- The Food and Drug Administration on Monday sent a warning letter to Curaleaf, telling the company that it is illegally marketing cannabidiol, or CBD, products as medicines.
- The regulatory sanction sent shares in the company, one of the largest in the booming cannabis market, down sharply. By law, Curaleaf products like CBD Lotion, CBD Pain-Relief Path and CBD Disposable Vape Pen are unapproved drugs, the FDA said.
- "Failure to correct the violations promptly may result in legal action, including product seizure and injunction," the agency said in an accompanying statement issued Tuesday.
Curaleaf is the latest cannabis company to get caught up in the confusion over CBD products regulations. Congress last year passed a bill that legalized hemp, a form of cannabis that doesn't get users high. But many people believe that CBD, derived from hemp, has medicinal potential.
The problem is the FDA has yet to offer a clear regulatory framework for CBD. It has only approved one prescription CBD product — GW Pharmaceuticals' Epidiolex for the treatment of rare forms of epilepsy — and says that other CBD products likely differ in composition and haven't been properly studied as medicines.
Meanwhile, attempts to market the products as dietary supplements, which don't require prior FDA approval, are running afoul of the agency. "FDA has concluded based on available evidence that CBD products are excluded from the dietary supplement definition," the agency told Curaleaf.
The FDA says it's working quickly to establish potential pathways for marketing CBD. In the meantime, consumers must beware of products with unsubstantiated claims, the agency says. The FDA has sent a series of warning letters to CBD producers in the past few years.
"There are many unanswered questions about the science, safety, effectiveness and quality of unapproved products containing CBD," acting FDA Commissioner Ned Sharpless said in the FDA's release.
The warning letter criticized Curaleaf for a range of statements on its website and social media accounts, including "CBD was effective in killing human breast cancer cells" and "CBD has been linked to the effective treatment of Alzheimer's disease."
The Wakefield, Massachusetts-based company has 15 working days to respond to the FDA. Curaleaf, which claims to be the world's largest cannabis company by revenue, earlier this month expanded by agreeing to buy Grassroots Cannabis for $875 million.
In a statement, Curaleaf said it would respond to the FDA's letter and that it is "fully committed to complying with FDA requirements for all of the products that it markets."