ASA Adjudication on Nutricia Ltd

Ad

A magazine ad, for Aptamil follow-on milk, showed a picture of a mother and a baby and stated "Your baby's natural immune system. We've done the research, he's doing the development". Underneath the picture, text stated " ... After 50 years of research into breastmilk, our Aptamil research experts have developed IMMUNOFORTIS, a patented mix of special prebiotics. This unique formulation helps to support your baby's natural immune system, making it the best follow on milk." On the following page, the text continued " ... Its unique formulation helps to support your baby's natural immune system and makes Aptamil the best follow on milk for babies aged 6 months and beyond IMMUNOFORTIS: Supported by science Intensive work has shown that IMMUNOFORTIS, the patented mix of special prebiotics in Aptamil Follow on milk, supports your baby's natural immune system ... ". A graphic illustration was shown beside this text; it had two bars next to an axis with the text "support for the immune system" and implied follow-on milk containing immunofortis provided twice as much support for the immune system than follow-on formula milk without prebiotics.

Issue

A representative of Baby Milk Action and a member of the public challenged:

1.  whether the claim "best follow on milk" was misleading, because they believed Nutricia could not show that Aptamil follow-on formula was superior to all other formula milks on the market; and

2. whether the claims "This unique formulation helps to support your baby's natural immune system ..." and  "Intensive work has shown that immunofortis ... supports your baby's natural immune system" could be substantiated.

3. The member of the public also challenged whether Milupa could substantiate the implication of the "graphic illustration" that Aptamil follow-on milk offered a superior level of support to the immune system than all follow-on milks without prebiotics.

CAP Code

Response

1. Milupa said the claim "best follow on milk" was a clear and specific comparison with other follow-on milks in the UK market; it did not include all infant milks, but follow-on milks only.  They explained that all follow-on milks had to comply with European Community (EC) law and provided a copy of The European Commission's Scientific Committee's statement on the suitability and safety of their prebiotic mix. They said their patented formula of prebiotics, immunofortis, was the only one approved by the EC for inclusion in infant and follow-on milks.  They argued that, because their follow-on milk was the only one which included both prebiotics and nucleotides in the UK market, it was superior to all other follow-on milks available: they provided a comparison table of the ingredients and nutritional benefits of the follow-on milk that they believed supported that.

2. & 3. Milupa explained that the ASA already held a body of evidence from a former case, Cow & Gate follow-on milk, that showed the associative effect of prebiotics when used in follow-on formula.  They said the same patented mix of prebiotics was used in both Aptamil follow-on milk and Cow & Gate follow-on milk, both owned by their parent company Nutricia Ltd, and therefore the research and results of the patented prebiotics mix applied to both products.  They explained that Cow & Gate follow-on milk differed and did not contain nucleotides.  They pointed out that the expert the ASA had previously consulted had said a study that showed reduced incidence of atopic dermatitis in infants at high risk of allergy in the first six months of age had been well designed.  They explained that, since the previous case, a follow up study had been performed which indicated the children of the prebiotic group at two years old still benefited from the effects; they had reduced atopic dermatitis, bronchial symptoms and no acute cutaneous reactions.  They said those children also showed a lower number of general infections, ear infections and required fewer antibiotics.  They said they had used this information to produce the graphic illustration.

Milupa also sent a further study.  They said the new study was not limited to children with a family history of allergy and used immunofortis in a standard non-hydrolysed milk formula. They believed it provided compelling and consistent evidence that immunofortis reduced infections.  They acknowledged that the children in the study began taking the formula from 15 to 120 days but pointed out that all children received the special prebiotic mix in infant formula when they were older than six months.  They believed it was important to recognise the applicability of research conducted in infants under six months to older infants.  Milupa argued that, physiologically, there was a continuum in the development of infants in which nutrition played a crucial role. They believed there was no scientific rationale to support a strict distinction between development in infants under and above six months of age with respect to the effect of factors, such as nutrients, on growth and development.  They said immune system development proceeded along a continuum, and after the early neonatal period there was continued acquisition of immune competence up to and throughout the second year of childhood.

Nutricia asserted that the differences between infant formula and follow-on formula were relatively minor.  They said follow-on formula contained more iron and vitamin D and did not contain long chain fatty acids.  They asserted that those differences simply reflected the changes in the infant's innate stores of those nutrients or were to supplement the intake of nutrients at risk of deficiency from six months of age.  They believed the differences would not be confounders to the results demonstrated in the new study and, from an infection standpoint, the formulae could be considered identical.

Assessment

1. Upheld

The ASA noted The European Commission's Scientific Committee's statement made clear that further research was required on the beneficial properties of Milupa's prebiotic mix and that what they had reviewed had not shown indicators of adverse effects.  We noted Milupa's follow-on milk had both prebiotics and nucleotides, whereas other competitor brands did not have both.  We noted the ad stated "This unique formulation helps to support your babys natural immune system, making it the best follow on milk" and "Its unique formulation helps to support your babys natural immune system and makes Aptamil the best follow on milk...".  We therefore considered that the overall impression readers were likely to take from the ad was that, of all the follow-on milks available, Aptamil supported the immune system the best.  We noted the substantiation provided had not compared the immuno-supportive effective of Aptamil against its follow-on milk competitors and we concluded therefore that Milupa had not supported the comparative claim.

