This article is from Ask the Expert, Exchange magazine issue 169 (September 2018)
Christine Clark, independent pharmaceutical consultant, says: ‘Commercially available products that are applied to the skin are either medicines or cosmetics. Medicines and cosmetics are used for different but often related purposes. Both categories are subject to tight regulation in the UK and the rest of Europe.
A medically licensed product is one that has a marketing authorisation (also known as a licence) as a medicinal product. This indicates that it has been through a rigorous assessment process to establish that it is safe and effective. It will be licensed for use in specific conditions. If a doctor chooses to prescribe it differently, this is known as ‘unlicensed’ or ‘off-label’ usage and the doctor is held responsible for prescribing it.
A medicine is defined by the Human Medicines Regulations as a product that prevents or treats disease by means of a ‘pharmacological, immunological or metabolic action’. Once licensed as a medicine, claims can be made, such as ‘for the treatment of…/immunisation against…/prophylaxis of…’ Such claims may not be made for cosmetics.
Licensed medicines fall into several categories: prescription-only medicines (POM), pharmacy (P), general sales list (GSL) and medical devices. Many emollients are licensed as medical devices because their main mode of action is believed to be through physical means, that is, skin barrier enhancement. Licensed medicines can be prescribed at NHS expense if they are also listed in The Drug Tariff (although local formulary restrictions might apply).
Cosmetics regulations are by no means a lightweight alternative. The European Directive and the Medicinal and Healthcare products Regulatory Agency (MHRA) define a cosmetic product as one that is ‘intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours’.
Before placing a cosmetic product on the market, the manufacturer must notify the European Commission through the Cosmetic Products Notification Portal (CPNP) and provide a dossier of specified information. It is an offence to supply an incorrectly labelled cosmetic product or a product that may cause damage to human health. The label must include the name and address of the manufacturer/importer, the ingredients (in order of weight), durability marking, function and precautions.
A product cannot be both a medicine and a cosmetic. Medicinal claims may not be made for a cosmetic product. If a product has a therapeutic effect, it should be licensed as a medicine. Where there is doubt about whether a product is a medicine or a cosmetic, the MHRA makes the final decision. The claims made for cosmetic products must be limited to the action of the product and may include terms (for dermatological products) such as, ‘soothing’, ‘reduces skin tightness’, ‘helps to relieve itching’ and ‘complements acne therapy’.
The manufacturer must hold appropriate and adequate scientific evidence to substantiate an efficacy claim, whether explicit or implied. Although the purpose of both sets of regulations is to ensure that products are safe and effective, we (NES) recommend the use of medical emollients to treat eczema rather than cosmetic products, which often contain fragrance and other irritants.’