Ingredient Descriptions Are Claims
All marketing must be compliant
This warning letter is a great teaching lesson of what not to do. Here are some extreme examples where the company crossed the compliance line by discussing the benefits of its ingredients.
From warning letter:
- “Not only can elderberry help prevent colds and flu, but it can also be used to treat allergies, including hay fever, and sinus infections.”
- “Ashwagandha powder can help reduce inflammation.”
- “The benefits of this adaptogen also extend to fighting inflammation.”
- “Lion’s Mane mushrooms are thought to protect from dementia.”
FDA inspected the company’s facility, but according to the warning letter, FDA did not review the company’s website until two months after the inspection. FDA then reviewed the company’s website again three months later. Here are some takeaways.
If you have been inspected by FDA within the past year, now is the time to triple-check your online presence to ensure there are no “forgotten” disease statements.
You can correct your online presence now, and if FDA is surveilling your website and sees that the disease claims have been removed, this reduces your warning letter risk. It’s “almost” never too late to be compliant.
Here’s the letter.
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