Claims on a website for a slimming aid, seen in November 2011. Text on the home page stated "BioBIND with the unique advanced formulation Slenmax, a blend of three natural ingredients proven to prevent fats from being absorbed by the body. Slenmax, a combination of three double action active ingredients shown to help people achieve a healthy body weight and prevent future weight gain. Nopal, cactus extract and Chitosan have been proven to bind dietary fats within the body, creating fat-fibre complexes too large to be absorbed. This results in the fat being naturally passed out of the body. The final ingredient is Psyllium Husk, a dietary fibre which helps reduce appetite and promote a feeling of fullness".
Under the heading "How does BioBIND work?" further text stated "Litramine is a substance contained within the cactus plant. The cactus has been used for millennia to suppress appetite for food and water and to increase energy by the San people, native to the Kalahari Desert. They cut the spines off the plant and eat the inner portion and drink the white latex. Litramine has been proven to bind up to 27.4% of fat from food. This creates a fat-fibre complex too large to be absorbed by the small intestine and is passed out of the body naturally. In addition, BioBIND also helps to reduce food cravings. The soluble fibres in BioBIND engorge in water and trap food, thus slowing down digestion and reducing blood sugar spiking. So as a result, the desire to eat is dramatically reduced and replaced by a feeling of fullness. Therefore, BioBIND works in three ways: 1. Reduces amount of fat absorbed from your diet. 2. Helps to suppress appetite. 3. Helps decrease food cravings".
The complainant challenged whether the efficacy claims for the product were misleading and could be substantiated.
Direct Healthcare Ltd (Direct Healthcare) provided the ASA with a study which tested the fat binding capacity of Opuntia ficus indica (nopal), an ingredient found in the BioBind product, using a complex, computer-controlled model of the stomach and small intestine. The study found that nopal was able to bind fat and thus prevent the absorption of approximately 28.3% fat in the gastrointestinal tract model.
Direct Healthcare also provided us with two studies that demonstrated the efficacy of chitosan, another ingredient of BioBind, with regards to weight loss.
Direct Healthcare said that the product itself had not been tested in a clinical trial but the ingredients had been.
The ASA noted the studies sent by Direct Healthcare which highlighted that some positive results had been found using some of the ingredients found in BioBind. However, we also noted that the first study, which demonstrated the efficacy of the ingredient nopal, was carried out on a gastrointestinal model and not on human subjects. We were concerned that the complex processes in the human gastrointestinal tract may not have been replicated using the model and that it may not have given an accurate representation of nopal's effect on the human body. We also noted that in both this study, and the two studies sent to demonstrate the efficacy of chitosan on weight loss, only ingredients found in BioBind were tested and no studies had been carried out that had been conducted using the BioBind product itself. We considered that to substantiate weight loss claims for the product, adequate evidence such as trials conducted on people, testing the product itself would need to have been carried out. We concluded that the efficacy claims for the product had not been substantiated and were therefore misleading.
The claims 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), 3.11 3.11 Marketing communications must not mislead consumers by exaggerating the capability or performance of a product. (Exaggeration), 13.1 13.1 A weight-reduction regime in which the intake of energy is lower than its output is the most common self-treatment for achieving weight reduction. Any claim made for the effectiveness or action of a weight-reduction method or product must be backed, if applicable, by rigorous trials on people; testimonials that are not supported by trials do not constitute substantiation. and 13.4 13.4 Before they make claims for a weight-reduction aid or regimen, marketers must show that weight-reduction is achieved by loss of body fat. Combining a diet with an unproven weight-reduction method does not justify making weight-reduction claims for that method. (Weight control and slimming).
The claims must not appear again in their current form. We told Direct Healthcare not to make efficacy claims for which they did not hold robust substantiation and to ensure all future health and weight loss claims complied with the Code.