The FDA’s proposal to make GRAS notifications mandatory could have a significant impact on the food, beverage and dietary supplement industries, but the agency faces substantial legal and policy hurdles, according to Todd Harrison, partner and co-chair of the FDA group at Venable LLP.
Harrison said the proposal could be “very significant” if it survives judicial scrutiny, noting that the Federal Food, Drug and Cosmetic Act (FD&C Act) does not explicitly require companies to submit GRAS notifications.
“The law says that you have to, if you’re a food additive, unless you’re GRAS,” Harrison said. “It doesn’t say unless you’re GRAS and you file a notification.”
He questioned why FDA has changed its position after previously stating it lacked the authority to mandate notifications and said the agency would need to provide a stronger rationale for the shift.
Harrison also warned that the proposal could have an outsized impact on ingredient suppliers and the growing functional food and beverage market, where dietary ingredients are increasingly appearing in consumer packaged goods.
“If it was [to withstand] judicial scrutiny, it may very well end the functional beverage space,” he said.
A key concern is what happens when FDA disagrees with a company’s GRAS determination after a notification has been submitted. Harrison argued that the proposal does not provide companies with a clear remedy or final agency decision, potentially leaving businesses exposed to commercial consequences even without formal FDA enforcement.
He also questioned whether FDA has the resources to review the potentially large number of ingredients and botanical extracts that could fall under the proposed system.
Harrison suggested the agency instead create a database requiring companies to identify ingredients being used in the food supply, allowing FDA to focus its resources on potential safety concerns.
The proposal’s legal vulnerability is heightened by the Supreme Court’s 2024 Loper Bright decision, which ended Chevron deference and requires courts to independently determine the best interpretation of a statute.
“I think they’re going to have a hard time in court,” Harrison said.
To hear more on the FDA’s proposed GRAS changes, the legal hurdles facing the agency and what the proposal could mean for the supplement and functional food industries, listen to the NutraCast above or on your preferred podcast platform.
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