Small Herbal Company Cited For Marketing Claims
Product names are marketing
Even very small companies that market online can attract an FDA warning letter. I am still surprised when I hear companies saying they are not big enough to be on “FDA’s radar.” This warning letter shows that anyone, even a tiny company, is “fair game” for enforcement.
Today’s Warning Letter Wednesday is a story of a small herb company cited for making serious disease claims, and I’m guessing they didn’t know the rules of dietary supplement marketing. This is one reason why I write Warning Letter Wednesday: to help raise awareness about enforcement trends and marketing rules in the digital era.
Unfortunately, many schools do not teach the basics of DSHEA and marketing compliance. One of my missions is to educate these communities about the dos and don’ts of supplement marketing. Here is my speaking schedule, which includes three days of classes at next month’s International Herb Symposium at Wheaton College. Please let me know if I can extend free education to your school. I also offer customized marketing compliance company training called the “Regulatory Expert Package.”
This warning letter contains numerous disease statements and is a cautionary tale of what not to do. This is one of the most glaring examples of a disease statement. Wow!
From warning letter: “[Echinacea Tonic] should be used for EVERY disease and illness.”
The product names “Insomnia Formula” and “High Blood Pressure II” were cited in this warning letter.
From warning letter: “Insomnia Formula • Product name: The product name implies that the product is intended to cure, mitigate, treat, or prevent insomnia.”
Read the full warning letter here.
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