Undeclared Clobetasol Propionate Detected in One-Third of Sampled Online OTC Skin Products
A JAMA Network Open study identified undeclared clobetasol in one-third of tested OTC skin products sold online at supratherapeutic levels. The findings expose limits of current FDA oversight and risks to patients with chronic dermatoses. Expanded chemical surveillance and platform-level verification are needed to close the gap.
Researchers at Beth Israel Deaconess Medical Center tested 18 products across three units each and identified pharmacologically active ingredients in all replicates of six items. Five contained clobetasol alone; two also carried miconazole or terbinafine. None listed these agents on labels. Products with positive findings accumulated more than 10,000 combined online reviews, indicating substantial consumer reach despite the absence of required disclosure.
The study highlights gaps in FDA post-market surveillance, which the authors note covers only a small fraction of contaminated products. Similar undeclared corticosteroid findings have appeared in prior observational surveys of imported creams for eczema and psoriasis. Chronic users risk hypothalamic-pituitary-adrenal axis suppression and tinea incognito when potent steroids are applied unknowingly for months.
Regulatory action remains reactive, relying on adverse-event reports rather than systematic testing of high-volume online listings. Expanded targeted chemical screening of best-selling platforms and mandatory third-party verification of ingredient lists would reduce exposure before clinical harm occurs.
Future work should include longitudinal cohort studies tracking adverse outcomes among users of products flagged in surveillance databases and randomized audits of enforcement impact on repeat offenders.
FDA: Within 18 months, at least three enforcement letters will target online platforms selling products with undeclared class I corticosteroids.
Sources (2)
- [1]Primary Source(https://jamanetwork.com/journals/jamanetworkopen/fullarticle/10.1001/jamanetworkopen.2026.38654)
- [2]Supporting Source(https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-about-potential-risks-unapproved-topical-products)