On March 27, 2026, the Food and Drug Administration (“FDA”) held a public meeting entitled “Exploring the Scope of Dietary Supplement Ingredients.”
Sponsored by FDA’s Office of Dietary Supplement Programs (“ODSP”), the meeting was designed for agency officials and stakeholders “to discuss the evolving landscape of dietary supplement ingredients and how recent scientific and technological advances are shaping the industry.”
The ODSP posed feedback questions for stakeholders to consider and provide responses to in connection with the topics covered during the meeting. We discuss those questions, and insights from the public meeting, in more detail below.
‘Dietary Supplements’
In Session 1, panelists explored the scope of the phrase “dietary substance for use by man to supplement the diet by increasing the total dietary intake” as used in the Dietary Supplement Health and Education Act of 1994 (“DSHEA”). The federal Food, Drug, and Cosmetic Act (“FD&C Act”) defines “dietary supplement” in part as a product that contains one or more dietary ingredients, including “a dietary substance” as defined above.
Feedback Question 1
Stakeholders are being asked to consider whether the phrase above, as used in DSHEA, can include substances that have never been part of the diet; and how emerging ingredient types fit within the dietary supplement framework.
Emerging Technologies/Production Technologies
Session 2 discussed production technologies and new methodologies that are being applied to the science of dietary supplements and how these advancements intersect with dietary ingredient production. An FDA Memo attached to the docket of information for the public meeting explains:
[N]ew technologies and approaches are being applied to the science of dietary supplements, including precision fermentation, cell culture technology, and recombinant production, which has led to the development of bioactive compounds derived from foods, plants, and other sources. . . . Accordingly, it would be helpful to better understand how these scientific and technical advancements intersect with dietary ingredient production to inform our assessment.
Feedback Question 2
FDA seeks public feedback on the question of emerging technologies: specifically, 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?
Feedback Question 3
FDA further seeks feedback on how production technologies should be characterized, e.g., in a new dietary ingredient notification—including potential byproducts, impurities, and structural or functional variations—to ensure that FDA can adequately assess the resulting ingredient.
Proteins, Enzymes, and Microbials
Session 3 explored questions related to determining the identity of notable supplement ingredients like proteins, enzymes, and microorganisms, not specifically listed in section 201(ff)(1) of the FD&C Act, and the different attributes that are important for assessing identity.
Feedback Question 4
Finally, the FDA seeks to discover the following from stakeholders: 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?
Takeaways
Stakeholders have time to comment on the issues and questions identified during the public meeting and listed above, at www.regulations.gov, docket number FDA-2026-N-2047, on or before April 27, 2026.
The public meeting and the questions posed for stakeholders are notable, as they highlight the FDA’s focus on potentially changing interpretations of law to allow ingredients that are not recognized as “from the food supply” to qualify as dietary substances. FDA has previously rejected New Dietary Ingredient notifications on the grounds that the substance itself was not in the food supply (e.g., it may be a substance only made in the human body, as opposed to consumed, or something considered a contaminant or impurity in the food supply—neither of which would qualify as a dietary substance currently, under the definition. Imposing such changes could greatly expand the amount of ingredients that may be added to dietary supplements.
For more information, see the meeting page. If you’d like assistance responding to these questions, or would like to discuss the implications of these changes more, please reach out to the authors of this article or the EBG attorney who regularly assists you.
Ann W. Parks contributed to this article
