FDA Modernization, Regulatory Uncertainty, Evolving Compliance Standards Lead Discussions at Annual CRN Forum

Legal, regulatory, and compliance professionals led discussions last week at the American Conference Institute (ACI) and Council for Responsible Nutrition (CRN) 14th annual Legal, Regulatory, & Compliance Forum on Dietary Supplements.

CRN’s experts led discussions on FDA modernization, interviewing FDA and FTC officials, and providing insights into issues shaping the future of law, regulation, and policy.

Megan Olsen, senior vice president and general counsel at CRN, served as co-chair of the event. She opened the event discussing challenges facing the industry, such as the accelerating pace of federal and state regulatory activity, emphasizing the need for professionals in the regulatory space to collaborate. Carlos Lopez, senior vice president and general counsel for Niagen Bioscience, served as a fellow co-chair.

Andrea Wong, PhD, CRN’s SVP and chief science officer, interviewed Cara Welch, PhD, director of FDA’s Office of Dietary Supplement Programs, covering her perspectives on FDA’s current priorities, how it plans to modernize dietary supplement oversight, and the scientific and regulatory issues she expects will impact the agency’s work in the years ahead.

Specific policy discussions were held around the New Dietary Ingredient Notification (NDIN) process, drug preclusion, Generally Recognized as Safe (GRAS), and other efforts to modernize oversight of the industry. Because each of these domains are anticipated to evolve at once, it was a recurring theme that companies should be proactive in their planning and collaborate more strongly with regulatory and policy experts.

Uncertainty Extends Well Beyond FDA

The patchwork of state laws regulating dietary supplements is becoming more difficult for states to navigate while maintaining compliance with national programs. At the event, CRN provided attendees with an update to its legal challenge against a law enacted in New York restricting the sale of certain dietary supplements to minors, and potential implications for commercial speech and future state laws. Class action litigation related to state laws, and other potential impacts, were also discussed.

The event also covered how AI is changing regulatory compliance, scientific substantiation, post-market surveillance, and risk monitoring. Companies are now using AI to identify emerging issues more quickly and strengthen regulatory decision-making.

Olsen interviewed Christine DeLorme, an attorney in FTC’s Division of Advertising Practices, about advertising compliance and consumer protection priorities, focusing on substantiation, responsible use of testimonials and reviews, and maintaining consumer trust in the digital marketplace.

“The conversations throughout this conference made clear that regulatory engagement and collaboration across the industry have never been more important,” said Olsen. “As the regulatory landscape continues to evolve, opportunities to engage directly with FDA and FTC leaders, hear diverse expert perspectives, and exchange practical experiences help companies make informed decisions while continuing to deliver safe, innovative products that consumers can trust.”