Lawyers, regulators and industry stakeholders convened at the 14th Annual ACI-CRN Legal, Regulatory and Compliance Forum on Dietary Supplements in New York City last week to compare notes on how to navigate a landscape with few bright-line legal rules while adapting to tariffs, supply chain pressures, evolving requirements, litigation and artificial intelligence.
Megan Olsen, senior vice president and general counsel at the Council for Responsible Nutrition (CRN), opened the forum by acknowledging the intensifying challenges of an increasingly complex mix of federal uncertainly, fast-moving state legislation and practical compliance demands.
“The last couple years have been so fast paced, this year has been no different,” she said. “We know that we are dealing with major challenges, both at the state and federal level.”
In this environment, businesses and their counsels are creating contingency plans and evaluating how much risk they are willing to accept while waiting for guidance and clarity.
The shifting regulatory landscape: What’s new and next
As in previous years, Cara Welch, director of the Office of Dietary Supplement Programs (ODSP) at the U.S. Food and Drug Administration (FDA), joined a keynote fireside chat to discuss her office’s strategic priorities, emphasizing that ODSP staff and its relationship with industry stakeholders have been central to navigating administrative changes, shifting priorities and ongoing regulatory demands.
Throughout the year, she has publicly spoken across industry events about delivering on modernizing dietary supplement oversight as the FDA works to implement the MAHA agenda.
Initiatives discussed include strengthening new dietary ingredient pathways, modernizing safety review practices, using external audit data to improve systems and risk prioritization, and refining regulations that may no longer deliver clear public health benefits.
Front of mind following the March 27 FDA public meeting exploring the scope of dietary supplement ingredients is the concerted effort to reconcile scientific developments with the legal definition of a dietary substance and the agency’s interpretation of that framework to ensure that measured decisions about scope to account for innovation while remaining grounded in statute. The agency is currently reviewing nearly 1,000 comments filed under FDA Docket No. FDA-2026-N-2047 in response to the open consultation.
“This question sits squarely at the intersection of science, policy and the law,” Dr. Welch said. “That intersection is not always straightforward to navigate.”
The scope of that definition also squarely impacts the wait-and-see tied to the MAHA movement’s push to eliminate a stated Generally Recognized as Safe (GRAS) loophole and the long-awaited new dietary ingredient (NDI) guidance—which presented as a major throughline of conference panel discussions in considering the what’s next.
At issue is resolving how a dietary ingredient enters the market once it meets the definition of a dietary ingredient under the Federal Food, Drug, and Cosmetic Act. FDA’s position has generally been that if the substance is an NDI, compliance with the NDI requirements is independent of whether the substance is also GRAS for use in conventional foods.
Here, progress toward issuing New Dietary Ingredient (NDI) guidance is also influencing how businesses assess their regulatory strategies, prompting some to revisit existing self-GRAS dossiers and evaluate whether the NDI pathway might be more appropriate. While the industry may still be waiting for the golden age of dietary supplements, Dr. Welch confirmed that it can expect guidance promised on NDI identity and safety information by end of year, a timeframe reflected in a June 29 update on FDA foods program guidance under development.
“A big aspect of the March 27 meeting was not just the dietary substance clause but identity and manufacturing, so I think what we heard in the public meeting is going to signal what we might see in the final guidance for identity,” said Bob Durkin, partner and co-chair of the regulatory group at Amin Wasserman Gurnani.
“I’m going to be very curious about how that’s written, because it’s hard to write guidance about something that is as varied as dietary ingredients. How specific can you get about what is required of identity when one thing is a live microbial, one is a small molecule, another is a ground-up botanical, something else is a cross-spectrum extract of a botanical […] It’s not your mom and dad’s vitamin C anymore.”
Subsequent discussion emphasized that companies must be able to clearly distinguish their ingredient from similar substances and connect that identity to a credible safety narrative.
