MEDICAL-GRADE MYTH

Is “medical-grade” cosmetics a term without definition?

There is a particular kind of language that the beauty industry has become very good at, one that sounds authoritative without quite committing to anything.“Clinically inspired”, “dermatologisttested”. These phrases occupy a useful grey zone where scientific credibility meets marketing flexibility. “Medical-grade cosmetics” is perhaps the most successful of them all, and almost certainly the most misleading.

It is not that the products described this way are necessarily inferior. Some are genuinely well-formulated, well-researched, and effective.

The problem is the label/term which implies a regulatory status that simply does not exist. From a legal standpoint, calling a cosmetic “medical-grade” is almost like calling a car “aviation-standard” because it has a particularly good GPS system.

The comparison sounds meaningful but lacks a factual basis.

WHAT THE LAW ACTUALLY SAYS

Under European Union law, cosmetics are governed by Regulation (EC) No 1223/2009 Article 1(a), which defines a cosmetic product in straight forward terms as: any substance or mixture intended to be placed in contact with the external parts of the human body – skin, hair system, nails, lips – for the purpose of cleaning, perfuming, changing their appearance, or protecting and maintaining the body in good condition.1

What is worth noting about this definition is not just what it includes, but what it intentionally excludes. A cosmetic cannot claim to treat, prevent, or cure disease. That distinction is fundamental.

Article 2 makes this even clearer, confirming that the scope of the regulation applies strictly to cosmetic products: it does not extend to medicinal or biocidal products.1 Classification is not based solely on what the product contains; it is determined by a combination of intended use, claims and presentation.

A high concentration of an active ingredient does not make something medical. A clinic shelf does not make something medical. Only meeting the legal definition of medicinal product does that.

The definition sits on the other side of a meaningful regulatory divide. According to the European Medicines Agency, a medicinal product is one that is intended to treat or prevent disease, or to restore, correct or modify physiological function through pharmacological, immunological, or metabolic action, including products used for medical diagnosis.2

In the UK, responsibility for making this determination sits with the Medicines and Healthcare products Regulatory Agency (MHRA).

The MHRA’s position on skin-facing products is clear: formulations intended to treat or prevent conditions such as eczema, psoriasis, dermatitis, or acne are medicinal, not cosmetic.3 And crucially, regulators do not examine the ingredients list when making that call. They look at the claim – both explicit and implied – at the primary intended purpose, and at how the product is being presented across its labelling, advertising and professional recommendation.

A recent enforcement action brought this principle into sharp focus. The Advertising Standards Authority banned adverts for LED face masks that used language such as “treating acne and rosacea” to describe the effects of at-home red light therapy devices.4

The devices themselves had not changed. What attracted the ban was the terminology, because that terminology implied a medicinal function the products were not authorised to claim.

WHERE THE BOUNDARY BLURS

One of the clearest illustrations of how classifications work, and how quickly it can shift, is the humble anti-dandruff shampoo. A standard shampoo is without question, a cosmetic. Add in a claim that the product treats dandruff or scalp dermatitis and the regulatory picture changes entirely. The formulation may be almost identical, but the difference lies within the language.

This is not a technicality. It is the governing principle of cosmetic regulation language determines classification, and classification determines what is legally permissible. If incorrectly used, that language can attract regulatory action – a point that practitioners and brand marketers often underestimate.

Sunscreen is another instructive case. In the UK , sunscreen ingredients may be included without SPF claims. For example, protection against “premature aging” may be suggested rather than an explicit reference to skin cancer prevention. These choices are what keep a product within cosmetic regulation.1

CHEMICAL PEELS: THE REGULATORY BLINDSPOT

Few areas expose the limits of cosmetic regulation as clearly as chemical peels. In clinical practice, peels are categorised by depth: superficial, medium, or deep, and these categories reflect dramatically different mechanisms, risk profiles and practitioner requirements. A low-strength gentle exfoliating peel aimed to work superficially and a high-acid formulation capable of causing significant epidermal injury sit worlds apart in clinical terms.

However, regulatorily, they may occupy exactly the same category.

If a peel is presented as improving the appearance of the skin and does not claim to treat disease or exert pharmacological action, it will be regulated as a cosmetic, regardless of its actual risk profile. This creates an uncomfortable gap.

Products that carry meaningful different risks share the same legal designation and burden of risk management falls to clinicians rather than the regulatory framework.

The idea of creating a third category-sitting between cosmetics and medicinal products has been debated for years. In theory, it would allow high-risk aesthetic products like chemical peels to be governed more appropriately. In practice, this would require years of legislative development, substantial financial investment, new governing bodies and international harmonisation. It is not a realistic near-term solution.

