ASA Adjudication on Nutricia Ltd

Ad

A TV ad for Aptamil showed a mother holding a young baby. The baby appeared to have a glowing halo around it. Voice-over stated "Breast milk is perfect for your baby. Nothing compares to it. It strengthens your baby's natural defences." The next scene showed the same mother with the same baby some months later. He still had the same halo around him. She was shown taking him to a park to play with other children, one of whom sneezed over him. Animated germs were seen to bounce off the halo. Voice-over stated "How time flies. If you decide to move on from breastfeeding, Aptamil Follow On contains Immunofortis to help support some of your baby's natural defences. Aptamil Follow On. Helping support your baby."

The ad showed a packshot of the product and a shield containing text which stated "IMMUNOFORTIS - To help support some of your baby's natural defences."

On-screen text stated "Aptamil Follow On milk should only be used as part of a mixed diet from 6 months. Aptamil Follow On is not a breast milk substitute. Talk to your healthcare professional" and "Discover more, visit aptamil.co.uk."

Issue

The ASA received complaints from 15 viewers.

1. Eleven challenged whether the ad was misleading for suggesting that Aptamil Follow On provided the same health benefits as breast milk.

2.  Five challenged whether the ad was misleading for suggesting that Aptamil Follow On could prevent children catching colds.

3.  Three challenged whether the ad was misleading for suggesting that follow-on formula was a natural progression from breastfeeding.

BCAP TV Code

Response

1.  Nutricia said that the ad was not intended to suggest that Aptamil Follow On provided the same health benefits as breast milk.  They cited the statement "Breast milk is perfect for your baby.  Nothing compares to it. It strengthens your baby's natural defences" and compared it with the claim the ad made about Aptamil Follow On, that it "contains Immunofortis to help support some of your baby's natural defences."  They said the wording of that claim reflected the ASA's findings in previous investigations for follow-on milk that contained the same prebiotic mixture as Aptamil.  They believed randomised controlled clinical trials had demonstrated the efficacy of the prebiotic mixture in: increasing beneficial bacteria; reducing levels of clinically relevant pathogens; positively altering the metabolism of gut flora; reducing markers for allergy and atopy; reducing incidence of recurrent upper respiratory tract infections and diarrhoea; reducing incidence of atopic dermatitis and reducing episodes of infections, all of which they believed supported the claim that Aptamil Follow On helped support some of a baby's natural defences.

Clearcast said their nutritional consultant approved the ad and the claims it made and was satisfied that the terms "breastfeeding" and "breast milk" were used correctly.  They said ads for follow-on formula were required to state that follow -n formula was for babies aged six months and older; that it was not intended as a replacement for breast milk; and that they were very much aware that ads must not suggest that follow-on formula was a substitute for breast milk.  They said the voice-over that stated "Breast milk is perfect for your baby.  Nothing compares to it.  It strengthens your baby's natural defences" made it clear that breast milk was best for babies.  They said they therefore believed the references the ad made to breastfeeding and breast milk were legitimate and justified.  They said the voice-over went on to state that the product contained "Immunofortis to help support some of your baby's natural defences."  They said that made it clear that Aptamil supported some of a baby's natural defences only, whereas the similar statement made about breast milk was a superior one not qualified by "some."

2. Nutricia said the ad the ad did not state that Aptamil Follow On prevented colds but that, because it contained Immunofortis, it would "help support some of your baby's natural defences."  They believed the claim reflected the ASA's findings in previous investigations for follow-on milk that contained the same prebiotic mixture.  They believed research demonstrated that Immunofortis prebiotics helped support a baby's natural defences, which they believed would be understood as an overarching description of the natural barriers and active defence mechanisms that protected against invading pathogens.  They said the concept and the data to support it was detailed and complex but that they had chosen to refer to it in a simple, visual way in the ad by showing a child sneezing on to another child, off whom the germs bounced because of the protection by Immunofortis prebiotics.  They said the visual illustration reflected the fact that many kinds of childhood infection that a baby's natural defences work against are transmitted aerially and that sneezing was a symptom of a number of infections, such as the upper respiratory tract infections that were considered in the clinical trials.  They believed parents and carers fully appreciated that children raised exclusively on breast milk were not protected against catching colds, that the ad already stressed that Aptamil Follow On was not superior to breast milk and that it was not reasonable, in the context of the ad as a whole, to take from the visual illustration that Aptamil Follow On offered special protection against the common cold.

