Summary of Council decision:
Two issues were investigated and both were upheld.
The website www.boots.com featured for sale Boots Pharmaceuticals Carb Control. Text stated "Boots Pharmaceuticals Carb Control may help reduce dietery [sic] carbohydrate absorption by up to 66% ... What does Boots Pharmaceuticals Carb Control do? Boots Pharmaceuticals Carb Control contains a glycoprotein complex, which may help to reduce the amount of dietary carbohydrate that are digested and absorbed by the body".
A complainant challenged whether the following claims were misleading and could be substantiated:
1. "Boots Pharmaceuticals Carb Control may help reduce dietery [sic] carbohydrate absorption by up to 66% ..."; and
2. "... contains a glycoprotein complex, which may help to reduce the amount of dietary carbohydrate that are digested and absorbed by the body".
1. & 2. Boots UK Ltd (Boots) said Carb Control was a Class IIa medical device, and that the regulations that surrounded that classification obliged manufacturers to ensure their products were safe and fit for their intended purpose. They said Carb Control contained Phaseolamin, which they believed had been shown to bind to enzymes in the small intestine and prevented carbohydrates being broken up into simple sugars so that they were excreted instead of being absorbed by the body. They supplied two research papers which they believed demonstrated that Carb Control prevented the absorption of 66% of carbohydrate from food and that it was suitable for weight management.
1. & 2. Upheld
Of the two studies Boots had supplied, the first was a randomised, double-blinded, crossover study which had shown, by checking glucose levels in participants' blood, a 66% reduction in the absorption of carbohydrates when eating four slices of bread. However, Phaseolamin had been added to the food in powder form, whereas Carb Control was taken in tablet form before food. When a more conventionally balanced meal was eaten, effectiveness fell to 41%. The two groups of participants numbered only 11 and seven respectively. The "Discussion" section of the study referred to other studies which the authors believed supported the results they had obtained. Little detail was given of those studies but one referred to having been conducted on animals and another had been conducted on obese subjects.
The second study Boots had supplied was randomised, placebo-controlled, double-blinded and had taken place over 12 weeks on 40 volunteers. However, the volunteers were all described as being obese. The CAP Code prohibited ads that targeted obese people. The ASA considered that evidence designed to support efficacy claims for people who were overweight, but not obese, should not relate to obese people and that the results could not be extrapolated to people who were overweight but not obese. The second study also concluded by saying it was difficult to determine a correct dose of the product and that, while they believed the results suggested the product might be useful, large-scale studies with an optimal dose were needed.
We considered the findings of the first study were limited and inconclusive and that the second study had focused inappropriately on obese subjects and also had inconclusive findings. We considered that the claims that had been challenged were cautious to some extent but that they nevertheless suggested that there was a sound basis to claim that Carb Control might reduce dietary carbohydrate absorption by up to 66%. We considered that Class IIa medical device classification did not in itself demonstrate that the MHRA had seen satisfactory evidence for efficacy claims. Because, for those reasons, we did not consider the evidence was sufficient to support the claims, we concluded that they were misleading.
On points 1. and 2. the ad breached CAP Code (Edition 12) rules 3.1 3.1 Marketing communications must not materially mislead or be likely to do so. (Misleading advertising) and 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).
The ad must not appear again in its current form.