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The agency sent warning letters to 15 companies for illegally selling cannabidiol products.
FDA announced on Nov. 25, 2019 that it had sent warning letters to 15 companies that were selling cannabidiol (CBD) in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The warning letters are in response to the agency’s ongoing efforts to develop pathways for CBD products to be marketed lawfully. The agency states there are unanswered questions regarding the toxicity of CBD that raise concerns about the safety of CBD-containing products.
The companies warned by FDA in the recent warning letters have used website pages, online stores, and social media to market CBD products across states, including products proposing to treat diseases, products marketed to children, and dietary supplements. The agency states this violates the FD&C Act, which states that products intended to treat a disease are considered a drug and must be approved by FDA. “Unlike drugs approved by the FDA, there has been no FDA evaluation of whether these unapproved products are effective for their intended use, what the proper dosage might be, how they could interact with FDA-approved drugs, or whether they have dangerous side effects or other safety concerns. In addition, the manufacturing process of unapproved CBD drug products has not been subject to FDA review as part of the human or animal drug approval processes,” the agency stated in a press release.
“As we work quickly to further clarify our regulatory approach for products containing cannabis and cannabis-derived compounds like CBD, we’ll continue to monitor the marketplace and take action as needed against companies that violate the law in ways that raise a variety of public health concerns. In line with our mission to protect the public, foster innovation, and promote consumer confidence, this overarching approach regarding CBD is the same as the FDA would take for any other substance that we regulate,” said FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD, in the press release. “We remain concerned that some people wrongly think that the myriad of CBD products on the market, many of which are illegal, have been evaluated by the FDA and determined to be safe, or that trying CBD ‘can’t hurt.’ Aside from one prescription drug approved to treat two pediatric epilepsy disorders, these products have not been approved by the FDA and we want to be clear that a number of questions remain regarding CBD’s safety-including reports of products containing contaminants, such as pesticides and heavy metals-and there are real risks that need to be considered. We recognize the significant public interest in CBD, and we must work together with stakeholders and industry to fill in the knowledge gaps about the science, safety and quality of many of these products.”