On Monday, the U.S. Food and Drug Administration (FDA) sent a warning letter to Curaleaf Holdings warning the company that their products are considered drugs due to health claims made on the company’s website and social media pages. The maker of CBD-containing vape pens, tinctures, pain relief patches, lotions and pet products received a letter outlining numerous violations and was directed to take prompt action.
"You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction."
"Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction."
CBD is legal when derived from hemp. However, the FDA hasn’t approved its use as an ingredient in food and beverages.
In a statement issued Tuesday when the warning letter was made public, Acting FDA Commissioner Ned Sharpless said, “Selling unapproved products with unsubstantiated therapeutic claims -- such as claims that CBD products can treat serious diseases and conditions -- can put patients and consumers at risk by leading them to put off important medical care.” There are still “many unanswered questions about the science, safety, effectiveness and quality of unapproved products containing CBD,” he said.