Defining "Dietary Substance": FDA Meeting Explores Scope of Dietary Supplements

On Friday, March 27, 2026, the US Food and Drug Administration held a public meeting titled, “Exploring the Scope of Dietary Supplement Ingredients.” The meeting comprehensively explored the language found in the Dietary Supplement Health and Education Act of 1994, how industry innovation has stretched and challenged the language of the statute, and whether these products fit within the framework. As part of this dialogue, the meeting explored production methodologies and specific classes of ingredients, including proteins, enzymes, and microbials.

How Do You Modernize Supplement Regulation?

The meeting opened with Kyle Diamantas, deputy commissioner of human foods at FDA, who highlighted some of the agency’s goals and how the meeting aligns with said goals. He explained that FDA aims to modernize its oversight of dietary supplements to keep pace with an industry that has grown dramatically in scale, complexity, and technological sophistication since 1994. “The industry has grown and changed tremendously in the last 30 plus years, yet the regulatory framework has largely stayed the same. It is not adapted to the change in your level of innovation,” he told the audience. “It's a goal of mine to modernize our oversight addressing some of the shortcomings that have allowed unscrupulous actors to thrive, the detriment of the overwhelming majority of players in this space who follow the law and regulations.”

Modernization, in his remarks, includes cutting unnecessary “red tape,” reducing label clutter (such as via the recent enforcement discretion on disclaimers), and re-examining notification and other regulatory requirements that may be burdensome without providing clear public health benefits. He also highlighted the agency’s interest in leveraging advancements in technology and data systems to streamline compliance while maintaining appropriate oversight. For the dietary supplement industry, this modernization agenda is meant to both strengthen FDA’s ability to act against unsafe or unlawful products and create a clearer, more efficient framework that supports legitimate innovation. Overall, Diamantas framed modernization as a shared responsibility between FDA, industry, and consumers, aimed at ensuring a safe, high-quality dietary supplement marketplace that can continue to grow.

What is a Dietary Substance?

Cara Welch, director of the Office of Dietary Supplement Program, Human Foods Program at FDA, moderated the first session on the scope of the phrase in DSHEA that reads “dietary substance for use by man to supplement the diet by increasing the total.” In her introduction, she explained that DSHEA’s legislative history is unusually sparse, so when Congress does not provide explicit intent, FDA must fall back on dictionary meanings and contextual clues from the statute itself. Using this approach, FDA has understood “dietary substance” to mean substances commonly used as human food or drink that are already part of the diet and then “increasing the total dietary intake” through supplementation. She emphasized that FDA cannot treat simply placing something into a supplement as making it part of the “diet,” because that would create a loophole and undermine the structure Congress designed. Welch also highlighted the growing challenges FDA faces as new technologies, production methods, and ingredient types push beyond the traditional food-based understanding embedded in the statutory phrase. She stressed that any future “working definition” or expansion of what counts as a dietary substance must still be anchored to the statutory language and its guardrails, not just to scientific or policy preferences.

Jensen Jose, regulatory counsel for the Center for Science in the Public Interest argued that while some dietary supplements have clear, evidence-based benefits (e.g., folate for neural tube defect prevention, iron for anemia, certain products for macular degeneration), the overall marketplace is far too large, underregulated, and risky for consumers. He noted that there are roughly 90,000 unique supplement products in a $60+ billion market, but expressed that “not all 90,000 supplements are needed, nor do they all make people healthier—in fact, many supplements do the opposite and harm people.” Jose’s core position is that “dietary substances” should be limited to substances commonly used in human food or drink, consistent with dictionary definitions of “diet” and the way FDA has interpreted DSHEA in its draft NDI guidance.

He emphasized that consumers routinely overestimate FDA’s regulation of supplements, mistakenly assuming they are vetted like prescription or OTC drugs, which leads them to trust claims and safety that have not actually been rigorously evaluated. Jose highlighted systemic weaknesses such as rare inspections by FDA of supplement facilities, poor safety data or evidence behind product claims, and the self-GRAS pathway which he characterized as a loophole that allowed new chemicals to enter the supplement market without FDA’s knowledge. He therefore urged FDA to tighten oversight, close the so-called GRAS loophole, and focus on making the existing marketplace safer rather than expanding what counts as a dietary substance.

Daniel Fabricant, PhD, president and CEO of the Natural Products Association, in contrast argued that DSHEA works incredibly well and has already achieved its core goal of promoting broad consumer access while giving FDA tools to police safety. Fabricant stressed that leading firms have invested hundreds of millions of dollars in R&D and regulatory science, and he rejects the notion that the industry is “under‑regulated” or “unscientific,” asserting that the safety record of supplements is strong and that they remain “one of the safest, if not the safest, commodity regulated at FDA.” He expressed support for discussion of new technologies and ingredient types (e.g., targeted microbial fermentation, peptides, synthetic biology, enzymes, nature‑identical plant constituents) and expressed a desire for clarity and flexibility in how statutory definitions apply to these innovations. Rather than tightening DSHEA or significantly expanding FDA’s powers, he urged focusing on “self‑modernization” within the existing statutory framework, leveraging current authorities more effectively and deepening collaboration between FDA and responsible companies. In his view, the policy conversation should shift away from claims that DSHEA is fundamentally broken toward figuring out how the agency and industry together can more efficiently regulate and police the marketplace without new acts of Congress.

It has long been clear that industry moves faster than bureaucracy. DSHEA passed in 1994, but clear guidance, on NDIs for example, took the better part of 20 years to be finalized. In that time, companies have developed innovative ingredients and products that have become staples consumers utilize to manage their health. Unfortunately, in that time, unscrupulous companies have also been active selling adulterated and dangerous products with unsubstantiated claims. This has informed much of the negative opinion about the dietary supplement industry among consumer groups. They feel justified in calling industry unregulated because of a perceived lack of action and oversight from FDA. From an industry perspective, of course, those that understand and follow regulations also feel frustration about the lack of enforcement as fly-by-night companies profit from lies at the expense of responsible industry. It is a shared frustration, but each sees a different solution to the problem. For industry, of course, it’s imperative to support the innovation that has and is currently taking place, and not set limitations on what constitutes a dietary substance.

Stay tuned for more coverage on the public meeting and the takeaways.

This article was created with assistance from AI. The content has been reviewed and edited by Sebastian Krawiec, Managing Editor. For more information on the extent and nature of AI usage, please contact us.