Applied Food Sciences (“AFS”), a company that offers a green coffee ingredient used in dietary supplements and foods, agreed to settle with the Federal Trade Commission (“FTC”) to pay a $3.5 million fine for “pushing” its product based on a “seriously flawed” weight loss study.

AFS sells the all-natural bulk extract under the Green Coffee Antioxidant (“GCA®”) trademark. According to the FTC complaint, AFS paid researchers in India to conduct a clinical trial to test whether a dietary supplement containing this green coffee extract reduced body weight and fat. FTC alleged that the lead investigator repeatedly altered the data collected, misstated which subjects were taking the placebo or GCA, and changed the length of the trial. The FTC charged that when the lead investigator was unable to publish this study, AFS hired two researchers at the University of Scranton to rewrite it, which they did despite conflicting data and without verifying the authenticity of the information, according to the complaint.Blog photo 3

The FTC stated that the study was so “seriously flawed” that no reliable conclusions could be drawn from it. Jessica Rich, director of FTC’s Bureau of Consumer Protection said, “Applied Food Sciences knew or should have known that his botched study didn’t prove anything . . . . In publicizing the results, it helped fuel the green coffee phenomenon.”

In fact, based on this study, AFS publicized that GCA caused consumers to lose 17.7 pounds, 10.5 percent of body weight, and 16 percent of body fat with or without diet and exercise in 22 weeks, according to the FTC complaint. Also, although AFS played no part in featuring its study on The Dr. Oz Show, Dr. Oz personally endorsed the unroasted green coffee as a “miracle” and a “fat-burner,” specifically directing consumers to purchase only the GCA® or Svetol® trademarks (Dr. Oz stated he accepts no money for promoting the products). AFS in turn issued a press release highlighting the show, including further false weight-loss claims about the product, according to the FTC complaint.

In addition to the $3.5 million fine, the settlement order bars AFS from misrepresenting any aspect of a test or study related to the products it sells; 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; requires the company to have scientific substantiation for any future weight-loss claims that it makes, including at least two adequate and well-controlled human clinical tests; and 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

Sources: September 8, 2014 FTC Press Release; FTC Complaint for Permanent Injunction, Case No. 1:14-cv-00851 (W.D. Tex. Sep. 8, 2014)

This article was prepared by Lidia Niecko-Najjum (+1 202 662 0278 / ) of Norton Rose Fulbright’s Life sciences and healthcare sector.