Background
Summary of Council decision:
Two issues were investigated, both of which were ‘Not upheld’.
Ad description
A TV ad for a fat-binding weight loss pill showed a woman with her young baby and then eating a sandwich before she was shown being unable to get into a dress. Her voice-over stated, "Over the years I slowly put on the pounds until I just didn't feel like me anymore." She was then shown decisively holding her palm out while her voice-over said, "That's when I said 'Enough!'" and she was shown laughing with a group of friends.
A male voice-over then said, "A study has shown that XLS Medical combined with eating less and keeping active could help you lose up to three times more weight than dieting alone" while a line graph with the title "Eating less + keeping active" was shown with a yellow line labelled "XLS-MEDICAL" substantially undercutting a blue line. Text at the bottom of the graph stated "2010 Clinical trial Germany, overweight patients n=81". The voice-over then said, "It binds some dietary fat and is gentle on your system", while a diagram of the product in action appeared overlaid on a woman's torso. The text "Litramine" appeared in the diagram. Qualifying text at the bottom of the screen stated "Can help aid slimming as part of a calorie-controlled diet and healthy lifestyle".
The woman's voice-over then said, "Lose up to three times more weight with XLS Medical" while large on-screen text stated "lose up to 3x more weight" next to a shot of the boxed product. Text on the box stated "XLS-MEDICAL Fat Binder".
Issue
The International Association for the Study of Obesity (IASO) and two other complainants challenged whether:
1. the efficacy claims for the product were misleading and could be substantiated; and
2. the ad breached the Code by making a prediction of specific weight loss.
Response
1. Omega Pharma Ltd explained that the aim of XLS-Medical was to provide overweight consumers with an effective and safe solution to reach their target weight responsibly. XLS-Medical contained Litramine which was a natural and plant-based fibre complex and certified medical device.
Omega Pharma said robust clinical data was available to support the claims used both in the ad and in all other media created to promote the product. A historical body of evidence that supported the action of Litramine was shared with Clearcast as part of the approval process for the ad and approval was only granted after a detailed review of all literature and substantiation data.
Omega Pharma said the efficacy of the product and specifically the claim "lose up to three times more weight" had been substantiated by a clinical trial by Grube et al. that had been peer reviewed and published in the journal Obesity; the leading journal for weight management in the UK. They explained that the Grube et al. publication was a multi-centred, randomised, double-blind, placebo controlled study on weight loss which clearly showed that the product was effective. A subgroup analysis of weight loss data for 81 overweight subjects showed that treatment with XLS-Medical resulted in more than a threefold body weight decrease compared to a placebo group. This was demonstrated in the ad by means of a graph and corresponding voice-over which explained the data.
Omega Pharma were confident the data provided supported the claims for XLS-Medical which had been peer-reviewed and also reviewed by independent consultants as part of Clearcast review. Omega Pharma said they refuted the complaints, had no intention to mislead and remained focused on responsible advertising and providing clear and supportable information to consumers.
Clearcast said Omega Pharma had submitted a large body of evidence to support the claims being made in the ad and they had been working with the advertiser and the creative agency for a year to ensure the legitimacy of their data and that any efficacy claims could be substantiated fully. They reserved approval until they were satisfied they had received a strong body of evidence to support the product claims. They also insisted that the clinical study upon which the core claims were based was published in a reputable peer-reviewed journal and this was confirmed in May 2012. They said they had had the proposed script analysed by their nutritional consultant and they provided that consultant's final report.
Clearcast said, throughout the pre-approval process, modifications were made to the script until the claims therein were acceptable. The "up to 3 times more weight" claim was approved by their consultant and they believed the appropriate wording was used in the script: the "up to" reflecting that not all users would achieve the full amount of weight loss but that a significant proportion could. Furthermore, the claim was clearly linked to the clinical study with the voice-over referring to "a study" alongside a graph which showed the clinical trial results. They believed that clear link would ensure viewers were aware that the efficacy claims being made for the product stemmed from this source. They believed the efficacy claims made in the ad were sufficiently substantiated and not misleading.
