Summary of Council decision:
Two issues were investigated, both of which were Upheld.
A website, www.bimuno.com, advertised TRAVELAID and Bimuno Probiotic Powder, both digestive health products.
a. A page headed "SCIENTIFIC SUPPORT FOR TRAVELLERS' (sic) GOING ABROAD" stated "Bimuno...supporting digestive and immune health... The scientifically proven prebiotic... New research demonstrated that Bimuno could help support the gut health of travellers' abroad... people who took Bimuno before and during their time abroad, found significant support for their digestive system... Shown to help support your tummy whilst abroad... Helps stop bad bacteria from getting a hold".
b. A page headed "TRAVELAID-SUPPORTS YOUR TUMMY WHILE ABROAD" stated "Bimuno TRAVELAID can help support digestive health while abroad... helps encourage and sustain a healthy level of your gut's 'good bacteria' (Bifidobacteria) helping to prevent 'bad bacteria' from becoming established... unlike other prebiotics, or indeed probiotics it also had unique anti-adhesive properties, which help the body to drive out "bad" bacteria you may have consumed. By maintaining a favourable balance of 'good' versus bad you can help to keep your tummy happy on its travels".
c. A page headed "BIMUNO RESEARCH AND CLINICAL TRIALS" stated "It is only the 2nd generation prebiotic and as such offers additional functionality over and above its prebiotic and bifidogenic (boosting of good Bifidobacteria) effect...in order to identify the most effective molecules that would offer protection of the gut from infection and inflammation... A mixture of trans-Galactooligosaccharides reduces markers of Metabolic Syndrome and modulates the fecal microbiota and immune function of overweight adults... Results showed significant differences between B-GOS and the placebo group in the incidence of digestive problems, abdominal pain... Consumption of the tested galacto-oligosaccharide mixture showed significant potential in preventing the incidence and symptoms of TD... B-GOS increased the number of fecal bacteria at the expense of less desirable groups. Increases in fecal secretory IgA and decreases in fecal calprotectin, plasma C-reactive protein, insulin, total cholesterol (TC), triglycerides (TG) and the TC:HDL cholesterol ratio were also observed... Administration of B-GOS to overweight adults resulted in positive effects on the composition of the gut microbiota, the immune response and insulin, TC and TG concentrations. B-GOS may be a useful candidate for the enhancement of gastrointestinal health, immune function, and the reduction of metabolic syndrome risk factors in overweight adults... B-GOS significantly increased the numbers of beneficial bacteria, especially bifidobacteria, at the expense of less beneficial groups compared with baseline and placebo. Significant increase in phagocytosis, NK cell activity, and the production of anti-inflammatory cytokine interleukin-10 (IL-10) and significant reduction in the production of pro-inflammatory cytokines (IL-6, IL-1ß, and tumour necrosis factor-a) were observed... B-GOS administration to healthy elderly persons resulted in positive effects on both the microflora composition and the immune response. Therefore, B-GOS may be a useful dietary candidate for the enhancement of gastro-intestinal health and immune function in elderly persons...Addition of the novel galactooligosaccharide mixture significantly increased the bifidobacterial population ratio compared with the placebo (P<0.05), whereas 7 g/d of the novel galactooligosaccharide significantly increased the bifidobacterial ratio compared with the commercial galactooligosaccharide (P<0.05)... Moreover, a significant relation (P<0.001) between the bifidobacteria proportion and the novel galactooligosaccharide dose (0, 3.6, and 7g.d) was observed. This relationship was similar to the effect of the novel galactooligosaccharide on the prebiotic index of each dose...by using enzymes originating from bifidobacterial species, an increase in the bifidogenic properties of the prebiotic product is achievable".
