At issue is a study that Applied Food Sciences commissioned in India and subsequently had reissued under the aegis of the University of Scranton listing researchers associated with that university as its authors. The study purported to demonstrate the striking weight loss benefits of the company’s GCA ingredient, a green coffee bean extract. GCA was one of two green coffee bean extracts mentioned on a Dr Oz Show segment on the botanical, and the results of the study were highlighted during the show. Oz called green coffee bean extract “the magic weight loss cure for any body type” in the 2012 show segment.
FTC said the study used to support GCA’s effects was “so hopelessly flawed that no reliable conclusions could be drawn from it.”
FTC previously outlined its criticisms of the study in a complaint filed against a company marketing a supplement containing GCA and using the results of the study in its advertising. The study, authored by Joe A Vinson, et. al and titled “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.
AFS, and the marketers of the supplement cited by FTC, claimed that the study showed that GCA caused consumers to lose 17.7 pounds, 10.5% of body weight, and 16% of body fat with or without diet and exercise, in 22 weeks, the complaint alleges.
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 in that earlier complaint.
“With only 16 subjects, that’s an incredibly small study,” attorney Marc Ullman of the firm Ullman, Shapiro and Ullman told NutraIngredients-USA. “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.”
“Applied Food Sciences knew or should have known that this botched study didn’t prove anything,” said Jessica Rich, Director of the FTC’s Bureau of Consumer Protection. “In publicizing the results, it helped fuel the green coffee phenomenon.”
In addition to citing structural flaws in the study’s design, FTC alleges there was outright falsification of results. The agency alleges thatthe study’s lead investigator in India repeatedly altered the weights and other key measurements of the subjects, changed the length of the trial, and misstated which subjects were taking the placebo or GCA during the trial. When the lead investigator was unable to get the study published, the FTC says that AFS hired researchers Joe Vinson and Bryan Burnham at the University of Scranton to rewrite it. Despite receiving conflicting data, Vinson, Burnham, and AFS never verified the authenticity of the information used in the study, according to the complaint.
As regards the serious criticism leveled at Vinson and Bunham, the University of Scranton issued this statement via a spokesman:
“The University of Scranton supports and encourages faculty research. The research study referenced was conducted by three parties. The role of University of Scranton professors was to analyze research results and data provided to them by the lead researcher in India. University professors had no part in data collection and have cooperated fully with the investigation of the study.”
Applied Food Sciences declined to comment on the FTC settlement and as such it has been impossible to determine if CGA is still on the market. In addition to paying the fine, AFS must provide a complete list to FTC of all the customers to which it sold GCA and to which it provided marketing materials.