On July 27, 2023, the U.S. Congress requested information to guide the assessment of the potential for a regulatory pathway for hemp-derived Cannabidiol (CBD) products with the goal to prioritize consumer safety and bring certainty to the U.S. market.
Since the passage of the 2018 Farm Bill, hemp-derived CBD has been de-scheduled, but its marketing as a food additive or dietary supplement is restricted. The FDA has raised concerns about safety, existing regulatory pathways, and the need for a new pathway for CBD products.
Congress is seeking a legislative approach in collaboration with the FDA and stakeholders. The request includes inquiries about the current market dynamics, regulatory pathway and scope, federal-state interaction, safety concerns, quality control, and issues related to form, packaging, accessibility, and labeling of CBD products. Written responses must be submitted by August 18.
EAS clients are encouraged to:
- Analyze the current market dynamics of CBD products, including types, manufacturing practices, and how they are marketed.
- Assess changes in the market since the 2018 Farm Bill and the impact of the lack of national standards.
- Comment on FDA’s concerns regarding regulation and the need for new regulatory pathways for CBD.
- Provide insights on defining CBD and cannabinoid-containing hemp products and appropriate limits on substances.
- Evaluate federal and state interaction and consider federal pre-emption in regulation.
- Share knowledge on safety, risk-benefit profile, and potential limitations on CBD in various products.
- Suggest frameworks to ensure consumer protections, quality controls, and labeling requirements.
- Consider age restrictions, marketing, packaging, and labeling in terms of appeal or usage by children.
- Submit all relevant data and primary source information by August 18 to the following email addresses:
Posted in Cannabis, FDA and USDA Regulatory Update.