TV’s Dr. Oz says that he personally believes unroasted green coffee is a “miracle” and a “fat-burner,” but he accepts no money for promoting it. He is also very specific in saying that consumers should purchase only those green coffee extracts carrying either the Green Coffee Antioxidant (GCA®) or Svetol® trademarks. Austin, TX-based Applied Food Sciences (AFS), which offers the all-natural bulk extract under the GCA® trademark, agreed on Monday to pay $3.5 million to settle Federal Trade Commission (FTC) charges that the company used results of a flawed study to support baseless weight-loss claims about the product. In the world of supplement marketing, AFS acknowledges it made the claims about the green coffee extract to retailers, who then repeated the claims about finished products that were being sold to consumers. In the FTC complaint, the study is depicted as so “seriously flawed” that no reliable conclusions could be drawn from it. FTC noted that the study was “touted” on the Dr. Oz Show. However, Dr. Oz opened his last season with his own audience-based study of the effectiveness of green coffee extract as a weight-loss supplement, and that exercise also found it was useful for shedding pounds. FTC’s settlement with AFS, which sells the green coffee ingredient used in dietary supplements and foods, requires the company to pay the $3.5-million fine 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 FTC’s Bureau of Consumer Protection. “In publicizing the results, it helped fuel the green coffee phenomenon.” According to the agency’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. 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, 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, the complaint alleged that 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. Although AFS played no part in featuring its study on The Dr. Oz Show, the company 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, 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 also requires AFS to notify trade customers of FTC’s conclusion that the company lacked reasonable scientific support for the weight-loss and fat-loss claims it made. The 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. In other FTC action on Monday, a federal district judge in Atlanta has issued an arrest order finding that two dietary supplement marketers failed to comply with a previous court order that required them to recall purported weight-loss products that they deceptively pitched to consumers. The current order, issued on Sept. 2, requires Jared Wheat and Stephen Smith to be jailed until they comply with the recall requirements. Both Wheat and Smith have surrendered. The defendants, who ran an operation known as Hi-Tech Pharmaceuticals Inc., continued to deceptively market weight-loss products in violation of a 2008 federal court order, with unsubstantiated claims such as “rapid fat loss,” “fat burner,” “thermogenic” and “curbs the appetite.” Earlier this year, FTC received a $40-million judgment in the case, one of the largest ever against a dietary supplement manufacturer. Specifically, in order to be released from jail, Wheat and Smith must: 1) ensure that the products are not available for purchase from retail stores; 2) send out a proper recall notice for each product; 3) ensure the recall notice has been distributed to all retailers and anyone else associated with the products, and 4) ensure that links to the recall notices are prominently displayed on each page of the company’s website. In issuing the order, the judge wrote: “The continued availability of the violative products in retail stores is not surprising considering the lack of effort by the defendants to comply with the court’s order to effectuate a complete recall. Despite [their] assurance to the contrary, a recall was and is necessary to protect consumers.”