When the FTC joined the Department of Justice and a slew of other federal agencies for a press conference on dietary supplements last fall, it announced that it had brought a lawsuit against companies and individuals marketing Pure Green Coffee weight loss supplements. On March 28, 2016, the Florida district court that handled the case approved a settlement between the parties. Under the terms of a stipulated order, the marketers agreed to pay $160,800 in monetary redress and transfer to the FTC assets including net proceeds from selling stocks and a Crown Victoria owned by one of the individuals. Under an avalanche clause in the order, if it is later found that the marketers misrepresented their financial situations, $30,000,000 in monetary redress will become due.
In addition to monetary relief, the order includes injunctive provisions stating the type of evidence the marketers must possess for any future weight loss claims for a food, dietary supplement, or drug. We’ve asked before how many studies the FTC really expects for weight loss claims, and now as before, the answer seems to be probably more than one. The stipulated order requires “Adequate and Well-Controlled Human Clinical Testing,” which is defined as “human clinical studies that are randomized, double-blind, and placebo-controlled and that are conducted by [p]ersons qualified by training and experience to conduct such studies.” In recent years, orders on other types of cause and effect claims have routinely required “human clinical testing,” rather than the plural, “human clinical studies.”