The US Food and Drug Administration (FDA) issued a warning letter to Curaleaf for illegally selling unapproved products containing cannabidiol (CBD) with claims that they could help treat Alzheimer’s disease, cancer and opioid withdrawal.
The agency noted that this action put patients at risk by leading them to ‘put off’ seeking medical care, as well as stating that there are unanswered questions about the science, safety, effectiveness and quality of unapproved products containing CBD.
Further than this, the FDA outlined that one of the primary causes for concern is that because such products do not pass through the regulatory pathway for treatments, the manufacturing process has not been reviewed.
This means that the quality and effectiveness of the products are not verified by the FDA.
By issuing Curaleaf with the warning letter, the FDA has singled out a significant player in the CBD market, with the company’s recent $875m (€785m) acquisition of GR Companies making it the ‘world’s largest cannabis company’, Curaleaf had claimed.
According to the company’s website, it possesses 13 cultivation sites and 12 processing sites where it produces its products. The sites meet good agricultural practices (GAP) but, as the products are not approved as drugs, have not received current good manufacturing practice (cGMP) approval by the FDA.
The warning letter arrives as the FDA seeks to regulate a booming CBD market, as regulators look to catch up with the pace of growth in the industry. In May, the FDA held a public hearing to obtain more scientific data and information about the safety and manufacturing quality of cannabis or cannabis-derived compounds.
As part of its announcement on the warning letter, the agency stated that “[It] continues to be concerned at the proliferation of products asserting to contain CBD that are marketed for therapeutic or medical uses that have not been approved by the FDA. The FDA approval process ensures that drugs on the market are safe and effective for their intended therapeutic uses.”
The agency provided examples of some of the claims that Curaleaf had more for its products:
- CBD has been demonstrated to have properties that counteract the growth of [and/or] spread of cancer
- CBD can also be used in conjunction with opioid medications, and a number of studies have demonstrated that CBD can in fact reduce the severity of opioid-related withdrawal and lessen the build-up of tolerance
- CBD has also been shown to be effective in treating Parkinson’s disease
Curaleaf has 15 days with which to respond to the warning letter. At the time of writing, the share price of the company had fallen by 7%.
According to FDA records, the company becomes the fourth to be issued with a warning letter this year regarding its CBD products.
At present, there is currently only one FDA-approved, CBD-based product for therapeutic use, GW Pharma’s Epidiolex. The cannabis-derived therapy is indicated for the treatment of epileptic seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients two years of age or older.