Outlined in the MHRA requirement, any product must obtain a marketing authorisation license from the government body before they can be sold on the UK market.
The Agency will only issue a license if clinical trials have proved; that the medicine successfully treats the condition it was developed for, its side effects are acceptable and meet high safety and quality standards.
According to the MHRA, the nasal spray has failed to undergo any clinical tests and is being advertised and sold illegally online, in beauty salons and gyms.
“The product came to the Agency’s attention as a complaint and has since received further referrals from Trading Standards Service,” a spokesperson for MHRA told CosmeticDesign.com.
“Putting your health on the line just in order to get a tan is just really not worth the risk”, said David Carter, head of MHRA’s Medicine Borderline section in a recent statement.
Adding; "None of these products have been clinically tested and as a result there is no way of knowing just how serious the side effects could be, or the impact on your health.”
Tests carried out by the MHRA; found that samples of the product revealed to contain melanotan II, “an unlicensed medicine with no evidence that it actually works or is safe in addition to unknown side effects”, say the government body.
Its origins in terms of who makes the product, who distributes it, are unknown.
On the other hand, Ubertan’s website describes their product as “entering the body's system safely through the nasal cavities and in turn heightening your own natural melanin in your skin.”
Also alleging that; “This process comes into its own when your skin is exposed to any type of UV light either natural sunlight or tanning beds and also protects the skin from burning. Enjoy looking and feeling great in a safe way.”
They were unavailable for comment despite CosmeticDesign-Europe.com’s efforts to contact them.
"A product can be a medicinal product either by function or presentation", says Mr. Frederic Vincent, spokesperson for 'health & consumer policy' at the European Medicines Agency.
"It is the competence of the Member States to decide on the classification of an individual product. In this case, it seems that the UK has decided that it is a medicinal product. In order to be legally on the market, a medicinal product must have a marketing authorisation", he added.
On a European level, Vincent says he does not know how the other member States classify this product.
"Not all products are eligible for the central (EU) marketing authorisation, based on an EMA assessment. Products such as Ubertan are unlikely to fall within this centralised procedure", he concluded.
In the meantime, the MHRA has instructed a number of retailers and websites to stop marketing the product and to cancel all advertising on the internet as well as social websites. While Carter also advises, “If you have this product at home do not use it again, throw it in the bin. And if you have used it and you have concerns then speak to your GP”.