Study finds undisclosed active drugs in online skin products
A targeted assessment of over-the-counter skin products sold online found undeclared pharmacologically active ingredients in six of 18 products tested, according to a study published in JAMA Network Open. The findings raise concerns that consumers using products marketed as over-the-counter treatments may be exposed to prescription-only medicines without knowing what they contain.
The research team, led by Zaur Abilov of Beth Israel Deaconess Medical Center in Boston, examined 18 preselected products marketed online. Undeclared pharmacologically active ingredients were found in one-third of the sample. The researchers also tested three units of every product that produced a positive result, and found the undeclared ingredients in all three units from each of those products.
That consistency matters because it suggests the findings were not confined to a single anomalous package among the products that tested positive. At the same time, the study was a targeted assessment of 18 products, not a survey designed to estimate the prevalence of contaminated or mislabeled skin products across the entire online marketplace.
Superpotent steroid was the main undisclosed ingredient
The most consequential finding involved clobetasol propionate, a superpotent class I corticosteroid that is prescription-only. Six products contained clobetasol propionate, despite product labels not disclosing the ingredient. Two of those products also contained either miconazole or terbinafine, both antifungal medicines, which likewise were not disclosed on the labels.
The detected amount of clobetasol propionate varied considerably. Researchers reported concentrations from about 0.01% to 0.46%. The highest concentrations were 9.2 times higher than those in topical formulations approved by the U.S. Food and Drug Administration, according to the report.
The study therefore identified two distinct issues: the presence of clinically active medicines not listed on the label, and substantial variation in the concentration of one of those medicines. A consumer selecting an OTC product has little basis for assessing either issue when the active ingredients are absent from the packaging information.
Online reach may amplify the issue
The products that tested positive were not necessarily obscure listings. Across online retail platforms, the positive products had more than 10,000 user reviews combined. That measure does not establish how many units were sold or how many people used the products, but it indicates that the products had meaningful visibility among online shoppers.
OTC skin products are often used by people seeking relief for chronic or recurring conditions. The authors said patients and the medical community should be aware of the potential risks from exposure to undeclared pharmacologically active ingredients in such products. Their warning is particularly relevant when consumers may assume that a product’s listed ingredients provide a complete account of what is being applied to the skin.
The report does not say that every online OTC skin product contains hidden medicines. Its evidence is narrower: in this targeted group of 18 products, six contained undeclared active ingredients. But the results show why targeted testing can uncover problems that labels and online product pages do not reveal.
A surveillance gap
The authors noted that the FDA has said its health fraud database covers only a small fraction of contaminated products on the market. In their view, that means products containing undeclared active ingredients, including superpotent corticosteroids, may remain available until targeted surveillance identifies them or adverse events are reported.
This creates a difficult detection problem. A label cannot alert buyers to an ingredient that is not declared, and a marketplace listing may reproduce the same incomplete information. As a result, laboratory testing, targeted monitoring, and reports of possible adverse events become important ways to surface products that may otherwise continue to circulate.
The findings also illustrate why the distinction between an OTC product and a prescription medicine matters. The study’s positive products were marketed as OTC skin products, yet the testing identified clobetasol propionate, a prescription-only corticosteroid classified as superpotent. In two products, the researchers also found undisclosed antifungal medicines.
What the study establishes—and what it does not
The investigation provides direct analytical evidence for the 18 selected products and for the three tested units of each positive product. It establishes that six sampled products contained undeclared active ingredients, and that clobetasol was present in all six of those positive products. It also documents the range of measured clobetasol concentrations and the additional detection of miconazole or terbinafine in two products.
It does not establish an overall rate for all OTC skin products sold online. The researchers performed a targeted assessment, and the supplied report does not describe the full universe of available products or claim that the sample represents every marketplace, brand, or skin condition category. Its most immediate contribution is to show that undisclosed medicines can be found through focused testing of products that are available to consumers online.
For clinicians and consumers, the central lesson is straightforward: an OTC label may not always reveal the pharmacologically active substances in a skin product. For regulators and marketplaces, the study points to the value of surveillance that can identify suspect products before exposure is discovered through adverse-event reporting.
Why the result deserves attention
Products marketed online can quickly reach large audiences, and positive products in this assessment had accumulated more than 10,000 combined reviews. The study does not connect those reviews to health outcomes. Still, the scale of visibility underscores why undisclosed ingredients are not merely a labeling technicality.
The authors’ conclusion is measured but important. Because official health-fraud records cover only a fraction of contaminated products, products with undeclared medicines may remain available until testing or reports bring them to light. The new analysis adds evidence that this risk is present in online OTC skin products and that active surveillance can reveal it.
This article is based on reporting by Medical Xpress. Read the original article.
Originally published on medicalxpress.com
