The FDA’s regulation of the CBD market has taken its toll on a heavy hitter in the marketplace. Curaleaf, which is sold in CVS Health stores, was issued a warning letter from the Food and Drug Administration over health claims made by the company. According to CBS News, Curaleaf is working to remedy issues raised in the FDA Warning letter. Shares of Curaleaf were down seven percent.
According to the Warning Letter, which was issued July 22, 2019, Curaleaf sold four products which the FDA classified as drugs under the Food, Drug, and Cosmetics act. This determination was made after Curaleaf made claims the products could treat or partially remedy chronic pain, anxiety, ADHD, Parkinson’s, depression, Alzheimers, opiod withdrawal symptoms, opioid tolerance, arthritic pain, cancer, hypertension, and high cholesterol.
The FDA has not currently approved hemp extracts or CBD as Generally Recognized as Safe (for use in foods) or a New Dietary Ingredient (for use in supplements). However, the FDA’s enforcement priorities in this area have generally focused on companies, such as Curaleaf, that have made health claims related to hemp extract and CBD. While the FDA is currently exploring its treatment of hemp extracts and CBD, nothing has yet been decided, and it is expected no clear guidance will come from the FDA until late in the year.
With the warning letter, Curleaf has 15 days to fix the violations. What is unclear is whether the FDA will continue enforcement against Curaleaf even if it remedies the health claims noted in the Warning Letter due to the murky status of hemp extract and CBD under the statute.
At Gleam Law, we work to keep up with the daily changes surrounding Cannabis, Hemp, and CBD, and help our clients to navigate their way through the often murky waters of regulatory compliance. If you have a question regarding Hemp and CBD, Gleam’s attorneys are here to help.