FOI release

Freedom of Information request on regulating CBD products (FOI 22/567)

Published 14 June 2022

FOI 22/567

8th April 2022

Dear

Thank you for your email.

The Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices and blood components for transfusion in the UK. It is unclear what is meant by products in the wellness/nutraceutical category however we would typically consider these to refer to food supplements and/or cosmetics products. These products would fall outside the remit of the MHRA and we therefore would not hold any information on these product types.

Food supplements and cosmetics are regulated locally by the Trading Standards Service. Furthermore, cannabis is a Class B controlled drug under the Misuse of Drugs Act 1971 and products containing cannabis would be dealt with in the UK by Home Office. It may also be worth noting that advertising which includes unsubstantiated claims may be in breach of advertising regulations and would be for the Advertising Standards Agency (ASA) to advise on.

Medicinal claims are not permitted for non-medicine products. If a product is presented with medicinal claims it would likely satisfy the First Limb of the definition of a medicinal product and require a marketing authorisation prior to being sold, supplied or advertised in the UK. Part of the marketing authorisation procedure would include the substantiation of any claims being made for the product.

The Agency does investigate complaints received for unauthorised CBD products being marketed with medicinal claims. During the period 2017-2021, the MHRA Borderline team dealt with 222 cases relating to CBD containing products which satisfied the definition of a medicinal product. In such cases the MHRA would issue a letter to the company advising them that the product satisfies the definition of a medicinal product and request that they voluntarily comply by either removing the product or the medicinal claims. Failure to do so may result in our proceeding to determine the product as a medicine in accordance with Part 9 of The Human Regulations 2012. It will be normal practice to publish material details of all final determinations. The following link provides details of Regulation 165 Notices issued from June 2016 – September 2019. This is due to be updated shortly to include details of Notices issued since September 2019 and will be available on the Borderline page of the MHRA website: https://www.gov.uk/guidance/borderline-products-how-to-tell-if-your-product-is-a-medicine.

If you have a query about the information provided, please reply to this email

If you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date you receive this response and addressed to: info@mhra.gov.uk

Please remember to quote the reference number above in any future communications.

If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:

Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF

Yours sincerely

MHRA Customer Experience Centre