The FDA’s proposal to make GRAS (Generally Recognized As Safe) notifications mandatory could have major implications for the food, beverage, and dietary supplement sectors. Todd Harrison from Venable LLP emphasized that while the initiative could be significant if it withstands legal scrutiny, the FD&C Act does not clearly mandate such notifications. He raised concerns about the FDA’s shifting stance on this issue and questioned the adequacy of the agency’s justification for the change.
Harrison warned that this regulation could disproportionately affect ingredient suppliers, particularly in the burgeoning functional food and beverage market. He highlighted uncertainties regarding the FDA’s response if it disagrees with a company’s GRAS determination after a notification is submitted, which could expose businesses to commercial risks.
Moreover, he doubted the FDA’s capacity to accommodate the potential influx of ingredient reviews suggested by the proposal and recommended instead a database for companies to list ingredients, thus allowing the agency to concentrate on genuine safety concerns.
This legal vulnerability is further compounded by recent court decisions, such as the Supreme Court’s 2024 Loper Bright ruling, which could challenge the FDA’s ability to enforce such mandates effectively. Harrison expressed skepticism about the FDA’s chances in court regarding this proposal.
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