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A Texas-based company, Applied Food Sciences, Inc. (AFS), has settled Federal Trade Commission charges that it used the results of a flawed study to make baseless weight-loss claims about its green coffee extract to retailers, who repeated those claims in marketing finished products to consumers.

The FTC complaint alleges 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 Applied Food Sciences, Inc. (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, Austin, Texas-based 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 charges 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 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.

Despite the study’s flaws, AFS used it to falsely claim 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, the complaint alleges.

Although AFS played no part in featuring its study on The Dr. Oz Show, it took advantage of the publicity afterwards 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 contends.

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.

Information for Consumers

The FTC advises consumers to carefully evaluate advertising claims for weight-loss products. For more information, see the FTC’s guidance for consumers of products and services advertised for Weight Loss & Fitness.

The Commission vote authorizing the staff to file the complaint and proposed stipulated final order was 5-0. The complaint and order were filed in the U.S. District Court for the Western District of Texas, Austin Division. The proposed order is subject to court approval.

The FTC is a member of the National Prevention Council, which provides coordination and leadership at the federal level regarding prevention, wellness, and health promotion practices.  The National Prevention Strategy, released June 16, 2011, aims to guide our nation in the most effective and achievable means for improving health and well-being. This case advances the National Prevention Strategy’s goal of increasing the number of Americans who are healthy at every stage of life.

NOTE: The Commission files a complaint when it has “reason to believe” that the law has been or is being violated and it appears to the Commission that a proceeding is in the public interest. Stipulated orders have the force of law when approved and signed by the District Court judge.

The Federal Trade Commission works for consumers to prevent fraudulent, deceptive, and unfair business practices and to provide information to help spot, stop, and avoid them. To file a complaint in English or Spanish, visit the FTC’s online Complaint Assistant or call 1-877-FTC-HELP (1-877-382-4357). The FTC enters complaints into Consumer Sentinel, a secure, online database available to more than 2,000 civil and criminal law enforcement agencies in the U.S. and abroad. The FTC’s website provides free information on a variety of consumer topics. Like the FTC on Facebook, follow us on Twitter, and subscribe to press releases for the latest FTC news and resources.