The Food and Drug Administration faces major legal and policy hurdles in its proposal to make Generally Recognized as Safe (GRAS) notifications mandatory, according to Todd Harrison, partner and co-chair of the FDA group at Venable LLP. While the shift could significantly reshape the food, beverage, and dietary supplement sectors if it survives judicial scrutiny, the agency lacks an explicit statutory requirement under the Federal Food, Drug, and Cosmetic Act for companies to file notifications rather than simply making internal safety determinations.
Legal Vulnerabilities and the Loper Bright Precedent
Under the existing statutory framework, the law mandates that substances be treated as food additives unless they qualify as GRAS. However, Harrison noted that the statute does not explicitly state “unless you’re GRAS and you file a notification,” creating a fundamental legal vulnerability for the agency’s new approach. The FDA previously maintained that it lacked the statutory authority to mandate these submissions, meaning the agency must now build a much stronger rationale for changing its position.
That vulnerability is further heightened by the Supreme Court’s 2024 Loper Bright decision, which ended Chevron deference and requires federal courts to independently determine the best interpretation of a statute without deferring to agency expertise. “I think they’re going to have a hard time in court,” Harrison said regarding the proposal’s survival odds.
Pro Tip: Companies operating in the functional food and dietary supplement spaces should audit their current ingredient safety documentation and closely monitor regulatory updates to prepare for potential shifts in compliance standards.
Impact on the Functional Beverage and Ingredient Supplier Markets
If the mandatory notification framework withstands legal challenges, it could exert an outsized impact on ingredient suppliers and the rapidly growing functional food and beverage market. Dietary ingredients are appearing with increasing frequency in everyday consumer packaged goods, raising the stakes for regulatory compliance.
“If it was [to withstand] judicial scrutiny, it may very well end the functional beverage space,” Harrison warned, pointing to the severe commercial disruption the rule could trigger.
A central anxiety for businesses is the lack of a clear remedy or final agency decision when the FDA disagrees with a company’s self-affirmed GRAS determination after submission. This leaves commercial entities exposed to market consequences and reputational harm even in the absence of formal enforcement actions by the agency.
Resource Constraints and Alternative Regulatory Approaches
Beyond statutory authority, critics question whether the FDA possesses the internal resources required to review the massive volume of botanical extracts and novel ingredients that would flood the system under a mandatory notification mandate.
As an alternative, Harrison suggested that the agency establish a comprehensive database requiring companies simply to identify the specific ingredients active in the commercial food supply. Such a registry would allow the FDA to direct its limited oversight resources precisely toward genuine safety concerns rather than administrative intake.
Did you know?
Frequently Asked Questions
What is a GRAS determination?
Why is the FDA proposing mandatory GRAS notifications?
The agency aims to increase transparency and oversight regarding novel ingredients entering the food and supplement supply, though legal experts question whether the current statute grants them the authority to make submissions compulsory.
How did the Loper Bright Supreme Court ruling impact this proposal?
The 2024 Loper Bright decision ended Chevron deference, meaning courts no longer defer to federal agencies when interpreting ambiguous statutes. This gives regulated industries a stronger footing to challenge agency overreach in court.
To hear an in-depth discussion on the FDA’s proposed GRAS changes, associated legal hurdles, and the implications for supplement manufacturers, listen to the NutraCast podcast on Apple, iHeart, Spotify, or your preferred platform.
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