The U.S. Food and Drug Administration (FDA) held a public meeting on March 27, 2026, to discuss “the evolving landscape of dietary supplement ingredients and how recent scientific and technological advances are shaping the industry.”
At the center of the discussion was one part of the definition of “dietary supplement” in § 201(ff) of the Federal Food, Drug, and Cosmetic Act (FDCA, 21 U.S.C. § 321(ff)). Specifically, a “dietary supplement” under the FDCA, means, among other things, a product “intended to supplement the diet that bears or contains . . . a dietary substance for use by man to supplement the diet by increasing the total dietary intake.” FDCA § 201(ff)(1)(E), 21 U.S.C. § 321(ff)(1)(E) (emphasis added).
While this definition of “dietary substance” might appear straightforward, its interpretation has gained new complexity as supplement manufacturers adopt modern technologies to create ingredients that have do not exist as natural dietary sources. FDA convened the meeting to gather perspectives on what exactly qualifies as a “dietary substance” as envisioned by Congress in enacting the Dietary Supplement Health and Education Act of 1994 (DSHEA, Pub. L. No. 103-417). Likewise, FDA’s exploration of these issues underscores a larger shift in regulatory thinking. As science advances, regulatory definitions rooted in the 1990s may no longer serve consumers and the modern dietary supplement market. At this meeting, FDA sought public input to aid in clarifying how these novel developments and innovations fit within the dietary supplement regulatory framework. Following the meeting, interested persons are encouraged to provide written feedback to FDA via Docket No. FDA-2026-N-2047 no later than April 27, 2026.
Redefining “Dietary Substance” in a Modern Context
Historically, FDA has interpreted the phrase “dietary substance” as referring to substances derived from conventional foods. Speakers urged FDA to consider the legislative intent of DSHEA, which purposely used broad and flexible language. Likewise, speakers argued that improvements in technology and scientific progress make it increasingly difficult and impractical to confine FDA’s interpretation of “dietary substance” to ingredients that have historically been part of the human diet.
Speakers noted, for example, that bioactive compounds produced via precision fermentation, cell culture, or other novel technologies serve the same nutritional and physiological purposes as naturally occurring substances. Several participants contended that excluding these innovations from the definition of “dietary substance” would conflict with Congress’ original intent to foster a dynamic and innovation-friendly supplement industry. Others emphasized the importance of maintaining a clear regulatory distinction between dietary supplements and conventional foods to prevent overlap or consumer confusion under separate statutory provisions and authorities.
Modern Manufacturing: When Technology Changes the Ingredient
Another major theme of this meeting was the increasing use of emerging production technologies in developing ingredients traditionally derived from plants, animals, or microbial fermentation. Participants debated the point at which a change in production methodology meaningfully alters an ingredient’s identity, composition, or safety profile, and whether such a shift should prompt additional regulatory scrutiny or premarket notification to FDA via a New Dietary Ingredient Notification (NDIN).
FDA sought public input on how manufacturers should characterize production methods in NDIN submissions, including disclosure of potential byproducts, impurities, or structural and functional variations. Many supplement industry participants emphasized that advanced technologies often produce safer and purer ingredients than those found in nature, thus suggesting that innovation should be met with regulatory flexibility rather than a presumption of increased risk.
Scientific Identity and Novel Ingredient Types
In addition to dietary substances intended to supplement the diet by increasing dietary intake, the definition of “dietary supplement” also includes vitamins, minerals, herbs, botanicals, amino acids, and concentrates, metabolites, extracts and combinations of these substances. See FDCA § 201(ff)(1). One panel focused on complex ingredient types beyond these enumerated substances, such as proteins, enzymes, peptides, and microorganisms. Determining the “identity” of such ingredients remains an important regulatory question because it directly affects whether a substance must go through the NDIN review process or whether it is exempt from this onerous requirement because it is an existing dietary ingredient. Participants recommended FDA develop clear scientific criteria for assessing the identity and equivalence of these substances. Such criteria might include biochemical composition, molecular structure, function, and physiological role. Participants noted that consistent, science-based standards would promote predictability while ensuring these substances meet safety and quality expectations.
Calls for Policy Modernization and Broader Interpretive Flexibility
During the open public comment session, participants urged FDA to reexamine its longstanding interpretation of what constitutes a “dietary substance.” Several participants claimed that FDA’s current approach is too narrow, effectively excluding ingredients that meet the intent of DSHEA but not its historical examples. Commenters noted that Congress deliberately avoided using language such as “present in the food supply” when drafting DSHEA, which signals intent to allow substances beyond conventional food components. Their view is that updating FDA’s interpretation would promote innovation, expand lawful dietary supplement pathways, and support consumer access to new, safe, and beneficial products. Participants also called on FDA to enforce the NDIN process more consistently and ensure the NDIN pathway remains viable for companies developing novel ingredients through advanced production methods.
Next Steps and Comment Deadline
FDA will consider both the information gathered from the March public meeting and written comments submitted by April 27, 2026, to inform future policy decisions on the classification and regulation of dietary substances manufactured via emerging technologies. This initiative reflects a growing acknowledgement that scientific innovation is outpacing regulatory definitions, and that FDA needs to clarify how it will adapt its oversight of dietary supplements to new realities.
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Please contact Jamie Woodside ([email protected]) or Kyla Kaplan ([email protected]) if you have any questions or are interested in additional assistance such as drafting comments to FDA.