Other items on the day-and-a-half program that counsel continues to track: the MAHA agenda, the future of the drug preclusion clause, how changes to “healthy claims” criteria might affect dietary supplements, the proposed Dietary Supplement Listing Act of 2026, DSHEA disclaimer enforcement discretion, shifting tariff regimes, the surge in state laws, the Dietary Supplement Regulatory Uniformity Act, compliance with new packaging and reporting obligations, the ever-present threat of class action lawsuits, consumer reviews, and FTC scrutiny of negative option and subscription practices, health-related and sourcing claims.
Recalibrating risk and opportunity: ‘When business as usual no longer applies’
In the face of rapid policy shifts, agency prioritization, state enforcement activity, consumer scrutiny and social media pressure, businesses are having to rethink how they manage risk.
One panel discussion titled “When Business as Usual No Longer Applies” focused on how supplement and functional food companies are recalibrating their approach to risk, noting that while the laws governing the industry have not substantially changed, the operating environment has.
Here, the pace of new initiatives, incomplete guidance and shifting public narratives have made it harder for companies to make long-term decisions with confidence.
Tara Martin, senior vice president and general counsel at Canadian natural health product manufacturer Jamieson Wellness, described navigating the current landscape as less about any single initiative and more about managing uncertainty—not only in substance but also its timing, and figuring out how to best to adapt to constant change.
“I think we’re all used to operating our businesses in a regulated industry, but we’re used to having laws that we need to abide by, enforcement, changes in enforcement, guidance from the FDA that will make us have to pivot or reexamine some of our practices or how we approach something,” she said. “But it’s the pace that things are coming at us and the lack of clarity that is creating challenges for us as a business.”
Jeff Brams, general counsel & business operations at electrolyte drink mix company LMNT, provided a brand perspective, explaining that he is more concerned with sourcing ingredients to which he can attach claims than about the pace of all the activity.
“I see it as that squirrel that wants to get my attention to the left and to the right, and I have my focus on satisfying my consumer with the best product possible,” he said. “Every year, we hear the same conversations and the same alarm. So, none of that, none of those squirrels are getting my attention.”
What is capturing his attention is the MAHA movement and its focus on ingredient transparency, contaminant testing, preventative health, gold standard science, artificial colors and unnecessary additives, which he said is driving the current industry dynamic and represents a transformative change, alongside the growing trend of delivering dietary supplements as food.
There was broad consensus that companies should expect continuing volatility but also significant potential for innovation, particularly where agility and risk tolerance is adjusted— incorporating stronger early-stage risk assessment, closer supplier coordination, better monitoring tools and a consumer-first approach to product development and communication.
“One thing that I think is important to remember when you are dealing with a lot of risk and trying to analyze challenges is that there’s also an incredible amount of opportunity in our industry,” Martin said. “Some volatility does increase risk initially, but there are ways to handle that, and we shouldn’t just operate from a fear-based point of view.”
Key takeaways
• Build regulatory, legal, quality and commercial review into the earliest stages of innovation. Panelists said companies should identify risks before products, claims or supply chains are locked in, rather than waiting until launch.
• Strengthen supplier engagement. Brands and ingredient suppliers should communicate early and often about ingredient status, safety data, claims support, formulation concerns and potential regulatory pathways.
• Maintain a written rationale for key decisions. Companies should document the basis for product, ingredient and claims decisions so they can explain and defend their approach if questions arise later.
• Monitor more than federal agencies. Companies should track FDA, FTC, HHS, state attorneys general, consumer litigation, international developments and social media because issues can move quickly across channels.
• Use technology to improve risk monitoring. Panelists noted that AI-enabled tools can help monitor online conversations, brand mentions, emerging concerns and market signals more efficiently than traditional watch services.
• Assess functional food products carefully. When supplement ingredients are used in food formats, companies should evaluate whether the ingredient is permitted in food, who may consume it, what claims are being made and whether supplement-specific disclaimers apply.
• Prepare to pivot. Because guidance and enforcement priorities may change quickly, companies should make decisions that are defensible today while remaining flexible enough to adjust in three to six months.
• Keep consumer trust and safety at the center. Panelists urged companies to focus on clear communication, substantiation, product quality and consumer decision-making as the foundation for long-term brand resilience.