2. Omega Pharma said the ad did not make any direct promises or predictions of specific weight loss. The voice-over made a clear reference to the fact that the results were based on a clinical trial which had shown that taking XLS-Medical combined with eating less and keeping active could help you lose up to three times more weight than dieting alone. It did not refer to specific amounts of weight loss.
Omega Pharma said they were focused on promoting responsible weight loss and made clear in all media that XLS-Medical should be used as part of a weight loss journey, i.e. in association with a healthy eating plan and exercise. Their online media provided helpful tools to enable consumers to identify the right eating plan and exercise regime to best suit them in conjunction with taking XLS-Medical to aid their weight loss.
Clearcast said the approved claim in the ad was "you could lose up to 3 times more weight" which was not a guarantee of specific weight loss. They had been adamant during the approval process that none of the claims in the script should imply that everyone who took the product would achieve a specific amount of weight loss. The "up to" wording of the claim made clear that weight-loss results would vary across users but that amounts as much as three times more than dieting alone were achievable for some. This was corroborated by the study results which showed that over 10% of those who took the product achieved a loss in line with that figure. They did not believe the ad breached the Code on this point.
Assessment
1. Not upheld
The ASA noted the response provided by Omega Pharma and Clearcast and we also noted their expert report. We noted that the same body of evidence had been submitted to CAP Copy Advice in late 2011, albeit in the context of slightly different claims, and that CAP had instructed an expert to assess it. We reviewed that expert advice also.
We noted that the trial submitted was a robust, double-blind placebo controlled trial. During the 12-week treatment period, subjects received either two tablets of XLS-Medical or a matching placebo, three times a day and were instructed to maintain a nutritionally balanced and calorie-reduced diet throughout the two-week run-in phase and the 12-week treatment phase. At the end of the trial the mean difference observed in weight between the placebo and treatment groups was a 2.6-fold increase in weight loss when Litramine was used at a dose of 3 g/day. We therefore considered that the study substantiated the efficacy of Litramine as a weight loss treatment.
In addition the ad made the specific claim that the product "could help you lose up to three times more weight". We again referred to the trial which included specific comment on those trial participants who had been classified as being overweight. We noted that, in that specific group, those subjects using Litramine lost 3.97 times more weight than those on placebo. We therefore considered that specific claim had been substantiated also.
Because the study provided showed that the advertised product had been effective in promoting weight loss and that it could help users lose up to three times more weight, we concluded that the efficacy claims for the product had been substantiated and were not misleading.
On this point we investigated the ad under BCAP Code (Edition 12) rules 3.1 (Misleading advertising), 3.9 (Substantiation), 12.2 12.2 If they are necessary for the assessment of claims, broadcasters must, before the advertisement is broadcast, obtain generally accepted scientific evidence and independent expert advice. 12.6 12.6 Broadcasters must obtain suitably qualified independent medical advice or other suitably qualified health specialist advice on the safety and efficacy of weight control and slimming products or services before broadcast. In particular, the advice must satisfy broadcasters that: 12.6.1 12.6.1 the slimming product or service is likely to be effective and will not lead to harm and 12.7 12.7 Promises or predictions of specific weight loss are not acceptable for any slimming product. (Weight control and slimming) but did not find it in breach.
2. Not upheld
We noted the complainants' concern that the ad breached the Code by making a prediction of specific weight loss. However, we considered that the statement "A study has shown ..." made clear that the following references to weight loss, both in the voice-over itself and in the graph, related to positive results achieved by participants in the clinical trial, and were not therefore predictions of what consumers would experience themselves. We considered that impression was further reinforced by the text on the graph which stated "2010 Clinical trial Germany, overweight patients n=81" which also made clear that the amounts shown related to the study.
Because we considered that the amounts of weight loss given related to the study and not to consumers, we concluded that the ad did not make a prediction or promise of specific weight loss.
On this point we investigated the ad under BCAP Code rule 12.7 12.7 Promises or predictions of specific weight loss are not acceptable for any slimming product. (Weight control and slimming) but did not find it in breach.
Action
No further action required.
