The Medicines and Healthcare products Regulatory Agency (MHRA) has issued an official warning on the illicit trade in unlicensed botulinum toxin products.
Released on August 30, 2025, the MHRA’s Criminal Enforcement Unit shares that this warning comes in response to 41 confirmed cases of botulism reported between June 4 and August 6. Affected regions include the North East, East Midlands, North West and Yorkshire.
According to the MHRA’s Criminal Enforcement Unit, unlicensed botulinum toxin products are being illegally obtained by a number of sellers and practitioners, then administered in informal and unregulated environments, including domestic kitchens and hair salons. The unit noted that these procedures are often promoted via social media platforms, where individuals are drawn in by adverts promising quick results at low cost.
The Criminal Enforcement Unit is currently investigating these illegal operations. Under the Human Medicines Regulations 2012, those found guilty of selling or supplying unlicensed botulinum toxin may face up to two years in prison and unlimited fines. This action forms part of the MHRA’s broader campaign to combat the illegal supply of botulinum toxin. Since May 2023, the agency has seized over 4,700 vials of unlicensed products, the majority of which originated from South Korea. These include brands not authorised for sale in the UK, such as Botulax, reNTox, Innotox and Toxpia.
Andy Morling, head of the MHRA’s Criminal Enforcement Unit, commented, “Criminals are exploiting the popularity of cosmetic treatments by peddling dangerous, unlicensed products, putting profit before safety. We are working across the country to identify those responsible, seize illegal products and bring cases to court. We use the full range of our enforcement powers and techniques to shut down these operations and bring offenders to justice.”
Dr Alison Cave, pharmacologist and chief safety officer of the MHRA, commented, “Botulinum toxin is a prescription-only medicine and should only be sold or supplied in accordance with a prescription given by an appropriate prescriber, such as a doctor or other qualified healthcare professional. Buying botulinum toxin in any other circumstances significantly increases the risk of getting a product which is either falsified or not licensed for use in the UK. This means that there are no safeguards to ensure products meet the MHRA’s standards for quality and safety.”
