Illegal Botox crackdown heightens urgency to regulate

Louise Fullwood of Pinsent Masons was commenting following a warning issued by the Medicines and Healthcare products Regulatory Agency (MHRA) that sellers of unlicensed botulinum toxin products – commonly known as Botox – could face up to two years in prison and unlimited fines.

The UK medicines agency said in a statement that it was prepared to exercise its powers under the Human Medicines Regulations 2012 to crack down on illegal Botox traders after a spate of botulism cases from unlicensed Botox left more than 40 people hospitalised across England between 4 June and 6 August.

The popularity of non-surgical cosmetic procedures (NSCPs) has soared across the UK, but increasing reports of botched treatments that have left people maimed, injured and requiring hospital treatment has spurred recent proposals in both Scotland and England to further regulate and licence these types of non-invasive treatments.

Although the UK government pledged in August to introduce tough new measures in England to regulate procedures such as ‘Brazilian butt lifts’, Botox and fillers, Fullwood, a medical law expert at Pinsent Masons, said the latest incidents underlined the need for faster government action. “The process of getting in place the new regulations in this area needs to be sped up as this is still in a second consultation stage and with no regulations yet tabled,” she said. 

Fullwood said the continued lack of overarching regulation in England had led to a “piecemeal” approach being adopted by different regulators across the sector in a bid to protect consumers from rogue traders.

While the MHRA has launched several criminal investigations into illegal trading of Botox products, in April the General Pharmaceutical Council (GPhC) issued its own guidance warning that all pharmacists who prescribe, supply and administer these types of products must have “appropriate training”. Since 1 June, the Nursing and Midwifery Council (NMC) has also required all registered members across the UK who are licensed to prescribe prescription treatments, including Botox and fillers, to carry out face-to-face consultations before offering such treatments.

Even with these safeguards, the growing normalisation of these cosmetic procedures has heightened the risk of consumer harm, with too many people still at risk of falling through the gaps in regulation, said Fullwood. “It would be better if we could get the new regulation through, which could take a stronger and broader approach to much-needed regulation of this sector,” she said. “There are risks and these medical products and medical procedures should not be comparable in the public’s mind with things like getting a haircut or a manicure.”

Separate to the developments in England, the Scottish government has proposed its own plans to bring in further regulation of NSCPs by the end of 2025. Wales introduced its own licensing regime for four special cosmetic procedures in November 2024, although this did not extend to beauty procedures like Botox or fillers.