Are polynucleotides safe in the UK?

Polynucleotide products sold in the UK are generally CE- or UKCA-marked medical devices, overseen by the Medicines and Healthcare products Regulatory Agency (MHRA). They are not licensed medicines, so unlike botulinum toxin they do not require a prescription.

The procedure itself is only lightly regulated. In England there is currently no legal requirement for a person injecting a non-prescription cosmetic device to hold a healthcare qualification. The Government has consulted on a licensing scheme for non-surgical cosmetic procedures in England, and Scotland and Wales have been developing their own approaches, but a UK-wide licensing regime is not yet fully in force.

Some elements are regulated: it is illegal to give dermal fillers or botulinum toxin to under-18s for cosmetic purposes, and in Scotland independent clinics run by healthcare professionals must register with Healthcare Improvement Scotland. In England, CQC registration applies to certain regulated activities but not to most purely cosmetic injecting.

Published studies and clinical reports describe polynucleotide injection as well tolerated over weeks to a few months, with local reactions that settle spontaneously. Serious adverse events are rarely reported in that literature.

Those studies are mostly small and short. They do not tell us much about rare complications, about long-term effects of repeated courses over many years, or about how safety differs between brands and injection techniques. Absence of reported harm in small studies is not the same as demonstrated long-term safety.

There is also no comprehensive national register of cosmetic injectable complications in the UK, so real-world rates are not well known. Adverse incidents can be reported to the MHRA via the Yellow Card scheme.

• Check the practitioner on a recognised register: the JCCP practitioner register, Save Face, or the statutory registers held by the GMC, NMC, GDC or GPhC.
• Confirm they hold current medical malpractice and indemnity insurance.
• Ask for a face-to-face consultation and a written medical history before any injection.
• Ask which product will be used, and see the sealed, in-date packaging.
• Check the setting is clinical: clean, private, with sharps disposal and hand hygiene.
• Ask what happens if there is a complication, who you contact out of hours, and whether they can access emergency drugs and onward medical support.
• Declare any fish or seafood allergy, pregnancy or breastfeeding, autoimmune conditions and all medication.

More detail is on who can administer polynucleotides in the UK.

• Long-term data beyond a year or two of repeated treatment is essentially absent.
• True complication rates in everyday UK practice are unknown because reporting is voluntary and incomplete.
• Product quality varies, and products bought through unofficial online channels may not be genuine or properly stored.
• Safety in pregnancy and breastfeeding has not been studied, which is why treatment is usually postponed.
• Much of the published work is linked to manufacturers, which is a recognised source of bias.

A reasonable summary: the material itself has a good short-term safety record in the published literature, the procedure is low-risk in trained hands, and the main avoidable dangers in the UK come from poor practitioner selection and unregulated settings. See also side effects.