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The term cosmeceutical remains a regulatory paradox, widely used in commerce but unrecognized in law. In the UK and the European Union (EU), there is no intermediate category between cosmetics and medicines: products are regulated either under the UK Cosmetics Regulation or as medicinal products overseen by the Medicines and Healthcare products Regulatory Agency, depending on their primary intended function and claims. Any claim to treat or prevent disease, or to exert a pharmacological effect, triggers classification as a medicine. Similarly, in the USA, the U.S. Food and Drug Administration states that ‘cosmeceutical’ has no meaning under federal law, which recognizes only drugs, cosmetics or products that are both.1 Despite this binary framework, an expanding cohort of topical products sold outside the prescription setting is now supported by mechanistic data and clinical studies approaching pharmaceutical standards. Dermatology can no longer dismiss this space as mere marketing; rather, it must define what level of evidence justifies clinical endorsement within a permissive regulatory environment.
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McGrath et al. (2026) studied this question.
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