October 28th, 2020
And, as evidenced by a recent decision involving the marketing of Benefiber by consumer goods giant GlaxoSmithKline (GSK), if the clinical studies aren’t a “good fit” for the “clinically proven” claim, it doesn’t matter how many studies an advertiser has.
In response to inquiries by the National Advertising Division (NAD) and the National Advertising Review Board (NARB), GSK submitted seven clinical studies in support of claims on product packaging and website advertising that the fiber supplement is “clinically proven to curb cravings.” NAD was the first to review the studies. It concluded:
After reviewing the totality of the advertiser’s evidence regarding satiety, NAD determined that the studies submitted were either not consumer relevant in terms of population and the conditions under which the data was collected, measured outcomes or fiber-types that were not relevant to the challenged claims, or did not provide critical information that would permit NAD to assess the reliability of the study.
NAD recommended that the “clinically proven” claims be discontinued, GSK appealed the ruling and the matter was referred to NARB, which affirmed the decision last week.
However, unlike NAD, NARB found that the evidence in the record could support claims that Benefiber “helps you feel fuller longer,” noting that the claim is appropriately qualified by the use of the word “helps.”
The appellate panel also upheld NAD’s recommendation that GSK drop claims that Benefiber is “100% Natural” given the multi-step process by which its sole ingredient, wheat dextrin, is manufactured.
GSK said it would comply with NARB’s decision.
The bottom line? If you see a supplement marketed as “clinically proven,” pump your brakes. It’s worth remembering that the FDA does not review supplements for safety and efficacy before they are sold to consumers.
Find more of our coverage on clinically proven claims here.