Disease Claims Turn Supplements Into Unapproved New Drugs
Screen all blogs and social media for disease claims
This Warning Letter Wednesday is an excellent lesson about turning a supplement into an “unapproved new drug” by making disease claims.
Other lessons here are:
- LinkedIn claims cited again!
- Eight-year-old social media post!
- Claims made on social media are top of mind for the FDA.
From Warning Letter: “Ayurveda has solutions for managing high blood pressure. . . . THREE PRODUCTS TO HELP HIGH BLOOD PRESSURE . . . Arjuna Arishtam supports healthy heart function and reduces high blood pressure.”
Social media is mentioned in this warning letter. The citation below is boilerplate in warning letters, and it is a good reminder that directing consumers to a website to purchase the product is the “material connection.” If these social media sites did not link to a commercial website or shopping cart, they likely would not be cited in this letter.
From Warning Letter: “these social media websites direct consumers to your website at https://kottakkal.shop/ to purchase your products.
An eight-year-old Facebook post is mentioned here, and this may be a record for the oldest post mentioned in a warning letter! As I’ve spoken about several times, the FDA looks at old social media posts in the same manner as current ones, and we talk about this here.
From Warning Letter: “On an April 3, 2014, post from your Facebook social media website”
Check out the citations at the bottom of the warning letter! They reference claims made on LinkedIn. I wrote about this just a couple of weeks ago, and it is a good reminder to clean up old social media pages, including LinkedIn. Join the discussion here.
Pro tip: This post includes a high-risk hashtag, which makes it easy for the FDA to find claims in the cluttered world of LinkedIn.
From Warning Letter: “This webpage is also linked from a post on your LinkedIn social media website, which states “# Highbloodpressure does not have to be permanent: # Ayurveda has solutions for managing high blood pressure. When turning the light of Ayurveda onto HBP, there is a priority toward each person’s imbalance and recommendations are made based on the best diet and activities for each person.”
Read the warning letter here.
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