Website Disease Claims
Product inserts are marketing
This warning letter is an example of how online ingredient/product education crosses the line into disease-claim marketing. There are numerous examples such as this.
From warning letter. “… contains six of the most effective immune supporting herbs with proven effects against colds and influenza.”
Also, I ran their Facebook account through Apex Compliance® and found numerous risky items, including COVID and flu claims. Given the state of the company’s website, this was not entirely surprising.
I was a bit perplexed that FDA did not cite any claims from their social media, especially since the company’s website linked to its Facebook page. Perhaps the FDA determined that the website claims were sufficient, and they did not need to look any further.
This got me thinking about marketing compliance. FDA warning letters often result in the specific issues mentioned in the letter being corrected, but the rest of a company’s marketing may still remain noncompliant. In my opinion, that is part of what repeat warning letters are for, though they seem relatively rare these days.
I am not an exposé-style person who publicly calls out seriously noncompliant brands. That just isn’t my style. This gets to the point of why I write Warning Letter Wednesday. Today marks 252 consecutive weekly posts, and my goal has always been to help educate and raise the tide of compliance across the industry. Many companies may not know better. But after reading WLW, hopefully, they have taken a small bite of compliance education and will adjust their marketing before it leads to a warning letter, lawsuit, challenge, or retailer issue.
In my opinion, the company’s product names, such as “Anxiety Support” and “Virasol,” fall outside the compliance boundaries. This is a friendly reminder that product names are marketing claims, or they at least signal intended use, which flags the authorities to have a closer look.
Product brochures sent with orders are marketing claims. In this example FDA references the product shippers. Since FDA didn’t inspect the company’s facility, it seems they purchased the product. The ‘purchase and test’ of sketchy-looking products is somewhat common for FDA, so I wonder if that’s what happened here, especially since the timeline between the website reviews and the warning letter is several months. Yes, I am an enforcement trends geek!
From warning letter. “From the promotional material entitled …,” shipped with orders of your products: “Virasol contains six of the most effective herbs with proven effects against colds and influenza. These ingredients in this formulation are some of the most powerful herbs for preventing and treating colds and influenza. VIRAsol has been used to breakdown and destroy the protein sheath of a viral cell and help with anti-viral prevention.”
The warning letter is a doozy.
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