The Texas-based company Applied Food Sciences (AFS) has agreed to a $3.5 million settlement with the FTC in the case FTC v. Applied Food Sciences, No. 1-14-cv-00851, in which the FTC challenged claims by AFS that consumption of green coffee extract causes weight loss. In 2010, AFS paid researchers in India to conduct a study to test whether Green Coffee Antioxidant (GCA), a dietary supplement containing green coffee extract, reduced the body weight and body fat of overweight adults. AFS claimed that the study showed that GCA caused consumers to shed 17.7 pounds, 10.5 percent of body weight, and 16 percent of body fat, without diet and exercise, in 22 weeks. The study was also featured on The Dr. Oz Show, after which AFS issued a press release highlighting the show and reiterating the weight loss claims. But the FTC alleged that investigators conducting the study committed numerous egregious errors, including altering the weights and other key measurements of the subjects and misstating whether subjects were taking GCA or the placebo. It further alleged that AFS was aware of these errors yet proceeded with publishing the study and making claims based upon it. 

In addition to the monetary settlement, the proposed settlement order also requires AFS to have scientific substantiation for any future weight-loss claims it makes, including a minimum of two controlled human clinical tests, and to notify its customers of the FTC’s conclusion that the company lacked reasonable scientific support for the weight-loss and fat-loss claims it made.

Tip: Hot-button topics like weigh loss are sure to get the attention of regulators, so well-randomized controlled studies supporting such claims are a must.