Background
Summary of Council decision:
Two issues were investigated, both of which were Upheld.
Ad description
A leaflet and a website, for Colief infant drops:
a. The leaflet was headlined "Reduce the hours of crying". It also included the claim "Studies have shown that the hours of crying may be greatly reduced when babies are fed their usual milk treated with Colief Infant Drops".
b. The website www.colief.co.uk included the claims "Reduce the Hours of Crying Research has found that the hours of crying may be greatly reduced when babies are fed their usual milk with Colief Infant Drops …" and "Colief Infant Drops is formulated to help give you and your baby relief from colic".
Issue
The complainant challenged whether the claims:
1. that research had shown that "… hours of crying may be greatly reduced when babies are fed their usual milk treated with Colief Infant Drops" in ads (a) and (b); and
2. "Colief Infant Drops is formulated to help give you and your baby relief from colic" in ad (b)
were misleading and could be substantiated.
Response
1. & 2. Crosscare said the product was used to diagnose colic in infants. It contained naturally occurring enzymes which, when added to babies' milk, broke down most of the lactose and made the feed more easily digestible and thereby greatly reduced the digestive discomfort associated with colic. They submitted a study, related to the improvement of symptoms in infants with colic, in support of the claims, which they said stated that infant colic could affect between 10 and 30% of babies aged three to 13 weeks. They said its cause was unclear but one theory suggested that it might be caused by transient lactase deficiency, which reflected an immature digestive system failing to break down all of the lactose in infant formula or breast milk.
They said the study investigated the pre-treatment of feeds with Colief to determine if it would offer benefits, which were measured by a reduction in crying time. They said the results indicated that breath hydrogen levels were 36.8% lower and there was a 40% reduction in crying time in 'compliant' babies, which were highly statistically significant results and therefore proof that the sample size of the 'compliant' subgroup was adequate. Crosscare accepted that the same was not true for crying time in the group as a whole but believed it was reasonable and justifiable to base claims on what happened when the product was used as instructed. In addition, a cross-over design was used that increased the power of studies with a small number of subjects. They said the study was a follow-up to a small study that was previously undertaken, which demonstrated that pre-incubation of feed with an identical formulation to Colief drops reduced crying time by 1.14 hours per day, which was also statistically significant. They also submitted that trial and said the statistical results of both studies demonstrated the effective use of lactase enzyme drops in babies with colic and therefore substantiated the claims. Crosscare also submitted a paper that included discussion of colic and lactose intolerance. They were of the strong opinion that the ad did not breach the Code.
Assessment
THIS ADJUDICATION REPLACES THAT PUBLISHED ON 25 JULY 2012. THE WORDING HAS CHANGED BUT THE DECISION TO UPHOLD THE COMPLAINT REMAINS.
1. & 2.Upheld
The ASA noted that the inside of the leaflet (ad (a)) included text such as "Although colic is not fully understood, it is thought to be associated with transient lactase deficiency in some babies", "It may be that a baby is not yet producing sufficient levels of lactase enzyme, due to being born with an immature digestive system. This is called Transient Lactase Deficiency and can result in temporary digestive discomfort caused by undigested lactose in food. This can be an important factor in some babies with colic" and, on the cover, "Lactase Enzyme Drops for adding to infant milk or breast milk to reduce lactose content". Similarly, ad (b) included text such as "Colief as a diagnostic tool A one week trial of Colief Infant Drops can help a parent discover if transient lactase deficiency is the cause of their baby's colic symptoms".
Although we acknowledged that text made reference to the lactose content of milk, or to cases of colic that related to lactase deficiency, we considered it contradicted, rather than clarified, the overall impression given by the headline, and other, claims in both ads. We considered the text "Reduce the hours of crying … The hours of crying may be greatly reduced when babies are fed milk treated with Colief", on the cover of ad (a), and "Colief Infant Drops represent a major breakthrough for babies with infant colic Reduce the hours of crying Research has found that the hours of crying may be greatly reduced when babies are fed their usual milk with Colief Infant Drops …" and "Colief Infant Drops is formulated to help give you and your baby relief from colic", in ad (b), was likely to be interpreted as suggesting the product could help reduce the hours of crying for cases of colic generally, rather than only for cases that might be associated with transient lactase deficiency.
We noted the first study submitted by Crosscare indicated that results had been obtained from only 32 'compliant' babies for the crying measure. Similarly, we noted that the second study involved only 13 babies. We considered the sample sizes were not sufficiently large to substantiate the claims "… hours of crying may be greatly reduced when babies are fed their usual milk treated with Colief Infant Drops" and "Colief Infant Drops is formulated to help give you and your baby relief from colic". We additionally noted that only 26% of the full trial group (46 babies for whom data was available), and 38% of compliers, had seen positive results (of at least a 45% reduction in crying time and breath hydrogen) compared to the placebo. Moreover, we were concerned that the study, which stated that earlier research had found no correlation between colic and lactose intolerance, related only those cases of colic it was believed could be caused by lactose intolerance, whereas we considered the claims were likely to be interpreted as relating to colic more generally.
In addition, we noted that the active phase of the first study lasted only ten days, with the second study's active phase being one week, and were therefore also concerned that any effect could not be said to endure beyond that, even with continued use of the product, whereas we considered the claims in both ads implied a longer-term effect. We acknowledged that ad (b) stated that "A one week trial of Colief Infant Drops can help a parent discover if transient lactase deficiency is the cause of their baby's colic symptoms" however, we considered the impression given by the claim "Colief Infant Drops is formulated to help give you and your baby relief from colic", and ad (b) more widely, was that the product could be effective beyond any trial period.
For the reasons given, we considered the claims had not been substantiated and therefore concluded that the ads breached the Code.
Ads (a) and (b) breached CAP Code (Edition 12) rules
3.1
3.1
Marketing communications must not materially mislead or be likely to do so.
(Misleading advertising),
3.7
3.7
Before distributing or submitting a marketing communication for publication, marketers must hold documentary evidence to prove claims that consumers are likely to regard as objective and that are capable of objective substantiation. The ASA may regard claims as misleading in the absence of adequate substantiation.
(Substantiation),
3.9
3.9
Marketing communications must state significant limitations and qualifications. Qualifications may clarify but must not contradict the claims that they qualify.
(Qualification) and
12.1
12.1
Objective claims must be backed by evidence, if relevant consisting of trials conducted on people. Substantiation will be assessed on the basis of the available scientific knowledge.
Medicinal or medical claims and indications may be made for a medicinal product that is licensed by the MHRA, VMD or under the auspices of the EMA, or for a CE-marked medical device. A medicinal claim is a claim that a product or its constituent(s) can be used with a view to making a medical diagnosis or can treat or prevent disease, including an injury, ailment or adverse condition, whether of body or mind, in human beings.
Secondary medicinal claims made for cosmetic products as defined in the appropriate European legislation must be backed by evidence. These are limited to any preventative action of the product and may not include claims to treat disease.
(Medicines, medical devices, health-related products and beauty products).
Action
The ads must not appear again in their current form. We told Crosscare to ensure they held adequate substantiation before making efficacy claims in future.
