Note: This advice is given by the CAP Executive about non-broadcast advertising. It does not constitute legal advice. It does not bind CAP, CAP advisory panels or the Advertising Standards Authority.
A medicinal claim is a claim that a product or its constituent(s) can be used with a view to making a medical diagnosis or can treat or prevent disease, including an injury, ailment or adverse condition, whether of body or mind, in human beings and, where relevant, animals. Medicinal or medical claims and indications can only be made for a medicinal product licensed by the MHRA, VMD or under the auspices of the EMA, or for a CE marked medical device (Rule 12.1).
Determine the classification of your product
Deciding whether a claim is medicinal isn’t always straightforward and advertisers in doubt ought to contact the Medicines and Healthcare Products Regulatory Agency’s (MHRA) Borderlines team to establish the classification of their product prior to marketing it.
It’s a medicine
If the MHRA classes a product as medicinal, marketers need to obtain a licence before selling or marketing that product in the UK. Once the appropriate licence has been obtained, marketing communications for that medicine must conform with the licence and the product’s summary of product characteristics (SPC).
It’s not a medicine
Once they are certain their claims are not medicinal marketers need to ensure they hold evidence to support their claims (Rule 12.1). Claims that a product can “cure”, “restore”, “prevent”, “avoid”, “fight” or “heal” are likely to be considered as medicinal and advertisers should avoid making reference to them. The MHRA’s Guidance Note 8 gives useful examples of words that could be unacceptable, subject to the context in which they appear. Marketers should note that even claims such as “clinically proven” might imply that a product has met the relevant efficacy test in relation to a disease or an adverse condition.
It’s a food
Marketers may now make reduction of disease risk claims for food products but only those that appear on the EU Register of nutrition and health claims (the EU Register). For more information about such claims, please see Food: Reduction of disease risk claims.
See ‘Healthcare: Medical Devices’.
Updated 15 March 2016