Weight Loss Claims Fall Flat But Marketer's Advertising Still Stands
This article was originally published in The Rose Sheet
Executive Summary
Council of Better Business Bureaus' investigative arm tells Truderma studies of separate ingredients do not support claims for an entire product and also advised the firm that the scant evidence it submitted from reports on bona fide clinical trials were poor matches even to support claims for separate ingredients and the remainder of its evidence – summaries of studies – was worthless.
A Las Vegas firm that agreed to pull weight loss claims for its supplements after providing no support in an industry self-regulation review continues pitching the products online with all the contested claims.
The Council of Better Business Bureaus' National Advertising Division on July 18 published its review of ad claims for Truderma LLC's Mangodrin brand supplements in regular and "stimulant free" formulations on a challenge by the Council for Responsible Nutrition. In its response included in the report, Truderma said it disagreed with NAD's conclusions but would comply with the recommendations "in the spirit of self-regulation."
As they have with many challenged supplement product advertising, NAD attorneys explained in their report that studies of separate ingredients do not support claims for an entire product. But they also advised Truderma that the scant evidence it submitted from reports on bona fide clinical trials were poor matches even to support claims for separate ingredients and the remainder of its evidence – summaries of studies – was worthless.
"The advertiser did not provide any evidence to support this claim," the NAD report states for most of Truderma's claims, including testimonials.
For the remainder, NAD attorneys explained how the results or methodologies of studies it cited as evidence did not support it claims. For instance, for the claim "See Results In 14 Days,” Truderma offered diet studies in which "the first measurements were taken after four weeks of intervention," the report states.
Key Ingredient Purported To Do Heavy Lifting
Truderma's claims for its products are typical for supplements attempting to sell consumers on rapid weight loss that requires no change in their diets or exercise levels while promising results from a little known herb or other botanical, usually cultivated outside the US, such as "African mango extract" said to be the key ingredient in the firm's products.
Mangodrin contains 200 mg caffeine, 150 mg irvingia gabonensis, green tea extract, phenethylamine, insositol niacinate, synephrine caprylate, nettle leaf extract, glucuronlactone, picamilon and yhimbe; the stimulant free product's formulation is a proprietary blend of irvingia gabonensis, apple cider vinegar, cissus quadrangularis, phenethylamine, decaffeinated green tea and resveratrol.
Additional online claims noted in NAD's review of Truderma's advertising, and which remained on the firm's site on July 18, include “Increase Energy Mental Focus, Control Appetite Fight Cravings, Raise Metabolism Burn Excess Belly Fat,” “Improve & Balance Mood”and “The active ingredient in Mangodrin helps correct your body’s leptin resistance and increase fats!”
For the claim “Lose Up To 28 lbs. In just 10 Weeks,” neither of the clinical trials Truderma noted as evidence provided any results quantifying the amount of weight any subject lost during any period of time.
NAD attorneys, conducting the review in the CBBB division's supplement advertising monitoring supported by CRN, said the two studies also did not support Truderma's claims because the trials were conducted with subjects unlike the likely users of the firm's supplements. Both were conducted outside the US.
The "discrepancies between the populations studied in these clinical trials and the advertising’s target audience" included a difference in typical diets. Participants in both the active and placebo groups consumed a diet with a nutritional breakdown of 56% carbohydrates, 29% protein and 15% fat, but "the typical American diet contains 50% carbohydrates, 15% from protein, and 35% from fat," NAD attorneys wrote.
The report from the second study didn't provide detailed information regarding the subjects’ diet but was also conducted outside the US and "raised similar concerns regarding the extrapolation of the results," the attorneys said.
FDA guidance on substantiating health claims and Federal Trade Commission guidance on supporting advertising state "that to be deemed competent and reliable evidence, the study population should be representative of the population to whom the claim will be targeted," the report states.
Truderma also scored no points with study summaries it submitted. Again noting FDA guidance, the attorneys said abstracts or informal summaries of an article are "less reliable, because such documents usually do not give the reader enough insight into how the research was conducted or how the data were analyzed to objectively evaluate the quality of the research data and the conclusions drawn by the authors. Moreover, the mere fact that the study was published does not necessarily mean that the research is competent and reliable evidence adequate to substantiate a particular claim."
They did allow that although the firm struck out on supporting the challenged claims, its evidence "might provide a reasonable basis for more narrowly tailored claims related to ingredients in" its products.