The U.S. Food and Drug Administration (FDA) convened a pivotal public meeting on March 27, signaling a critical juncture in the ongoing dialogue surrounding the definition and regulation of dietary supplements. As the industry witnesses an unprecedented surge in novel ingredients and sophisticated manufacturing techniques, stakeholders from across the spectrum converged to present their perspectives on the adequacy of existing regulatory frameworks. The central focus of the day-long discussion revolved around the interpretation and potential expansion of the Dietary Supplement Health and Education Act of 1994 (DSHEA), particularly its foundational definition of a dietary supplement as "a dietary substance for use by man to supplement the diet by increasing the total dietary intake."
The urgency for this re-evaluation stems from the rapid pace of innovation within the dietary supplement sector. Over the past three decades since DSHEA’s enactment, scientific advancements have unlocked the potential of a vast array of compounds previously not associated with traditional food sources. This has led to a growing divergence between the letter of the law and the realities of modern product development, prompting calls for a more adaptable and forward-looking regulatory approach. The FDA’s initiative to solicit public comment, which remains open until April 27 under docket FDA-2026-N-2047, underscores the agency’s recognition of the need to engage with industry, consumer advocates, and scientific experts to chart a path forward.
FDA Sets the Stage: Adapting to Innovation While Ensuring Safety
Opening remarks from senior FDA officials set a clear tone for the day’s proceedings, emphasizing the agency’s commitment to fostering innovation while upholding its mandate to protect public health. Cara Welch, Ph.D., director of the Office of Dietary Supplements Programs (ODSP), provided an overview of the current regulatory landscape, reiterating the established definitions of "dietary supplement" and "dietary substance." She astutely pointed out that mere use as a dietary supplement does not automatically confer the status of a "dietary substance" under existing interpretations, highlighting a key area of ambiguity that the agency is seeking to clarify.
Dr. Welch framed the central question for the public meeting: how should the definition of a dietary supplement be adapted to encompass the innovations emerging from the industry? She underscored the delicate balance the FDA must strike between ensuring robust safety oversight for all products and removing unnecessary barriers that could stifle the development of beneficial new ingredients. "We must ensure robust safety oversight and remove unnecessary barriers to innovation," Dr. Welch stated, encapsulating the dual imperatives guiding the FDA’s deliberations.
Kyle Diamantas, deputy commissioner for Human Foods at the FDA, echoed this sentiment, stressing the need for the agency to be "nimble and adaptable" in its response to the dynamic evolution of the supplement industry. His overarching objective, he articulated, is to "ensure a safe and thriving dietary supplement marketplace for all." This statement suggests a proactive stance from the FDA, indicating a willingness to explore regulatory adjustments that can accommodate advancements without compromising consumer safety.
Industry Voices: Expanding Definitions and Enhancing Trust
The overwhelming consensus among most speakers at the public hearing leaned towards expanding the definition of "dietary supplement" to include substances not traditionally found in the food supply. This perspective was championed by representatives of various industry associations, who argued that a more inclusive definition is essential to capture the full spectrum of beneficial compounds now available. Loren Israelsen, President of the United Natural Products Alliance (UNPA), articulated this position succinctly, stating, "Our job now in comments is to make the case (for expanding the definition)."
Daniel Fabricant, Ph.D., president and CEO of the Natural Products Association (NPA), presented a robust defense of DSHEA, asserting that the existing framework "works and works incredibly well." He argued that DSHEA is "not fundamentally broken" and advocated for "definitional flexibility" alongside greater clarity on the drug preclusion clause. Fabricant highlighted the challenges in defining ingredients like live probiotics and microbials, noting that their pathways to market are not always clear despite their presence in fermented foods or their origin from human sources. He offered the example of beneficial bacteria isolated from human milk, which are often sold as dietary supplements but are not purchased at a grocery store, to illustrate the need for flexibility beyond traditional food sources. Fabricant’s core argument centered on the principle that innovation should not be impeded and that the focus should be on leveraging existing authorities and fostering industry support. "Advancing ingredients to promote health and wellness doesn’t make a dietary ingredient a drug," he asserted, pushing back against potential misinterpretations of new ingredients as pharmaceuticals.
Conversely, representatives from consumer advocacy groups expressed more cautious views, prioritizing stringent safety regulations and consumer trust. Jensen Jose, senior regulatory counsel at the Center for Science in the Public Interest (CSPI), voiced concerns about the sheer volume of supplement products on the market – estimated at over 90,000 – arguing that this scale makes effective FDA regulation exceedingly difficult. Jose advocated for a more constrained definition of dietary supplements, limiting them to substances commonly found in food and drink. He posed a critical question: "If the definition can include substances outside the diet, what was the purpose of having it tied to diet in the first place?" This point sparked a lively debate, with audience members questioning whether compounds found in breast milk, for instance, should be considered outside the scope of dietary supplements. Jose also emphasized the widespread consumer misconception that dietary supplements are regulated with the same rigor as prescription drugs, stating, "Consumers cannot trust supplements in the way they trust drugs." Consequently, he urged that the primary objective should be to "build consumer trust in FDA oversight."
