Earlier this week, the House Appropriations Committee approved the fiscal year 2020 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies bill by a vote of 29 to 21. The committee report accompanying the bill included notable language on CBD. Specifically, it expressed concern regarding potential safety issues such as drug interactions, somnolence, liver toxicity, the presence of THC or other compounds, and aggressive health benefit claims. These were among the many issues discussed at FDA’s May 31 public meeting.
The report urges the agency to focus on public health and, should there be a non-drug pathway for CBD, to preserve the incentives to invest in drug-level research. It states in part:
The Committee recognizes the FDA is considering a public regulatory process to evaluate the appropriateness, and possible parameters, of a regulatory pathway that would permit CBD in certain foods and dietary supplements. The Committee expects the FDA to assert its commitment to identifying lawful federal regulatory pathways for CBD foods and dietary supplements if such pathways are consistent with protection of the public health. Such pathways may include necessary public health and safety parameters that will protect the public health, such as labeling requirements and limits on CBD or other cannabis-derived ingredients in products, based upon anticipated total exposure levels. The Committee also expects the FDA to preserve the integrity of its drug development and approval processes, which ensures that products marketed for drug uses have undergone a rigorous scientific validation process demonstrating quality, safety and efficacy. It is also imperative that any FDA regulation of foods and dietary supplements containing CBD or other cannabis-derived ingredients preserve incentives to invest in robust clinical study of cannabis, so its therapeutic value can be more fully understood.
This position from the House Appropriations Committee stands in contrast to other Congressional pressure on FDA regarding CBD. Specifically in a January 2019 letter, Sens. Wyden and Merkley, both Democrats from Oregon, urged then-Commissioner Scott Gottlieb to “immediately begin updating regulations for hemp-derived CBD and other hemp-derived cannabinoids, and give U.S. producers more flexibility in the production, consumption, and sale of hemp products.” The letter demanded that FDA answer questions regarding whether food and dietary supplement pathways were available for hemp products, even though FDA had recently announced three GRAS affirmations on hemp ingredients and re-stated its public position regarding CBD.
What’s the takeaway? The House Appropriations Committee, charged with review of funding for FDA, wants public health and rigorous clinical evaluation to be the top priorities. Meanwhile, as evidenced by Sens. Wyden and Merkley (among many others), consumers are clamoring for CBD and U.S. businesses are fearful of losing opportunity. Given that FDA has acknowledged that the administrative notice and comment process may not be the most efficient way to address CBD pathways, we shall see whether the agency can strike a balance between the call for regulation that protects and informs consumers and the business community’s fear of missing out.