March 09, 2020

Long-Awaited FDA Report Leaves CBD Stakeholders Longing for More

On Thursday, March 5, the Food and Drug Administration (FDA) submitted its long-awaited report on the agency’s activity related to regulation of cannabidiol (CBD) and CBD-containing products. The FDA was required to submit a report to the House and Senate Appropriations Committees within 60 days of the December 20, 2019 enactment of the Fiscal Year 2020 Consolidation Appropriations Act (PL 116-94). FDA missed its statutory deadline by nearly two weeks.

The report represents FDA’s response to Congress’s request for the agency to develop a comprehensive plan around regulation of CBD and CBD-based products. Since the passage of the Agriculture Improvement Act of 2019 (Farm Bill), which rescheduled hemp-derived CBD from a Schedule 1 substance to a non-controlled substance, new CBD products have flooded the market. In May 2019, the FDA held a public hearing to gather information on CBD science and public health impacts.

The March 5 Report to Congress focuses on a few top-line issues while failing to answer the big question of how the FDA will clarify regulatory pathways for non-prescription drug CBD products. In the report, the FDA:

  • Emphasizes concern about the potential safety risks and side effects of CBD use, as well as the problems related to a number of current CBD products (including mislabeling and contamination with THC, pesticides, heavy metals, or other potential adulterants).
  • Notes that data released since the May 31, 2019, meeting further demonstrates that CBD is “not a risk-free substance”; in light of these developments, commits to ongoing work to better understand the safety profile of CBD.
  • References the limited research and data available on CBD and notes it will refine and revise its approaches as more data is released.
  • States that it is evaluating issuance of a risk-based enforcement policy that would provide greater transparency and clarity regarding the agency’s enforcement priorities while it potentially engages in the process of a rulemaking.
  • Reports that moving forward, the agency will continue to act to address violations that put the public at risk.

Importantly, the FDA report emphasized that the agency is focused on “encouraging further CBD-drug development and ensuring that there remain adequate incentives for clinical research. If the widespread availability of consumer CBD products were to significantly discourage clinical research, our knowledge of CBD’s potential medical uses could be stunted.”

Beyond the more than 4,000 comments received during the initial public comment period almost one year ago, the agency remains committed to further data gathering and analysis based upon all available evidence. As such, stakeholders can expect a reopening of the public docket, indefinitely, by which FDA will establish another channel for information sharing and cross-sector collaboration.

Still, the March 5 FDA report to Congress left many searching for more guidance from the agency on what comes next as it does not offer any recommendations around the future of the agency’s oversight of the CBD industry. In so many words, the FDA told Congress: “We’re working on it; please stay tuned.”

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