JUNE 4
The House Committee on Appropriations, Subcommittee Agriculture, et al. has released a report outlining priorities for FY20 Agriculture-Rural Development-FDA appropriations. Included within: a call for FDA to find a regulatory pathway to market for hemp-derived CBD.
Cannabidiol Regulatory Pathway.—The Committee is concerned about the proliferation of foods and dietary supplements marketed in violation of the Federal Food, Drug & Cosmetic Act (FFDCA), including products containing cannabis and cannabis-derived ingredients. Non-FFDCA-compliant products pose potential health and safety risks to consumers through unsubstantiated and misleading claims such as treating a wide-range of life-threatening diseases and conditions; excessive cannabidiol (CBD) concentrations that can result in harmful drug-drug interactions, somnolence, and elevated transaminases or liver toxicity; and the presence of significant levels of intoxicating compounds such as tetrahydrocannabinols (THC). The 2018 Farm Bill expressly preserves FDA’s public health authority to take appropriate actions regarding cannabis, including hemp and its derivatives. 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.
CRN has been very involved in efforts to establish a legal, regulatory pathway to market for hemp-derived CBD. CRN’s repeated engagement with Congressional offices and committees has ensured strong legislative focus on this issue. The CBD language is not final, and will need to be reconciled with the Senate, but efforts continue and this is a promising step in the right direction. The Subcommittee will mark up the Agriculture-Rural Development-FDA draft legislation June 4, with more information to come. CRN will monitor the progress and inform members.