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Understanding the Crackdown on Unlicensed Botulinum Toxin in the UK

Updated: Dec 19, 2025


The UK has taken significant steps to combat the illicit trade in unlicensed botulinum toxin. Following a surge in hospital admissions during the summer of 2025, the Medicines and Healthcare products Regulatory Agency (MHRA) initiated criminal investigations. Offenders now face up to two years in prison and unlimited fines under the Human Medicines Regulations 2012. Since May 2023, over 4,700 vials of unlicensed toxin have been seized, with many traced back to South Korea.


The Importance of This Issue


Between June and August 2025, the UK Health Security Agency (UKHSA) reported 41 confirmed cases of iatrogenic botulism linked to cosmetic injections. Patients exhibited symptoms such as slurred speech, difficulty swallowing, and respiratory issues. Several individuals required intensive care. Epidemiological investigations indicated that unlicensed products and non-clinical settings were involved.


The MHRA’s Criminal Enforcement Unit highlighted organised networks supplying unlicensed neurotoxins. Untrained injectors offered low-cost treatments in homes and salons. The seized products included Botulax, reNTox, Innotox, and Toxpia, none of which are authorised for use in the UK.


Licensed Toxin Brands in the UK


The UKHSA lists the botulinum toxin products currently licensed for aesthetic purposes as follows: Alluzience, Azzalure, Bocouture, Botox, Letybo, Nuceiva, and Relfydess. This expansion from the previous six to seven brands in 2025 is corroborated by independent sources and the MHRA product listings.


Important Compliance Reminder: All botulinum toxin products are prescription-only medicines. They cannot be advertised to the public and must only be supplied following a face-to-face consultation with a prescriber. Full documentation, including batch and lot numbers, is required.


How to Identify Safe Practices


To ensure a safe treatment experience, consider this three-step mental model:


  1. Place: Treatment should occur in a clinical setting equipped with resuscitation equipment and written emergency protocols. Yellow Card reporting is available for adverse events.

  2. Person: The practitioner must be a registered healthcare professional. A prescriber should be involved face-to-face before any toxin is supplied.

  3. Product: Ensure the use of a UK-licensed brand with sealed packaging. Batch and lot numbers should be recorded in your notes. Be sceptical of unusually low prices or “kitchen-table” offers.


Our Commitment at Haus of Ästhetik


At Haus of Ästhetik, patient safety and legal compliance are our top priorities.


  • Governance: We provide prescription-only treatments only after a prescriber consultation. This includes identity checks, medical history assessments, cooling-off periods, and complete documentation of batch numbers and expiry dates.

  • Sourcing: We obtain medicines exclusively through MHRA-regulated UK suppliers. We audit invoices and serials and maintain provenance records for traceability.

  • Environment: All procedures are conducted in a clinical room equipped with an anaphylaxis kit, oxygen, and written escalation pathways. Any complications are reported through appropriate channels, including the Yellow Card scheme where relevant.


Evidence-Based Alternatives We Offer


Many clients seek aesthetic enhancements that can be achieved without the use of prescription-only medicines (POMs). Our offerings include:


  • Bioremodeling HA Treatments (e.g., Profhilo): These treatments improve hydration and skin firmness through high-molecular-weight hyaluronic acid. They are ideal for addressing crepey texture and loss of radiance.

  • Polynucleotide Biostimulators: These medical-device class products support dermal repair and enhance skin glow through extracellular matrix signalling and hydration.

  • Microneedling with Mesoestetic Protocols: This technique stimulates collagen production and improves fine lines and superficial scarring.

  • Chemical Peels and LED Treatments: These address skin tone, texture, and photoaging with minimal downtime when appropriately selected.


These options can be combined in a staged plan to meet your aesthetic goals while avoiding exposure to illicit neurotoxin supply chains. If a prescriber determines that a toxin is clinically appropriate, it will be provided under prescription using a UK-licensed brand with full documentation.


What to Do If You Experience Concerns After Treatment Elsewhere


If you notice eyelid or facial droop, slurred speech, difficulty swallowing, or breathing issues after an injection, seek urgent medical attention. Clinicians should consider the possibility of iatrogenic botulism and liaise with the UKHSA. Any suspected product issues can be reported to the MHRA’s Yellow Card scheme.


Conclusion: Prioritising Safety in Aesthetic Treatments


The crackdown on unlicensed botulinum toxin in the UK highlights the importance of safety and compliance in aesthetic treatments. By choosing licensed practitioners and products, you can enhance your natural beauty with confidence. Always prioritise your health and well-being when considering aesthetic procedures.


Key References


  • MHRA. Crackdown on illegal “Botox”; 30 Aug 2025. Seizure totals and penalties under the Human Medicines Regulations 2012.

  • UKHSA. Iatrogenic botulism outbreak associated with aesthetic procedures; HPR vol.19 issue 8; Aug 2025. Case numbers and investigation summary.

  • UKHSA. News: UKHSA issues warning over botulism; 18 Jul 2025. Public health alert and actions.

  • Guardian. Sellers of fake Botox jabs could be jailed for two years; 30 Aug 2025. Media overview of enforcement and risks.

  • UKHSA Research Portal. Local outbreak linked to unlicensed product with higher-than-label potency; 2025.

  • MHRA CEU and partners. Seizures and enforcement updates, overview pieces.

  • JCCP information sheet on licensed UK toxins; context on brands used in aesthetics.

  • Medicines.org.uk EMC. Ingredient and product listings for botulinum toxin type A, including Relfydess.


By staying informed and vigilant, we can all contribute to a safer aesthetic landscape.

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