NAD Case: Supporting Substantiation

Where is the line between needing an ingredient study or a full product study for substantiation? This National Advertising Division (NAD) case explores the nuances of reasonable consumer interpretation of labeling claims. It’s really interesting!

Here are my extrapolations.

Study population matters: NAD examined the ashwagandha Randomized Controlled Trials (RCTs) and determined that one of the trials was insufficient for substantiation, as the study group consisted of perimenopausal women, and the product is not specifically marketed toward women in this group.

From NAD case: “NAD determined that one study did not adequately support the claimed sexual health benefits due to its focus on perimenopausal women and thus could not qualify as competent and reliable support for the challenged claims.”

Attributing benefits to ingredients is a “safer” strategy. It’s “common-ish knowledge” in certain regulatory circles that attributing benefits to ingredients rather than to the entire product may lessen the need for a product RCT. This can also help reduce litigation risk. What is odd is that Example #37 in FTC’s Health Products Compliance Guide seems to suggest that ingredient studies may not be enough. This got me thinking about context and the reasonable consumer takeaway. The theme is CONTEXT MATTERS, so reviewing the entire advertisement rather than just a specific claim is essential. 

From NAD case: “Of the eight express claims, five specifically named ashwagandha as providing the expected benefit. The three remaining challenged claims did not specifically reference ashwagandha, but appear in contexts that make clear that ashwagandha is the source of the claimed benefits. NAD determined that in this context, reasonable consumers would interpret the claims as attributing the product benefits to ashwagandha.”

This a big victory for KSM-66 whose ashwagandha extract studies were likely used for substantiation.

Read the NAD case here.