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A third of tested OTC skin products contained undeclared active ingredients — including a superpotent prescription steroid. Researchers found clobetasol propionate, a prescription-only corticosteroid, hidden in 6 of 18 products at concentrations up to 9x the FDA-approved limit. Experts are calling for immediate regulatory action to pull these products from shelves.
A new study published in JAMA Network Open found that one-third of tested over-the-counter (OTC) skin products contained undeclared pharmacologically active ingredients (UPAIs) — substances never listed on the label. Researchers from Beth Israel Deaconess Medical Center and Harvard Medical School screened 18 products marketed online for conditions like eczema, psoriasis, and hyperpigmentation, and flagged six as containing hidden active compounds.
The most alarming find: clobetasol propionate, a superpotent prescription-only corticosteroid, was detected in all six flagged products — at concentrations reaching up to 9.2 times the FDA-approved limit. Two products also contained undisclosed antifungals (miconazole or terbinafine). These products had racked up over 10,000 combined user reviews online and were among top sellers in their respective categories.
By the Numbers:
Why it matters: Chronic, unsupervised exposure to hidden steroids like clobetasol can cause skin atrophy, hormonal disruption, and even glaucoma from periocular use. With no standardized system to detect UPAIs in OTC products, experts say the FDA must act swiftly to remove these products and strengthen surveillance frameworks.