The Cutting Edge of Manufacturing: Plant Cell Culture and Precision Fermentation
Beyond the definitional debate, panels also delved into the implications of advanced manufacturing techniques that are reshaping the production of dietary supplement ingredients. Innovations such as plant cell culture and precision fermentation are yielding high-purity compounds with consistent profiles, raising questions about their classification within the current regulatory paradigm.
Wesley Glenn, Ph.D., vice president of innovation at Ayana Bio, elaborated on the variability inherent in traditional botanical sourcing. Factors like growing conditions and cultivation methods can lead to significant differences in the composition and concentration of active components in plants like ginseng and saffron. Plant cell cultivation, he explained, offers optimized conditions to ensure consistent concentrations of key active components. Glenn stressed that the method of origin does not inherently dictate safety or novelty, stating, "Just because it’s grown in the ground doesn’t mean it’s safe. Just because it’s grown in a tank doesn’t mean the phytocomplex is novel." This highlights the need for safety assessments to be ingredient-specific, regardless of whether the component is derived from traditional agriculture or advanced biotechnology.
Duffy MacKay, senior vice president of dietary supplements for the Consumer Healthcare Products Association (CHPA), also underscored the importance of the flexibility afforded by DSHEA. He cited tartaric acid as an example, where synthetically produced tartaric acid posed no new safety concerns compared to the naturally occurring byproduct of winemaking. MacKay further pointed to the acceptance of New Dietary Ingredient (NDI) notifications for synthetic zeaxanthin and hydroxycitric acid without objection, emphasizing the necessity for NDI guidance that accommodates bioidentical compounds. "Manufacturing methods inform safety assessment but do not preclude evaluation as NDI," MacKay asserted, advocating for the evaluation of NDIs irrespective of their manufacturing process or prior presence in the diet.
Anthony Pavel, a partner at Keller and Heckman, concurred with this perspective, posing the rhetorical question, "Should the manufacturing method matter? No, as long as the appropriate evaluation has been done on that ingredient and manufacturing method." The discussion extended to precision fermentation, a technique employed for producing bioactive compounds and proteins, which may not neatly fit within existing regulatory frameworks for dietary substances.
Probiotics: A Case Study in Regulatory Ambiguity
Probiotics emerged as a particularly prominent topic, dominating discussions during a panel that also addressed proteins and enzymes – categories that are not explicitly defined as dietary supplements under current regulations. Amy Smith, senior director of medical affairs at Kerry North America and president of the International Probiotics Association (IPA), explained that the recent emergence of probiotics, with clear definitions only established in 2001, contributes to their ambiguous status. "The FDA’s current interpretation of a dietary substance includes only intentional constituents of food," Smith stated, suggesting that the focus on "intentional constituents" might exclude many beneficial microorganisms.
Smith advocated for the validation of probiotics at the strain level, drawing an analogy to the distinct characteristics of different dog breeds to illustrate the importance of specificity. Andrea Wong, Ph.D., senior vice president and chief science officer at the Council for Responsible Nutrition (CRN), echoed the call for strain-specific safety establishment. She argued that "A more inclusive approach to NDI notification and removing barriers to innovation will give the FDA more oversight," suggesting that a clearer regulatory pathway would enhance the agency’s ability to monitor and ensure the safety of these products.
Public Comments: A Clear Mandate for Clarity and Expansion
The closing public comments reinforced a prevailing sentiment among many stakeholders: the urgent need to clarify and expand the definition of "dietary ingredient" to encompass a broader range of substances not currently found in the conventional food supply. Megan Olsen, senior vice president and general counsel for CRN, argued that the current definition does not mandate an ingredient’s presence in the food supply and should remain flexible as long as the substance serves to supplement the diet. "I want to urge the FDA to align its interpretation of dietary supplements with its plain language and its legislative history," Olsen implored. "Doing so will support both regulatory clarity and the continued safety and innovation of these dietary supplements on the marketplace."
Graham Rigby, president and CEO of the American Herbal Products Association (AHPA), emphasized the critical link between innovation, industry evolution, and inclusive definitions. "Dietary ingredient innovation enhances consumer choice and addresses the evolving health needs of American consumers," Rigby stated. "Regulatory definitions of identity should be driven by substantive safety concerns." This viewpoint suggests that regulatory frameworks should adapt to scientific advancements and market demands, with safety being the paramount criterion for inclusion.
Ivan Wasserman, managing partner of Amin Wasserman Gurnani, characterized the current situation as an "issue of statutory interpretation," asserting that under existing laws, dietary substances are not required to be present in the food supply. He also highlighted the intentionality behind the legislative choice of the word "dietary" over "nutritional," a nuance that Lon Israelsen, who participated in DSHEA negotiations, confirmed.
The overarching message from the public meeting is a clear call for the FDA to modernize its regulatory approach to dietary supplements. The agency is actively seeking ways to balance the imperative of public safety with the need to support innovation and reduce regulatory burdens. As the comment period draws to a close, the industry and consumer advocates alike await the FDA’s next steps, hopeful that the agency will translate the discussions and submissions into concrete regulatory actions that foster a safer, more innovative, and trustworthy dietary supplement marketplace. The implications of these decisions will resonate throughout the industry, impacting product development, consumer access, and the overall landscape of health and wellness products available to the public.