Rx for Claim Substantiation – Part IV – Recent Developments

Recent developments underscore the importance of conducting high quality clinical studies for claims substantiation.  In a recent $5.5 million settlement against a producer of a dietary supplement that claimed to cause weight loss, the Federal Trade Commission (FTC) stated that at the time of making claims, companies should “possess competent and reliable scientific evidence that substantiates that the representation is true.” (United States District Court, Western District of New York Case No. 10-CV-587, 2010). As defined in the aforementioned court order, competent and reliable scientific evidence consists of at least two randomized, double-blind, placebo controlled, human clinical studies of the Covered Product, or of an Essentially Equivalent Product, conducted by different researchers, independently of each other. The FTC recently applied the same standard to a manufacturer of a probiotic drink, but did not levy a fine. A representative from FTC (Mary Engle) stated that whether FTC assesses a fine or asks a firm to refund consumers depends on multiple factors, including “how well a firm’s evidence supports its claims.” Engle further stated that “firms sometimes offer quality studies that do not support claims, poor studies of little value or no supporting studies at all.” (The Tan Sheet, July 19, 2010).

An additional article published a week earlier (The Tan Sheet, July 12, 2010) addressed the issue of consumer mistrust of claims made by supplement and nutritional product manufacturers.  The trust issue was based on a recent survey conducted with 3,013 people nationwide and indicated that on a scale of one to five (with one being “not at all trustworthy” and five being “very trustworthy”), 59% of people rated the trustworthiness of claims by dietary/nutritional supplement manufacturers a one or two. Daniel Fabricant, VP of Scientific and Regulatory Affairs for the Natural Products Association stated in the Tan Sheet (July 12, 2010) that “consumers want to see the studies that support the ads to see that there is something real in the claims” and that “a solid study does more than any advertising piece could ever do.”

Both the FTC’s actions and the high degree of consumer mistrust of claims signal that dietary supplement manufacturers must be prepared to conduct well-designed clinical studies to substantiate claims, or risk fines or poor sales. In previous and prescient Burdock Group newsletters published in 2008 and 2009, Burdock Group’s Dr. Carabin  published guidance on the factors that need to be considered when designing clinical studies (See Rx For Claims Substantiation – Parts I, II and II by Ioana Carabin).  Due to the new, more r