News Category: Regulatory news
The Health Products Regulatory Authority (HPRA) is today alerting the public of the serious health risks posed by using the unauthorised substance Melanotan 2 often described as a self-tanning aid on social media and on the internet. The substance, also known as Melanotan, Melanotan II, or MT2, is being sold as an injectable powder, nasal spray or drops. Melanotan 2 is not authorised by the HPRA or any medicines regulator to treat any condition, including for the purpose of changing skin colour. 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.
The HPRA has noted a marked increase in activity on social media illegally advertising and offering Melanotan 2 products for sale. Between January 2020 and June 2022, over 500 social media or e-commerce listings relating to Melanotan 2-containing products were removed by the HPRA. The HPRA is also actively engaging with international social media platforms with the goal of limiting the sale and promotion of these products.
As Melanotan 2 has not been authorised as a medicine, there is no guarantee of its safety, what it contains and how it is manufactured. Despite the manner in which products containing Melanotan 2 may be presented to consumers they are not cosmetic products. Products intended to be inhaled, injected or absorbed from under the tongue cannot be classified as cosmetics.
Concerning health effects arising from the use of Melanotan have been reported here and internationally. These include the development of new moles, darkening of existing moles and freckles, vision loss, stroke, muscle tremors and anaphylaxis.
According to Grainne Power, Director of Compliance with the HPRA, there is increased growth in social media activity in relation to this substance. This, in turn, has resulted in increased HPRA enforcement activity to stem supply with the need also to raise awareness among the public of the dangers of using Melanotan 2.
“Consuming Melanotan 2 presents a real risk to your health. We urge people to consider the fact that there is no supporting safety data available for this substance before they inject it into their body or inhale it into their lungs. Melanotan 2 is not an authorised medicine in any form; it is not available in any pharmacy or any mainstream retail outlet. However, we are seeing the growth of marketing and promotion akin to a cosmetic product, using images of glamour and golden tans, and offering simple ‘tanning injections’ or ‘nasal sprays’ to replicate an aspirational body image. The promotion, advertising or sale of Melanotan 2 via online sources or social media platforms is in effect selling a dangerous substance that has not been declared safe for human use and is illegal. There is no data to support any safe use in any form and anyone using it is taking huge personal health risks,” says Ms Power.
The HPRA is responsible for prosecuting cases where it considers that there is a significant risk to public health or where there are persistent non-compliances. There has been consistent enforcement activity in relation to Melanotan, including successful prosecutions.
Members of the public can report suspicious activities around the supply of Melanotan and other health products to the HPRA, in confidence, by emailing email@example.com or by calling 01 634 3871 or 01 634 3431. The HPRA website contains further information for consumers on the dangers of purchasing prescription medicines online.
The HPRA has also published a corresponding safety notice relating to the dangers of using Melanotan 2.
Our advice to anyone using Melanotan is to stop immediately. If you are concerned that you have experienced ill effects from using Melanotan, we recommend you speak to your doctor. You can also use our online form to report such effects to the HPRA.
For further information
Káno Communications Tel: (01) 679 8600
Siobhán Molloy / Kathryn Moley (086) 817 5066 / (086) 733 4438