Zeno's Blog

It really is just not good enough to supply loads of papers — scientific or otherwise — to the Advertising Standards Authority when your claims are challenged.

In an adjudication published today on an advert for the ‘pro-biotic drinking yogurt’ Actimel, the advertiser (Danone) supplied a plethora of 23 papers to try to substantiate the claims they made in their advert.

The papers did seem to have a lot going for them. They were:

…human studies conducted on over 6000 people across different age ranges. [Danone] said that of those studies, eight had been carried out on children up to 16 years of age.

So far, so good. At least they were not trying to get away with customer satisfaction surveys, letters to the editor, etc or other evidence the ASA sensibly reject.

However, after establishing that the advert clearly conveyed that the advert was claiming that children would benefit from Actimel, they rejected all the adult studies and noted that Danone tried to maintain that it was the totality of their evidence that should be the prime consideration:

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.

The ASA sensibly responded:

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.

They then went on to look at each of the eight papers. Some got thrown out immediately because they were irrelevant to the claims being made on healthy children:

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.

Another:

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.

More are rejected:

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.

This time because of the age range:

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.

Wrong dose:

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.

Again, papers reporting on children with an underlying health condition could not be used to substantiate claims about healthy children:

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.

And the last two (unpublished) studies:

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.

…and again, the wrong dose:

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.

So, the ASA concluded, despite the plethora of evidence supplied by Danone to substantiate their claims:

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.

So, even supplying a plethora of evidence, it has to be robust and must apply directly to the group about which you are making claims.

I note, however, they are still citing the same studies on their website — out of the reach of the ASA.

I wonder if they have a paper leaflet they can send me?