Supplement & CBD company cited for disease claims

FDA inspected the company facility in October 2021, then six months later reviewed the website for disease claims, finding many that resulted in a warning letter.

This is a trend. In the past year, there have been several warning letters like this, where an FDA inspection led to a website review several months later, and many disease claims were uncovered. This is a friendly reminder to re-review the website for disease words after an FDA inspection, as they will look at this months later. Even well-intentioned companies may unknowingly have high-risk words lurking on old blogs and social media posts. Here is a post about this.

From warning letter: “On your webpage for “Elderberry Plus Vitamin C”…“Aids with cold, flu and virus symptoms”

Takeaway: This is an example of an unknowing copywriter using common language about elderberries, then copying this onto a product page. This is another reason to build a culture of compliance from within to help social and copywriter employees, the ‘front line of defense’ employees, understand how not to inadvertently turn a disease claim into a drug. I have lots of free content to support this, such as this post and video.

This letter also includes CBD. There have been 26 CBD-related warning letters this year, up from just seven in 2021. This is a clear sign that the FDA will continue to focus on CBD companies making disease claims while essentially leaving CBD companies that follow GMP manufacturing practices and do not make risky claims alone.

From warning letter: “CBD Gummies may help relieve pain, inflammation, anxiety, and depression.”

Takeaway: Using words like “may” and “studies suggest” is not a get-out-of-claims-jail-free card.

Read the full warning letter here.