Misleading Marketing of Skincare Cosmetics as Medicines: Regulatory Gaps, Consumer Risks and Recommendations for Safer Practice

Background: The global beauty and personal care industry has grown substantially, with market valuations exceeding USD 500 billion in recent years. Concurrently, a subset of skincare products marketed as cosmetics employ labelling, packaging, and claims that closely resemble those of approved medications. This practice, sometimes referred to under the informal industry term ‘cosmeceuticals’, exploits regulatory distinctions between cosmetics and drugs and can expose consumers to delayed medical care, adverse effects from undeclared ingredients, and financial waste. Objective: This review examines the regulatory frameworks distinguishing cosmetics from drugs under United States and Indian law, analyses common categories of misleading claims and packaging strategies, summarises documented health risks associated with adulterated or misbranded products, and outlines practical guidance for clinicians and consumers. Methods: Narrative review of regulatory definitions and guidance from the US Food and Drug Administration (FDA), the Indian Drugs and Cosmetics Act, 1940 and Cosmetics Rules, 2020, Central Drugs Standard Control Organisation (CDSCO) materials, World Health Organization (WHO) reports on hazardous ingredients, published analyses of warning letters, and selected clinical literature on adverse events linked to unapproved topical products. Key findings: Under both US and Indian law, product classification is determined primarily by intended use. Cosmetics are limited to cleansing, beautifying, or altering appearance; drugs are those intended to diagnose, cure, mitigate, treat, or prevent disease or to affect the structure or function of the body. The term ‘cosmeceutical’ has no legal meaning in either jurisdiction. Documented problems include undeclared corticosteroids in ‘acne’ or ‘eczema’ creams, mercury in skin-lightening products, high-concentration acids sold without appropriate safeguards, and unsubstantiated structure/function claims. Regulatory oversight of cosmetics remains predominantly post-market in both systems, in contrast to the stricter requirements applied to drugs. Conclusions: Clearer consumer education, clinician awareness of common marketing tactics, routine scrutiny of ingredient lists and formal drug labelling panels, and continued regulatory enforcement are needed to reduce harm. Products claiming therapeutic benefit without meeting drug requirements should be treated with caution and, when clinically indicated, replaced by evidence-based prescription or over-the-counter medications.