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Lessons From The Front Line: Warning Letter Review

Updated: Sep 26, 2021

The popularity of medicinal mushrooms shows me the world is finally ready to embrace natural medicine. It is no surprise however to see mushroom product marketers being called out in warning letters for making high-risk claims. Here's a recent warning letter that covers many of the common mistakes to avoid. Most of this I've talked about here in my blog or my #WarningLetterWednesday LinkedIn post.


Here Are The Learning Targets:

* Follow Enforcement Trends: Depression & Anxiety Claims Are Super High-Risk

*Hashtags Are Claims

*High-Risk Words Should Be Avoided

*Implying "Clinically Studied" Is High-Risk

* Clean Up Claims On Old Social Media Posts

* Social Media is Marketing



Many warning letter recipients are not bad folks but perhaps just do not know any better. A purpose of my free Regulatory Education Series platform, my public speaking tour, and my free video channel is to educate those looking to raise the bar of ethics and compliance in the industry. Please share this blog or any of my content (with attribution) if it may be of value to your network. We are stronger together!


Follow Enforcement Trends: Depression & Anxiety Claims Are Super High-Risk

Earlier this year the FDA cracked down on companies making depression and anxiety claims which I write about here. Anyone who was paying attention to enforcement trends would have removed these words from their marketing. I love enforcement trends, they give us an opportunity to learn from other's mistakes and course correct. Read my Reasons To Follow Enforcement Trends post for a detailed discussion.



Hashtags Are Claims

It is pretty obvious but in this warning letter, the following hashtags were called out.

#DepressionAndAnxiety #BeatDepression #BeatAnxiety

The quickest way to wave a stick at the FDA/FTC is by using non-compliant hashtags,



High-Risk Words Should Be Avoided

I have developed a risk-rating system on a scale of 1-5. Here are some examples of words in the 5 of 5 risk categories: cancer, COVID, Alzheimer’s, depression, PTSD, Diabetes should never be used. Words such as pain and inflammation carry a risk level of 3 of 5. For context, anything 3+ is likely to attract a warning letter. Contact me for a list of other high-risk words to avoid with some possible lower-risk alternatives. Here are some tips to know if a claim is being made! I also made a video on this!




Implying "Clinically Studied" Is High-Risk

This is definitely a trend to watch out for. We are seeing references to clinically studied types of claims showing up not just in warning letters but also in class action lawsuits.

A company cannot imply their commercial product has the same uses as a clinical study. We talk about what defines clinically proven here. There are many factors including serving amount, formulation, and delivery size which play a role in this.

Here are some egregious examples from the warning letter in grey.

On the scientific studies webpage, under the heading “Lion’s Mane Scientific Studies”:

• “Lion’s Mane May Be Effective in Combating Dementia/Alzheimer’s Disease”

• “Lion’s Mane Has Shown In Studies That It Could Reduce Anxiety And Depression”

• “Animal Testing Shows Lion’s Mane Helps Control Diabetes Symptoms By Keeping Blood Sugar Low”

This is a good example of a company pushing out content without having a compliance review. I review this and more in this Hiring Supplement Experts for Rapid Company Growth blog post. I loved that post and poured by 20 years of experience into it!

Clean Up Claims On Old Social Media Posts

The authorities look at a very old social media in the same manner as a current one! In this warning letter, a 2019 tweet is referenced! Please please please, delete or clean up old non-compliant social media posts. I really don't want to tell you I told you so! Read about this in my Operation CBDeceit blog.

From the warning letter in grey. Notice the 2019 date!

On your social media website

• “LVL:MAX . . . Protects Against Ulcers in the Stomach: Goodbye Pain… Relieves Depression and Anxiety… Lowers Cholesterol: Live Longer…Lower Inflammation…” [From a Nov 12, 2019 post]

Social Media is Marketing

Anything used to sell a product, including all commercial social media posts are marketing, and therefore must be compliant. Most warning letters reference social media I find it helpful to think of all marketing as an extension of the label. We wouldn't use the word anxiety on a label, so it's important to not use disease claims in any marketing, including social media infographics. Anything used to market must be truthful and not misleading.



I hope you enjoy this warning letter report from the front line of compliance. I read every FDA warning letter and report back on enforcement trends. I love this aspect of compliance!


For a free consultation regarding your compliant marketing contact me here.