Probiotics

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.

European Nutrition and Health Claims Regulation

Marketers must ensure they are familiar with European Regulation (EC) No 1924/2006 on Nutrition and Health Claims Made on Foods which applies to all health and nutrition claims made in commercial communications, whether in the labelling, presentation or advertising of foods.  It is our understanding that, because the term "probiotic" refers to a function of the body, the claim "contains probiotics" is likely to be seen as a health rather than a nutrition claim. 

The European Union Register of Authorised health claims now exists, however it is not yet complete.  The Register can be viewed here:

http://ec.europa.eu/food/food/labellingnutrition/claims/community_register/authorised_health_claims_en.htm

Once the Register is complete, the only health claims which will be acceptable will be those on the Register.  Until then the ASA will continue to investigate claims that are not listed on the Register (and have not been specifically rejected) and will require advertisers to provide substantiation to support them.

We understand that marketers may now only make a nutrition claim if it appears in the Annex to the Regulation and if their products meet the criteria set out in the Annex.  Nutrition claims may differ in wording to those set out in the Annex but will still need to meet the relevant criteria.  The Annex to the Regulation can be found here:

http://ec.europa.eu/food/food/labellingnutrition/claims/community_register/nutrition_claims_en.htm

Marketers should be aware that any claims deemed to provide a nutritional benefit to the consumer are likely to be considered “nutritional claims” and should therefore seek guidance from the Department of Health if they suspect they are making such a claim.  The Department of Health has produced guidance in relation to the application of the Regulation see http://www.dh.gov.uk/health/2011/11/health-claim/ for further information.

Rule 15.6 of the CAP Code refelects the fact that under the Regulation, marketers may, for the first time, make disease risk reduction claims.  However the only acceptable claims of this type are those on the Register:

http://ec.europa.eu/food/food/labellingnutrition/claims/community_register/authorised_health_claims_en.htm

Aside from approved disease reduction claims, claims that state or imply a food prevents, treats or cures human disease are not acceptable in marketing communications for food products (Rule 15.6.2).

The situation in relation to producing marketing communications under the Regulation is complex and continues to develop.  Owing to changes in the timescale, certain aspects of the Regulation which have been incorporated into the CAP Code are not yet in force. Please contact the Copy Advice team if you have any questions in relation to the status of particular rules of the CAP Code.

General Background regarding Probiotics for consideration during transitional periods

Probiotic products usually contain so-called “friendly bacteria” such as lactobacilli and bifidobacteria. CAP is aware that consumers might benefit from specific bacterial species and strains but that the exact manner in which many claimed benefits are achieved is still the subject of some speculation. Marketers should take care not to overstate any claims (Rule 12.1 and the CAP Help Note on Substantiation for Health and Beauty Claims) and, generally, should have peer-reviewed, double-blind, placebo-controlled experiments, on humans.

CAP understands that probiotics (featuring a proven strain) could have an effect on the make-up of intestinal flora and aid in the digestion of some food components, but that levels of intestinal flora are influenced by a wide range of factors and can vary from person to person. Marketers should therefore not imply a general floral imbalance across the population of the UK or exaggerate the need for individuals to enhance their concentration of certain components of intestinal flora. Marketers should make only conditional claims to avoid implying that everyone will definitely benefit in the same way. Marketers should also avoid implying that probiotics can help gut function that may be disturbed as a result of specific factors such as menstruation (Yakult UK Ltd, 18 May 2005).

CAP acknowledges the existence of research on both prebiotics and synbiotics. Claims made in relation to the marketing of those types of products require similar substantive evidence to that described for probiotics. To date neither CAP nor the ASA has seen evidence to show the direct effects of prebiotic consumption on the immune system or general health. In a 2006 investigation into claims made for follow-on milk for infants, the ASA assessed a wide body of evidence for prebiotics and their effects on immunity; the evidence was largely associative and did not show causality. That said, the marketer – Cow & Gate – was able to show that their prebiotic (a unique oligosaccharide mix) could build an infant’s defences against atopic dermatitis (Nutricia Ltd t/a Cow & Gate, 8 November 2006). Marketers wishing to make similar claims would need to hold product-specific evidence because Cow & Gate’s evidence naturally related only to their unique mix.

Last modified : 29 March 2012

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