d. A page headed "PREBIOTIC POWER FOR YOUR GUT" stated "Discover the valuable role unique prebiotic Bimuno powder can play in increasing and energising your good gut bacteria, helping you to manage your gut health...Studies have demonstrated Bimuno can significantly increase your good gut bacteria". A clickable link stated "MORE ABOUT BIMUNO ORIGINAL"
e. Clicking the "MORE ABOUT BIMUNO ORIGINAL" link redirected to another page headed "PREBIOTIC POWER FOR YOUR GUT", which stated "Bimuno original powder is the natural way to increase and energise your good gut bacteria helping you to manage your gut health. Bimuno works in a similar way to prebiotics naturally found in human breast milk which promote a healthy bacterial balance within the gut... This unique patented and highly effective prebiotic powder has been specially developed... for individuals who wish to maintain healthy digestive balance... Scientific studies indicate that the unique second generation Galacto-oligosaccharide formulation of Bimuno powder, can help to encourage and sustain a healthy level of your friendly gut bacteria (Bifidobacteria). In fact Bimuno has the most potent bifidogenic (Bifidobacteria promoting) effect of any available prebiotic. Published scientific studies have shown that, with daily use, the majority of Bimuno users experience a significant increase in their gut Bifidobacterium within just 7 days... it also helps flush 'bad' bacteria from your gut at the same time for a healthy gut balance... Bimuno powder: Increases your Bifidobacteria levels, helping to maintain a healthy intestinal balance...Energises your immunity supporting bacteria...Reduces harmful bacteria levels."
f. A page headed "SCIENTIFICALLY TESTED FOR DIGESTIVE HEALTH" stated "Bimuno can significantly increase-levels of Bifidobacteria (good bacteria) in the gut... Bimuno...is a truly unique prebiotic with a powerful Bifidogenic effect. It selectively boosts Bifidobacteria which play a key role in immune function and maintaining and building a healthy digestive system. The expertise behind BIMUNO...the immune system... symptoms associated with Irritable Bowel Syndrome (IBS)...Travellers' Diarrhoea...various aspects of human metabolism... Increases your good bacteria"
g. A page headed "TRAVEL TUMMY WOES" stated "Discover the secret to a happy travel tummy. Your body's natural defence against 'foreign tummy bugs' is the good bacteria in your gut. However whilst abroad, local drinks, climate and even the stress of travelling itself can affect your normal bacterial balance making you more vulnerable to 'bad' bacteria. Most people rely on measures they can take once the problem has occurred But is there another approach?"
The ASA received two complaints about the ad.
1. Which? Ltd challenged whether the health claims and reduction of disease claims made about Bimuno Prebiotic Powder were authorised on the EU Register of Nutrition and Health Claims for Foods (the EU register).
2. A member of the public challenged whether the health claims and reduction of disease claims made about TRAVELAID were authorised on the EU Register of Nutrition and Health Claims for Foods (the EU register).
1. & 2. Clasado Ltd noted that the recent publication of Commission Regulation 1017/2013 in the Official Journal of the European Union ratified the negative European Food Safety Authority (EFSA) opinion for the claim "Bimuno may reduce intestinal discomfort". However, they said that the Regulation also set out the provision of a six-month transition period for the use of the claim 20 days after its publication in the journal. They also understood that this transition period applied to claims that had the same meaning as the original claim, which they believed applied to claims such as "supporting your tummy while abroad". They said they sought to work within the scope of the Regulation, and believed that the claims on their website were legal and would continue to be so until the expiry of the transition period on 13 May 2014.
They said they continued to engage with EFSA and were making a further digestive health claim application addressing the scientific points that were highlighted in EFSA's rejection of their previous application. They said they had completed a large study that demonstrated that Bimuno had digestive health benefits.
1. & 2. Upheld
The ASA noted that under Regulation EC 1924/2006 on Nutrition and Health Claims made on Foods which was reflected in the CAP Code, health claims (claims that stated, suggested or implied that a relationship existed between a food category, a food or one of its constituents and health) could not be made unless they were authorised on the EU Register. We understood that Clasado believed there was a transition period that allowed them to continue making the claims in their advertising for six months after the publication of EC Regulation 1017/2013, which had confirmed that their application for authorisation for the claim "Bimuno may reduce intestinal discomfort" had been rejected. As that Regulation came into force on 13 November 2013, we understood Clasado should be able to make the rejected claim, and claims with the same meaning, until 13 May 2014.
