FTC filed the case against the marketers of a diet product based on green coffee bean extract. The marketers, who go by different names including NPB Advertising, Nationwide Ventures and Olympus Advertising, market a product under the brand name Pure Green Coffee. The company made a number of weight loss claims that included losing 17 lbs. in 22 weeks and losing 16% of body fat in the same amount of time. FTC asserts that the company has insufficient evidence to back up these claims.
“This is a textbook case of what not to do. This is just an invitation for the FTC to take action,” said attorney Marc Ullman of the firm Ullman, Shapiro and Ullman. Ullman counts a number of dietary supplement comapnies among his clients and has also worked on advertising compliance with the Natural Products Foundation.
FTC: Single study has numberous problems
In the filing, FTC took the marketers to task for basing their claims on a single study that was conducted by Applied Food Sciences in its ingredient, GCA. The study, authored by Joe A Vinson, et. al and titles “Randomized, Double-Blind, Placebo-Controlled, Linear Dose, Crossover Study to Evaluate the Efficacy and Safety of a Green Coffee Bean Extract in Overweight Subjects,” ran in the May 2012 edition of Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy
FTC said the study was too small, at 16 subjects, to provide convincing data. And the agency cited what are in its opinion a number of critical flaws in the design and results of the study. For one, the largest amount of weight loss occurred during the washout periods, and the largest weight loss recorded occurred in a group receiving a placebo. It also criticized a lack of clarity about the blinding of the study and whether participants exercised during the study.
“These flaws undermine the reliability of all of the study data,” the agency wrote.
Two study standard doesn’t apply
“With only 16 subjects, that’s an incredibly small study,” Ullman said. “You are only talking about at most 8 people in the active group. I would advise any of my clients against making a ‘clincally proven’ claim with so little data.”
But how about the much-talked-about “2-clinical-trials standard” that FTC seems to have been following lately? Nowhere in the green coffee complaint does FTC say that in addition to the problems with the first study, a second study was absent.
“This two study requirement is still not etched in stone. We are seeing it in consent decrees as a means of ‘fencing in,’ ” Ullman said.
FTC also cited the company for advertising the efficacy of green coffee bean via a number of fake news websites. The agency had previously moved against marketers of acai-based weight loss products for using similar tactics.
Relying on Oz?
The green coffee bean marketers had also aggressively linked themselves to claims made about green coffee’s potential as a weight manangement on the Dr Oz Show, including, FTC said, using footage from the show in advertizing. The Vinson study that FTC so roundly criticized was the centerpiece of the 2012 Oz segment on the efficacy of green coffee bean. On the segment and in subsequent documentation on his website, Oz specifically directs consumers to seek out products containing one of two branded green coffee bean ingredients: GCA was one of these, with Svetol from Naturex being the other.