ACI-CRN conference: Megan Olsen’s takeaways

Attending the Legal, Regulatory & Compliance Forum on Dietary Supplements, co-hosted by the American Conference Institute (ACI) and my employer, the Council for Responsible Nutrition (CRN), has always been an immensely valuable experience. And this year — our 12^th year of co-hosting and the 30^th anniversary of the Dietary Supplement Health and Education Act of 1994 (DSHEA) — was no different.

In my opening remarks, I emphasized the resilience and adaptability of our industry in the face of unprecedented challenges over the past few years. But I also spoke of the tremendous opportunities ahead, especially when you consider that we still enjoy robust consumer support for dietary supplements, with nearly 75 percent of Americans having used them and over half of U.S. adults being regular users.

This strong consumer base reinforces the importance of our work in ensuring access to safe and beneficial products. Coupled with the fact that supplement use can translate into billions of dollars of savings on the health care system, attendees of this year’s event kicked off the conference with a sense of shared purpose and a collective sentiment that the work we do truly matters.

Another key point I addressed was the ongoing evolution of DSHEA, enacted three decades ago. And while we have made great strides in those three decades, I also discussed the need for continued dialogue over how to best align supplement oversight with the current complexities of the dietary supplement marketplace. This includes enhancing FDA’s ability to oversee the market, improving transparency, and increasing resources for enforcement against non-compliant actors. The implications of state-level regulations, such as the new legislation in New York age-restricting access for weight-loss and certain sports nutrition supplements, were also highlighted, showcasing CRN’s commitment to protecting consumer access and industry rights through ongoing litigation efforts.

If nothing else, tumultuous times bring people together. And one of the positive aspects of this year's conference, for me, was the significant number of attendees that were able to join us in New York City. The event attracted a diverse group of professionals, ranging from legal and regulatory experts to scientists, which facilitated rich discussions and networking opportunities. The presence of many new faces highlighted the industry's ongoing evolution and the increasing importance of staying informed about regulatory changes.

The conference always aims to cover a wide range of regulatory, legal and policy issues affecting supplements. Pre-conference workshops focused on cGMP (current good manufacturing practices) compliance and social media claims substantiation. FDA's reorganization was discussed, and its impact on the industry. Industry leaders addressed challenges such as class action litigation, ingredient overages and health claims substantiation. The conference also featured critical insights into FTC guidance, retailer requirements, and the use of AI in dietary supplement advertising.

As I mentioned, the state-level regulatory challenges also took center stage, particularly the new legislation in New York imposing restrictions on supplement sales and similar legislation pending in a number of states. We heard concerns from panelists about the possibility that a patchwork of state regulations could emerge and that challenges shipping supplements in New York under the age-restriction requirements limit consumers access to these products.

These state-level concerns above highlight the need to ensure a robust federal framework for supplement regulations. We are seeing a number of consumer protection issues, from state privacy laws to state food additive legislation. When states perceive a gap in federal oversight, many of them enact their own legislation creating a tricky regulatory environment for compliance.

Hearing from regulators — including representatives from FDA, FTC and DOJ — provided invaluable insights into how enforcement priorities are shaping our industry. The sessions revealed, for example, the regulators' desire for more precise laws to facilitate easier enforcement, which can help guide future conversations about enforcement efforts.

We also heard FDA’s position recognizing complexities with interpreting the drug-preclusion clause in DSHEA and signaling the agency remained open to discussions over how best to balance drug and supplement interests with the intent of the statutory language. Such remarks may have foreshadowed the unified agenda announcement a week later that FDA intends to engage in a rulemaking under the drug-preclusion section. This would represent the first such rulemaking ever undertaken using this authority. 

A recurring theme throughout the conference was the importance of collaboration within the industry. Bringing together legal experts, regulatory professionals and scientists created a comprehensive dialogue that addressed both theoretical and practical aspects of compliance. This multi-disciplinary approach ensures we are not only aware of regulatory requirements but also understand how to implement them effectively within our businesses.

Panels discussed topics such as: clinical research practices; claim substantiation considerations; emerging inspection issues; threats posed by product contamination; social media and consumer review practices; use of AI in marketing and other potential business applications. Panel discussions also flagged best practices for compliance, as well as new threats on the horizon.

Further, no dietary supplement legal conference would be complete without a discussion of class action challenges. Panelists provided a comprehensive overview of the class action landscape, highlighting how class actions evolve in response to court precedent limiting certain lines of attack. Over the two-day conference, a common theme is the need to monitor regulatory actions, guidance, and other challenger positions to help spot emerging threats.

Personally, I was delighted to see the level of engagement from attendees. The questions posed during sessions and the discussions that continued outside the conference rooms demonstrated a deep commitment to understanding and navigating the regulatory landscape. The conference succeeded in providing clarity on many issues, though it also highlighted areas where the industry still seeks consensus and clearer guidance from regulators.

Like past years, ACI 2024 was a testament to the dynamic nature of the dietary supplement industry and the critical importance of staying informed and engaged. The knowledge shared and the connections made during these two days are invaluable. Personally, I learn something new every year. Making this environment for learning and growth possible is one reason why CRN is proud to co-host such a significant event and remains committed to supporting our members and the broader industry through education, advocacy and collaboration.

Thank you to all who attended and contributed to making this conference a resounding success. Let us continue to work together to advance our industry and uphold the highest standards of regulatory compliance. And it’s never too early to start planning for next year. We will meet again for next year’s conference in New York City from June 24 to June 26 and hope you can make it.