FDA’s Office of Dietary Supplement Programs Signals Key Enforcement and Policy Priorities for the Year Ahead

During a recent industry webinar, Cara Welch, Ph.D., Director of the Office of Dietary Supplement Programs (“ODSP”) within the U.S. Food and Drug Administration (“FDA”), outlined the agency’s 2026 priorities for the dietary supplement industry.

Dr. Welch’s remarks reflect both continuity in FDA’s long-standing focus areas and a push toward modernization within existing statutory authority.

Core Strategic Priorities Remain Unchanged

Dr. Welch emphasized that ODSP’s overarching strategic priorities continue to center on three pillars:

1. Product Safety;
2. Product Integrity; and
3. Informed Decision-Making.

In practical terms, this means ensuring that dietary supplements on the market are safe for consumers, contain what their labels claim (and nothing more), and are manufactured and labeled in compliance with current good manufacturing practices. Equally important, FDA views transparency—both for consumers and industry—as essential to enabling informed choices and compliance.

New Dietary Ingredients Front and Center

A major focus for the coming year will be the regulation of new dietary ingredients (“NDIs”). Dr. Welch confirmed that ODSP is prioritizing finalization of long-pending guidance addressing how firms should establish both the identity and safety of NDIs. FDA intends to publish this guidance in final form this year, an update many in the industry have been waiting on for nearly a decade.

In parallel, ODSP is examining ways to improve its internal NDI review processes, particularly in light of a recent increase in NDI notification submissions. Dr. Welch noted that FDA is exploring whether artificial intelligence or machine-learning tools could help streamline reviews while maintaining consistency and scientific rigor. These efforts are also being driven by anticipated downstream effects of potential reform to the generally recognized as safe (“GRAS”) framework, which FDA expects could shift more ingredient safety submissions into the NDI pathway.

Post-Market Chemical Safety and Risk Prioritization

Dr. Welch also highlighted closer coordination with FDA’s Office of Post-Market Assessment to support a broader food chemical safety initiative. For dietary supplements, this translates into enhanced post-market review of ingredients already in commerce and a more structured approach to prioritizing risk mitigation efforts.

“Modernization” Without Product Listing Mandates

Another key takeaway from the webinar was Dr. Welch’s clarification that dietary supplement oversight modernization does not mean renewed pursuit of mandatory product listing requirements.[1] Instead, FDA is focusing on what it can accomplish through guidance, policy development, and selective regulatory reform within existing authority. This includes evaluating whether certain long-standing regulations remain necessary or could be modified or eliminated without compromising consumer protection.

As one example, Dr. Welch pointed to FDA’s recent exercise of enforcement discretion regarding placement of disclaimers required under the Dietary Supplement Health and Education Act of 1994 (“DSHEA” disclaimers), signaling a broader willingness to reconsider rules that may be duplicative or outdated. EBG previously discussed this development in a blog post, available here.

Compliance First, Targeted Enforcement Where Needed

Finally, Dr. Welch stressed that FDA’s enforcement strategy is designed to encourage compliance rather than default to punitive action. By improving communication around priorities and expectations, ODSP aims to help responsible firms stay compliant, reserving enforcement tools for actors who choose not to do so. While warning letters and inspection data remain key transparency tools, Dr. Welch acknowledged the ongoing challenge of balancing real-time disclosure with active investigations.

Takeaways for Industry

Taken together, Dr. Welch’s remarks suggest that 2026 will be marked by incremental but meaningful regulatory movement, particularly on NDIs and internal FDA processes. Firms developing new ingredients—or relying on novel substances already in commerce—should expect closer scrutiny, clearer guidance, and increasing emphasis on safety substantiation. At the same time, FDA appears open to dialogue and modernization efforts that support innovation while maintaining consumer protection.

Endnotes

[1] While FDA may not be renewing the pursuit of product listing requirements, Senator Richard J. Durbin has reintroduced the “Dietary Supplement Listing Act” (S. 3677), a bill that would amend the Federal Food, Drug, and Cosmetic Act to require manufacturers to list dietary supplements with FDA and submit key product information — including ingredient lists, label text, allergen statements, and claims — for inclusion in a publicly searchable database.