However, we considered that a number of the claims in the ad appeared to go beyond that for which authorisation had been sought. We noted that the ad featured a range of health claims, for example "support your tummy while abroad" and "Discover the valuable role unique prebiotic Bimuno powder can play in increasing and energising your good gut bacteria, helping you to manage your gut health", which we considered did not have the same meaning as the rejected claim and were not authorised on the EU Register.
We noted that EC Commission guidance stated that a claim was a health claim "if in the naming of the substance or category of substances, there is a description or indication of a functionality or an implied effect on health" and, as an example, stated "the reference to probiotic/prebiotic implies a health benefit". We also noted that guidance from the Department of Health stated "… claims, such as 'probiotics and prebiotic fibre', refer to a function in the body, and are therefore defined as health claims and will need to be authorised via Article 13". We therefore considered that the terms "probiotic" and "prebiotic" were health claims, which must be authorised on the EU Register, and as they were not authorised health claims on the EU Register, we concluded that use of these terms was in breach of the Code.
We considered that the claim "Bimuno has the most potent bifidogenic (Bifidobacteria promoting) effect of any available prebiotic" also constituted a health claim, with a comparative element. We noted that to be acceptable, any such comparative health claims would themselves have to be authorised on the EU Register, which we understood was not the case.
We noted that the ad also contained reduction of disease risk claims (claims that stated, suggested or implied that the consumption of a food category, a food or one of its constituents significantly reduced a risk factor in the development of a human disease), which were only acceptable under the CAP Code if they were listed as authorised on the EU Register. For example, we considered the claim "Discover the secret to a happy travel tummy. Your body's natural defence against 'foreign tummy bugs' are the good bacteria in your gut ... Most people rely on measures they can take once the problem has occurred but is there another approach?" suggested that Clasado's products could reduce a risk factor in the development of disease. We noted that Clasado had not provided evidence that the reduction of disease risk claims in the ad were authorised by the European Commission.
We concluded that the ad contained health claims and reduction of disease risk claims for Bimuno Prebiotic Powder and TRAVELAID that were not authorised on the EU Register, nor were they a variation of the rejected claim to which the transition period applied, and the ad therefore breached the Code in those regards.
We also noted that on the "Bimuno Research and Clinical Trials" page of the website, under the heading "Irritable bowel syndrome", text stated "The galactooligosaccharide acted as a prebiotic in specifically stimulating gut bifidobacteria and is effective in supporting their digestive health", which we considered suggested that the product could be used to treat irritable bowel syndrome. Claims that a food supplement could treat, prevent or cure disease were not allowed under the CAP Code, and so we concluded that claim was also in breach of the Code.
The ad breached CAP Code (Edition 12) rules
Marketing communications that contain nutrition or health claims must be supported by documentary evidence to show they meet the conditions of use associated with the relevant claim, as specified in the EU Register. Claims must be presented clearly and without exaggeration.
Only nutrition claims listed in the updated Annex of the EU Regulation (as reproduced in the EU Register) may be used in marketing communications.
Only health claims listed as authorised in the EU Register, or claims that would have the same meaning to the consumer may be used in marketing communications.
http://www.ec.europa.eu/food/food/labellingnutrition/claims/community_register/authorised_health_claims_en.htm. 15.2 15.2 References to general benefits of a nutrient or food for overall good health or health-related well-being are acceptable only if accompanied by a specific authorised health claim. 15.6.2 15.6.2 Claims that state or imply a food prevents, treats or cures human disease. Reduction-of disease-risk claims are acceptable if authorised by the European Commission and 15.7 15.7 Nutrition and health claims for food supplements must be permitted or authorised as provided for at rule 15.1.1 above. Marketing communications that contain nutrition or health claims must be supported by documentary evidence to show they meet the conditions of use associated with the relevant claim as specified in the EU Register. (Food, food supplements and associated health or nutritional claims).
The ad must not appear in its current form. We told Clasado Ltd to remove health claims that did not have the same meaning as the claim "Bimuno may reduce intestinal discomfort", to which a transition period applied, from their advertising. We also told Clasado Ltd not to make other health claims or reduction of disease risk claims that were not authorised on the EU Register. We told them not to make claims that foods could prevent, treat or cure disease.