By: Linda L. Goodman
Not all studies are created equal and not all studies will provide sufficient substantiation for marketers in the weight loss vertical. Texas-based, Applied Food Sciences, Inc. (“AFS”), learned this lesson the hard way and paid $3.4 Million for using a flawed study to make weight–loss claims about its green coffee extract to retailers and marketers who repeated those claims in marketing the product to consumers.
The Federal Trade Commission (“FTC”) complaint charged AFS for deceptive marketing based on allegations that their study was so hopelessly flawed that no reliable conclusions could be drawn from it. 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. This is a good step to compliance.
However, 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.
Not only was AFS held responsible for their own marketing, but the FTC appears to have blamed them for the green coffee phenomenon that hit the market shortly after the flawed study was highlighted on the Dr. OZ show. “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.”
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 settlement requires AFS to pay $3.5 million to the FTC, and to be able to produce “scientific substantiation” for any future weight-loss claims it makes. The settlement defines “scientific substantiation for weight loss to include at least two adequate and well-controlled human clinical tests. In addition, it 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.
Finally, the order 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. So, for the next 10 years, AFS will be telling the FTC all about their business, products, and testing.
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This article is a publication of The Goodman Law Firm and is intended to provide information on recent legal developments. This article does not create an attorney-client relationship, nor should it be construed as legal advice or an opinion on specific situations. This may constitute “Attorney Advertising” under the Rules of Professional Conduct and under the law of other jurisdictions.
Linda L. Goodman is the founder of The Goodman Law Firm, concentrating its practice in internet business and law. Her firm’s clients include Advertisers, Affiliates, Affiliate Networks, and ISP’s.
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