FDA Crackdown on Anxiety & Depression Claims

The FDA just issued 10 warning letters to companies marketing products for depression and anxiety. These letters include claims made on website product pages, infographics, videos, testimonials, and when discussing individual ingredient benefits. Here are some highlights.

Product Names Are Claims

This is common knowledge but I was surprised by the brazen claims made in some of the product names.

  • Wholesome Wellness got called out for a product named "Natural Anxiety Depression Relief". As my daughter would say this is OTT (Over The Top).

  • Dr. Garber’s Natural Solutions got called out for products named "Depression Relief" and "Anxiety Relief". Yikes! On the product label, the depression statement is linked to an FDA disclaimer. Although well-intentioned, the disclaimer isn't a "get out of warning letter jail free card", and does not protect from disease claims. I review What Is A Claim here. The Suggested Use also includes dosing for children which is ultra high-risk.

The manufacturer should not have applied these. This is another reason to hire a dietary supplement expert.

I use a risk level rating system for clients when analyzing the riskiness of different words. Depression has always been 4.5 of 5 due to FDA warning letter enforcement precedent. Anxiety has been 3 of 5, but after these "Big 10" warning letters I have increased to a 3.5 of 5. As a quick aside, anything 3 or more is at risk for warning letter enforcement and should never be used. Interested in learning more? Set up a free consult

"About Us" Section: Called Out in Warning Letter

"After a tough go-around with postpartum depression, Sylvia decided there had to be a better way to feel better. Her research led her down the rabbit-hole of the gut-brain connection. Her idea for a probiotic specifically designed to help with mood and anxiety was the springboard for Lifted and Mood Boosting Probiotic was their first product."