Supplement company’s brochures and online marketing lead to a warning letter
There are no FDA approved supplement facilities or supplement products
The FDA inspected a facility, then six months later they reviewed the company website. This is a continuing trend and a reminder to screen for disease words online, especially after a GMP inspection.
Here the FDA refers to a product brochure as labeling. This is an important reminder that all marketing is an extension of the label. Here is a video about this.
From warning letter: “On your product labeling (brochure) for “Kidz DHA,” which directs consumers to your website …. where the product is available for purchase: “DHA supplements are purported to treat certain health problems in children, such as allergies, asthma, and attention deficit-hyperactivity disorder (ADHD).”
Several other disease words are mentioned in this letter, such as anti-bacterial and anti-inflammatory. As a rule, words containing “anti” should be avoided. The one exception here is antioxidant.
Also interesting in this letter is the mention by FDA that they do not approve facilities or supplement products. If a company claims to have FDA approval of their supplements, this is a marker they do not understand the basics of dietary supplement regulations.
From warning letter: "We note that your website includes the statement that …. are made . . . in an FDA approved facility.” Although certain facilities must register with FDA, FDA does not approve facilities.
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.