In the meantime, the industry relies on distribution controls and professional accountability. Many peels are marketed explicitly for professional use only, which signals risk even if the regulatory status remains unchanged.

"Professional-only” is not a legal classification, but it is a meaningful piece of communication to clients."

So where does “medical-grade” fit? It does not. The term carries no legal standing in cosmetic regulation. It is not recognised by the European Commission, the EMA, or the MHRA. A cosmetic does not become medicinal because it sold in a clinic, recommended by a doctor or formulated with high concentrations of active ingredients. Unless it meets the legal definition of a medicinal product – which depends on purpose and claim, not format or setting – it remains a cosmetic.

Confusion persists partly because “medical-grade” is a legitimate designation in other regulated contexts. Medical-grade honey for example, is a genuine regulatory classification: it is approved for wound care based on purity, sterility and intended medical use. Medical-grade polymers are manufactured to meet specific medical standards for use in medical devices. However, in skincare, the term is typically used as marketing language rather than a reflection of a regulatory classification or clinical approval.

THE COSMECEUTICAL PROBLEM

A similar issue exists with the term “cosmeceuticals” – coined as a portmanteau of cosmetics and pharmaceuticals by Dr Albert Kligman in 1984, to describe a topical preparation sold as a cosmetic but with performance characteristics suggestive of pharmaceutical action.5

Over time, the word has been stretched considerably. It now tends to function as shorthand for “science-led” or “superior” skincare, regardless of whether the product actually sits in any meaningful grey zone.

The problem is that cosmeceuticals do not formally exist in European Law.

Regulatory authorities classify such products as cosmetics unless medical claims are made.1

Despite this, consumers often assume cosmeceuticals are tested or regulated like drugs, which is simply not the case.

The US Food and Drug Administration take a different approach, recognising over-the-counter drug products that consumers can use without professional intervention.6

This does not translate directly to the EU or UK frameworks, where division between cosmetics and medicines remains distinct and binary. However, the growing cosmeceutical market across both regions reflects the genuine consumer appetite for scientifically advanced skincare – even in the absence of a category that formally accommodates it.

NATURAL IS NOT A FREE PASS

One more layer of complexity comes from the clean beauty movement, where botanical and herbal ingredients often carry an implicit promise of safety – because that is natural. It is worth stating clearly that this assumption does not hold.7

At low concentrations, plant extracts often function primarily as marketing tools depending on consumer trends and ingredient storytelling. At higher concentrations some botanicals raise genuine safety concerns and require an entirely different regulatory assessment. Toxicity at a given percentage can shift a cosmetic towards medicinal territory or “unsafe” within a surprisingly narrow margin.

"Natural origin is not a regulatory buffer. It is simply a formulation characteristic. "

WHAT LANGUAGE SHOULD WE BE USING?

This is where the conversation becomes genuinely useful for practitioners and brands alike. The challenge is not formulation quality – many professional skincare products are excellent. It is how that quality is communicated.

WHAT ACTUALLY MAKES A SKINCARE PRODUCT ADVANCED?

It might be a higher or more complex combination of actives. It might be years of research and development, peer-reviewed data behind an ingredient, or a sophisticated delivery system that allows compounds to penetrate more effectively and target specific concerns. These are real and communicable differentiators.

“Medical-grade” persists because it fills a linguistic gap, it is compact, authoritative sounding, and intuitively understood by consumers to mean something better. The problem is that it does so inaccurately.

Terms like “advanced formulation skincare” or “targeted cosmetics” communicate expertise and innovation without implying medical treatment or regulatory status that does not exist.

“High-performance” was considered as an alternative though it is worth noting that this may also require clinical substantiation depending on how it is used.

From a marketing perspective this is not a limitation but an opportunity. The aesthetic patient and the engaged skincare consumers are increasingly informed, and increasingly sceptical of inflated claims. Transparency builds more trust than ambiguity. Regulatory literacy, when it is demonstrated through brand communication, signals credibility. Advanced skincare does not need to borrow the language of medicine to justify itself. It needs to be well-formulated, well-evidenced, and

Scan for references: positioned with clarity. That is where long-term trust- and long-term commercial success actually comes from.

CARLY MUSLEH

Carly Musleh is a cosmetic scientist, NPD consultant and marketing strategist with over 17 years of experience across global beauty brands. She is completing an MSc in Digital Marketing and Analytics at the University of Sunderland, where she also is an academic tutor.