Lessons From NAD Decision
Clinical study parameters must match claims
Most of the claims here are not high-risk, but this demonstrates that even lower-risk statements, especially when combined with "clinically proven" types of claims, can lead to increased scrutiny and potentially increased substantiation requirements.
I usually write about FDA supplement warning letters, but they've been relatively quiet this year, so today's Warning Letter Wednesday discusses an interesting National Advertising Division (NAD) decision. NAD is a self-regulatory body under Better Business Bureau (BBB) programs, and I enjoy reading NAD cases to look for clues about claims substantiation and enforcement.
After reviewing the substantiation, NAD recommended that the company discontinue the following claims.
All "clinically tested," "scientifically tested," "mood support," "calmPM S symptoms," "ease cramps, bloat and moodiness" and help consumers "experience a better period" claims and
Express and implied ingredient claims for ashwagandha, magnesium, vitamin B6, turmeric, and chasteberry.
It seems the company had conducted a clinical study on its OTC product and its dietary supplement botanicals product together, but NAD found tissues with the study. Unfortunately, there is no specific information on the study, such as if it was blinded or placebo-controlled.
"NAD found that the study did not meet the standard for competent and reliable scientific evidence."
"several significant flaws, which rendered it insufficiently reliable to provide a reasonable basis for Pamprin Botanical's establishment and health-related claims."
I've noticed that some companies use additional "creativity" in their Amazon descriptions, and this NAD case shows that even claims on Amazon are fair game for scrutiny. This is obvious, but it is uncommon for claims on Amazon pages to be cited unless they are high-risk disease statements.
From NAD statement. "The National Advertising Division (NAD) determined that, in context, the "tried and trusted" claim that appeared on the Amazon product tile refers to Pamprin's history and that no modification was necessary."
I find the company's approach to marketing the OTC and supplement products together to be an interesting strategy, and I wonder what FDA's position is on marketing drugs and supplements together in an instance like this.
A little more about NAD.
NAD reviews advertising disputes between competitors and other claims it becomes aware of. It is where companies can challenge each other's claims they feel are affecting their sales. NAD evaluates the truthfulness and accuracy of advertising and offers a streamlined resolution process to address advertising disputes. However, unlike a regulatory court, NAD cannot enforce its decisions, but if a company doesn't comply with NAD's recommendations, NAD can refer the case to the appropriate governmental regulatory authority, such as the Federal Trade Commission (FTC). This can also alert plaintiff attorneys.
Read the NAD case here. It's really interesting and definitely worth checking out.
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.