Posted 07 September 2011
This is an interesting ruling for it illustrates a common problem with health products: taking evidence or proof from one product and extrapolating it to another without considering the dose may vary, the ingredients are not the same, etc.
ASA Adjudication on Livelarge Ltd
A leaflet, for a weight-loss drink, distributed on 26 May 2011, stated “What are the benefits of taking Bios Life Slim? 1. Promotes fat loss 2. Reduces appetite and cravings 3. Improves cholesterol levels 4. Balances blood sugar 5. Reduces fat levels in the blood 6. Regulates bowel function 7. You don’t have to change your eating habits for Bios Life Slim to work”. A page headed “90 Day Success Story” showed photographs of a man at 0 days, 30 days, 60 days and 90 days. Under the “0 days” image, text stated “NECK 18” CHEST 46” WAIST 43” ”. Under the “90 days” image, text stated “NECK 16.5” CHEST 43.5” WAIST 39.5” ”. Text beneath the images stated “My name is Paul O’Donnell and throughout my life, I have battled constantly to control my weight. After some real personal challenges in the past few years, my weight ballooned to 251 pounds … my heaviest ever and I felt dreadful. A friend of mine sent me a birthday present in early July this year and told me it would help me … HOW RIGHT SHE WAS!!! After only 60 days, I have dropped 29 pounds in weight and lost 8% excess bodyfat [sic] … not water or muscle, actual FAT!!”.
Further testimonials stated “In 90 days of drinking Bios Life Slim my weight dropped by 36 pounds and I lowered my body fat count by almost 10%. It is a truly wonderful feeling! Paul O’Donnell Glasgow”, “My friend Christie introduced me to Bios Life Slim and it really works! I love the way it makes me feel, keeps me motivated and gives me energy. Now I can fit into clothes I never thought I would fit in … again! Darla Sanders Texas”, and “I have tried a lot of fat loss products with mixed results, some kept me awake for days. I tried Bios Life Slim and lost 8 kilos in 8 weeks without a massive change to my lifestyle. Chris Large London.”
The final page of the leaflet showed before and after pictures of a woman, and was headed “Darla Sanders Lost 80 pounds and 37.75 inches”.
The complainant challenged whether:
1. the efficacy claims with regard to the “benefits” of the product were misleading and could be substantiated;
2. the efficacy claims with regard to the “benefits” of the product were implied medicinal claims for an unlicensed product;
3. the ad breached the Code, because it implied that consumers could not fail and could eat as much as they liked and still lose weight;
4. the testimonials were genuine and could be substantiated; and
5. the claims, in particular those in relation to Paul O’Donnell’s testimonial, that consumers could lose weight from specific parts of the body, breached the Code.
6. The ASA challenged whether the claims that users had lost particular amounts of weight were compatible with good medical and nutritional practice.
CAP Code (Edition 12)
Livelarge said the effects of Bios Life Slim (BLS) had been studied in several peer-reviewed clinical studies. They provided full copies of three clinical studies on BLS and three abstracts of clinical studies on BLS. They provided copies of six further research papers, including two research reviews, which related to some of the ingredients of BLS, which they said provided background information and confirmed that the ways that BLS worked on the body were based on solid science.
1. Livelarge said the studies on BLS showed that it promoted fat loss by reducing the amount of fat absorption and the rate of sugar absorption from a meal. They said that, in one study, participants lost an average of 6.7 lb over 90 days, without making changes to their diet. They said that in another study all participants were required to follow the same diet during the study and for a six-week period prior to starting to consumer BLS. They said the group which consumed BLS showed an average weight loss of 2 kg over the eight-week period of the study, with no obvious weight change in the placebo group. Livelarge added that the studies which had not been conducted on BLS itself showed generally that consuming high amounts of dietary fibre reduced blood glucose levels after a meal, and that that in turn led to a reduction in the amount of insulin released by the body. They said the studies showed that insulin blocked the release of stored fat, so the lower the insulin levels in the blood, the more the body was able to access and break down stored fat. They said they felt that those studies therefore substantiated the claim that BLS promoted fat loss.
Livelarge said there had been numerous studies conducted on the effects of fibre on appetite and cravings. They provided a copy of a paper which reviewed published studies on the effects of dietary fibre on hunger, satiety and energy intake, and a study paper which they said showed that after eating fibre-rich food, participants experienced a delay in feelings of hunger.
