In an official statement last week, the U.S. Food and Drug Administration (FDA) announced its conclusion that the existing regulatory framework for foods and dietary supplements is not appropriate for the regulation of certain products containing cannabidiol (CBD). In the same statement, FDA invited Congress to create a new regulatory pathway for such CBD products.
FDA’s determination that a new regulatory pathway is necessary for certain CBD products comes after the enactment of H.R. 8454, the “Medical Marijuana and Cannabidiol Research Expansion Act,” which will expand legal research on CBD and marijuana. The new law streamlines the approval process for research and cannabis manufacturing and permits the use of federal funds to study the health effects of cannabis without approval from multiple federal agencies. Here, we analyze both the agency’s statement on CBD regulation and the Medical Marijuana and Cannabidiol Research Expansion Act.
FDA determines new regulatory pathway needed for certain CBD products
In an official agency statement, FDA Principal Deputy Commissioner Janet Woodcock announced that, after four years of review, the agency’s internal working group studying CBD products has concluded that the current framework for foods and dietary supplements will not work for regulating CBD. Specifically, it determined that the existing framework is not equipped to manage and minimize risks related to CBD in dietary supplements and food. As a result, FDA said it does not intend to pursue rulemaking allowing the use of CBD in dietary supplements or conventional foods. Instead, the agency called on Congress “to develop authorities for a new pathway, consistent with FDA’s public health mission,” to regulate the approval and sale of such CBD products.
Alongside its announcement of the CBD working group’s findings, FDA also announced the denial of three citizen petitions asking FDA to conduct rulemaking to allow the marketing of CBD products as dietary supplements.
The working group said it “closely examined the existing scientific data, including studies related to the CBD-based drug Epidiolex, published scientific literature, information submitted to a public docket, as well as studies both conducted and commissioned by the agency,” and determined “it is not apparent how CBD products could meet current applicable safety standards.” FDA said the scientific studies it reviewed showed the potential for (a) liver harm, (b) interactions with certain medications, and (c) possible harm to the male reproductive system. “CBD exposure is also concerning when it comes to certain vulnerable populations such as children and those who are pregnant,” FDA stated.
FDA’s statement further cited agency concerns over CBD risks to animals, and that people could be unknowingly exposed to CBD through meat, milk, and eggs from animals fed CBD. “Because it is not apparent how CBD products could meet the safety standard for substances in animal food, we do not intend to pursue rulemaking allowing the use of CBD in animal food,” FDA said.
This recent announcement does not alter FDA’s previous conclusion that CBD products cannot be lawfully marketed in foods and dietary supplements under the federal Food, Drug, and Cosmetic Act’s exclusionary rule. It’s unclear whether FDA’s enforcement approach toward CBD companies will change in light of this recent announcement. To date, the agency has generally only targeted CBD companies making egregious health claims, focusing its enforcement discretion on products that pose the most immediate risks. Going forward, we will closely monitor if (and how) the agency uses these new findings to expand its enforcement scope and priorities.
For companies in this space, this recent announcement extends the regulatory uncertainty. However, depending on Congress’ appetite to take on this issue, there may be new opportunities under a workable regulatory framework.
Medical Marijuana and Cannabidiol Research Expansion Act enacted
FDA’s statement comes after U.S. President Biden signed into law H.R. 8454, the “Medical Marijuana and Cannabidiol Research Expansion Act,” which creates an expedited registration process for conducting research on marijuana and for manufacturing such products for research purposes and drug development.
Notably, however, the Act does not de-schedule marijuana under the Controlled Substances Act, keeping it as a Schedule I substance alongside drugs like heroin, lysergic acid diethylamide (LSD), 3,4-methylenedioxymethamphetamine (ecstasy). It also does not permit researchers to obtain marijuana from state-authorized dispensaries.
Instead, the law:
- provides for a streamlined process for the approval of cannabis and CBD research applications and for applying to manufacture cannabis products for research purposes,
- authorizes registered covered institutions of higher education (like medical schools and research schools) to manufacture, distribute, dispense, and possess cannabis and CBD for medical research, with guidance from HHS and FDA, and
- allows for doctors to discuss with their patients, and their patients’ parents if the patient is a minor, the potential benefits and risks in using medical cannabis or CBD under state medical cannabis laws.
The law also requires HHS to ensure an “adequate and uninterrupted supply” of marijuana to scientists approved under the new streamlined process. These actions are targeted at helping patients with conditions like Parkinson’s, epilepsy, and severe post-traumatic stress, U.S. Senate Majority Leader Chuck Schumer said.
The law also requires HHS to report to Congress on particular topics of research, including, but not limited to, the effects of cannabis on the human body, effects on the adolescent brain, potential impairment of cognitive ability, and barriers and solutions to studying cannabis from states with legal cannabis.
The passage of the Medical Marijuana and Cannabidiol Research Expansion Act is notable as the first stand-alone federal cannabis reform measure to become law in more than 50 years. The bill's passage comes on the heels of President Biden’s announcement of sweeping changes to federal cannabis policy, including a pledge to pardon all federal offenders convicted of simple marijuana possession, and a directive to health and law enforcement officials to review the drug's federal Schedule I status.
Other Congressional efforts are also advancing cannabis legislation, including the SAFE Banking Act, which would allow financial institutions and ancillary service providers to provide banking services to cannabis-related businesses; however, the SAFE Banking Act was excluded from the 2023 omnibus spending bill. Yet, these efforts continue, as a bipartisan group of Congressmembers have also recently circulated a “dear colleague” letter within Congress requesting that the Biden Administration de-schedule marijuana.