New FDA Warning Letter Issued Curaleaf Hemp Over Improper CBD Disease Claims
FDA has issued a warning letter dated July 22, 2019 against Curaleaf Hemp, online retailer of CBD products for both humans and pets, for selling unapproved and misbranded drugs. Curaleaf made improper disease claims about their products, such as “CBD has been linked to the effective treatment of Alzheimer’s disease” and “CBD was effective in killing human breast cancer cells.” Only an FDA approved drug can properly claim to “diagnose, treat, cure or prevent any disease.” This warning letter follows a trend of FDA warning letters against companies who make disease claims about their CBD products.
The FDA does not consider CBD to be a lawful dietary ingredient for dietary supplements. Despite this, CBD is seemingly for sale everywhere. The FDA has historically only taken action against companies making disease claims about their products, and Curaleaf Hemp now joins that unfortunate list.
If you are in the CBD market, or thinking about entering, you need experienced counsel who understands the current state of the law. Call us at 516-294-0300 or email us at [email protected] to discuss how we can help.
To read more about the FDA warning letter for Curaleaf Hemp, and additional information about FDA and CBD policies surrounding unsubstantiated claims, click here.