Key Takeaways:

  • Congressional leaders in both chambers are seeking public input on the potential development of a new regulatory pathway for hemp-derived cannabidiol (CBD) products.
  • Thissignals that Congress is considering legislation that would address concerns raised by the Food and Drug Administration (FDA) that the agency's current regulatory authorities are not appropriate for such products.
  • Congress is seeking information related to the current market dynamics for CBD products, the need for a new pathway and its potential scope, the safety profile of CBD, and the effectiveness of available quality, packaging, and labeling controls to protect consumers.

On July 27, 2023, House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) and Ranking Member Frank Pallone, Jr., (D-NJ), along with Senate Health, Education, Labor, and Pensions (HELP) Committee Chair Bernie Sanders (I-VT) and Ranking Member Bill Cassidy, M.D. (R-LA) announced a request for information(RFI) to inform Congress' development of a potential regulatory pathway for hemp-derived cannabidiol (CBD) products.

In 2018, Congress made the first significant changes to CBD law through the Farm Bill, which removed hemp from the definition of marijuana under the Controlled Substances Act (CSA) and removed hemp-derived-CBD from Schedule I status under the CSA. However, the Food and Drug Administration (FDA) still has authority over CBD in FDA-regulated products and has maintainedthat hemp-derived CBD may not be safely marketed as a food additive or dietary supplement under the FDA's current regulatory authority.

This uncertainty has led to many questions about the current legal status of CBD products and the commercial implications for this growing market. Below, we summarize some of the key takeaways from the RFI.

RFI Assesses Safety, Quality Concerns in Regulating CBD

The RFI by these four key members is a strong signal that Congress is serious about exploring a bipartisan solution to this issue. The RFI acknowledges that greater certainty is needed for consumers, manufacturers, and other stakeholders, and is broken down into the following categories:

>Current Market Dynamics

Congress is seeking more information on how the market for CBD products has changed since 2018, with a focus on how the lack of national standards has affected the market. It is also looking for information on the types of products available, industry manufacturing practices, and how CBD products are marketed and sold.

Pathway

Congress is seeking feedback from stakeholders on the FDA's view that there is a need for a new regulatory pathway for CBD products, instead of regulating CBD products through the FDA's existing pathways.

Scope

Congress is seeking information on how CBD and/or cannabinoid-containing hemp products should be defined, and specifically which compounds should be included and excluded from a regulatory framework.

Federal-State Interaction

Congress is interested in learning about state regulatory programs relating, but not limited, to warning labels, minimum age of sale, manufacturing and testing, ingredient prohibitions, and adverse event reporting, that could be used as models for regulation of CBD products.

Safety

Congress is interested in learning more about the safety profile of CBD and what actions lawmakers can take to better understand the benefits and harms of CBD products and other cannabinoids.

Quality

Congress is asking stakeholders for feedback in creating an FDA-implemented framework to ensure that appropriate consumer protections and quality controls are in place. Additionally, Congress is looking for alternative quality approaches that Congress can consider for CBD products.

Form, Packaging, Accessibility, and Labeling

Congress is interested in understanding the potential benefits and risks around packaging and labeling of CBD products. Specifically, Congress is interested in feedback on the types of claims product manufacturers are permitted to make about CBD products, as well as labels to highlight risks to special populations, such as children or pregnant women.

Next Steps

This RFI serves as a roadmap as Congress takes a more active posture in establishing a legal and regulatory framework for CBD products. Stakeholders interested in submitting comments have until August 18, 2023, to provide feedback. Comments can be submitted to CBD@mail.house.gov or CBD@help.senate.gov.

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