Underwriters Shouldn't Be Reading Lab Reports
Underwriters Shouldn't Be Reading Lab Reports The Manual COA Problem Is Becoming One of the Biggest Compliance Gaps in Regulated Payment...
The dietary supplement industry faces an unexpectedly compressed timeline to respond to proposed changes in the generally recognized as safe (GRAS) pathway, according to insights shared at the United Natural Products Alliance (UNPA) Annual Retreat in Asheville, North Carolina.
The U.S. Food and Drug Administration filed a proposed rule in early September 2025 requiring mandatory submission for all GRAS notices, eliminating the current GRAS affirmation without notice pathway. According to UNPA President Loren Israelsen, the proposed requirements are expected to be published in the Federal Register in October 2025.
The timeline for implementation appears significantly accelerated compared to typical regulatory processes. Israelsen indicated that insights from officials at the Office of Dietary Supplement Programs (ODSP) suggest completion before the midterm elections, potentially by March 2026. Israelsen characterized this as "a new attitude at FDA unlike anything we have ever seen before."
The proposed changes emerge within the broader Make America Healthy Again (MAHA) movement and a new Unified Regulatory Agenda targeting several FDA and USDA rules around foods, supplements and cosmetics. U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr. has been critical of the current GRAS pathway.
Israelsen noted that GRAS reform "arrived late to the MAHA movement but now appears to be an issue that is elevating in importance." The accelerated timeline reflects what Israelsen described as business-as-usual in Washington, D.C. speeding up and becoming more politically charged.
The supplement industry will have a limited window to submit comments on the proposed rule changes. While FDA is strongly encouraging industry input, Israelsen cautioned that competing industry interests require a thoughtful approach to comments.
Israelsen outlined potential risks in industry response strategy. Opposition to the rule could risk litigation and losing support from the White House and HHS, he suggested. "There is no one to blame for a process that took too long and was too expensive," Israelsen stated.
The shift reflects broader issues with dietary ingredient regulatory pathways. "The New Dietary Ingredient system was not working, so companies defaulted to GRAS without notice," Israelsen explained. Industry comments have pointed out that "the GRAS pathway is not a loophole but rather a well-established, science-driven process that has safely served the public for decades."
The question of how industry adapted to regulatory challenges by utilizing the GRAS without notice pathway rather than the NDI system raises questions about the effectiveness of existing regulatory frameworks for bringing new ingredients to market.
Israelsen identified several elements that would need to accompany GRAS reform to maintain functional pathways to market for dietary supplements. These include completing an "old" dietary ingredient 2.0 list and revising the NDI guidance alongside any changes to GRAS.
"GRAS without notice is probably gone," Israelsen stated, "so we must have a more robust ODI List." The availability of alternative pathways could determine whether the supplement industry can continue bringing new ingredients to market efficiently if mandatory GRAS submission requirements are implemented.
The retreat emphasized the importance of determining the White House's view of the supplement industry in both short and long term considerations. How industry stakeholders frame their response to proposed changes may affect not only the specific GRAS rule but also the broader regulatory relationship between supplement manufacturers and federal agencies.
The compressed timeline requires companies to balance multiple considerations: regulatory compliance needs, competitive positioning, litigation risk, and maintaining constructive relationships with regulatory bodies during a period of significant policy change.
As regulatory requirements accelerate and evolve, maintaining comprehensive documentation and compliance systems becomes essential. Qredible's Q-Trust quality management system provides dietary supplement and nutraceutical companies with the tools to adapt quickly to changing regulations while maintaining product quality and safety standards. Schedule a discovery call to learn how our AI-powered compliance monitoring can help your business respond effectively to regulatory changes.
