ASA Adjudication on Danone UK Ltd

Ad

A TV ad, for Actimel, showed a bottle of the product jumping over a skipping rope and featured the sound of children playing in the background. A voice-over stated "Kids love Actimel and it's good for them too". The ad then featured the sound of children cheering. The voice-over continued "Actimel. Scientifically proven to help support your kids' defences". The final image showed the text "Scientifically proven" stamped on the screen.

Issue

One viewer challenged whether the claim that Actimel was "scientifically proven to help support your kids' defences" could be substantiated.

BCAP TV Code

Response

Danone UK Ltd (Danone) explained that Actimel, which contained Lactobacillus casei, was a pro-biotic drinking yogurt intended for consumption by the general population (children, adults and the elderly). They said the health benefits of Actimel had been demonstrated in 23 human studies conducted on over 6000 people across different age ranges. They said that of those studies, eight had been carried out on children up to 16 years of age.

Danone explained that the health benefit of the product was its support of the human body's natural defence system, which helped to protect us against pathogens and harmful environmental factors. They said that some of the most important defence systems were located within the gastrointestinal tract, and were made up of three key components. Firstly, intestinal microbiota, which directly keeps the activity of some pathogens under control (microbial barrier), secondly the intestinal epithelium, which represents a physical barrier able to prevent the intrusion of unwanted agents, and finally the intestinal immune system, which is able to react to pathogens (immunological barrier).

Danone said they had referred to Actimel as being "scientifically proven" in their ads since November 2007, and that the basis for that claim was a significant body of published scientific evidence that showed that Actimel supported the natural defences of different age groups, including children. Danone said the body of evidence should be considered in its totality, and not judged as a group of individual papers. They argued that each individual study did not need to demonstrate multiple health benefits, as long as they pointed towards a positive effect for Actimel overall. Danone said that Clearcast had approved an earlier claim made in 2006 that stated "Every morning I like to give my kids Actimel to help support their bodies' natural defences". They said Clearcast's nutritional consultant was satisfied that the evidence showed that Actimel could support the body's defences in that particular age group; they said that view was also supported by UK and international scientific experts. Danone provided us with copies of the evidence used to support the claims made in the 2006 ad.

Danone said the claim made in the current ad was also supported by new studies that added to the scientific proof for the benefits of Actimel. They explained that those studies had not been completed, or made available to Clearcast, at the time the ad was approved, but that they had since been presented to Clearcast and their nutritional consultant. Danone explained that, because those trials were still awaiting publication, they had asked for independent advice from external experts in order to confirm the validity of their interpretation of the studies' results. Danone submitted copies of those recent studies, as well as two letters from experts who had reviewed the studies and data from one of those experts on the immune systems of children.

Clearcast said they received substantiation for the claim from Danone, which was assessed by their nutritional consultant. They said their consultant was satisfied that the claim had been supported, and they had approved the ad on that basis.

Assessment

Upheld

The ASA took expert advice.

We considered that the image in the ad of the bottle of Actimel jumping over the skipping rope, together with the sound of children playing in the background, would be understood by most consumers to imply that the product was aimed at normal, healthy children of school age (five to sixteen years old). We also considered that most consumers would understand the claim that Actimel "was scientifically proven to support your kids' defences" to mean that the product would help defend those children against common, every-day childhood infections.

We acknowledged Danone's comments regarding the totality of their evidence. We considered, however, that it was necessary to assess the accuracy and relevance of each individual study in order to be able to assess the merits of the body of work as a whole.

We noted the five scientific studies submitted in support of the claims made in the 2006 ad. We noted that two of those studies, though well-designed, examined the effect of Actimel on hospitalised children in India suffering from acute diarrhoea or receiving medication for chronic Helicobacter pylori respectively. We considered that both trials were unsuitable for use in support of a claim that was likely to be seen as referring to normal, healthy children.

We noted that one of the five trials, Guerin-Danan et al. (1998), was a randomised, controlled study that assessed the effect of consumption of Actimel on the faecal microflora of children aged between 10 and 18 months. We understood from the expert that the impact of Actimel on the health of the child subjects, or their immune systems, was not assessed in the study. We therefore considered that the study did not support the claim made in the ad that Actimel supported children's natural defences.