Livelarge referred to some studies on BLS which they said substantiated the claims that it could improve cholesterol levels, balance blood sugar and reduce fat levels in the blood. The first research paper studied the effects of BLS in patients with dyslipidemia, a condition where individuals had abnormal concentrations of lipids or lipoproteins in the blood. The conclusion of the study was that BLS was beneficial in patients with dyslipidemia in lowering total cholesterol levels. A second research paper detailed the four ways in which BLS was thought to work on the body to lower cholesterol, and concluded that after eight weeks of consuming BLS there was a 4.8% reduction in LDL cholesterol (“bad” cholesterol), which they believed was a significant reduction. The study also concluded that cholesterol reduction was greater in individuals who had higher LDL cholesterol levels at the start of the study. A third study concluded that consumption of BLS could reduce LDL cholesterol by 10% compared to a placebo. Three abstracts related to studies on the effects of BLS on glucose and cholesterol levels in individuals with Type II diabetes.
Livelarge said there had been many studies on the effects of fibre on bowel movement. They provided copies of two research reviews, one published in 1984 and the other in 2009, which they said examined some of those studies and summarised the findings. They said they felt the reviews showed clearly that an increase in fibre intake resulted in more regular bowel movements. In particular, they highlighted that the review published in 1984 stated that studies of dietary fibre intake and large bowel function undertaken in the 1970s confirmed the long-held view that fibre had a marked effect on bowel habit. The review published in 2009 noted that insoluble fibres were especially effective in increasing faecal mass and promoting regularity.
Livelarge said they believed the clinical papers showed the effects of BLS were due to its unique blend of ingredients and its method of use rather than due to a change in diet. They said that some of the studies on BLS isolated the variable of diet by asking study participants to follow a certain diet, but in another study they instructed participants not to make changes to their diet. They said the research showed that if individuals consumed BLS twice a day before meals there would be a reduction of fat in the blood and a reduction in sugar and insulin levels after eating, and that fat loss and overall health would be promoted. They said the product worked with the body by creating a healthier internal environment so the body could start working more efficiently and use up stored fat when it needed energy. They added that the effects of BLS would be greater if a consumer combined it with a low fat healthy diet and incorporated some form of regular exercise into their lives. They said they advised consumers on this in detail on their website and in the welcome letter that accompanied all purchases. They said they also clearly explained in the leaflet that taking BLS was a three-month commitment and they didn’t intend to imply anywhere in the ad that BLS could cause a large amount of weight loss in a short space of time.
2. Livelarge said that BLS was not a medicinal product, and was not licensed as a medicine. They said that, after reading the CAP Codes, they realised they needed to re-word some of the claims in relation to the product’s benefits in order to comply with the Codes.
3. Livelarge said the research documents they had provided substantiated the claims that consumers would not need to change their diet for the product to work. They said they did not intend to imply that consumers could not fail but only to say that the company offered a guarantee of their money back if they were not satisfied with the results. They said they were aware that weight gain could be due to factors other than diet, including hormonal imbalances or biochemical reasons. They said those abnormalities would have to be treated in order to achieve any weight loss and in those cases any attempt to lose weight by diet change would also be unsuccessful. They added that they did not want to give consumers the wrong message and so would be happy to re-word the claim to avoid misunderstanding.
4. Livelarge said they could get signed copies of the testimonials. They provided a signed testimonial from Chris Large and provided links to YouTube videos of Chris Large documenting his weight loss and a TV report about Darla Sanders’ weight loss. Livelarge said that if those were not sufficient they would remove the testimonials from the ad.
5. Livelarge said they were happy to remove the claims in the testimonials which related to weight loss from specific areas so that their advertising complied with the Code.
6. Livelarge said they were happy to remove claims in the testimonials which related to the amount of weight loss so that their advertising complied with the Code.
The ASA noted Livelarge’s willingness to amend aspects of the ad so that it complied with the Code.
We noted the three studies and three abstracts on BLS referenced by Livelarge. We noted we had not seen the full studies relating to the abstracts, and therefore considered that those abstracts alone were not sufficiently robust to substantiate the claims.
