Confusion surrounds the legality of melatonin as an ingredient in health and beauty products in the UK, after Superdrug and Boots were found offering products containing melatonin that the Medicines and Healthcare products Regulatory Agency (MHRA) insist should not be sold.
Melatonin, a sleep aid, is a prescription-only medicine in the UK, but available to purchase over the counter in the US and elsewhere.
Last week an investigation by Which? revealed products using melatonin as an ingredient were being sold on Superdrug Marketplace, and other popular websites, including Amazon Marketplace and Temu.
All companies who sent a response to Which? either claimed that the products were being removed or were in the process of being reviewed.
Superdrug, however, defended the “melatonin skin patches” sold on Superdrug Marketplace, and told Which?: “Topically applied products that contain melatonin as one of their ingredients are widely available for general sale across the UK.
“We have contacted the Medicines and Healthcare products Regulatory Agency (MHRA) for clarification on the guidelines for including melatonin as an ingredient within topically-applied products.”
Clarification
But C+D found after publication of the Which? investigation that Superdrug was still selling a different type of melatonin skin patch, the “Friendly Co. Relief Joint and Muscle” patches, containing 6.5mg of melatonin.
Superdrug was asked by C+D about these patches and also whether they had heard from the MHRA regarding the legality of topical products such as these.
Superdrug said in response: “The product referenced is no longer available for purchase on Superdrug Marketplace.
“We have not yet received further clarification from the MHRA. Once we receive updated guidance, we will take appropriate action where necessary.”
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After then searching Superdrug.com for ‘melatonin’ C+D was subsequently offered several more melatonin-containing products on general sale to UK customers.
These include products such as the Organic Shop’s “Sleeping Calming Whipped Body Butter” and “Sleeping Moonlight Relaxing Body Scrub”.
Two of the melatonin-containing products were sold via Superdrug and not Superdrug Marketplace, which hosts third-party sellers.
Boots
Searching ‘melatonin’ on the Boots website immediately directs shoppers to the Boots Doctor Jet Lag Treatment prescription service.
But elsewhere on the Boots website, one of the melatonin items available on Superdrug, the Vichy Mineral 89 Moisture Recovery Night Cream, which is offered by Superdrug in packaging labelled ‘Pure Melatonin’, was also available.
Despite C+D informing them of the MHRA’s stance that these products should not be for sale in the UK, both Superdrug and Boots believe UK Cosmetic Regulations permit them.
Classified
Superdrug said: “Cosmetic products that contain melatonin as one of their ingredients are widely available for general sale across the UK.
“Under UK Cosmetic Regulation, melatonin is not classified as a controlled ingredient provided that its function is strictly cosmetic.
“We are awaiting formal clarification of this cosmetic position from the MHRA and we will take action where necessary in line with MHRA guidance.”
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It also sent through guidance from the Cosmetic Toiletry & Perfumery Association (CTPA), which said: “Melatonin is not listed in Annex II (prohibited substances) or Annex III (restricted substances) of the UK, and EU, Cosmetics Regulation.
“Therefore, it can be used in cosmetic products provided that its use in and the finished cosmetic product are safe – as determined above.”
Boots said: “Cosmetic products that contain melatonin for functions such as antioxidants are permitted for use in the UK.
“To our knowledge melatonin is not banned or restricted for use in cosmetic products and is in line with guidance from cosmetic regulatory bodies.
“For any more specific product information you can try reaching out to the brand.”
“Skincare or otherwise”
Asked by C+D whether these types of products were allowed for sale in the UK, the MHRA said: “Melatonin is a prescription only medication in the UK and if it was an ingredient in a product, skincare or otherwise, it would be considered a medicine.”
C+D clarified whether this included cosmetic items such as “creams”, “shower gels” and “moisturisers”, to which the MHRA said, “no products containing melatonin should be used without a prescription, this includes skincare.”
The General Pharmaceutical Council’s (GChP) chief pharmacy officer, Roz Gittins, said: “The MHRA is the lead regulator responsible for the legal classification of medicines.
“We work closely with the MHRA, and if any concerns are identified in this area relating to pharmacies, pharmacists or pharmacy technicians, we will investigate.”
