ASA Adjudication on Nutricia Ltd

Ad

Two magazine ads for Cow & Gate follow-on milk:

a. The first ad showed a toddler; text stated "Still building their self-defences Cow & Gate follow-on milks support your baby's natural immune system." Small print at the bottom of the ad stated "Important notice: Breastfeeding is best for your baby. Cow & Gate follow-on milks should only be used as part of a mixed diet and not as a breastmilk substitute before 6 months."

b. The second ad showed a photograph of a baby; small print next to the baby stated "aged 9 months". Text in the body copy stated "Immune system under construction Cow & Gate follow-on milks support your baby's natural immune system." Small print at the bottom of the ad stated "Important notice: Breastfeeding is best for your baby. Cow & Gate follow-on milks should only be used as part of a mixed diet and not as a breastmilk substitute before 6 months."

Issue

1. The National Childbirth Trust (NCT) challenged whether the ads misleadingly implied that Cow & Gate follow-on milk could boost the immune system of children or babies.

2. The ASA challenged whether the claim "Cow & Gate follow-on milks support your baby's natural immune system" in both ads was misleading and could be substantiated.

CAP Code

Response

1. Cow & Gate argued that the ads did not imply that their follow-on milk boosted the immune system.  They said such a claim would be a medicinal one which they would never make.  They pointed out that both ads stated follow-on milks "support" your baby's natural immune system; they argued that the only other text in the ads - "immune system under construction" and "still building their self-defences" - confirmed the message of support.

2. Cow & Gate asserted that the infant immune system was immature at birth and needed to learn what to respond to and how, and resistance to infection was dependant on developing their own innate and adaptive immunity.  They said innate immunity consisted of anatomical barriers (e.g. skin, digestive enzymes, mucosal barriers), as well as other immune cells, that we were all born with. Adaptive immunity, involving lymphocytes and antibodies, was used to describe the immune responses which developed over time in response to exposure to environmental factors.  They believed diet during infancy could therefore play a key role in shaping the adaptive immune system of infants and throughout life.

Cow & Gate referred to a previous ASA adjudication which stated they could state "help build some natural defences", because the ASA had considered that Cow & Gate had shown that their prebiotic mix could build an infant's defences against atopic dermatitis.  They asserted that, to comply fully with that adjudication, they had decided not to use the term "natural defences" to avoid any potential misunderstandings unless or until further substantiation became available.  They said, consultation with experts in the field of immunology and paediatrics had indicated to them that "immune system" was more meaningful than the term 'natural defences'.

They explained that, since that 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 also said those children showed a lower number of general infections, ear infections and required fewer antibiotics.  They asserted that data showed that the special prebiotic mix, immunofortis, used in their follow-on milks affected mechanical, chemical, biological and immunological defences, with evidence of resultant health benefits.  Their research experts were confident that "supports the immune system" was an accurate collective description of those effects.

Nutricia 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.  Nutricia 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 infants 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. Not upheld

The ASA considered that the ads did not imply that Cow & Gate follow-on milk would boost a child's immune system and noted that both ads stated "Cow & Gate follow-on milks support your baby's natural immune system".  We noted text in ad (a) stated "Still building their self-defences" and text in ad (b) stated "Immune system under construction" but considered that text, which appeared beside the pictures of the toddler and baby respectively, would be interpreted by readers that the children were still building or developing their immune system and not as claims about the product boosting their immune system.

On this point, we investigated the ads under CAP Code clauses 3.1 (Substantiation), 7.1 (Truthfulness) and 50.1 (Health & beauty products and therapies - General) but did not find them in breach.

2. Upheld

We noted, in a previous ASA investigation, an expert had assessed trials on Cow & Gate's prebiotic mix and we concluded that the product could build an infant's defences against atopic dermatitis and that Cow & Gate could claim the product could help build "some" but not "all" natural defences.  We noted the current ads used the claim "natural immune system" but considered this would be understood by readers as meaning the same as natural defences.

We noted the NCT had questioned the evidence, both in the previous investigation, the follow-up study and the new study, and we therefore sent it 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 Cow & Gate's prebiotic mix) was not sound.

We considered that the ads implied that Cow & Gate follow-on milk available to the public (a non-hydrolysed formula) would support all children's natural immune systems by working alongside children's immune systems.  We noted the main 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 Cow & Gate follow-on milk available to the public would support all children's 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 "should only be used as part of a mixed diet and not as a breastmilk substitute before 6 months".  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 Cow & Gate 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 the diet they received, we considered that the evidence was not sufficient to support the implied claims that Cow & Gate follow-on milk available to the public would support all children's immune systems when used from six months onwards. We considered that the ads were therefore misleading.

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

Action

The ads must not appear again in their current form.  We told Nutricia to hold robust evidence to support their claims in future ads.

Adjudication of the ASA Council (Non-broadcast)