The March 27 meeting will open by discussing the scope of the phrase “dietary substance for use by man to supplement the diet by increasing the total dietary intake” (Section 201(ff)(1)(E)), as used in the Dietary Supplement Health and Education Act (DSHEA).
Dr. Cara Welch, director of FDA’s Office of Dietary Supplement Programs (ODSP), will be joined by Daniel Fabricant, PhD, CEO and president at the Natural Products Association (NPA) and director of the FDA’s Division of Dietary Supplement Programs during the Obama administration, and Jensen Jose, regulatory counsel for the Center for Science in the Public Interest (CSPI).
FDA is particularly interested in responses to whether this phrase can include substances that have never been part of the diet.
“This is the innovation section. Sixteen simple words, that’s the whole innovation section,” Scott Bass, principal at Scott Bass Life Sciences LLC and one of the architects of DSHEA, told NutraIngredients, adding that DSHEA expanded dietary supplements beyond vitamins and minerals to encompass other products.
“We called it the CoQ10 Provision,” he said. “The reason was that in 1990 FDA sued to take some CoQ10 off the market. Originally, CoQ10 was sourced from mushrooms grown on logs, but then synthetic versions entered the market. FDA sued to have these removed. The industry lost the appeal, and we had to figure out how to protect CoQ10 and other ingredients like melatonin and probiotics.”
“We didn’t know what would be invented in the future,” he added. “We were 100% clear that 201(ff)(1)(E) was the innovation door of DSHEA, but FDA kept it locked until now. I’m very encouraged that FDA is now opening the door to what the law has said for the last 32 years.”
Bass explained that this section was not written in a vacuum and was tied to the safety screens that a substance had to go through.
“You have to meet several thresholds,” he noted.
Accommodate innovation, don’t freeze it in time
Loren Israelsen, president of the United Natural Products Association (UNPA) and another DSHEA architect, said the conversation all comes down to the definition.
“We need precision lexicon,” he said. “What is a ‘dietary substance’? If we look at the evolution of new ingredients in the market, many are coming to us as foods from other cultures, like fermented foods, bitters and so on.
“DSHEA was intended to be expansive. It’s about what an individual believes is useful for their health, well-being, and nutrition, and it’s not for the government to decide. The government’s role is to look at this from a question of safety.”
Jeff Ventura, vice president of communications for the Council for Responsible Nutrition (CRN), said his organization, which will be represented by Andrea Wong, PhD, CRN’s senior vice president and chief science officer, at the public meeting, will urge the agency to stay faithful to DSHEA’s intent and to recognize that the law was written to accommodate innovation, not freeze the market in time.
“Our longstanding position is that ‘dietary substances’ are not limited to ingredients with prior use in conventional food, but include a wider range of innovative substances,” Ventura told NutraIngredients. “Historically, FDA has forced industry to take the circuitous route of seeking GRAS status for ingredients first before qualifying as dietary ingredients when a direct route provided by the NDI notification would have been more efficient.
“Going forward, FDA should pair that legally-sound interpretation with a straightforward, science-based pathway for evaluating innovative ingredients.”
Scientific and technological advancements
The meeting will then turn its attention to new methodologies to produce existing dietary ingredients.
FDA wants to hear responses to the question of when existing dietary ingredients are produced using emerging technologies such as synthesis, cell culture, precision fermentation or recombinant production, at what point does a change in production methodology meaningfully alter the ingredient’s identity, composition or safety profile—and therefore warrant additional regulatory scrutiny or data submission?
Phil Yeager, ODSP’s director of research and evaluation, will be joined by Weslee Glenn, vice president of innovation at plant cell culture player Ayana Bio, Dr. Duffy MacKay, senior vice president of dietary supplements at the Consumer Healthcare Products Association (CHPA), Dr. John Deaton, vice president of science and technology at microbiome player Biohm Technologies, Tony Pavel, partner at Keller and Heckman LLP, and Frank Romanski, global vice president of strategic trowth & revenue management at Lonza Capsules & Health Ingredients.
Graham Rigby, president and CEO of the American Herbal Products Association (AHPA), credited FDA with organizing the meeting at a time when there is “a need to pave the way for innovation and innovative technology.”
“AHPA supports a broad and expansive definition of dietary supplements predicated on safety, consumer choice and public health,” he said, but noted that his association will be stressing that consumers have a right to understand where their dietary ingredient is coming from, whether that’s a rhizome grown in the ground or from a new technology.
“This will allow responsible companies to compete and differentiate in the herbal marketplace,” he said. “There are a lot of innovative technologies out there, but we also must be mindful of our farmers and how these ingredients were traditionally grown and consumed. We need to make sure that they can both be honored.”
Peptides, proteins, enzymes and probiotics
After lunch, the meeting will focus on identity attributes for ingredient types such as proteins, enzymes and microbials.
“For ingredient types such as peptides, proteins, enzymes and microbials, what scientific criteria are important in determining the identity of a substance? For these ingredient types, what scientific criteria are important in determining whether two substances are sufficiently similar to be considered the same dietary ingredient for regulatory purposes?” FDA asks.
Dr. Betsy Jean Yakes, chief of the Identity and Status Branch at ODSP, will be joined by Professor Elvira Gonzalez de Mejia from the University of Illinois Urbana-Champaign, Linda Neckmar, senior vice president of human health at Novonesis, CRN’s Dr. Andrea Wong, Dr. Gregory Leyer, founder of Biotic Solutions Consulting, and Dr. Amy Smith, senior director of medical affairs North America for Kerry ProActive.
Novonesis, Kerry and Biotic Solutions Consulting are all members of the International Probiotics Association (IPA).
IPA’s executive director, George Paraskevakos, told us that his association continues to uphold its position from the 2019 meeting, “advocating for a clear definition of live microbial ingredients and greater regulatory clarity for probiotics.
“As research advances, IPA remains committed to supporting innovation while ensuring strong consumer protection and safety,” he said. “Clear, evidence based and practical frameworks are essential to maintain trust and support responsible industry growth.”
Paraskevakos also noted, “that microbials are a unique class of ingredients, and IPA will definitely have experts presenting on manufacturing, identity, showing how this unique substance fits into the statutory definition.”
Comments
Following the meeting, a comment period will remain open for 30 days. Electronic comments should be submitted to www.regulations.gov at docket number FDA-2026-N-2047.
“It is super important that there is a very strong comment response that would provide a mandate for change,” said UNPA’s Israelsen. “I’d like to see thousands of comments.”
FDA has provided the following materials:
