Ad description

A TV ad for Johnson's Baby - Extra Sensitive wipes featured a baby crawling around and starting to walk, along with images of the product being used on its bottom. On-screen text stated "Safe and gentle for newborn skin from the very first day" and the voice-over stated, "They put their trust in you like you put your trust in us, and that's why we promise that Johnson's baby extra sensitive wipes are proven safe and gentle for newborn skin from the very first day." The ad also featured a pack-shot which included the claim "Proven safe for newborn skins from the first days".

Issue

The complainant, a midwife, challenged whether the claims that the product was proven safe for newborn skin from the very first day, was misleading and irresponsible because they believed it contradicted Department of Health (DH)and NICE guidelines.

Response

Johnson and Johnson Ltd (J&J) said that the National Institute for Clinical Excellence (NICE) Guideline 37, issued in 2006, included a section on skin which stated that "… parents should be advised that cleaning agents should not be added to a baby's bath water nor should lotions or medicated wipes be used within the first 6-8 weeks". They said the NICE Guideline 37 was formulated by a Guideline Development Group (GDG) using clinical research studies but that since none of the studies at that time specifically addressed the general skincare of full-term infants and also met GDC and NICE criteria, the NICE Guidance was based on the collective experience of the GDC as opposed to being based on clinical evidence. They said there was debate amongst healthcare professionals on the issue and that because of the lack of empirical evidence on the issue, it was tradition, opinion and experience that informed practise.

They said NICE guidelines were purely advisory and that NHS Trusts adopted their own local guidelines on caring for newborns. They referred to one NHS Foundation Trust which had recently amended its guidelines to recommend the product in question as an alternative to water and provided a copy of the Guidance from that Trust which stated that the recommendation to use the advertisers 'extra sensitive wipes' was based on clinical evidence which showed that the product was just as safe and hydrating for newborns as water.

J&J stated that to be effective at cleansing, harmful impurities such as urine and faeces needed to be removed from the skin and that water alone did not completely remove greasy, fat soluble substances like faeces. They said that because prolonged contact with these substances caused nappy rash, effective cleaning was vital in order to prevent it. They supplied a clinical trial which they believed supported the claims and which justified an alternative to the NICE guidance for cleansing newborn skin. They said that the randomised controlled trial (RCT) was published and peer viewed and believed it was fair to say that it was safe on newborn skin as water and cotton wool and can in fact be of benefit to newborn babies (by reducing the incidence of nappy rash). They believed it could not be considered socially irresponsible to provide such information because it allowed healthcare professionals and parents to make informed decisions when choosing how best to clean newborn skin. They said healthcare professions could still follow the NICE guidelines, but that they could now also use the product.

Clearcast said that at pre-production stage they discussed the issue with their consultant and concluded that the NICE Guidance consisted of recommendations rather than rules and that it was largely based on the experience of healthcare professionals and parents rather than scientific testing.

They said that having agreed in principle to the fact it was not wrong to use cleaning agents on very young babies, they then looked at the evidence itself and concluded the results showed that the product was just as safe as the approach recommended by the DH and NICE.

Assessment

Not upheld

The ASA noted the blinded randomised controlled trial examined the skin of 280 babies who were split into two equal groups, one of which was allocated the product, and the other was allocated the use of water and cotton wool, which was the currently recommended method by healthcare professionals. The study group mothers were asked to clean their new-born babies' bottoms in the same way (after soiling) and both groups used the same type nappies. We noted the trial required the assessments of the babies' skin to be carried out by the mothers and by visiting midwives (who were blinded to the study) and that it reported that the wipes had an equivalent effect on skin when compared with cotton wool and water. We noted the trial reported statistically significant results in relation to equivalent skin hydration in the wipes group and water group and that no adverse effects, were reported from using the product for a period of four weeks.

We understood the complainant believed the claims in the ad that the product was safe for use on new born skin directly contradicted the NICE and DH guidance. However, the ad did not state or imply that all medicated wipes (including others within the same brand or those by other manufacturers) were suitable for new-borns and made clear that the "safe" claim related only to the advertised product. Furthermore, we noted the existing recommendations were Guidelines only and were issued before the product was tested and the results published, and that whilst the section of the Guidance on "skin" stated that "medicated wipes" should not be used on newborns, it did not suggest the use of medicated baby wipes on newborns should be prohibited, or their sale restricted or that the Guidance consisted of anything more than good practice recommendations. We further noted evidence demonstrated that at least one NHS trust now recommended the product's use

Because evidence demonstrated that the extra sensitive wipes were proven to be safe for use on the skin of newborn babies, we concluded that the ad was neither misleading nor irresponsible.

We investigated the ad under BCAP Code rules  1.2 1.2 Advertisements must be prepared with a sense of responsibility to the audience and to society.  (Social responsibility),  3.1 3.1 Advertisements must not materially mislead or be likely to do so.  and 3.2 (Misleading advertising) but did not find it in breach.

Action

No further action required.

BCAP Code

1.2     3.1     3.9    


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