Website Marketing Claims Lead To Warning Letter

This company was cited for making high-risk claims related to colds, the flu, and viruses in product and ingredient descriptions. This warning letter is an excellent lesson on what not to do when marketing supplements. Learning from other’s mistakes can help inform compliant marketing, which is one of the reasons why I love writing Warning Letter Wednesday.

Here are some high-risk “trigger words” from this letter that should always be avoided. These are some of the preloaded words Apex Compliance scans for when conducting website and content reviews.

• Antimicrobial, antiviral, and antifungal: Most words with “anti” should be avoided.

• Fight infection, viruses, influenza, cold and flu.

• Arthritis

• Diabetic support

Even though the company removed the direct references in the warning letter, the rest of the website still contains product statements such as “Used for over 88 years as an alternative approach to treating cancer.” I’m always bewildered when I see companies only removing the statements called out in warning letters but leaving other high-risk claims elsewhere in their marketing. Perhaps we can support FDA to provide a more comprehensive warning letter list of violations or offer education to companies that do not understand the sometimes confusing world of supplement marketing. I volunteer to help, and my Apex Compliance product is also made for this.

There are also lower-risk statements cited that are not likely to attract a warning letter on their own. These “secondary” claims are added when there are higher claims made, but they can help us understand what FDA considers a disease claim and what is an “allowable” structure-function claim.

• From warning letter.  “a natural antihistamine that can help stop damaging particles in the body known as free radicals, which negatively impact how cells work. “

• From warning letter. “Kudzu - an herb used in ancient medicine to ease an upset Stomach Ache.”

I see companies making the mistake of overexplaining ingredients and products using widely available language such as “Garlic Bulb Extract - contains antimicrobial, antiviral and antifungal properties that assist in alleviating colds as well as other infections” all the time. This is an essential reminder that clinical studies, “educational” websites, and herbal texts do not always translate to compliant marketing. Marketing that focuses on quality-of-life statements such as “wellness support” and “help you feel like yourself” usually gets the message across without making disease claims.

This is a shorter WLW than usual, as I’m writing this from the French Riviera on a family holiday.

I invite you to read the full warning letter. 

Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading.