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 rigorous standards for claims substantiation, it is time to revisit this guidance.

In Part I of our series, Dr. Carabin (an MD involved in many clinical trials) stated that “a full-scale clinical trial relies on a significant financial investment and time, therefore demanding meticulous and advance planning at the outset.”  Several factors that need to be considered in advance include (1) the existence and strength of the safety data, (2) prior evidence of efficacy (in animals and/or in humans), and (3) determination of the effect/outcome to be studied. In Part II of the series, Dr. Carabin stated that “exact wording for the claim (understanding not only the meaning of the claim, but also clearly identifying each implied and expressed element of the claim) is critical and represents the basis of the human study’s hypothesis and protocol. There must be a straight line relationship between the trial’s finding and the claim.” Otherwise, a lot of time and money will be spent on a study that does not support the claim.

The ruling by the FTC indicates that nothing less than two randomized, double-blind, placebo controlled, studies in humans will suffice for claims substantiation. Furthermore, the studies must be “product-specific”. Additional factors that must be considered are use of: (1) an appropriate population (including sex, race and age) and samples size to allow attainment of statistical significance (including an estimate of the number of drop-outs); (2) pertinent screening and baseline evaluations and inclusion/exclusion criteria; (3) dosing regimens and patient management procedures that will optimize compliance; (4) a study duration that will allow for the effect that substantiates the claim to be uncovered; (5) markers that support the claim; and (6) monitoring procedures that will uncover potential adverse effects. The approach that will be taken to classify and handle anticipated and unanticipated adverse events (AERs) must be stipulated in the protocol, and will be scrutinized by the Institutional Review Board (IRB) during the review process.

In our practice, we often review and interpret published or unpublished clinical studies in order to determine if their results will substantiate claims. Many clinical studies do not meet the randomized, double-blind, placebo controlled, product-specific standard mandated by the FTC. It is clear that the majority of the studies were not designed with the desired claim in mind before the study was conducted – therefore there was no straight line relationship between the trial’s finding and the claim. By mandating conduct of “gold-standard studies”, the FTC will help dietary supplement makers establish this line, without veering off course. Burdock Group can help you establish this line, by assisting you with protocol development and clinical study placement and monitoring.