On January 26, the Food and Drug Administration essentially threw up its hands and announced that Congress needs to create a new regulatory pathway for cannabidiol (CBD) products because the existing pathways are inadequate to mitigate possible health risks. The agency simultaneously denied three long-pending requests to allow marketing of CBD products as dietary supplements. The move came as a major setback to industry stakeholders that have waited years for clear guidelines on CBD from FDA.
In a press release, Janet Woodcock, M.D., who serves as chair of the FDA’s internal working group to explore regulatory pathways for CBD products, stated the agency believes the products raise several safety concerns, especially with long-term use. She said: “Studies have shown the potential for harm to the liver, interactions with certain medications and possible harm to the male reproductive system,” and “CBD exposure is also concerning when it comes to certain vulnerable populations such as children and those who are pregnant.” In particular, she noted the working group found the existing evidence inadequate to determine “how much CBD can be consumed, and for how long, before causing harm.”
In other words, the agency believes it still lacks enough evidence to regulate CBD, which is surprising. In October 2021, FDA published a “Cannabis Derived Products Data Acceleration Plan” expressly designed to gather the type of evidence necessary to answer health safety questions. And just recently, FDA signaled new CBD regulations could be on the way when it hired a cannabis policy expert with a background creating and overseeing state CBD regulations, including restrictions on quantities of CBD in consumer products.
The U.S. Hemp Roundtable speculated that FDA’s health safety concerns might be rooted in studies involving doses of CBD much higher than in a typical retail product. This association indicated it had “met with the FDA and shared a broad range of safety studies showing that standard CBD serving sizes are safe, while the FDA continues to rely on pharmaceutical studies that show risk at significantly larger doses that are not commonly found in CBD products sold at retail.”
If the agency lacks sufficient evidence on safe levels of CBD, it begs the question whether the agency’s decision to conclude that CBD is not appropriate for an existing regulatory pathway is premature. Are there additional studies that could be performed that could answer what a safe level of CBD as a food additive or dietary supplement might be?
According to FDA, the agency also needs risk management tools that would allow it to require “clear labels, prevention of contaminants, CBD content limits, and measures, such as minimum purchase age, to mitigate the risk of ingestion by children.” Woodcock noted the FDA’s existing authorities for foods and dietary supplements only had “limited tools” for managing such risks.
This too, was surprising. There are several tools available to FDA for addressing these types of issues. For instance, dietary supplements are subject to good manufacturing practices to help ensure safety, including requirements related to packaging and labeling; manufacturing personnel; manufacturing facility sanitation, design, and construction; equipment; quality controls; manufacturing operations; monitoring of adverse events; and recordkeeping. See 21 C.F.R. § 111 et seq. Similarly, when considering whether to approve a petition for a new food additive, FDA can impose restrictions through a regulation that specifies “the conditions under which such additive may be safely used (including, but not limited to, specifications as to the particular food or classes of food in or in which such additive may be used, the maximum quantity which may be used … , the manner in which such additive may be added to or used in or on such food, and any directions or other labeling or packaging requirements for such additive deemed necessary … to assure the safety of such use.” 21 U.S.C. § 348(c)(1)(A). In other words, FDA could promulgate regulations that impose specific requirements on how CBD might be used, packaged, and marketed as dietary supplements or in foods but has instead punted the issue to Congress.
So what’s next? House Representatives Angie Craig and Morgan Griffith have already expressed a willingness to work with FDA to find a new path forward for CBD, and Senator Ron Wyden indicated he planned to reintroduce a bill that would allow hemp-derived CBD to be marked and sold. It’s unclear, however, how long these efforts might take or if they will be successful.
While we wait for congressional action, we expect FDA to continue prioritizing enforcement against a subset of CBD products that it believes pose special harms. In recent months in particular, FDA has targeted companies selling CBD products that make unauthorized health claims, such as claiming the products help mitigate COVID-19, and marketing products that pose a particular risk to children, such as flavored CBD gummies, fruit snacks, candy, and lollipops.
Given FDA’s statements that CBD may not be used as dietary supplements or food additives, however, all CBD manufacturers will continue to face a patchwork of state CBD regulatory schemes under a cloud of legal uncertainty at the federal level.