The U.S. Food & Drug Administration (FDA) issued a warning letter to Alternative Laboratories, a dietary supplement manufacturer based in Naples, Florida, that markets
CBD oil under the “Green Roads” brand name.
The FDA letter notes that CBD is the active ingredient in the approved drug product Epidiolex and is designed to treat certain rare, severe forms of epilepsy. Further, the FDA also notes that significant clinical research investigations concerning the use of CBD have been made public, including investigations related to Epidiolex and Sativex, a drug for the treatment of spasticity due to multiple sclerosis (MS) that has been approved for use in 25 countries outside the U.S. The manufacturer of Sativex, GW Pharmaceuticals, has disclosed its plans to seek FDA approval.
This letter is one in an ever growing list of FDA and FTC enforcement related to CBD products. While we await regulatory rules on CDB use, companies operating in the space should remain vigilant and adhere to a compliance policy that reflects–for now–the reality of current regulations and restrictions.
CBD businesses may contact our attorneys at SINI Healthcare LLP for legal guidance by scheduling an initial consultation here.