FDA Crackdown on Anxiety Claims

Описание: This video is a teaching tool for business owners and marketers.

I review the increase in anxiety claims enforcement. In 2021 there was 40 anxiety-related product FDA warning letters, a 95% increase over 2020 (21), which is a clear sign of the FDA’s enforcement priorities.

Here is a breakdown of the 2021 anxiety warning letters.
*75% (30) include both anxiety and depression. This shouldn’t come as a surprise to anyone following enforcement trends, as the FDA sent ten anxiety/depression letters last February. I write about this here. https://www.asawaldstein.com/post/fda...

*45% (22) include claims made on social media. I would have guessed this number would be higher.

*10% (4) include hashtag claims, and 25% (10) include claims made in testimonials. I expect warning letters with hashtag claims and testimonial claims to increase, which is an enforcement trend to watch.

*All 2021 letters also include higher-risk disease words such as hypertension except for one that involved a drug spiked product (sibutramine). The FDA looks at a company’s complete online presence. One claim may not attract a warning letter, but, for example, claims made on social media, YouTube, Amazon, and blogs are pieced together for one big picture of noncompliance.

*It is worth noting the 2021 warning letters did not include the term “occasional anxiousness,” which is, if substantiated, often considered not to be a disease claim.

Anxiety is considered a 3.5 of 5 on the “Asa Risk Scale” and should not be used. If truthful and substantiated lower risk alternatives are:
*happy mood support
*balanced state of mind
*mental resilience
*support when things get overwhelming
*helps support smiles

Inspired by this LinkedIn post.   / asa-waldstein-989360b_warningletterwednesd...  

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Thank you,
Asa Waldstein
https://www.asawaldstein.com/

#RegulatoryEducationSeries
#WarningLetterWednesday

-These comments are educational only and are not intended as legal or regulatory advice.

My name's Asa Waldstein and I love reading FDA warning letters. Anxiety claims enforcement in FDA warning letters was up 95% in 2021 over the previous year. Now, this is a clear sign of enforcement trends. We really want to pay attention to any use of anxiety on any of our online marketing. So let's break this down a little bit.
Of the 40 FDA anxiety related warning letters in 2021, 75% of them, included the words, anxiety, and depression. Now this shouldn't come as a surprise to anyone who's been paying attention and following enforcement trends, because earlier in 2021, the FDA sent out 10 warning letters in one day to companies making anxiety and depression claims. That's a clear sign of their enforcement priorities. Now, of these 40 warning letters in 2021, 45% of them included claims made on social media. Now, I have to say that I'm pretty surprised by that number. I would've thought that this would've been higher, because it seems like almost every FDA warning letter I read includes social media.
The important point here is that the FDA is paying close attention to claims made on social media. So it's very, very important to not only not use words like anxiety and other high risk buzz words in your social media, but go back and clean up old social media posts.
Now, 10% of the warning letters included claims made in hashtag. So, this is four of the 40 warning letters in 2021 that included anxiety. 10% of them included hashtag claims and 25% of them included claims made in testimonials or product reviews. Now, I expect this number to increase. So, expect to see in 2022 and beyond more warning letters citing claims made not only in hashtags, but testimonials and product reviews.
Now, the FDA, they look at the 30,000-foot view of a company's complete online persona. Now, one claim may not attract a warning letter, but when this claim is attached to a claim made on social media, claim made on YouTube, a claim made on Amazon or claim made in blogs, they're pieced together for one big picture of non-compliance.
Now, it's worth noting that the 2021 warning letters did not include the term, occasional anxiousness or occasional anxiety, which if substantiated, is often considered to not be a disease claim. Now, as many of you know, I have a risk scale, it's called the, Asa Risk Scale, for lack of a better word. Now, anxiety as a word is rated three and a half out five on the, Asa Risk Scale. So anything three or above is likely to attract a warning letter. So anything 3.5 or above is a hard, no, should never be used in my personal opinion.
So, as long as we're being truthful and not misleading, here are some possible other alternative words for anxiety: happy mood support, balanced state of mind, mental resilience, and help support smiles.