Cosmetics: Afamelanotide
The question
To ask the Secretary of State for Health and Social Care, if he will set out the legal status of the sale of tan- enhancing nasal products containing Melanotan II for cosmetic purposes.
Answered by Dr Zubir Ahmed
The Medicines and Healthcare products Regulatory Agency (MHRA) is required to determine whether products are medicines on a case-by-case basis, taking into account the definition of a medicine in The Human Medicines Regulations 2012, relevant case law, and any other evidence.
There are many products which modify physiological function but which are not medicinal products, and case law has established that products that do so while having no beneficial effects on human health cannot be medicines.
Melanotan II injections and pens are considered medicinal products due to their similarity to an authorised medicinal product and potential application to other medical conditions.
However, tan-enhancing nasal products, which are clearly marketed for self-tanning purposes and which do not have a medical purpose, do not fall under medicines regulations and therefore are not within the MHRA’s remit.
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