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Undeclared pharmacologically active ingredients (UPAIs) are detected in one-third of over-the-counter (OTC) skin products marketed online, according to a study published online Oct. 8 in JAMA Network Open.
Zaur Abilov, M.D., from Beth Israel Deaconess Medical Center in Boston, and colleagues performed a targeted assessment to examine the presence of UPAIs in 18 OTC skin products marketed online.
The researchers identified UPAIs in six of the preselected products (33.3%) and in all three analyzed units of each of the positive products. Six products contained the superpotent (class I) prescription-only corticosteroid clobetasol propionate; two also included the antifungals miconazole or terbinafine. There was variation in detected concentrations of clobetasol propionate, ranging from about 0.01% to 0.46%; the highest concentrations were 9.2-fold higher than those in U.S. Food and Drug Administration-approved topical formulations.
Product labels did not disclose any of these clinically proven active ingredients. Across online retail platforms, products that tested positive had more than 10,000 combined user reviews.
"FDA states that its health fraud database covers only a small fraction of contaminated products on the market," the authors write. "As a result, products containing UPAIs, including superpotent corticosteroids, may remain available to consumers until they are identified through targeted surveillance or adverse-event reporting.
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