While the industry has spent years bracing for and fending off a heavier regulatory hand, what it heard instead from Cara Welch, PhD, director of the Office of Dietary Supplement Programs (ODSP) at FDA, was something more nuanced: not a call for regulation for regulation’s sake but making the case for smarter oversight modernization that reflects how dramatically the market has changed.
“I would like to talk this morning about the relationship between FDA and the dietary supplement community and specifically how that partnership is the cornerstone of our shared mission to ensure that the American people have access to a marketplace of safe, high quality dietary supplements they can trust,” she told stakeholders gathered at the United States Pharmacopeia facility in Rockville, MD on May 14.
“This mission is more critical now than ever, and it is a mission that we can only accomplish together. Across the federal government, we are witnessing a determined shift in how we think about food, nutrition and public health. It’s not a minor adjustment; it is a paradigm shift.”
‘Empowerment without protection is incomplete’
FDA messaging increasingly reinforces the Make America Healthy Again agenda, shifting from a reactive posture toward a more proactive strategy focused on promoting empowered wellness.
“That mission aligns directly with where the federal government is headed, but empowerment without protection is incomplete,” Dr. Welch said. “A marketplace that supports consumer wellness must be one where products are safe, where labels are truthful and where health claims are substantiated by credible evidence.”
In this context, empowering consumers does not embolden free-range consumption in a marketplace of unbridled innovation and commercialization but rather informed use of the well-characterized, health-promoting, self-care products codified and regulated by the Dietary Supplement Health and Education Act (DSHEA) of 1994.
This includes clarifying the scope of dietary substances to reconcile the definitions in DSHEA with modern biotechnology and manufacturing methods developed decades later to determine whether ingredients made through novel production methods still qualify as both safe and lawful.
“We want to foster responsible innovation and ensure that our application of the law accommodates scientific progress where possible, but we need to do this all while keeping consumer safety paramount,” Dr. Welch said, adding that the agency is weighing risks and benefits of new methods as well as the identity attributes of ingredients like proteins, enzymes and microbials that are not listed as dietary ingredients in the governing statute.
She also highlighted that DSHEA assigns real regulatory responsibilities and boundaries to ensure that “consumers are able to distinguish legitimate wellness support from fraudulent or potentially dangerous products.”
“It’s our job at the FDA to operate effectively within that framework, working with all the tools available to us to ensure that we can do this work well,” she said. “The two goals before us, empowering consumers and protecting the public, are not in conflict. They are two sides of the same coin.”
As such, FDA is prioritizing modernization of its oversight strategy, with an emphasis on regulatory, communication and policy initiatives that strengthen safety, product integrity and informed decision-making within existing authority.
Key areas of focus: promoting compliance with existing regulations, reducing duplicative requirements, investigating the use of artificial intelligence and third-party audit data to strengthen inspection coverage, streamlining the review process for new dietary ingredient notifications and improving communication of agency priorities to stakeholders.
Kyle Diamantas, recently elevated to acting commissioner of the FDA, noted in April that the agency is having to think outside the box as part of this effort to keep pace with a dietary supplement market that has grown dramatically in scale, scope and complexity in the last 30 years while also directing constrained resources toward the highest risk areas.
“How do you get over some of that groupthink that might exist on certain issues or certain topics?” he asked. “I think we’re taking a fresh look to better understand how we can better serve the constituents here, how we can better protect consumers, how we can ensure food safety. That’s been a challenge, and I would just say what’s made it easier is that health, wellness, nutrition, food policy is having a bit of a moment.”
Moringa, yellow oleander and gummies, oh my
Dr. Welch highlighted some of these higher risks, most recently surfaced in several multistate outbreaks of extensively drug-resistant Salmonella linked to contaminated moringa leaf powder used in dietary supplements. This contamination resulted in 97 reported cases and 26 hospitalizations from November 2025 through February 2026, with two additional cases detected in Minnesota in April.
While the Center for Disease Control officially closed the investigation in March, the seriousness of the outbreak has prompted FDA to issue a call for stakeholder input on developing effective kill steps for agricultural commodities like moringa that can be implemented without compromising the integrity of the raw botanical.
“Thanks to the hard work of FDA, CDC, state and local partners, and the cooperation of the firms involved, the specific outbreaks are closed out, but our work is not over, and we are turning now to the root cause analysis and prevention,” Dr. Welch said. “We need to understand how this happened and what we can do to stop it from happening again.”
That work entails identifying botanicals that may pose similar risks within their supply chains or processing methods, while ensuring that appropriate test methods are available to detect this kind of contamination in complex botanical mixtures.
Dr. Welch also referred to the FDA’s investigation of dietary supplements contaminated with highly toxic yellow oleander as an example of successful stakeholder collaboration among government agencies, healthcare providers, laboratories, businesses, online retailers and consumers to identify the danger, warn the public and remove unsafe products from the market.
“The collective work was integral in the, unfortunately, ongoing efforts to identify unsafe products,” she said. “It helped us get an understanding of the scope of the contamination and the support to take action to protect consumers.”
FDA maintains a safety alert list for products containing yellow oleander and continues to identify and test suspect products as part of its surveillance efforts.
The agency is also closely monitoring gummy supplements, a product format that has surged in popularity over the last decade but has raised formulation, manufacturing and analytical testing challenges that continue to draw regulatory attention. FDA engagement in 2024 highlighted issues including dose uniformity, stability of active ingredients and the need for validated analytical methods capable of detecting contaminants and verifying composition in complex gummy matrices.
During her presentation to the consortium, Siobhan Gallagher Taylor, a national expert on dietary supplements at the FDA, outlined a range of quality and safety concerns observed during gummy manufacturing inspections such as contamination with extraneous materials like lab coat fibers and Teflon shavings, uncontrolled overages that may pose health risks, uneven mixing that can compromise product efficacy, and manufacturing processes that fail to consistently meet finished product specifications or ensure adequate shelf stability.
Self-regulation and ‘a fully staffed expert FDA’
The Rockville meeting also aired a previous call communicated last September at the SoCal Dietary Supplement Consortium’s West Coast meeting for enhanced industry self-regulation to comply with Current Good Manufacturing Practices (CGMPs).
Codified in 2007, federal regulation 21 CFR Part 111 and its preamble detail everything from specifications and testing requirements to supplier qualification and production control to ensure that supplements are properly manufactured, consistently produced, accurately labeled and free from contamination.
“The dietary supplement marketplace benefits when we combine the FDA’s regulatory authority with your self-regulatory initiatives and your on-the-ground knowledge,” Dr. Welch said. “Whether that’s developing and publishing new analytical methods to identify adulterants, establishing industry-wide best practices or publicly calling out problematic or fraudulent practices, your contributions are essential.”
In his comments during the closing expert panel, Graham Rigby, president and CEO of the American Herbal Products Association (AHPA) underscored the importance of safeguarding the detailed expertise required of regulators on the other side of the coin, noting that “a fully staffed expert FDA is the best way to ensure consumer safety and innovation going forward. It’s not an either or, it’s both.”
“This is a growing, incredibly important category that people rely on for self-care, and we need the regulatory agency to be staffed with folks who have the same passion and detailed experience with which to deploy it and are keeping up with the differing challenges that you have heard,” he said. “And what I really appreciate about this forum is that it allows you to see that expertise firsthand, both on the stage, in the questions, in the networking times, it’s probably the most accessible the agency is at any event.”
