On December 22, 2020, the U.S. Food and Drug Administration (FDA) issued five warning letters to companies selling products containing cannabidiol (CBD). In a statement, the FDA’s Amy Abernethy, principal deputy commissioner, explained that the agency remains “focused on exploring potential pathways for CBD products to be lawfully marketed while also educating the public about these outstanding questions of CBD’s safety,” and that the agency “will continue to monitor and take action, as needed, against companies that unlawfully market their products—prioritizing those that pose the greatest risk of harm to the public.”
The warning letters were issued to five companies marketing products containing CBD, including foods and pet care products. The FDA highlighted that certain products were not ingested but rather administered through different means that were “especially concerning from a public health perspective,” including through the nose or eyes.
In one warning letter, the agency noted that it was “particularly concerned” that a CBD product was promoted to address “Childhood ADD/ADHD” and marketed for use by children, more generally. The agency stated: “The use of untested drugs can have unpredictable and unintended consequences, especially in vulnerable populations such as children who may be at greater risk for adverse reactions associated with certain drug products due to differences in the ability of children to absorb, metabolize, distribute, or excrete such drug products or their metabolites.”
As the cannabis industry awaits the FDA’s forthcoming CBD enforcement policy guidance, the FDA’s latest warning letters serves as an important reminder that the agency continues to monitor the marketplace and has taken particular interest in the area of unsupported health claims. As we detailed earlier this month, the Federal Trade Commission has also taken recent action on unsupported CBD claims as part of its Operation CBDeceit.