Botulinum toxin and dermal fillers in the UK: how they are regulated

Botulinum toxin products are licensed for specific medical and cosmetic uses. Because they are prescription-only, a prescriber must assess the patient and prescribe, taking responsibility for the decision. The General Medical Council gives guidance on cosmetic interventions, including the need for appropriate consultation, consent and reflection time. The Advertising Standards Authority and MHRA take action against advertising of prescription-only medicines to the public, including social media posts that name products or promote price offers.

Fillers, such as hyaluronic acid products, are medical devices, which are regulated through conformity marking, now UKCA or CE, and the MHRA is responsible for market surveillance. They do not need a prescription, which is one reason that they are widely offered. Product quality still matters, and counterfeit or unregulated products have been reported. Practitioners should be able to tell you the product name and show batch information.

There is no general licensing scheme in England at present for non-surgical cosmetic procedures, though the government has legislated powers to introduce licensing. This means practitioners can vary widely in training. Voluntary registers and standards exist, and professional regulators set standards for registered healthcare professionals. Always check registration and ask about training and insurance.

The Botulinum Toxin and Cosmetic Fillers (Children) Act 2021 made it an offence in England to administer these treatments for cosmetic purposes to under 18s, and to arrange such treatment. Penalties can apply. Similar rules in the other nations differ, so check local law. Medical use of botulinum toxin for conditions such as spasticity in children is separate.

• Botulinum toxin: bruising, headache, drooping of eyelid or brow, asymmetry, rarely spread of effect causing swallowing or breathing problems.

• Fillers: swelling, lumps, infection, delayed nodules and, rarely, blockage of blood vessels causing tissue damage or blindness.

• Vascular occlusion is an emergency requiring immediate treatment, often with hyaluronidase for hyaluronic acid fillers.

• Allergic reactions are uncommon but possible.

• Results are temporary and may require repeat treatment.

Report suspected side effects to the MHRA through the Yellow Card scheme, which covers medicines and medical devices. Report concerns about a practitioner to the relevant regulator. In England, concerns about registered providers can go to the Care Quality Commission. The advertising regulator handles misleading ads.

Ask who will prescribe the botulinum toxin, whether you will be assessed by them and how they can be reached after treatment. Ask for the product name and batch number to be recorded in your notes. For fillers, ask which product will be used, what to do in an emergency and whether hyaluronidase and a written complication plan are available on site. Ask about insurance and how complaints are handled. If a practitioner cannot answer plainly, consider taking longer to decide.