Health Law Advisor

On January 30, 2026, Representative Michael Lawler introduced H.R. 7291, the “GRAS Oversight and Transparency Act.” H.R. 7291 is the latest congressional effort to address longstanding concerns about the federal regulatory framework governing “generally recognized as safe” (“GRAS”) designations for food-related substances.

A newly introduced House Bill, H.R. 7366, titled the Dietary Supplement Regulatory Uniformity Act, would amend the Federal Food, Drug, and Cosmetic Act (“FDCA”) to expressly clarify and affirm the Food and Drug Administration’s (“FDA”) preemptive authority over dietary supplement regulation.

The bill would prohibit states from establishing or maintaining dietary supplement requirements that are different from or in addition to federal requirements, unless a state successfully applies for a specific exemption from FDA preemptive authority. Such exemptions would be limited to circumstances where a state requirement is more stringent than federal law or addresses a compelling local condition without placing a product out of compliance with federal standards.

In effect, the proposed legislation reinforces a uniform national regulatory framework for dietary supplements, while preserving a narrow pathway for state involvement under FDA oversight.

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.

On December 11, 2025, the U.S. Food and Drug Administration (“FDA”) announced in a letter to the dietary supplement industry that it is actively considering requests to amend its dietary supplement labeling regulation at 21 C.F.R. § 101.93(d), which governs placement of the disclaimer required for structure/function claims under the Dietary Supplement Health and Education Act of 1994 (“DSHEA”).

The regulation currently requires the DSHEA disclaimer—which states that the product has not been evaluated by FDA and is not intended to diagnose, treat, cure, or prevent disease—to appear on each panel of a product label where a qualifying structure/function claim is made.

Based on its initial review, FDA indicated that removing the “each panel” requirement would be consistent with the DSHEA, could reduce label clutter and unnecessary costs, and would align with the agency’s historical enforcement posture, noting that the requirement has rarely, if ever, been enforced. FDA further stated that, absent significant concerns, it is likely to propose formal rulemaking to amend the regulation.

The Second Circuit dealt a blow to the dietary supplement industry last month as it affirmed a lower court’s decision not to temporarily pause enforcement of New York’s new restrictions on sales of certain dietary supplements to minors as legal challenges continue to proceed through the court system.

“Master Files” are not just for PowerPoints. On April 4, 2024, the Food and Drug Administration (FDA) issued its “New Dietary Ingredient Notification Master Files for Dietary Supplements: Guidance for Industry” (“Draft Guidance”). These latest recommendations build upon the agency’s Final Guidance issued in March—the subject of our prior blog post—regarding procedures and timeframes for industry stakeholders to submit NDINs. The new recommendations also replace and expand upon those portions of a 2016 Revised Draft Guidance, called “Dietary ...

On March 5, 2024, the Food and Drug Administration (FDA) issued its “Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry” (“Final Guidance”). The purpose of the Final Guidance is to assist manufacturers and distributors of new dietary ingredients (“NDIs”) and dietary supplements in preparing and submitting new dietary ingredient notifications (“NDINs”) to the FDA.

The Final Guidance finalizes Section V, “NDI Notification Procedures and Timeframes,” of a 2016 revised Draft Guidance (“Draft ...

Whether a consumer is taking calcium carbonate for strong bones, magnesium to fall asleep, or high-dose caffeine to stay awake, the U.S. Food and Drug Administration (FDA) does not approve dietary supplements for safety and effectiveness. So how do consumers know if a product is safe, and how can manufacturers protect themselves in the case of a problem?

In response to stakeholder feedback, the FDA on February 21, 2024, released its updated directory of FDA actions and communications with respect to “Information on Select Dietary Supplement Ingredients and Other Substances.”