In the ever-evolving world of dietary supplements, a recent gathering of industry experts in New York City highlighted the critical role of regulatory compliance and risk management. The 14th Annual ACI-CRN Legal, Regulatory, and Compliance Forum brought together lawyers, regulators, and stakeholders to navigate the complex landscape of dietary supplement regulations.
The event, led by Megan Olsen, senior vice president and general counsel at the Council for Responsible Nutrition (CRN), acknowledged the intensifying challenges posed by an increasingly complex regulatory environment. Olsen emphasized the need for businesses to adapt to a mix of federal uncertainties, fast-moving state legislation, and practical compliance demands.
One of the key takeaways from the forum was the importance of staying ahead of the curve when it comes to regulatory changes. Cara Welch, director of the Office of Dietary Supplement Programs (ODSP) at the U.S. Food and Drug Administration (FDA), discussed the agency's strategic priorities, highlighting the need for collaboration between ODSP and industry stakeholders to navigate administrative changes and shifting priorities.
A major focus of the forum was the FDA's efforts to modernize dietary supplement oversight, as outlined in the MAHA agenda. Initiatives discussed included strengthening new dietary ingredient pathways, modernizing safety review practices, and refining regulations to ensure clear public health benefits.
One particularly intriguing aspect was the FDA's exploration of the scope of dietary supplement ingredients. The agency is currently reviewing comments on the legal definition of a dietary substance and its interpretation of this framework. Dr. Welch emphasized the complexity of navigating the intersection of science, policy, and law in this context.
The forum also delved into the impact of the MAHA movement's push to eliminate the Generally Recognized as Safe (GRAS) loophole and the long-awaited new dietary ingredient (NDI) guidance. Bob Durkin, partner and co-chair of the regulatory group at Amin Wasserman Gurnani, highlighted the influence of these developments on businesses' regulatory strategies.
In the face of rapid policy shifts and agency prioritization, supplement and functional food companies are recalibrating their approach to risk. A panel discussion titled "When Business as Usual No Longer Applies" emphasized the need for companies to adapt to a changing operating environment.
Tara Martin, senior vice president and general counsel at Jamieson Wellness, described the current landscape as one of managing uncertainty, not just in terms of substance but also in timing. Jeff Brams, General Counsel & Business Operations at LMNT, offered a brand perspective, focusing on the importance of ingredient sourcing and claims rather than the pace of regulatory activity.
The consensus among panelists was that while volatility and risk are increasing, so too are opportunities for innovation. Companies were encouraged to adopt a proactive approach, incorporating stronger early-stage risk assessment, closer supplier coordination, and a consumer-first mindset.
Key takeaways from the forum included the importance of building regulatory, legal, quality, and commercial reviews into the earliest stages of innovation. Panelists stressed the need for companies to identify risks before product launch, strengthen supplier engagement, and maintain written rationales for key decisions.
In conclusion, the ACI-CRN Legal, Regulatory, and Compliance Forum underscored the critical role of regulatory compliance and risk management in the dietary supplement industry. As the industry navigates an evolving landscape, the insights and strategies shared at the forum will undoubtedly shape the future of supplement innovation and consumer safety.
