OTC-Cosmetic Borderline

Some of the most expensive regulatory mistakes happen at the border between categories: a product sold as a cosmetic that the authorities consider a medicine, a product needlessly over-classified into a heavier regime, or a formula that is a cosmetic in one market and a drug in the next. The classification turns on claims and function, and it differs sharply between the EU, UK and US. Getting it right before launch is far cheaper than getting it wrong after.

How the line is drawn in the EU and UK

A cosmetic is defined by Article 2 of Regulation (EC) No 1223/2009 as a substance or mixture intended to be applied to the external parts of the body, the teeth or the mucous membranes, with a view to cleaning, perfuming, changing the appearance, protecting, keeping in good condition or correcting body odours. A product becomes a medicinal product under Directive 2001/83/EC by one of two routes: by presentation, meaning the claims present it as treating or preventing disease, or by function, meaning it restores, corrects or modifies physiological functions through a pharmacological, immunological or metabolic action. Either route is sufficient on its own, and the doubt provision settles overlap: where a product could fall within both the cosmetic and the medicinal definitions, it is regulated as a medicine. The MHRA in the UK, the member-state competent authorities, and the European Commission’s guidance on the borderline adjudicate the hard cases.

The recurring flashpoints are predictable. Anti-dandruff products tip over when they claim to treat a condition rather than improve appearance; anti-acne and certain intimate or antifungal products raise the same question; and depigmenting or whitening products containing actives such as hydroquinone are treated as medicinal. The claims and the actives are assessed together, because a benign formula can be pulled across the line by its wording alone.

Cosmetic or medical device

The line is not only to medicines. A product whose principal intended action is achieved by physical means, rather than by a cosmetic, pharmacological, immunological or metabolic action, can be a medical device under the EU Medical Devices Regulation (EU) 2017/745 or the UK Medical Devices Regulations 2002. Dermal fillers are regulated as devices, and some barrier or mechanically exfoliating products fall to be assessed there too. The device regime is more demanding than cosmetics, typically requiring conformity assessment and a notified body, so a borderline device classification is best identified before the product is built.

The US is different again

In the United States the classification is starker and is judged on intended use. A product is a drug under the Federal Food, Drug, and Cosmetic Act if it is intended to treat or prevent disease or to affect the structure or any function of the body. Several everyday categories fall on the drug side and are regulated as over-the-counter drugs under FDA monographs, administered through the OTC monograph order process: sunscreens, anti-dandruff shampoos, anticavity fluoride toothpastes, antiperspirants, acne treatments and skin protectants. These sit outside the cosmetic MoCRA pathway entirely and carry drug obligations instead, including monograph compliance and drug-establishment registration. A product can also be both a cosmetic and a drug at once, a moisturising sunscreen or an antidandruff conditioner being the classic examples, in which case it must satisfy both sets of requirements.

How we help

We assess the formula and the intended claims together, across each market a product is destined for, and tell you which category it belongs in where, the EU and UK on the cosmetic, medicinal or device line, and the US on the cosmetic or OTC-drug line. Where the aim is to stay a cosmetic, we set the claims and, if needed, advise on the formula so the product stays firmly on that side. Where the drug or device pathway is genuinely unavoidable, we flag it early, so the heavier regime is planned for rather than discovered at the border.