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.
Before submitting any evidence to CAP, marketers must first check that their claims are legal under medicines law (Rule 12.11) or food law. If the Medicines and Healthcare products Regulatory Agency (MHRA) classes a product as medicinal, either by function or presentation, marketers need to obtain a marketing authorisation from it before selling that product in the UK. 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. See ‘Medicines: General’.
The MHRA Borderline Section will advise whether a product is medicinal and can be contacted at: Borderline Section, 16-1, MHRA, Market Towers, 1 Nine Elms Lane, London SW8 5NQ; Tel: 020 084 2759, Fax: 020 7273 2439 or by e-mail at info@mhra.gov.uk
Once they are certain their claims are not medicinal, marketers need to ensure they hold evidence to support their claims (Rule 12.1). As a general rule of thumb, claims to “maintain”, “help maintain” or “support” health are unlikely to be considered medicinal claims (they are known as “health maintenance” claims. But claims that a product can “cure”, ”restore” “prevent”, “prevent” “avoid”, “fight” or “heal” are likely to be considered as medicinal. 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 “clinically proven” might imply that a product has met the relevant efficacy test in relation to a disease or an adverse condition.
The MHRA publishes on its website decisions about products found to be either medicinal by function or medicinal by presentation (or both). See www.mhra.gov.uk under ‘Final Determinations’
The Copy Advice team frequently advises against claims such as “burns fat”, “increases metabolic rate” and “boosts the immune system”. And the ASA regularly rules against advertisers making medicinal claims for unauthorised products (Healthy for Life, 2 July 2008; Goldshield Ltd, 7 May 2008; The Nutrition and Health Institute, 9 April 2008, and Health & Living Foundation, 29 August 2007).
In 2007, the ASA considered a TV ad, for Danone Activia, that included the claims “Want to beat that bloated feeling?” and “… 82% of people with digestive discomfort said they felt better [by eating the product]”. The MHRA complained because it believed the ad made unacceptable medicinal claims. But Danone Activia is a food and food legislation differs from medicines legislation. The ASA considered that a medicinal claim was one that conveyed the impression, expressly or implicitly, that the product had the qualities of a medicinal product. To establish what constituted a medicinal product and its qualities, the ASA considered, among other factors, EU and UK law, including Directive 2001/83/EC on the Community code relating to medicinal products for human use and the Food Labelling Regulations 1996. It considered that bloatedness and digestive discomfort were common consequences of healthy digestion and the claims were therefore unlikely to be seen as medicinal. (Danone UK Ltd, 21 November 2007). Marketers of foods should ensure that their marcoms comply with food legislation.
Marketers would not only break rule 12.11 if they made medicinal claims for unauthorised products but also risk breaching rule 12.2, which states that marketers should not discourage essential treatment. They should not offer specific advice on, diagnosis of or treatment for conditions for which medical attention should be sought.
Rule 12.6, introduced to reflect Annex practice 17 of the Consumer Protection Regulations, states that marketers should not falsely claim that a product is able to cure illness, dysfunction or malformations.
Last modified : 26 July 2010