Herpes Product Name & Imagery Cited in Warning Letter
Product names & images can communicate disease claims
FDA recently sent a group of herpes-support product warning letters. This one caught my eye since FDA used secondary marketing, such as imagery and website claims to further support their premise that the product, “Herpes B Gone” is an unapproved new drug. Let’s see what we can learn.
First, the product name “Herpes B Gone” is a red flag which signals obvious intended use of herpes treatment. It’s probably enough to attract a warning letter on its own but FDA kept digging.
From warning letter. “Herpes B Gone” and images of what appears to be cold sores on the lips
From warning letter. “Say No to Sores on Your Mouth or Genitals” and “Lower the dangers of herpes virus”
As noted in this warning letter FDA is concerned that non-approved treatment protocols may lead to serious health concerns or additional viral spreadage. Their concern that consumers taking unapproved products may forego other treatment is a common warning letter theme, especially when there may be serious ramifications of foreshowing the treatment (e.g. SSRIs, heart disease health, viral treatment, etc).
From warning letter. “Individuals who rely on these products may forgo timely, appropriate medical care, increasing their risk of severe complications such as infertility, sepsis, and death. Further, a false sense of having been adequately treated may lead individuals to unknowingly transmit infections to their partners.”
I looked at the company’s website and they appear to be a groovy holistic healing center; the type of place I’d love to visit. Where they went wrong is making products for herpes, and also chronic pain (although this one is not referenced in the warning letter) without FDA approval. This is where well intentioned companies get intro trouble, by making products and marketing them online, without knowing the rules of compliance. This is one reason why I write WLW, to help education companies so they can adjust their marketing and processes and stay ahead of the enforcement curve.
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