Late last night, the President signed into law the government funding package that includes a sweeping amendment redefining “hemp” and imposing a 0.4 mg total THC limit per finished product. This marks the most significant federal policy shift for the hemp industry since the 2018 Farm Bill—effectively closing the so-called “intoxicating hemp loophole” and reshaping the national marketplace for hemp-derived cannabinoids.
What the New Law Does
- Redefines Hemp: Expands the statutory definition to include total tetrahydrocannabinols, rather than just Delta-9 THC by dry weight. There are also new exclusions regarding what types of products may be considered “hemp” and thus compliant.
- Sets a 0.4 mg Cap: Excludes from the definition of hemp any final hemp-derived cannabinoid products containing greater than 0.4 mg combined total per container of total tetrahydrocannabinols, including THCA and any other cannabinoids that have similar effects or are marketed to have similar effects on humans or animals (as determined by the Secretary of Health and Human Services). This amount will likely disqualify nearly all existing full-spectrum and intoxicating hemp products from meeting the definition of hemp.
- Excludes Synthetics: Removes from the definition of hemp any intermediate or final hemp-derived cannabinoid products that a cannabis plant can naturally produce and that were synthesized outside the plant.
- Compliance Window: The law takes effect 12 months from enactment, providing a short transition period for reformulation or product withdrawal.
Immediate Impact
- Delta-8, Delta-10, HHC, THCP, and similar intoxicating hemp-derived products will no longer qualify as “hemp” and may be treated as controlled substances.
- Full-spectrum CBD products that contain total THC above the 0.4 mg threshold will need reformulation or market withdrawal.
- Retailers and distributors risk federal liability for non-compliant inventory once the compliance period ends.
- FDA authority remains unchanged, but this new definition narrows the category of hemp products that can be lawfully marketed in interstate commerce.
Options and Next Steps
- Reformulate Now:
Begin cannabinoid testing and reformulation to ensure total THC (including THCA and isomers) remains below 0.4 mg per product. - Refocus on Non-Ingestibles:
Topicals, cosmetics, textiles, and industrial hemp uses remain viable, as the restriction primarily targets ingestible or inhalable forms of cannabis. - Invest in Safety Data:
Consider generating toxicology and human safety data to support potential GRAS or NDI filings once FDA reengages on cannabinoid regulation. - Engage in Advocacy:
The industry still has an opportunity—during the one-year implementation window—to push for amendments or regulatory interpretations that shift the discussion from arbitrary THC limits to science-based safety standards.
How to Prepare
Companies should immediately:
- Audit product portfolios for THC/THCA content;
- Prioritize compliant reformulations;
- Develop internal compliance documentation; and
- Monitor forthcoming agency guidance during the transition period.