We considered that the claims in the ad would need to be supported by robust, controlled and blinded studies. However, we noted that neither the first nor second studies on the effects of BLS were controlled or blinded. We therefore considered the studies did not constitute robust clinical evidence and concluded they did not substantiate any of the product benefit claims. We considered the final study on the effects of BLS had a more robust methodology, because it was randomised, controlled and blinded. However, we noted the version of BLS used during the study was called ‘Bios Life 2’ and had a different composition to BLS; Bios Life 2 contained 4.5 g of fibre per serving, whereas we understood that the version of BLS sold in the UK contained only 3 g of fibre per serving. We also noted that, whilst the two products both included guar gum, locust bean gum and pectin as part of the fibre content, other ingredients contributing to the total fibre content differed between the two products. We therefore concluded that, whilst the study was conducted on a similar product to BLS, it was not conducted on BLS itself and therefore was not robust substantiation for claims relating to the efficacy of BLS.
We noted the contents of the four studies and the two research reviews that related to the efficacy of the ingredients in BLS. However, we considered that in order to substantiate the claims made in relation to the specific composition of ingredients in BLS, Livelarge needed to provide robust clinical evidence that BLS itself had been proven to have the effects stated in the product benefits.
Because we had not seen robust clinical evidence to substantiate the claims, we concluded the ad was misleading.
On this point, the ad breached CAP Code rules 3.1 (Misleading advertising), 3.7 (Substantiation), 13.1 and 13.4 (Weight control and slimming).
We considered that the claims “Improves cholesterol levels”, “Balances blood sugar”, “Reduces fat levels in the blood” and “Regulates bowel function” suggested the product could restore, correct or modify a physiological function by pharmacological or metabolic action and was, therefore, medicinal. We noted such claims for food and drink were prohibited by law and therefore concluded the ad breached the Code.
On this point, the ad breached CAP Code rule 1.10 (Legality).
We considered the claims “Promotes fat loss” and “You don’t have to change your eating habits” were absolute claims and implied that individuals could not fail to lose weight if they used BLS. We also considered the claims implied that individuals could eat as much as they liked and still lose weight if they used BLS. Because such claims were not allowed under CAP Code 13.8, we concluded the ad breached the Code.
On this point, the ad breached CAP Code rule 13.8 (Weight control and slimming).
We noted Livelarge had provided a signed testimonial from Chris Large, and had directed us to YouTube videos which documented his weight loss at two and four weeks. We considered that the signed testimonial and videos were adequate substantiation that Mr Large’s testimonial was genuine.
Nonetheless, we noted we had not seen any evidence to substantiate that Paul O’Donnell’s testimonial was genuine. Furthermore, we understood that the version of BLS sold in the US had a different composition to that sold in the UK, and we therefore considered that, because Darla Sanders’ testimonial did not relate to the specific product sold in the UK, it should not be used in Livelarge’s advertising to UK consumers.
On this point, the ad breached CAP Code rules 3.1 (Misleading advertising), 3.7 (Substantiation), 3.45 and 3.46 (Endorsements and Testimonials).
We noted the text under the images of Paul O’Donnell stated his neck, chest and waist measurements before starting to consume BLS and after three months of consuming BLS. We considered that most consumers would interpret that information to mean that consuming BLS would result in weight or fat loss from those specific areas of the body. Because such claims were not allowed under CAP Code 13.9, we concluded the ad breached the Code.
On this point, the ad breached CAP Code rule 13.9 (Weight control and slimming).
We noted the Code required claims that an individual had lost an exact amount of weight to be compatible with good medical and nutritional practice. We noted Paul O’Donnell’s testimonials stated he had lost 29 pounds in 60 days and 36 pounds in 90 days, and Chris Large’s testimonial stated he had lost 8 kg in eight weeks. We noted that those rates of weight loss exceeded 2 lb per week, which for individuals who were normally overweight was unlikely to be compatible with good medical and nutritional practice. We therefore concluded the ad breached the Code.
On this point, the ad breached CAP Code rule 13.10 (Weight control and slimming).
The ad must not appear again in its current form. We told Livelarge they should not make efficacy claims for the product that were not substantiated by robust clinical evidence for the product itself, and that they should not make implied medicinal claims. We told them they should ensure they held documentary evidence that testimonials were genuine and that they held contact details for the people that gave them. We also told them they should not imply that people could not fail to lose weight, could eat as much as they liked, or that they could lose weight from specific areas of the body. We told them not to make claims about weight loss that were incompatible with good medical and nutritional practice.