We noted that two of the five studies were produced by the same research group, Pedone et al. (1999) and (2000). We noted that the 1999 study showed that consumption of Actimel had a slight effect on the duration of diarrhoea in children but that the sample size used was too small to show any effect on the incidence of diarrhoea. Conversely, the larger 2000 study did show a benefit for Actimel on the incidence of diarrhoea amongst the child subjects, but the study observed no effect for Actimel on the duration of diarrhoea. We also noted that the children studied by the Pedone group were between six and 33 months old, with a mean age of six months in the 1999 study and 15.5 months in the 2000 study, and we considered that that age-group was lower than the target group of school-age children suggested by the ad. We understood that the immune systems of children aged two and over were likely to be representative of the immune systems of older children. However, we also understood that the developing immune systems of children under two differed from those of older children, and we therefore did not consider that it could be safely assumed that the results reported for the young children in the Pedone studies would be the same for school-aged children. We noted that the children in the studies were supplemented with either Actimel or the control product in portion sizes that were larger than the recommended serving size of one 100 g pot of Actimel per day, and we were therefore concerned that the observed benefit for Actimel in the clinical trials might not be representative of the efficacy of the product when consumed on an 'everyday' basis. We considered that the inconsistency in the results between the two studies, the young age-group of the participants and the portion sizes used in the trials meant that the studies were not sufficient to support the claim that Actimel supported the natural defences of school-age children.

We noted the three recent studies submitted by Danone in support of the current ad. We noted that one published study, Giovannini et al. (2007), assessed the effect of Actimel on the occurrence and duration of a range of symptoms, including asthma, rhinitis, diarrhoea, nausea and vomiting, abdominal pains and fever, in children aged two to five years who suffered from allergic asthma and allergic rhinitis. We noted that no health benefit was reported for the group of asthmatic children taking Actimel. We understood from our expert that the study reported a reduction in the number of episodes of rhinitis and reduced duration of diarrhoea in children with allergic rhinitis in the Actimel group, although the difference between the Actimel and control groups was small. We considered that the fact the children in the study suffered from allergic conditions meant that the results of the study could not necessarily be extrapolated to apply to normal, healthy children.

We understood that the final two studies were unpublished trials designed to assess the rate of change in activity due to illness, and the cumulative number of all Common Infectious Diseases (CIDs), in children aged three to six years in day care centres in Russia and America. We acknowledged that the Russian study did show a benefit for Actimel in the cumulative number of rhinopharyngitis (common cold) episodes. However, we also noted that there were no statistically significant differences between the Actimel and control groups in the number of CIDs as a whole, or in the rate of change in activity due to illness. We noted that the American study reported a benefit for Actimel in the cumulative number of CIDs during the three-month study, although we also noted that the difference in the rate of change in activity due to illness between the Actimel and control groups was not statistically significant, and that no other differences were reported between the two groups. We also noted that in both studies the child participants were given doses of Actimel or control products that were twice as large as the recommended daily serving size of 100 g. We considered that the Russian and American studies showed that some children might see a beneficial effect when consuming twice the recommended daily serving of Actimel. However, we also considered that the ad was making an absolute claim that Actimel would support the defences of children, and that the reference to "your kids" in particular would be understood by consumers to mean that Actimel would benefit their child. Because we understood that some children would not see a benefit from consuming Actimel, and because we were concerned that any observed effects for Actimel in the trials might not be representative of the efficacy of the product when consumed in line with the recommended daily serving, we considered that the Russian and American studies were not sufficient to substantiate the claim made in the ad.

We considered that the evidence provided by Danone did not support the claim made in the ad that a serving of Actimel was scientifically proven to support the defences of normal, healthy school-aged children against common, every-day childhood infections. We therefore concluded that the ad was misleading.

The ad breached CAP (Broadcast) TV Advertising Standards Code rules 5.1 (Misleading advertising), 5.2.1 (Evidence) and 8.3.1 (a) (Accuracy in food advertising).

Action

The ad must not be broadcast again in its current form.

Adjudication of the ASA Council (Broadcast)