ICSB 2026: Distinguishing the old from the new through scientific rigor

The annual conference, now in its 24th year, brought together scientists, regulators, academics and industry in Oxford, MS just days ahead of the comment deadline set by the U.S. Food and Drug Administration (FDA) as it reviews the scope of the definition and how advances in science may activate the New Dietary Ingredient Notification (NDIN) process in a market that has expanded significantly since the Dietary Supplement Health and Education Act (DSHEA) was enacted in 1994.

“We are seeing innovative ingredients and novel production methods that simply weren’t contemplated 30 years ago,” said Cara Welch, director of the Office of Dietary Supplement Programs (ODSP) at FDA, in her opening remarks. “A key part of our recent public meeting is exploring and understanding how these innovative ingredients fit within the existing dietary supplement framework. We want to foster responsible innovation and ensure that our application of the law accommodates scientific progress, all while keeping consumer safety at the forefront. We also must acknowledge the realities of the market. There are still unscrupulous actors who cut corners, putting the blame on us.”

When is old new again?

Considering how innovation impacts dietary ingredients is not new for the FDA. The agency has been working to increase the number of new dietary ingredient notifications (NDIN) to address risk factors including varying extraction solvents, altered chemical composition and increased bioavailability—all of which might trigger additional safety data expectations.

Two years ago, during her ICSB presentation titled “What’s old is new again and other changes to ingredients: Insights from the FDA”, Betsy Yakes, chief for the Identity and Status Branch at ODSP, first explored how changes in manufacturing might affect the safety profile of an ingredient. This year, she focused specifically on the complexity of establishing the safety profile of mushroom ingredients.

“There are 14,000 different species, 300 of which are edible and 30 of which are domesticated,” she said. “If we just stop right there, and I never say anything else in the talk, you should completely understand why the FDA may want to know the identity of your product and whether it’s safe.”

While valuations of the functional mushroom market vary, it is a segment that has skyrocketed as consumers seek out reishi, cordyceps, lion’s mane and chaga, among others, for their publicized calm-, longevity-, energy- and immune-enhancing benefits.

“Anything that explodes that much over time needs to have attention, and we need to understand what the risks might be to the consumers,” Dr. Yakes said, underscoring the importance of detailing everything from substrates and their byproducts to how lifecycle stage influences bioactive profiles.

Her talk was followed by a series of presentations on research from ingredient suppliers Nammex, M2 Ingredients and Fungi Perfecti that delved into the standardization of functional mushroom materials and fungal metabolomics.

In an explanatory session on FDA regulation of botanical dietary supplements, Kaila Fuller, a chemist with ODSP who reviews identity information in new dietary ingredient (NDI) notification applications, shared best practices for identifying compounds produced through yeast fermentation.

Yeast is a eukaryotic, single-celled microorganisms that belongs to the fungi kingdom and is considered a botanical under the definition of dietary ingredient. Through advances in biotechnology and the use of inserted genetic pathways, it can be engineered into what Keller described as a “microbial factory”, capable of producing large quantities of native or non-native bioactive compounds for use in a dietary supplement.

“If you’re working on an ingredient like this, you should evaluate very carefully to determine if you need to submit a notification to the FDA,” she said, citing the agency’s 2024 draft guidance on NDINs as useful resource. “Ingredients produced using yeast fermentation should be evaluated carefully to determine if the production strategy changed the physical chemical properties, bioavailability or source material of the ingredient.”

She emphasized that the agency must understand how ingredient manufacturers characterize yeast strains and maintain genetic stability to ensure the synthesized product meets identity, purity and safety specifications.

Modernizing oversight

One of the stated priority deliverables of ODSP—responsible for safety, compliance and enforcement rather than research and education on dietary supplements—is modernizing its oversight of an industry that is much changed since its formalization in 1994.

“This mission is more critical now than ever and is a mission we can only accomplish by working together,” Dr. Welch said, noting that at the heart of the FDA’s oversight is a deep and unwavering commitment to science.

“The current administration has reinforced this principle, calling for a restoration of a gold standard for science across the federal government, and this isn’t just a slogan. It’s a directive that shapes our daily work. It means ensuring that federally funded research is transparent, rigorous and impactful.”

Scientific evidence determined to be reliable and impartial is then used to inform federal decisions that contribute to implementing the Make America Healthy Again (MAHA) agenda, which Dr. Welch noted is a paradigm shift from reactive treatment to proactive wellness promotion. Here, consumers are empowered to make informed self-care decisions, and dietary supplements are a prime example of the movement’s agenda.

“Three out of four Americans rely on dietary supplements as a part of their self-care routines, making proactive and informed decisions about their health and wellness,” she said. “They deserve an oversight approach that evolves alongside the marketplace. They deserve a system that ensures they have access to accurate information and, above all, safe products. Empowering consumers and protecting the public are not in opposition.”

She added that while DSHEA remains a landmark law that successfully balanced consumer access with regulatory oversight, the scale, complexity and scientific advancement of today’s supplement industry require the FDA to continually assess how it applies existing rules to ensure that they remain fit for purpose.

To modernize its oversight and strengthen its risk minimization efforts, FDA is focusing on leveraging third party data sourced from the marketplace, the research community, industry-regulatory initiatives and independent auditors.

“When novel problems arise, it is often researchers, third party labs and responsible companies who can take swift action,” 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. To do our work effectively, to be the modern, responsive, regulatory agency that consumers and industry deserve, we need your knowledge, your feedback and your partnership.”

Presentations across the four-day ICSB program explored pharmacovigilance and risk characterization in the botanical supplement industry, integrated analytical workflows for botanical standardization and bioavailability and toxicity screening tools.