FOI release
Botox botulism cases, unlicensed products and evidence supplied by Save Face and JCCP
This request was refused in part, so we didn't provide some of the information the requester asked for. This may include information where we can neither confirm nor deny that we hold it.
Case reference FOI2026/00952
Received 24 August 2026
Published 18 September 2026
Request
I am requesting recorded information concerning cases of iatrogenic botulism associated with cosmetic botulinum toxin treatment, and evidence or statistics supplied to the MHRA by Save Face and the Joint Council for Cosmetic Practitioners. This request follows public statements about the 2025 outbreak and the MHRA's subsequent Drug Safety Update of 15 July 2026. The JCCP has published the following statement concerning the 2025 cases: "Between 4 June and 14 July 2025, the UK Health Security Agency (UKHSA) confirmed 38 cases of iatrogenic botulism in England, which were traced to unlicensed or counterfeit botulinum toxin injections in nonclinical settings." Save Face has separately stated publicly that the number of Botox-related complaints it received increased by more than 350% between 2019 and 2024. It has also stated that, across its reporting years, more than 80% of complainants were treated by a non-healthcare practitioner and that recent complaints commonly concerned products not approved for use in the UK. The MHRA Drug Safety Update published on 15 July 2026 describes iatrogenic botulism following botulinum toxin treatment as rarely reported. It also identifies JCCP and Save Face among the organisations involved in stakeholder engagement. Against that background, please provide the following recorded information. For the period 1 January 2025 to the date of this request: The number of reports received by the MHRA concerning suspected iatrogenic botulism following cosmetic use of botulinum toxin, broken down by calendar year. Where held, the number of those reports that were subsequently: a. clinically confirmed as iatrogenic botulism; b. considered probable or suspected; c. not confirmed. For those cases, where recorded, the number involving: a. a botulinum toxin product authorised for use in the UK; b. an unlicensed or unauthorised product; c. a counterfeit product; d. a product whose identity or regulatory status could not be established. Where recorded, the name or brand of the product involved in each case, together with whether it was licensed, unlicensed, suspected counterfeit or unidentified. Personal information about patients is not requested. The number of relevant Yellow Card reports received during 2025 and 2026. The number of cases referred to, investigated by, or otherwise considered by the MHRA Criminal Enforcement Unit. Where this information is recorded, the professional status of the person who administered the product, including whether they were a doctor, dentist, nurse, pharmacist, other regulated healthcare professional, independent aesthetic practitioner, beautician, other practitioner category, or unknown. Where recorded, the treatment setting, including clinic, salon, home, mobile setting, other premises or unknown. Any statistical information, datasets, case summaries, complaint figures, briefings or other evidence supplied to the MHRA by Save Face concerning botulinum toxin, Botox-related complaints, unlicensed products, counterfeit products or iatrogenic botulism from 1 January 2024 onwards. Any equivalent statistical information, datasets, case summaries, complaint figures, briefings or other evidence supplied by the JCCP during the same period. Any recorded assessment, verification, checking or discussion by the MHRA concerning the methodology, provenance, reliability or evidential status of figures supplied by Save Face or JCCP. Correspondence between the MHRA and Save Face or JCCP concerning iatrogenic botulism, the 2025 outbreak, unlicensed or counterfeit botulinum toxin, or the July 2026 Drug Safety Update. Any recorded information showing what evidence led the MHRA to include Save Face and JCCP in the stakeholder engagement identified in the Drug Safety Update of 15 July 2026. Electronic copies are preferred. I am not requesting patient-identifiable information. Where records contain personal information, please redact that material and disclose the remainder rather than withholding documents in their entirety. If any part of this request would exceed the appropriate cost limit, please provide advice and assistance under section 16 of the Freedom of Information Act 2000 so that the request can be narrowed while preserving the principal questions concerning case numbers, product status and evidence supplied by Save Face and JCCP.
Response
See attached
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