OTC Regulatory & Market Alerts

FDA proposed removing oral phenylephrine as an OTC nasal decongestant ingredient in November 2024, after concluding it is not effective at approved doses. The comment period closed in May 2025. No confirmed final order has published as of this edition, despite some legal trackers projecting one by May 2026. The proposal targets efficacy, not safety, and does not affect phenylephrine nasal sprays. Brand teams carrying oral phenylephrine SKUs should have reformulation or delisting plans ready to execute on short notice once the final order posts.

Haleon's Centrum Nutrient Replenish, Vitafusion, Bariatric Fusion, and Herbalife's GLP-1 Nutrition Companion line have all launched multivitamin, fiber, or protein products explicitly marketed to GLP-1 users in the past year. Clinicians quoted in trade coverage note a lack of strong controlled evidence for these products' effect on GLP-1 side effects specifically, even as the positioning drives shelf placement and marketing spend. Claims built on GLP-1 adjacency are outrunning the clinical substantiation base, raising FTC and NAD challenge risk.

FDA issued a final order on June 9, 2026, adding bemotrizinol at concentrations up to 6 percent to the sunscreen monograph, based on a DSM Nutritional Products order request. Manufacturers can begin adding it to products on August 9, 2026, and DSM-Firmenich holds 18 months of exclusive marketing rights. Kenvue has confirmed plans to use it in Neutrogena and Aveeno lines. Brands without a supply agreement or reformulation plan in place will watch competitors claim the "new filter" positioning through at least early 2028.

The president signed OMUFA II into law on November 12, 2025, as part of a continuing appropriations package, reauthorizing monograph user fees for fiscal years 2026 through 2030. FDA published FY2026 facility and order-request fee rates in the months following, confirming the program is operating on schedule. Five-year funding certainty means the streamlined monograph order pathway is now a durable, predictable route to market. Sponsors should budget monograph order requests into multi-year innovation planning.