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HHS Secretary Kennedy Directs FDA To Consider Axing Self-Affirmed GRAS ‘Loophole’

 
• By Malcolm Spicer

Eliminating self-affirmation process would require companies to publicly notify FDA of their intended use of ingredients and provide safety data before they’re introduced. Kennedy says the process is “a loophole” for introducing ingredients and chemicals “with unknown safety data.”

(Source: Shutterstock)
Key Takeaways
  • HHS announcement frames the order as part of Kennedy’s “Make America Healthy Again” commitment as enhancing assurances of the safety of food products available to US consumers helps improve public health.
  • FDA regulations also allow dietary ingredients to be used for the first time in supplements after they’re introduced through the GRAS pathway.
  • Supplement industry stakeholders contend self-affirmed GRAS works if the FDA conducts sufficient enforcement.

One of Robert F. Kennedy Jr.’s first decisions as the top US health care official is ordering a look at eliminating the self-affirmed pathway for food ingredients as generally recognized...

The Health and Human Services Department’s 10 March announcement framed the recently confirmed secretary’s order as part of his “Make America Healthy Again” commitment. Enhancing...

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