FDA Calls First Public Meeting in Years to Redefine What Can Be Sold as a Dietary Supplement | Himiyer

Himiyer.com — March 23, 2026

Table of Contents

• Background: What DSHEA Says
• What the FDA Is Asking
• Novel Technologies at the Center of the Debate
• Broader 2026 Regulatory Push
• What It Means for Consumers and Brands
• How to Participate
• Sources

Background: What DSHEA Says

The rules governing what can legally be sold as a dietary supplement in the United States have not been fundamentally revisited since the Dietary Supplement Health and Education Act (DSHEA) became law in 1994. That 32-year-old statute defines a dietary supplement as, in part, a product containing "a dietary substance for use by man to supplement the diet by increasing the total dietary intake." The law also carved out specific categories of qualifying ingredients: vitamins, minerals, herbs or botanicals, amino acids, and a catch-all that covers virtually any other dietary substance. For three decades that language held. Now the FDA says it no longer provides enough clarity.

What the FDA Is Asking

On March 3, 2026, the FDA's Office of Dietary Supplement Programs (ODSP) announced a hybrid public meeting scheduled for March 27, 2026, titled "Exploring the Scope of Dietary Supplement Ingredients." The agency says the event will help it determine "next steps regarding the meaning of the dietary ingredient categories defined in DSHEA." Three specific questions are on the table:

• What does "a dietary substance for use by man to supplement the diet by increasing the total dietary intake" actually cover?
• Do new production methods — such as precision fermentation or cell-culture technology — produce ingredients that qualify under DSHEA, even when those methods differ from how the same compound was historically made?
• Where do proteins, enzymes, and microbials fit within the existing DSHEA framework?

The meeting runs from 9 a.m. to 3 p.m. ET and is open both in-person at the FDA's Human Foods Program offices in College Park, Maryland, and virtually. Public comments can be submitted through April 27, 2026, to docket number FDA-2026-N-2047 at regulations.gov.

Novel Technologies at the Center of the Debate

At the heart of the discussion is a wave of new production technologies that did not exist when DSHEA was drafted. Precision fermentation uses engineered microorganisms to produce bioactive compounds that are chemically identical to those found in food or plants. Cell-culture technology grows animal or plant cells outside a living organism to generate ingredients. Recombinant DNA processes let manufacturers produce proteins and enzymes at commercial scale. Companies are already using these techniques to produce collagen peptides, enzymes, and probiotic strains. The question the FDA has not yet answered definitively is whether the resulting ingredients qualify as "dietary substances" under the existing 1994 language, or whether they fall into a regulatory gray zone — or outside the definition entirely.

Broader 2026 Regulatory Push

The March 27 meeting is one piece of a larger 2026 regulatory agenda that industry observers are calling the most consequential for the supplement sector since FDA imposed current Good Manufacturing Practice (GMP) standards in 2007. The FDA's Human Foods Program published its 2026 priority deliverables in January, listing dietary supplement modernization as a top goal. Separately, the agency is expected to release final guidance on New Dietary Ingredient (NDI) notifications — which govern how companies introduce ingredients that were not on the market before October 15, 1994 — with an emphasis on higher evidence standards for safety and identity. The agency is also weighing changes to the GRAS (Generally Recognized as Safe) self-affirmation pathway, which HHS Secretary Robert F. Kennedy Jr. flagged for overhaul during his confirmation hearings. Meanwhile, Senator Richard Durbin reintroduced the Dietary Supplement Listing Act of 2026 in January, which would require manufacturers to register their products with the FDA in a public database — legislation that failed in 2022 and 2024 but now has support from the Council for Responsible Nutrition.

What It Means for Consumers and Brands

For consumers, a tighter or better-defined ingredient scope could eventually mean greater confidence that what is labeled a dietary supplement meets a consistent legal standard. Currently roughly 80,000 to 100,000 supplement products are on the U.S. market, with no premarket approval requirement — manufacturers are responsible for ensuring safety before a product reaches shelves. For brands, the stakes are higher and more immediate. If the FDA decides that precision-fermented or cell-cultured ingredients do not meet the existing DSHEA definition, formulations built around those ingredients could face enforcement action or be forced through the lengthier New Dietary Ingredient notification process. Conversely, clear guidance that such ingredients qualify could open the door to a new generation of biotech-derived supplement products. Regulatory consultants advise that companies developing novel ingredients monitor the March 27 meeting closely and consider submitting formal comments to the docket before the April 27 deadline.

How to Participate

The meeting is free and open to the public. Registration is required for both in-person and virtual attendance; details are posted on the FDA's meeting page at fda.gov. Written or electronic comments must be submitted to regulations.gov under docket FDA-2026-N-2047 no later than April 27, 2026.

Sources

• FDA: Announces Public Meeting on Dietary Supplement Innovation and the Scope of Dietary Ingredients (March 3, 2026)
• FDA: Public Meeting — Exploring the Scope of Dietary Supplement Ingredients (March 27, 2026)
• Food Safety Magazine: FDA to Hold Public Meeting on Scope of Dietary Supplement Ingredients
• WholeFoods Magazine: Call for Comments — FDA Public Meeting Will Explore Scope of Dietary Supplement Ingredients
• EAS Consulting Group: FDA Announces Public Meeting on Dietary Supplement Innovation and Ingredient Scope
• Intermountain Nutrition: FDA Human Foods Program 2026 — What Brands Need to Know
• Nutraceutical Business Review: FDA Calls Public Meeting to Explore Scope of Dietary Supplement Ingredients Under DSHEA
• NutraIngredients: Could 2026 Be the Biggest Year for Dietary Supplements Since the Introduction of GMPs?
• NutraIngredients: Sen. Durbin Introduces Dietary Supplement Listing Act of 2026