On July 23, 2019, the Food and Drug Administration (FDA) announced the issuance of a Warning Letter to the manufacturer of certain products containing cannabidiol (CBD). Specifically, the FDA provided a laundry list of examples where Curaleaf, Inc. (Curaleaf) made unsubstantiated claims on its website and on social media “that the products treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety, among other conditions or diseases.” The FDA considers Curaleaf’s actions as the “illegal selling of unapproved products,” pursuant to the Federal Food, Drug, and Cosmetic Act.
Incidentally, Curaleaf products were being sold by a major pharmacy retailer as part of its roll-out of CBD products in 8 states and 800 stores. In response to the Warning Letter to Curaleaf, CVS immediately pulled Curaleaf products from its shelves. The Curaleaf products they carried were limited to its lotion and transdermal patches.
I encourage you to read the Curaleaf Warning Letter as well as the several Warning Letters issued by FDA regarding claims made by other companies’ CBD products. The Curaleaf letter is the most recent reminder from FDA that consumers should be wary of companies making medical claims with products containing CBD, at least until a regulatory scheme is in place involving these products.
The letter is also a reminder to retailers who are trying to cash in early on what is expected to be a multi-billion-dollar industry. The CBD market is like the Wild West right now. None of the regulations mandated by the Farm Bill have been promulgated, and the FDA does not expect to provide additional guidance on CBD products until this coming fall. Thus, the manufacturers of these products must be closely scrutinized and continuously monitored to ensure that products are safe for sale to consumers. The FDA says it best in its press release:
Unlike drugs approved by the FDA, the manufacturing process of these products has not been subject to FDA review as part of the drug approval process, and there has been no FDA evaluation of whether these products are effective for their intended use, what the proper dosage is, how they could interact with FDA-approved drugs, or whether they have dangerous side effects or other safety concerns.
We will keep you posted as this subject evolves.