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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."

This is a new one for me, although it is not surprising. Lifted Naturals has an origin story in their About Us section. This could have been made lower-risk by removing the buzzwords and not discussing the product (material connection).


Suggesting A Product is Better Than Drugs is a No-No

Implying consumers should purchase products instead of taking medications is a great way to irritate the FDA into issuing a warning letter. In the eyes of the FDA, what if someone stopped taking their medications and hurt themselves or others. The mission of the FDA is to prevent this. Personally, I am a natural health enthusiast and have my own opinions here, but I keep these to my dinner table discussions.

  • In the Blossom Nature, LLC warning letter they state "St. John's Wort is effective as prescribed antidepressants but with no side effects." 


Blogs and Testimonials Continue to Show Up In Warning Letters

Read all about this here.


The picture above is from a presentation over a year ago where I spoke about depression claims. Learning how to read enforcement trends can protect your company.


Reasons to Avoid Warning Letters

Warning letters are a big deal. I review reasons to avoid letters below and in this video.

Ripe Ground For Plaintiff Attorneys

Class action lawsuits commonly sprout from warning letters, as attorneys can use the letter as proof of wrongdoing. In the case of FDA Nutrition Inc. and Sleep Group LLC, there are likely incorrect Made In the USA & All Natural claims being made on their websites, and these letters can bring a larger magnifying glass on potential other deceptive marketing claims. We review Made in the USA and All Natural claims here.


What Else Can We Learn?

Well, we should all know by now that making high-risk claims will attract trouble. I review this in most of my blogs including this post on FTC enforcement.

  • Step #1: Remove all mentions of the depression and anxiety buzzwords from any web or social media presence. This includes metatags and hashtags which are considered advertising. I review this in loving detail here.

  • This includes going back in time to retroactively clean up old Facebook, Twitter, and Instagram posts that may have these, and other claims.

  • Develop ways to ensure these claims don't seep into your marketing. This can be done by having your in-house regulatory expert or consultant review all marketing material before posting. I love helping companies develop in-house expertise. This is literally the reason why I started my regulatory consulting company.

  • Discussing ingredient benefits can be considered a claim, especially when used overtly to sell products. Here is a full webinar on marketing claims.

  • We review compliant marketing strategies here.


There is so much to discuss but you get the drift, making claims such as anxiety and depression in any format is bad, and should be avoided.

For a free compliant marketing strategy consultation contact me here. I love this stuff!

Disclaimer: The educational information provided on this website is for informational purposes only. Contact an attorney for specific legal advice.

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Disclaimer: The educational information provided on this website is for informational purposes only. Contact an attorney for specific legal advice.