Finished Product: Clinical Study Required

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 (product) from tailoring its claims to the benefits specific ingredients in (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.

Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading.