Injectable CBD Warning Letter

Injectable CBD? The first CBD warning letter of the year is an odd one.

The company was cited for selling injectable CBD products and making disease claims on its website and social media. Here are some key takeaways.

🔹Where is the commerce (sales) taking place? The company's website is designed for practitioners, and it looks like no actual commerce takes place on the website or social media. I even looked at archived website versions of the Wayback Machine. I didn't see anywhere to actually purchase the product unless I set up an appointment with a licensed therapy professional or provided professional credentials. Typically, these "gated" or "commerce-removed" websites do not attract FDA warning letter attention since no public commerce takes place. This type of situation is rare and is really interesting.

🔹Curated testimonials: The agencies are generally "hands off" with third-party, non-curated, non-compensated product reviews or testimonials. These become "marketing" when the company engages with them or curates them, such as adding them to a banner, product page, or social post. Also, FDA sometimes considers separate "testimonial" or "product review" pages as being curated, meaning they are fair game for enforcement. In this letter, the "testimonials" web page had many disease claims. This testimonial shows that making a "better than drugs" statement will increase the chance of a warning letter.
 

👉From warning letter. "I have now completed two PICO CBD infusions (each 14 days apart) and have had no need to take any Xanax. It's been years since I have been able to go 30+ days without an anti-anxiety pill."

🔹Products marketed as a dietary supplement. Even though the product image label does not appear to list a "supplement" statement of identity or fact panel, the FDA did some investigation work.

 👉From warning letter. "You appear to be marketing your "Pico IV" as a dietary supplement. For example, marketing material found on your website states that "CBD, and other cannabinoids, are considered dietary supplements by the FDA . . . even if they're administered intravenously."

🔹Social media disease claims. FDA cited several disease claims in this letter. What's fascinating about this example is the company's use of "potentially." The softening words do not allow a company to make disease claims.

 👉From warning letter. "CBD [p]otentially reduce anxiety and inflammation. CBG [c]an support bone health and neuroprotection"

This letter came in a group of other injectable-related warning letters which shows that FDA wanted to make a statement about the dangers of IV therapeutics.

Read the full letter here. 

DATE ORIGINALLY POSTED: 3/19/25

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.