Glutathione and Unlicensed Medicines Used in Cosmetic Procedures

Product: Glutathione IM/IV 600mg including Tatonil® and similar.

This advisory is intended for the guidance of all individuals providing services using parenteral glutathione, for prescribers who authorise its use and for all organisations importing and/or supplying the medicine for cosmetic purposes. It may also be of interest to members of the public responding to marketing associated with the product.

The Joint Council for Cosmetic Practitioners (JCCP) and regulators have long had concerns about the parenteral use of glutathione for procedures without any medical or therapeutic purpose, and we note that these concerns have more recently taken an international perspective. Glutathione is commonly promoted for various cosmetic indications, including skin whitening and brightening, as well as for various purported well-being benefits. There is little clinical evidence to support any of these claims and little understanding of the risks. For the purposes of this guidance, common wellbeing indications such as ‘detox’, ‘immune support’ and ‘energy boost’ are considered as cosmetic indications.

Glutathione is licensed for therapeutic use in several countries. In Italy it is approved for prophylactic use during chemotherapy and elsewhere it has been used for the treatment of liver disease. The MHRA advise that Tatonil does not possess a Marketing Authorisation for use in the UK, and therefore the regulations associated with unlicensed medicines apply.

In previous guidance, the JCCP remind prescribers that when prescribing unlicensed medicines, they must only do so when there is no suitable licensed alternative available to meet the patient’s needs. The MHRA further advise that where an indication is ‘strictly cosmetic’:

Special needs must be medical in nature and unable to be met by an available equivalent licensed product. Cosmetic use is therefore not an admissible special need. MHRA 2016

The JCCP therefore advise that practitioners and prescribers should consider their definition of ‘special need’ in this context, and not prescribe unlicensed medicines including glutathione in the absence of a clinical diagnosis and therapeutic indication. In this context, practitioners should further consider their obligations towards CQC registration, as well as the additional restrictions imposed in relation to the promotion of unlicensed medicines.

The importation of unlicensed medicines for purely cosmetic purposes is not permitted. Therefore, for those organisations, including pharmacies, who import and supply glutathione and other unlicensed medicines for use within the cosmetic sector, we advise that you should consider the context in which you are importing and supplying the medicine. This is particularly the case where pharmacies operate principally within what could be considered strictly cosmetic online platforms.

This guidance has been shared with the MHRA to confirm accuracy.