TOPLINE

One third of tested over-the-counter (OTC) skin products marketed online for inflammatory skin conditions contained undeclared clobetasol propionate, a prescription-only corticosteroid. Some products contained concentrations more than nine times higher than US Food and Drug Administration (FDA)-approved limits.

METHODOLOGY

• Researchers conducted a targeted quality improvement assessment of 18 OTC skin products purchased from major online retail platforms between February and December 2025.
• Products were selected using predefined criteria: claims of benefit for inflammatory or persistent skin conditions (dermatitis, psoriasis, eczema, hyperpigmentation), absence of listed clinically proven ingredients, and 100 or more customer reviews on at least one platform.
• High-resolution liquid chromatography–mass spectrometry with tandem mass spectrometry confirmation was used to screen for 28 corticosteroids and antifungals from April 2025 to April 2026.
• When undeclared ingredient was detected in the product, two additional units of the same product were purchased and analyzed.

TAKEAWAY

• Undeclared corticosteroid, clobetasol propionate, was identified in six of 18 preselected products (33.3%), with consistent detection across all three analyzed units of each positive product.
• The concentrations of undeclared clobetasol propionate ranged from approximately 0.01% to 0.46%. The highest detected concentrations exceeded those in FDA-approved topical formulations (0.05%) by 9.2-fold.
• Two products additionally contained the antifungals miconazole or terbinafine; none of these clinically proven active ingredients were disclosed on product labels.
• Positive products had more than 10,000 combined user reviews.

IN PRACTICE

"[P]roducts containing UPAIs [undeclared pharmacologically active ingredients], including superpotent corticosteroids, may remain available to consumers until they are identified through targeted surveillance or adverse-event reporting," the authors wrote. "Patients and the medical community should be aware of the potential risks associated with UPAI exposure from the use of OTC products for chronic skin conditions."

SOURCE

The study was led by Zaur Abilov, MD, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston. It was published online on October 8 in JAMA Network Open.

LIMITATIONS

The main limitation was testing of small number of products. The screening may have failed to detect alternative chemical forms of UPAIs and data on actual population exposure were unavailable.

DISCLOSURES

No specific funding was reported. The authors reported having no relevant conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.