Representatives of the US Food and Drug Administration issued warning letters on Monday to multiple companies for marketing CBD-specific products in ways that violate federal law.
The agency issued warning letters to 15 commercial entities. Seven additional companies received similar letters earlier this year.
The FDA alleges that the companies marketed CBD as either a dietary supplement or as a food additive, or in a manner that implied it could prevent or cure serious disease –- all of which violate the federal Food, Drug & Cosmetics Act.
Following the passage of the 2018 Farm Bill, which removed low-THC hemp and extracts from the plant from the Controlled Substances Act, the agency advised: “Cannabis and cannabis-derived products claiming in their marketing and promotional materials that they’re intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases are considered new drugs or new animal drugs and must go through the FDA drug approval process for human or animal use before they are marketed in the U.S. … Additionally, it’s unlawful under the FD&C Act to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived.”
Earlier this month, a review of 300 leading online CBD retailers by the group LegitScript.com reported that 92 percent of sellers marketed products in a manner that was non-compliant with current FDA guidelines.
The FDA also issued a separate advisory today acknowledging that many commercially available CBD products lack appropriate regulatory controls and may be of variable quality and purity. NORML has previously highlighting several independent investigations identifying product mislabeling and/or the presence of adulterants and/or heavy metals in some commercially available CBD products, such as those here, here, and here.
Currently, commercially available CBD products are not regulated by the FDA, despite the fact that some three in four Americans presume otherwise. By contrast, CBD-infused products sold at state-licensed dispensaries are typically subject to state-specific regulations and lab testing protocols. However, such facilities are typically only open to either state-qualified patients or to adults in states that legally regulate whole-plant cannabis sales.
In May, NORML provided written testimony to the FDA urging the agency to move expeditiously to provide regulatory guidelines governing CBD-infused products, including best practices for their manufacturing, standardization, and purity. In Monday’s announcement, the agency acknowledged that it “plans to provide an update on its progress regarding the agency’s approach to these products in the coming weeks.”