HPRA alert on dangerous Melanotan 2 in self-tanning products

On June 27, 2022, the Health Products Regulatory Authority (HPRA) published an alert about the serious health risks linked to the substance Melanotan 2. The HPRA is the Irish Competent Authority responsible for cosmetics, medicines, and medical devices, and as such, it is in charge of post-market surveillance.

Melanotan 2 in self-tanning products

Melanotan 2 (MT2) is a synthetic substance that stimulates melanogenesis, which was first studied as a medicine to cure sexual dysfunctions. However, the scientific community interrupted the research due to the severe adverse effects linked to the use of this drug: stroke, vision loss, and anaphylaxis. Hence, at the moment, MT2 is not authorized as a medicine.

MT2 also affects tanning since it stimulates melanin production. Thus, recently, there have been many online advertisements about self-tanning products that contain MT2. These items are illegally commercialized as cosmetic products. In fact, they are in the form of injectable powder, nasal spray or drops to be inhaled or absorbed from under the tongue and, therefore, cannot be classified as cosmetic products. According to Article 2 of the EU Cosmetics Regulation, cosmetic products can only be used on the external parts of the human body, teeth, or mucous membranes of the oral cavity. Clearly, MT2 products do not meet this requirement.

In this regard, between January 2020 and June 2022, the HPRA ordered the removal of over 500 social media or e-commerce advertisements for these products, and it is prosecuting other cases of non-compliance. Furthermore, “the HPRA is advising any consumers who have used these products not to use them again and to seek advice from their doctor regarding any health concerns” (HPRA, 2022).

Post-market surveillance in the EU

In the EU, Competent Authorities do not approve cosmetic products before commercialization. Indeed, the Responsible Person (RP) shall ensure they are safe. Nevertheless, Competent Authorities perform an in-market control: they systematically monitor that the products available on the EU market are compliant (Article 22 of the EU Cosmetics Regulation). In case of non-conformities, they can fine the beauty brand, order the withdrawal and even ban the marketing of the products.

As a beauty brand, you should appoint a professional Responsible Person to assist you through the compliance process. Your RP will check the Product Information File (PIF) to confirm it meets the EU requirements and act as the contact point for the Competent Authorities.

Obelis, with over 30 years of experience, is a perfect choice! Contact us Today to appoint us as the Responsible Person for your cosmetic products.

Francesca Santacatterina

Publications Department



– HPRA. (2022). HPRA highlights serious health risk of ‘Melanotan 2’ self-tan products. Retrieved on 28/07/2022 from https://www.hpra.ie/homepage/medicines/news-events/item?t=/hpra-highlights-serious-health-risk-of-melanotan-2-self-tan-products&id=b9db1126-9782-6eee-9b55-ff00008c97d0

– Wein, Kavoussi, Novick, Partin, Peters. (2011). Campbell-Walsh Urology. Tenth Edition. Retrieved on 29/07/2022 from https://books.google.be/books?id=W1aeyJD46kIC&pg=PA743&redir_esc=y#v=onepage&q&f=false

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