The FDA has sent a pointed warning letter to Curaleaf Holdings Inc., a seller of cannabidiol (CBD) products, for not following the regulating body’s labeling guidelines. The FDA called out two marketing strategies which it found troubling. It stated that the company tried to market CBD products as a dietary supplement despite it being excluded from the dietary supplements definition. The FDA has clearly stated that CBD extracts and hemp products do not fall under the category of dietary supplements.
The second and more likely trigger for the action was the marketing of the products on its website and social media platforms like Facebook and Twitter. The FDA scrutinized the website and blog posts and found unfounded claims like:
- “CBD has also been shown to be effective in treating Parkinson’s disease.”
- “CBD has been linked to the effective treatment of Alzheimer’s disease.”
- “CBD is being adopted more and more as a natural alternative to pharmaceutical-grade treatments for depression and anxiety.”
These claims about the CBD products preventing or treating diseases made it easy for the agency to conclude that the products could be classified as unapproved new drugs that didn’t follow the FDA’s labeling guidelines and are hence ‘misbranded’. The FDA likely chose a multi-billion dollar company like Curaleaf Holdings to send a clear message to all the other sellers of CBD products that it’s going to penalize them if they do not follow the guidelines. The company released a statement saying that it would reply within 15 days and is fully committed to working with the FDA to address the concerns.