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May 22, 2024 By: Asa Waldstein

Clinically Proven Claims Lead To Scrutiny

Takeaway -

Study design must be correct

This NAD case shows that making “clinically proven” claims attracts the highest level of scrutiny.

The National Advertising Division (NAD) has been paying close attention to skincare marketing claims, and this monitoring case shows that this trend is continuing. A celebrity-supported skincare brand was making the following statement.

“Clinically-proven to quickly and visibly lift, firm, and diminish the appearance of fine lines for a revitalized eye area.”

Reading NAD’s comments on the clinical study design is interesting.

The clinical study “included instrumental measurements of skin hydration and elasticity, digital photographs, and participant questionnaires,” but NAD determined the subjective portion of the study questionnaire could not support all of the ‘clinically proven to quickly and visibly lift’ statements but “NAD found that other portions of the claim were supported, therefore recommended the claim be modified to reflect that the “quick” and “visible” results pertain only to hydration and “the appearance of fine lines.”

This shows how even small marketing statements may be picked apart and should be adequately substantiated. 

There are also some other items in this case which are worth reading. Full disclosure: I am a big Reese fan, but the folks in charge of her brand ambassador compliance can learn from this. From NAD. “The National Advertising Division (NAD) also recommended that actress Reese Witherspoon’s status as a … brand ambassador be clearly and conspicuously disclosed. NAD’s inquiry further focused on whether the format of the challenged advertising gives the impression of editorial content from InStyle and Hello! Magazines and Sephora when, in fact, they are advertisements.” 

The company also discontinued the “#1 best selling product at Sephora” claim. NAD cases continue to reference claims like “#1 best selling” and “#1 doctor recommended,” which should be avoided unless the company has solid substantiation. These types of claims should not be confused with puffery statements such as “world’s best cup of coffee,” which are permitted. I write more about puffery here

Read the NAD case here.

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