the self-affirmed GRAS pathway. Understandably, this news has triggered significant concern across the food tech ecosystem and across the U.S. food industry. Brian provides information on what has been happening and what the risk is of the GRAS pathway being eliminated. As he states, “There is no immediate reason for companies to panic, as any attempt by FDA to eliminate the self-GRAS pathway would likely take years and require both Congressional action and FDA notice-and-comment rulemaking.”

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