Warning Letter Marketing Lessons

We can learn from others’ mistakes, and this warning letter outlines what to avoid when marketing herbal supplements.

This company was inspected by FDA and received some 483s, but today, I am going to focus on the website disease claims cited in the letter.

From warning letter: “It’s known to help reduce anxiety ….”

Asa comments: Suggestive words like “may” and “known to” do not allow us to make disease claims. If accurate, perhaps writing “occasional anxiety” would be lower risk, as this phrase likely represents normal life events and is not related to a disease I write about this here. 

From warning letter: “It’s often used as a folk remedy for…the common cold and flu … helping allergies and sinus infections, treating diarrhea ….”

Asa Comments: Calling something a folk remedy or citing traditional use does not allow us to make strong disease claims like this.

From warning letter: “From the list of hyperlinked “Tags” on the product page:
“anxiety” “depression”

Asa Comments: Product tags and meta tags are considered marketing.

From warning letter: “Various studies have shown that it can be effective as a natural remedy for preventing and treating colds and flu …”

Asa Comments: Citing studies and discussing clinical research is marketing, and it can also trigger plaintiff lawsuits, who love bringing action against companies making “clinically proven” claims. This is especially true for on-pack (on-the-label) statements.

From warning letter: “The lions mane mushroom contains a variety of compounds… [that] have anti-inflammatory, anti-cancer…properties.”

Asa Comments: Discussing ingredient benefits on a website is a marketing claim, even if there is no hyperlinking to a shopping cart. This is a very common mistake that continues to be cited in warning letters.

Okay, so I ran Apex Compliance™ on their website and was hoping that all disease claims were cleaned up. Unfortunately, I was WAY WRONG, as the site is still riddled with high-risk words like “cancer.” 

Learn more about this award-winning compliance software, Apex Compliance™. 

Can we envision a day when FDA requires companies who receive warning letters to go through some type of training? Is this a good idea or a terrible one?

I suggest everyone read the full warning letter as a way to demonstrate what not to do.