On this point, the ad breached CAP Code clauses 3.1 (Substantiation), 7.1 (Truthfulness) and 19.1 (Comparisons).

2. Upheld

We noted, in a previous ASA investigation, an expert had assessed trials on the same patented prebiotics mix as used in Milupa's follow-on milk and we concluded that the product, Cow & Gate follow-on milk, could build an infant's defences against atopic dermatitis and that Cow & Gate could claim their product could help build "some" but not "all" natural defences.  We noted the claim in Milupa's ad was "support(s) your baby's natural immune system" and considered this would be understood by readers as meaning the same as natural defences.

We sent Nutricia's evidence for the previous case, the follow-up study and the new study to a new expert.  The expert said that the main clinical study provided high quality evidence that supplementation of Nutricia's particular prebiotic mix to an extensively hydrolysed formula (formula that had been structurally changed so that it was less likely to cause allergic reactions) had some beneficial effect among infants of high risk of allergy; in terms of both the allergic manifestations and overall infection rates.  However, she said it had to be considered that the main study remained the only study with that particular prebiotic mix in that particular population.  Although absence of evidence did not mean absence of effect, it was not known whether the same effects would be seen with infants without a family history of allergy and when added to regular, unmodified cow's milk formula, i.e. not hydrolysed.  She said the evidence for that could only be provided through large scale population based clinical trials.   She said, in the absence of such evidence, extrapolation of the results found in one study with a characteristically different population of infants (high risk infants) using a different intervention (hydrolysed formula with Milupa's prebiotic mix) was not warranted.

We considered that the claims "This unique formulation helps to support your baby's natural immune system ..." and "Intensive work has shown that immunofortis ... supports your baby's natural immune system" implied that the Milupa follow-on milk available to the public (a non-hydrolysed formula) would have a proven effect in supporting all children's natural immune systems by working alongside children's immune systems.  We noted the main clinical study and follow-up study showed the effects on children at high risk of allergy using a hydrolysed formula.  In the previous investigation, the ASA had not considered that the results of the main study could not be extrapolated to support claims for healthy children using a non-hydrolysed formula.  Given the report by the new expert in this case, we considered that that evidence  was not sufficient to support the implied claims that Milupa follow-on milk available to the public would have a proven effect in supporting all children's natural immune systems.

We noted the new study used non-hydrolysed formula on children without a family history of allergy.  However, we also noted the infants in the study were given infant formula with immunofortis from the age of 15 to 120 days, whereas the ads stated the follow-on formula advertised was "the best follow on milk for babies aged 6 months and beyond".  Our expert said what was fed to an infant before four to six months would have a different effect to what was fed after six months.  She said it was not  known if feeding prebiotics after six months only, would have the same effect as feeding it from 15 days and continuing beyond six months.  The expert also said it was important to take the diet into account, especially the prebiotic and probiotic content of the weaning diet.  She pointed out that Milupa did exclude infants who received probiotics and prebiotics prior to the diet, but did not mention anything regarding confounding dietary factors during the study.  The expert said some foods, such as onions, garlic and tomato, were high in prebiotics and could potentially influence the data.  She said, although that could be disputed, there were no studies looking at the effect of prebiotics in weaning foods on the immune system.

The expert did not think the differences between infant formula and follow-on formula were likely to have an effect on the outcome of the new study, because the nutritional value of an infant formula compared to a follow-on formula was not that different.

Given the experts concerns about the age of the infants in the new study and diet they received, we considered that the evidence was not sufficient to support the implied claims that Milupa follow-on milk available to the public would support all children's immune systems when used from six months onwards. We considered that the ad was therefore misleading.

On this point, the ad breached CAP Code clauses 3.1 (Substantiation), 7.1 (Truthfulness), 19.1 (Comparisons) and 50.1 (Health & beauty products and therapies - General).

3. Upheld

We considered that the "graphic illustration" implied that Aptamil was better at supporting the immune system than all follow-on milks without prebiotics.  We noted Milupa's follow-on milk had both prebiotics and nucleotides, whereas other competitor brands did not have both.  We also noted the main evidence Milupa had sent showed that, compared to a placebo without prebiotics, a hydrolysed version of their follow-on milk could help lower the incidence of some allergic and infectious conditions in children with a history of allergy.  We noted the new study used non-hydrolysed formula on children without a family history of allergy, but the infants in the study were given infant formula with immunofortis from the age of 15 to 120 days.  We considered, however, that that was not sufficient to support the implication that Aptamil was better at supporting the immune system than all follow-on milks without prebiotics.  We considered that, because we had not seen substantiation that compared the immuno-supportive effective of Aptamil against all follow-on milks without prebiotics, Milupa had not supported the implied comparative claim.

On this point, the ad breached CAP Code clauses 3.1 (Substantiation), 7.1 (Truthfulness) and 19.1 (Comparisons).

Action

We told Milupa to remove the claims "best follow on milk" "This unique formulation helps to support your baby's natural immune system ..." and  "Intensive work has shown that immunofortis ... supports your baby's natural immune system", and the "graphic illustration", unless they held robust evidence to support them.

Adjudication of the ASA Council (Non-broadcast)