Prescription Drugs: Artificial Sweeteners

The Medicines and Healthcare products Regulatory Agency (MHRA) does not issue specific guidance mandating the reduction or removal of sugar from prescription medicines. Decisions on formulation, including the use of sugars or artificial sweeteners as excipients, are made by manufacturers but are subject to MHRA assessment as part of the marketing authorisation process to ensure that medicines meet appropriate standards of safety, quality, and efficacy. In practice, sweeteners may be required to ensure medicines are palatable and acceptable to patients. The safety of excipients, including artificial sweeteners, is considered during licensing, and their use must be appropriately justified. Where relevant, information is included in product information to support healthcare professionals in advising patients, including those who may have sensitivities or intolerances.

The MHRA’s role is to regulate medicines to ensure that they are acceptably safe, of suitable quality, and effective, rather than to determine individual product formulations. Manufacturers are responsible for developing medicines, including decisions on the use of excipients such as artificial sweeteners, which must be justified and are assessed as part of the licensing process. The MHRA requires that excipients are clearly described in product information, enabling prescribers to take account of patient-specific factors, including any known intolerance. Where alternatives are available, prescribing decisions can be made to select the most appropriate formulation for the patient. The MHRA continues to work with partners across the system to support the availability of a broad range of medicines to meet patient needs.