02  ·  Monthly Pulse

OTC & Consumer Health Pulse

Top signals across four OTC therapeutic segments, framed for consultant use. Monograph reform, Rx-to-OTC pipeline, and competitive brand moves — updated monthly by Brendan Walsh.

Edition 04  ·  July 2026

July 2026
US OTC market size
$52B
↑ 4.8% CAGR to 2028
Category disruption
PE Ruling
↓ Oral phenylephrine ruled ineffective
Fastest growing format
Topical NSAID
↑ Rx-to-OTC converts outpacing oral
Pipeline watch
Rx-to-OTC
Migraine Rx candidates in FDA review
Top five signals this month Ranked by consultant relevance
01
Sun Care Dermatology
FDA finalizes bemotrizinol as the first new US sunscreen active ingredient in two decades

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.

So what: Brands without a supply agreement or reformulation plan in place will watch competitors claim the "new filter" positioning through at least early 2028.
Tier 1FDA — FDA Expands Sunscreen Options for the First Time in 20 Years
Tier 2Drug Topics — FDA Approves Bemotrizinol as an OTC Sunscreen Ingredient

Consumer search and social signals also inform velocity rating.

Velocity
02
Regulatory/Market Access
Congress locks in OMUFA II, funding FDA's OTC monograph program through FY2030

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.

So what: 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.
Tier 1FDA — OMUFA Understanding FY 2026 User Fees

Consumer search and social signals also inform velocity rating.

Velocity
03
Cough, Cold & Allergy
FDA's final order on oral phenylephrine remains unpublished as the 2026 cold season approaches

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, and some legal trackers projected a final order by May 2026, but no confirmed final order was located as of this edition. The proposal targets efficacy, not safety, and does not affect phenylephrine nasal sprays.

So what: Brand teams carrying oral phenylephrine SKUs should have reformulation or delisting plans ready to execute on short notice once the final order posts, rather than waiting for a hard deadline that keeps slipping.
Tier 1FDA — FDA Proposes Ending Use of Oral Phenylephrine
Tier 1FDA — Key Information about OTC Oral Phenylephrine

Consumer search and social signals also inform velocity rating.

Velocity
04
Regulatory/Market Access Rx-to-OTC candidates
FDA sets a legislated timeline to modernize Rx-to-OTC switch guidance and stakeholder engagement

Under OMUFA II, FDA must publish a stakeholder engagement plan for identifying Rx-to-OTC switch candidates by November 2026, and must issue updated guidance on switch application clarity and evidence standards by May 2027. Industry groups are separately pushing FDA to modernize consumer behavior testing standards to reflect digital tools and real-world data.

So what: Sponsors with switch candidates in the pipeline have a defined 10-month window to influence the new guidance before it locks in. Early engagement with FDA on evidence standards now has outsized leverage.
Tier 1FDA — Prescription-to-Nonprescription (Rx-to-OTC) Switches
Tier 2Hogan Lovells — FDA to publish guidance to improve the Rx to OTC switch application process

Consumer search and social signals also inform velocity rating.

Velocity
05
Vitamins/Minerals/Supplements Digestive Health
Legacy OTC brands are repositioning core SKUs as GLP-1 "companion" products faster than clinical evidence supports

Haleon's Centrum Nutrient Replenish, Vitafusion, Bariatric Fusion, and Herbalife's GLP-1 Nutrition Companion line 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.

So what: Marketing claims built on GLP-1 adjacency are outrunning the clinical substantiation base, raising FTC and NAD challenge risk for brands that lean on implied efficacy rather than general nutrition-gap framing.
Tier 2Medscape — Can OTC Remedies Help With GLP-1 Adherence?
Tier 2Haleon — Centrum GLP-1 Nutrient Replenish Overview

Consumer search and social signals also inform velocity rating.

Velocity
Ingredients/topics to watch
Bemotrizinol (BEMT)
First new US sunscreen active in 20 years. Manufacturers can add it to products starting August 9, 2026, but DSM-Firmenich holds 18 months of marketing exclusivity before generics can follow.
GLP-1 companion nutrition
Legacy OTC brands are relabeling existing SKUs faster than new clinical evidence is accumulating. Claims exposure, not efficacy, is the near-term risk to watch.
Oral phenylephrine
No final order has published yet. Category planning should assume removal proceeds and reformulation toward pseudoephedrine-behind-counter or non-oral formats is the safer default.
OMUFA II reauthorization
Five-year fee certainty locks in FDA's modernized monograph pathway. Sponsors should treat OTC monograph order requests as a viable, time-bound alternative to Rx-to-OTC switch applications.
Regulatory radar
WatchOral phenylephrine final order pending. FDA proposed removal in November 2024; comment period closed May 2025. No confirmed final order as of this edition.
MonitorGLP-1 companion product claims substantiation gap. Trade coverage notes a lack of strong controlled evidence for GLP-1-specific side-effect claims.
ClearedBemotrizinol final order cleared. Market entry begins August 9, 2026, under DSM-Firmenich's 18-month exclusivity window.
ClearedOMUFA II funding secured through FY2030, confirming FDA's monograph order pathway is operating on a durable, predictable schedule.