Clearcast said that, although the ad showed some germs bouncing off the baby, it nevertheless made clear that Aptamil would help support some (not all) of a baby's natural defences and that it would therefore reduce the risk of infection. They said nowhere did the ad say babies would not catch colds if they were fed Aptamil.

3. Nutricia said the ad was for follow-on milk, a product that was suitable for infants aged six months and over, which was not a sole source of nutrition and which was not a breast milk substitute.  They cited the on-screen text that stated "Aptamil Follow On milk should only be used as part of a mixed diet from 6 months.  Aptamil Follow On is not a breast milk substitute.  Talk to your healthcare professional."  They said the Department of Health (DH) recommended that an infant should be breastfed for at least six months but that cows' milk should not be introduced to the diet until a child was over 12 months.  They disagreed that the ad suggested Aptamil Follow On was a natural progression from breastfeeding but said that, because the product was suitable from six months, if a mother ceased breastfeeding at any time after her child was six months old, Aptamil was a suitable and safe option.

Clearcast said they believed the ad made it clear that breast milk was best for babies and that it supported their natural defences without qualification, whereas Aptamil would support "some" only.  They believed it was clear that breast milk was the preferable choice.  They also pointed out that the voice-over stated "If you decide to move on from breastfeeding ..." They said that, if the ad had intended to suggest follow-on formula was a natural progression from breastfeeding, it would have stated "when" and not "if."

Assessment

1.  Not upheld

The ASA noted that the opening voice-over of the ad - "Breast milk is perfect for your baby.  Nothing compares to it.  It strengthens your baby's natural defences" - stated the benefits breast milk was understood to provide as unqualified statements.  We noted that the ad then went on to state in voice-over and text in a more conditional context the benefits Nutricia believed Aptamil provided - "Aptamil Follow On contains Immunofortis to help support some of your baby's natural defences ... Helping support your baby" voice-over, and "IMMUNOFORTIS - To help support some of your baby's natural defences" text.  Notwithstanding the claims for Aptamil that we address in point two below, we considered the voice-over and text did not suggest Aptamil Follow On provided the same health benefits as breast milk.

On this point, we investigated the ad under CAP (Broadcast) TV Advertising Standard Code rules 5.1 (Misleading advertising) and 5.2.2 (Implications) but did not find it in breach.

2.  Upheld

We noted that, in a previous ASA investigation, an expert had assessed trials on the same patented prebiotics mix as used in Aptamil Follow On and we concluded that the product could build an infant's defences against atopic dermatitis and that the advertiser (Cow & Gate, since taken over by Nutricia) could claim their product could help build "some" but not "all" natural defences.

We sent that previous adjudication and Nutricia's evidence for the current case to a new expert.  We considered that the main clinical study provided high quality evidence that supplementation of Nutricia's particular prebiotic mix to 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 at high risk of allergy, in terms of both allergic manifestations and overall infection rates, but that that study was, at that stage, the only one with that particular prebiotic mix in that particular population that had been published.  It was not known from that study 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).  In the absence of evidence that was based on large scale population based clinical trials on infants without a family history of allergy and using regular, unmodified cow's milk formula (i.e. not hydrolysed), we did not consider it was possible to extrapolate the results from the advertiser's study.  We considered that the evidence presented in the first study did not support the claim.

