
Finished Product: Clinical Study Required
Review of NAD case
Are clinical studies really needed on finished dietary supplements? Here, I review a recent National Advertising Division (NAD) case on the topic.
Full disclosure: I like NAD, and their cases are a wealth of learning opportunities, but the interesting and somewhat mind-boggling portion of this case has to do with performance claims. Based on the information provided, it seems that NAD requires a finished product study to substantiate the “helps maintain healthy eyesight and visual performance” statement.
NAD states: “[this is] because the studies and meta-analysis relied on by the advertiser were not conducted on [the product].”
NAD goes on to say: “NAD recommended the claim be discontinued but noted that nothing in its decision prevents [the product] from tailoring its claims to the benefits specific ingredients in [the product].”
A takeaway here is attributing substantiated structure-function claims to ingredients like “vitamin C for skin health” rather than simply stating the product is used for skin health is a risk-lowering strategy. I still feel like I am missing something here because I can’t imagine agencies or courts requiring finished product studies for low-risk structure-function claims that do not state the product is clinically proven. I write more about these important points from the FTC’s Notice of Penalty Offence letters here.
There’s more to this case, including bioavailability claims, and I suggest everyone read it. Please let me know your thoughts.