The FTC complaint alleged the study was so hopelessly flawed that no reliable conclusions could be drawn from it. The flawed study, which purported to show that the product causes “substantial weight and fat loss,” was later touted on The Dr. Oz Show.
The FTC’s settlement with AFS, which sells a green coffee ingredient used in dietary supplements and foods, requires the company to pay $3.5 million, and to have scientific substantiation for any future weight-loss claims it makes, including at least two adequate and well-controlled human clinical tests.
“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.”
According to the FTC’s complaint, in 2010, AFS paid researchers in India to conduct a clinical trial on overweight adults to test whether Green Coffee Antioxidant (GCA), a dietary supplement containing green coffee extract, reduced body weight and body fat.
The FTC charged that the study’s lead investigator 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 said 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.
Despite the study’s flaws, AFS used it to falsely claim 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 alleged.
Although AFS played no part in featuring its study on The Dr. Oz Show, it took advantage of the publicity afterward by issuing a press release highlighting the show. The release claimed that study subjects lost weight “without diet or exercise,” even though subjects in the study were instructed to restrict their diet and increase their exercise, the FTC contended.
The proposed order settling the FTC’s charges bars AFS from misrepresenting any aspect of a test or study related to the products it sells, and prohibits the company from providing anyone else with the means of falsely advertising, labeling, promoting or using purported substantiation material in marketing their own products.
The order further requires AFS to notify trade customers of the FTC’s conclusion that the company lacked reasonable scientific support for the weight-loss and fat-loss claims it made. Finally, the proposed order requires AFS to pay $3.5 million.