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July 3, 2024 By: Asa Waldstein

Finished Product: Clinical Study Required

Takeaway -

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.

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.

Written by

Asa Waldstein
Asa Waldstein
Asa Waldstein is a 24-year veteran of the dietary supplement industry, with experience spanning manufacturing, marketing, and regulatory compliance. He is the principal of Apex Compliance, a software company dedicated to streamlining regulatory marketing compliance for the dietary supplement and natural products sectors. Asa also leads Supplement Advisory Group, a boutique consultancy focused on marketing risk analysis, labeling, and practical compliance strategies for websites and social media. Asa has helped oversee three FDA GMP inspections with no 483s and was honored with the 2023 AHPA Herbal Hero Award and the 2024 What's Up Supps Policy and Change Agent Award. He currently serves as Chair of the American Herbal Products Association’s (AHPA) Cannabis Committee, helping shape policy and industry best practices