The U.S. U.S. Food and Drug Administration (FDA) held a public meeting on March 27, 2026 (Washington, D.C. time) at the Wiley Auditorium in College Park, Maryland. The meeting was titled “Exploring the Scope of Dietary Supplement Ingredients.” The docket number is FDA-2026-N-2047, which has entered the public comment period with a deadline of April 27, 2026. The meeting was organized by the Office of Dietary Supplement Programs (ODSP) and conducted in a hybrid format combining in-person and virtual participation.
The core of the meeting was to re-examine the scope of applicability of relevant provisions on dietary supplements under the Federal Food, Drug, and Cosmetic Act (FD&C Act), with a focus on the wording in Section 201(ff)(1)(E): “a dietary substance for use by man to supplement the diet by increasing the total dietary intake.” Through this public meeting, the FDA aims to clarify whether this “scope” remains fully applicable in the context of rapid technological advancement, and whether the boundaries of this scope require further interpretation or may become more restrictive in practice.
Three key areas were discussed in this meeting.
1. New Production Methods for Existing Dietary Ingredients
The FDA specifically focused on precision fermentation, cell culture, and recombinant production. When the “same ingredient” is produced using different technological pathways, whether its regulatory status changes and whether it still falls within the existing scope of dietary supplement ingredients were key questions.
2. Identity Determination of Specific Ingredient Types
Proteins, enzymes, and microbials were discussed. These ingredient types are not explicitly listed in the statutory text, and whether they fall within the scope of “dietary supplement ingredients” was examined.
3. Criteria for “Identity” Determination Under New Technologies
In assessing whether a substance falls within the scope of dietary supplement ingredients, what key “attributes” should be used for determination was discussed. This implies that technical and regulatory criteria for evaluating “identity consistency” of ingredients may be further strengthened in the future.
As a professional regulatory service team, BYSEE will continue to monitor the subsequent developments of Docket FDA-2026-N-2047 and support compliant market access for products globally.
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