Rule ProposalcriticalComment deadline: July 1, 2024
USDA-FDA Joint Comment Period: Hemp-Derived Intoxicants and Farm Bill Reauthorization
Interagency request for public input on regulating THC isomers and novel hemp cannabinoids
Announced: April 29, 2024
FDA Docket: AMS-NOP-24-0090
Federal Register: 89 Fed. Reg. 34201
Delta-8 THCHemp Δ9-THCDelta-10 THCTHCPHHCOtherFoodBeverageDietary SupplementVape / InhalableOther
Summary
In conjunction with Farm Bill reauthorization negotiations, the USDA and FDA jointly opened a public comment period in April 2024 requesting input on the regulatory treatment of hemp-derived intoxicants — specifically delta-8 THC, delta-9 THC at or below 0.3% by dry weight in the final product, delta-10 THC, THCP, HHC, and other novel cannabinoids that may be psychoactive.
Key policy questions posed:
- Should the 2018 Farm Bill's 0.3% delta-9 THC threshold apply to intoxicating hemp derivatives when consumed as a single serving?
- Should FDA establish a total THC threshold (all THC isomers combined) for hemp products?
- What role should the USDA play in regulating intoxicating hemp-derived cannabinoids versus the FDA?
- What labeling and testing requirements should apply to hemp products containing potentially intoxicating cannabinoids?
- Should age restrictions apply uniformly to intoxicating hemp products?
The comment deadline was July 1, 2024. Comments received are under review as part of the ongoing Farm Bill reauthorization process.
Deep-Dive Analysis
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What Operators Should Do Now
Critical regulatory moment — immediate actions:
1. Monitor the Farm Bill reauthorization closely — hemp provisions could change dramatically, with 60–180 days implementation window once enacted.
2. Prepare for total THC threshold scenarios: run your product formulations through a total THC analysis to understand your position under alternative regulatory frameworks.
3. Engage with your state association to track state-level delta-8 restrictions and ensure compliance in each state where you operate or ship.
4. Review multi-state distributor agreements for change-of-law provisions — Farm Bill changes may trigger material adverse change clauses.
5. Consult counsel now to model your regulatory exposure under each of the three likely federal outcomes.