NAD is an investigative unit of the advertising industry’s system of self-regulation. It is administered by the Council of Better Business Bureaus.
As part of NAD’s initiative with the Council for Responsible Nutrition to expand NAD review of advertising claims for dietary supplements, CRN challenged certain advertising claims made by the advertiser in July of 2012 for Healthe Trim, a dietary supplement that includes green leaf tea extract, hoodia gordonii, caralluma fimbriata stem extract, and several other herbal extracts. The Healthe Trim weight loss program includes a nutritional guide that can be downloaded from the Internet and lifestyle coaching advice, available via telephone.
A key issue in this case was NAD’s review of the results of the Udani Study, a clinical trial that compared the effectiveness of the product to the effectiveness of diet and lifestyle interventions and served as the advertiser’s primary support for its claims.
The Udani study compared the Healthe Trim program – the product combined with the Healthe Trim coaching program and behavioral modifications – to a control group which used the American Dietetic Association (ADA) weight management diet and was administered by a dietician. The trial lasted for 12 weeks.
At the close of the study, NAD noted, there was no statistically significant difference between the weight loss achieved by those in the Healthe Trim or control groups. Because the Udani study did not reach statistically significant weight-loss results, NAD recommended that the advertiser discontinue the claim that “Healthe Trim is a natural weight loss supplement that fits into any lifestyle. With all natural ingredients and clinically proven results, Healthe Trim equips your body to maximize weight loss.”
With regard to the claims, “lose weight,” “Healthe Trim … can help you achieve your weight loss goals and gain the body you’ve always wanted” and “Healthe Trim gets you started losing unwanted pounds,” NAD recommended that the advertiser discontinue these claims or modify them to include the other aspects of the Healthe Trim program – nutritional and exercise modifications, restricted caffeine intake and weekly lifestyle coaching sessions – that were part of the testing.
Due to lack of statistical significance and/or clinical relevance between the control group and the Healthe Trim treatment group in the Udani study, NAD recommended that the advertiser discontinue the following claims regarding appetite suppression and increased energy and metabolic claims:
· “Healthe Trim safely suppresses your appetite and speeds your metabolism so you can lose weight without feeling hungry or deprived.”
· “It also boosts your energy so you can: go to the gym-and not think about food, be more productive – and not think about food, enjoy life – and not think about food!”
· “Using only natural ingredients, Healthe Trim … makes you feel great by supplying you with a LONG-LASTING ENERGY BOOST!”
· “The secret to Healthe Trim’s success is its natural ingredients. These ingredients work together to curb your appetite and increase your energy so that eating less and enjoying a more active lifestyle will come naturally, without hunger pangs or listlessness other diets can induce.”
· "Some dietary supplements may leave you hungry, feeling low on energy or with impaired digestion. Healthe Trim's advanced formula includes thermogenic appropriateties to promote fat loss without irritability.”
· “Our Revolutionary Formula will not only suppress your appetite but will also give you a great energy boost.”
· “…power your metabolism…”
Because of the inconsistent clinical results between the Udani study and second study, NAD further recommended that the advertiser discontinue its fat loss claims that:
· “When used as part of a calorie controlled diet that includes moderate exercise, Healthe Trim will help promote fat oxidation”
· “Our supplement works to promote fat loss while making you feel great.”
Finally, NAD recommended that the advertiser modify its safety claim that “Healthe Trim is perfectly safe” to include a reference to the length of time that the safety of Healthe Trim was studied and also that the safety study was conducted on participants that limited their caffeine intake to one serving a day or less.
HealthyLife Sciences, in its advertiser’s statement, said that while the company “disagreed with NAD’s interpretation of the results of the Udani Study … HLS will review and adjust its claims to include the other aspects of the Healthe Trim Program, including nutritional and exercise recommendations and lifestyle coaching where appropriate. HLS will take NAD’s recommendations into consideration in future marketing materials and advertising.”