The Silent Threat: Why Undeclared Steroids in OTC Skin Products Demand Global Regulatory Action

By Giorgi Pkhakadze, MD, MPH, PhD
Editor-in-Chief, Georgian Medical Journal

Last month, a 34-year-old woman presented to our dermatology clinic with severe facial atrophy, persistent telangiectasia, and uncontrolled hypertension. Her history revealed a common narrative: for eight months, she had purchased an inexpensive over-the-counter cream from an online marketplace, marketed as a "gentle brightening treatment" for melasma. She used it daily, saw rapid results, and never questioned its safety. Laboratory analysis of her product revealed undeclared clobetasol propionate—a potent Class I corticosteroid reserved for short-term prescription use under medical supervision. She had unwittingly exposed herself to months of systemic absorption without informed consent, without monitoring, without any possibility of managing adverse effects.

This case is not exceptional. It is emblematic of a regulatory catastrophe unfolding silently across continents.

The Scope of the Problem

Recent investigations have documented undeclared prescription-strength corticosteroids in cosmetic and over-the-counter skin products marketed internationally. These are not contamination incidents—they are intentional adulterations designed to produce visible results that create consumer dependence and market advantage. Products labeled as herbal remedies, natural brighteners, or anti-aging treatments routinely contain betamethasone valerate, hydroquinone combined with clobetasol, and other potent steroids at concentrations that would require prescriptions in regulated markets.

The human cost is measurable: irreversible skin atrophy, steroid-induced rosacea, systemic absorption leading to hypothalamic-pituitary-adrenal suppression, and in vulnerable populations—children whose parents apply these products without warning labels—growth retardation and metabolic complications. Yet because these harms emerge over months and years, and because patients often do not connect their symptoms to products they believed were safe, epidemiological surveillance fails to capture the true burden.

Why Regulatory Fragmentation Enables This Crisis

The answer is structural. No harmonized international framework exists to test OTC topical products for undeclared pharmaceuticals before market entry. The European Union, the United States, and other developed economies maintain strong post-market surveillance within their borders, but enforcement is reactive and territorially limited. A product manufactured in South Asia, distributed through e-commerce platforms, and purchased by consumers in North America and Europe exists in regulatory limbo.

Manufacturers face asymmetric incentives: compliance costs are real and immediate; profits from adulteration are substantial; and the probability of detection before significant market penetration is low. Online commerce has eliminated the traditional gatekeeper function of pharmacy networks and local regulatory authorities. A product can reach millions of consumers before any single regulatory body becomes aware of it.

Perhaps most troubling is the absence of harmonized testing standards. What constitutes adequate pharmaceutical screening of cosmetics? Which methods are mandatory? Who bears the cost? Without international consensus, this vacuum becomes a space where the lowest standards dominate.

What Must Change

First, we require a binding international protocol for pre-market screening of OTC topical products. This should include high-performance liquid chromatography and mass spectrometry analysis for common corticosteroids, and this testing should be mandatory before e-commerce distribution, not after consumer harm is documented.

Second, pharmaceutical regulatory authorities in developed nations must expand post-market surveillance to include products sold online to their populations, regardless of manufacturing origin. This demands resource commitment and bilateral enforcement agreements.

Third, we must establish transparent adverse event reporting specifically for topical products, with standardized data collection across nations. Currently, a patient experiencing steroid-induced complications may report to a national pharmacovigilance system, but that signal often dies there, never reaching manufacturers or international bodies.

Finally, the e-commerce platforms themselves must be held accountable. They possess the technological capacity to flag products making dermatological claims, to require documentation of regulatory approval, and to remove sellers with patterns of non-compliance. Voluntary compliance has failed.

The Responsibility of the Medical Community

Clinicians must ask patients about OTC products with the same rigor we apply to medications. We must educate the public that "over-the-counter" does not mean unregulated or inherently safe. And we must document and report cases, contributing data to the epidemiological picture that regulatory bodies cannot ignore.

This crisis exists not because we lack the science to detect undeclared steroids, but because we lack the political will to enforce harmonized standards across borders. That must change now.