As the dietary supplement industry has evolved to include new ingredients and manufacturing techniques, discussions have proliferated over the role of regulatory framework and existing definitions. Stakeholders from all sides of the debate presented at the March 27 public meeting on the scope of dietary ingredients, hosted by the U.S. Food and Drug Administration (FDA).
Called into question is the existing language of the Dietary Supplement Health and Education Act of 1994 (DSHEA) that defines a dietary supplement as “a dietary substance for use by man to supplement the diet by increasing the total dietary intake.”
Almost all who spoke at the public hearing advocated for expanding the definition of “dietary supplement” to include substances not present in the food supply, while also pressing for clarity and safety.
“Our job now in comments is to make the case (for expanding the definition),” said United Natural Products Alliance (UNPA) President Loren Israelsen.
Public comment regarding the scope of dietary supplements remains open until April 27 under docket FDA-2026-N-2047.
FDA: Regulatory frameworks should evolve with innovation
Opening remarks from key leaders at the FDA set the stage for public discussion on defining dietary supplement ingredients, emphasizing the need for adapting regulatory frameworks as the industry evolves.
Cara Welch, Ph.D., director of the Office of Dietary Supplements Programs (ODSP), reviewed the existing definitions of “dietary supplement” and “dietary substance,” while noting that use as a dietary supplement does not inherently make something a dietary substance.
Laying out the agenda for the day, Welch questioned how the definition of a dietary supplement should be expanded, emphasizing recent industry innovations and the need for safe, efficacious products.
“We must ensure robust safety oversight and remove unnecessary barriers to innovation,” Welch said.
The FDA must be “nimble and adaptable” in response to how the supplement industry has evolved, said Kyle Diamantas, deputy commissioner for Human Foods at FDA.
He stated the primary goal is to “ensure a safe and thriving dietary supplement marketplace for all.”
CSPI favors a limited definition of dietary supplements
“We need to make sure dietary supplements are safe and actually do the thing they claim to do,” said Jensen Jose, senior regulatory counsel at Center for Science in the Public Interest (CSPI).
In his remarks, he highlighted that there are 90,000 supplement products on the market, making the industry too large for the FDA to adequately regulate. He believes the focus should be on making the industry safer instead of allowing more substances into supplements.
The crux of his argument was the belief that dietary substances should be limited to what is commonly found in food and drink.
“If the definition can include substances outside the diet, what was the purpose of having it tied to diet in the first place?” Jose asked.
This sparked fierce discussion during a question period, in which audience members debated whether breastmilk counts as food and compounds in breastmilk should be allowed in dietary supplements.
Jose also cited that many consumers believe dietary supplements are regulated similarly to prescription drugs.
“Consumers cannot trust supplements in the way they trust drugs,” he said.
For this reason, Jose stated the primary goal should be to “build consumer trust in FDA oversight.”
NPA: DSHEA works well as is
Daniel Fabricant, Ph.D., president and CEO of Natural Products Association (NPA), took counterpoint to CSPI’s argument that the definition of “dietary supplement” should be limited, citing the “need for definitional flexibility” along with clarity on the drug preclusion clause.
“DSHEA works and works incredibly well,” Fabricant said. “DSHEA is not fundamentally broken.”
He discussed how DSHEA doesn’t define live probiotics or microbials, and their pathway to market isn’t always clear, yet such ingredients are common in fermented foods or come from human beings.
“We don’t buy breast milk at the grocery store,” Fabricant said, referring to beneficial bacteria isolated from human milk that are often sold as dietary supplements.
Fabricant’s stance stressed that innovation should not be stifled, but rather the focus should be placed on leveraging existing authorities and how the industry can provide support.
“Advancing ingredients to promote health and wellness doesn’t make a dietary ingredient a drug,” Fabricant said.
The implications of innovation in ingredient manufacturing
Subsequent panels focused on new technologies used in the manufacturing of ingredients, such as plant cell culture and precision fermentation, and why modernization is necessary to support the dietary supplement industry.
The composition of botanicals and concentration of active components vary because of growing conditions and cultivation methods, according to Wesley Glenn, Ph.D., vice president of innovation at Ayana Bio. Citing ginseng and saffron as examples of diversity within species, Glenn shared that plant cell cultivation uses optimized conditions to ensure consistent concentrations of key active components.
“Just because it’s grown in the ground doesn’t mean it’s safe,” Glenn said. “Just because it’s grown in a tank doesn’t mean the phytocomplex is novel.”
Duffy MacKay, senior vice president of dietary supplements for the Consumer Healthcare Products Association (CHPA), also stressed the importance of flexibility provided by DSHEA. He cited tartaric acid as an example, stating that no new safety concerns arose for synthetically produced tartaric acid versus the byproduct of winemaking.
He also pointed out that new dietary ingredient (NDI) notifications for synthetic zeaxanthin and hydroxycitric acid were accepted without objection, stressing the need for NDI guidance to allow bioidentical compounds.
“Manufacturing methods inform safety assessment but do not preclude evaluation as NDI,” MacKay said. He stated NDIs should be evaluated regardless of manufacturing process or presence in the diet.
Anthony Pavel, partner at Keller and Heckman, agreed with this sentiment.
“Should the manufacturing method matter?” Pavel asked. “No, as long as the appropriate evaluation has been done on that ingredient and manufacturing method.”
Precision fermentation, whether for producing bioactive compounds or proteins, also was discussed as a new manufacturing method that might not necessarily be included in current regulatory frameworks for dietary substances.
The precarious position of probiotics
Probiotics were a popular topic at the public meeting, dominating discussion during a panel that also covered proteins and enzymes, none of which are clearly established as dietary supplements under current definitions.
This could be because of the recent emergence of probiotics, which were not clearly defined until 2001, according to Amy Smith, senior director of medical affairs at Kerry North America and president of the International Probiotics Association (IPA).
“The FDA’s current interpretation of a dietary substance includes only intentional constituents of food,” Smith said.
Probiotics are defined by genus, species and strain of the microbe. Smith advocated validating probiotics at the strain level, comparing them by analogy to different dog breeds.
Andrea Wong, Ph.D., senior vice president and chief science officer at the Council for Responsible Nutrition (CRN), also stressed this method of establishing safety.
“A more inclusive approach to NDI notification and removing barriers to innovation will give the FDA more oversight,” Wong said.
Public comments support expanding and clarifying ‘dietary supplement’ definition
Public comments closing the session largely focused on the need to clarify and expand the definition of “dietary ingredient,” allowing for more ingredients not currently in the food supply.
Megan Olsen, senior vice president and general counsel for CRN, said the current definition does not mandate that an ingredient must be present in the food supply and it should remain flexible as long as the substance supplements the diet.
“I want to urge the FDA to align its interpretation of dietary supplements with its plain language and its legislative history,” Olsen said. “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 importance of innovation and industry evolution while supporting inclusive definitions.
“Dietary ingredient innovation enhances consumer choice and addresses the evolving health needs of American consumers,” Rigby said. “Regulatory definitions of identity should be driven by substantive safety concerns.”
Ivan Wasserman, managing partner of Amin Wasserman Gurnani, said this is an “issue of statutory interpretation,” noting that dietary substances do not have to be present in the food supply under existing laws.
Additionally, “the language to use ‘dietary’ rather than ‘nutritional’ was very intentional,” said Israelsen, who participated in DSHEA negotiations.
“The FDA is looking for ways to modernize supplement regulations to keep up with innovation and reduce regulatory burdens while keeping its mandate of public safety,” Wasserman said. “We are hopeful and optimistic they will carry through with those efforts.”
