CellMark BioPharma and its CEO have agreed to settle Federal Trade Commission ("FTC") charges that they marketed cancer treatment products without proper substantiation for their advertising claims. The FTC alleged that they improperly marketed CellAssure as a treatment for cancer-related malnutrition and Congnify as a treatment for "chemo fog."
As part of the settlement, the defendants agreed to have competent and reliable scientific evidence before making health claims in the future.
What does the FTC think "competent and reliable scientific evidence" looks like? In the settlement, it's defined as "human clinical testing . . . that is sufficient in quality and quantity based on standards generally accepted by experts in the relevant disease, condition, or function to which the representation relates, when considered in light of the entire body of relevant and reliable scientific evidence." The FTC also said that the testing should be randomized, double-blind, and placebo-controlled and conducted by researchers qualified by training and experience to conduct such testing.
according to the FTC complaint, the defendants did not possess scientific evidence that these products provided any of the claimed benefits