We noted that the spoken claims - "Aptamil Follow On contains Immunofortis to help support some of your baby's natural defences" and "IMMUNOFORTIS - To help support some of your baby's natural defences" - referred to "some" of a baby's natural defences but that the visuals of the animated germs from another child's sneeze bouncing off the halo around the child that had been fed with Aptamil showed all the germs being repelled.  We noted Nutricia's comments but considered that implied the Aptamil Follow On available to the public would have a proven effect in supporting all children's natural immune systems by working alongside children's normal immune systems, including helping prevent them catching colds (which we considered was one of the most likely viruses parents and carers would expect young children to catch from each other).  We noted that the main study was followed up by a second study, which had not previously had the status of a peer reviewed, published study.  Unlike the main study, the new study used non-hydrolysed formula on children without a family history of allergy.  We noted, however, that the infants in the study began being given infant formula with IMMUNOFORTIS when they were aged 15 to 120 days, whereas the ads stated the follow-on formula advertised "should only be used as part of a mixed diet from 6 months" and was not a breast milk substitute.  The infants in the study were therefore given the formula from an earlier age than they would be given Aptamil Follow On, which was designed for children aged six months and over.  From the expert advice we received, we considered that what was fed to an infant before four to six months would have a different effect to what was fed after six months and that it was important to take diet into account, especially the prebiotic and probiotic content of the weaning diet.  Our expert pointed out that Nutricia had excluded infants who received probiotics and prebiotics before the study, but did not mention other relevant dietary factors during it.  She said some foods, such as onions, garlic and tomato, were high in prebiotics and could potentially influence the data.  She said that, although that could be disputed, there were no studies that looked at the effect of prebiotics in weaning foods on the immune system.  We noted that the advice Nutricia had received from their expert was that there was no scientific rationale to support a distinction between development in infants under and over six months of age with respect to the effect of factors such as nutrients on growth and development.  Because it was not known whether what was fed to an infant after six months (only) would have the same effect on a baby's immune system as what was fed top the baby from as early as 15 days and continuing beyond six months, we concluded that neither the evidence from the main study nor from the second study showed it was justified to extrapolate results from a study that had fed prebiotics beginning from as early as 15 days and continuing to infants who were not given them until they were six months old, and that it therefore did not substantiate the claim.

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

3.  Not upheld

We noted that the Infant Formula and Follow On Formula (England) Regulations 2007 (and equivalent in Scotland, Wales and Northern Ireland) required that ads for follow-on formula should "provide the necessary information about the appropriate use of the product so as not to discourage breastfeeding and (should) not contain the terms 'humanised,' 'maternalised,' 'adapted' or any similar term."  We considered the opening voice-over of the ad - "Breast milk is perfect for your baby.  Nothing compares to it.  It strengthens your baby's natural defences" - suggested that breast milk provided benefits that were superior to any alternative.  We noted that time in the ad appeared to move forward some months, after which the voice-over stated "How time flies.  If you decide to move on from breastfeeding, Aptamil Follow On contains Immunofortis to help support some of your baby's natural defences."   We also noted that on-screen text stated "Aptamil Follow On milk should only be used as part of a mixed diet from 6 months.  Aptamil Follow On is not a breast milk substitute ..."  We considered the combination of voice-over and text distinguished between breastfeeding and feeding with follow-on formula, that it suggested breastfeeding was superior but that if, after the age of six months, a mother took the decision not to continue breastfeeding, Aptamil could be used as part of the baby's diet.  We noted that the references to the benefits of breast milk were presented as undisputed and unqualified whereas the references to the decision to use follow-on formula were more cautious and conditional.  We did not, therefore, consider the ad suggested follow-on formula was a natural progression from breastfeeding.  Because of that, we concluded that the ad was unlikely to mislead.

On this point, we investigated the ad under CAP (Broadcast) TV Advertising Standards Code rules 5.1 (Misleading advertising) and 5.2.2 (Implications) but did not find it in breach.

Action

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

Adjudication of the ASA Council (Broadcast)