FDA Misses Congressional Deadline To Publish Cannabinoid Lists And Clarify Hemp ‘Container’ Definition As Looming Federal THC Ban Raises Industry Alarm
Failure To Meet February Mandate Complicates Implementation Of Sweeping Hemp Policy Changes Set To Reshape Cannabinoid Marketplace
The U.S. Food and Drug Administration has missed a congressionally mandated deadline to publish key regulatory guidance on cannabinoids, intensifying uncertainty as federal hemp laws are poised for major changes later this year.
Under appropriations legislation signed by Donald Trump last year, many hemp-derived products legalized during his first term through the 2018 Farm Bill are set to be prohibited again beginning in November. The spending law also directed federal agencies to study the cannabinoid marketplace and produce detailed classifications of cannabis compounds to guide enforcement.
FDA was given 90 days to publish three lists: all cannabinoids naturally producible by cannabis, all naturally occurring tetrahydrocannabinol (THC) class cannabinoids, and other cannabinoids with similar or marketed effects to THC. The agency was also tasked with clarifying the regulatory meaning of “container” for hemp product THC serving limits.
That guidance was due February 10. The agency did not meet the deadline.
A spokesperson for the U.S. Department of Health and Human Services said FDA intended to publish the materials in the Federal Register, but they have yet to appear, and officials have not provided a revised timeline.
Industry Leaders Say Regulatory Delays Strengthen Case For Congressional Extension Of Pending Hemp THC Ban
Hemp industry stakeholders argue the missed deadline underscores the need to delay implementation of the forthcoming federal restrictions.
Jonathan Miller, general counsel of the U.S. Hemp Roundtable, said the lapse reflects a broader pattern of slow federal action on hemp oversight.
“We’re disappointed, but not surprised,” he said, adding that Congress should extend the timeline before new prohibitions take effect. According to Miller, regulators lack sufficient time to craft a workable framework to replace the ban.
“This just makes it even more imperative for Congress to pass an extension,” he said. “There is a whole lot of work to do, and the FDA is going to be in the middle of this.”
New Federal Hemp Definition Will Expand THC Calculations And Potentially Recriminalize Popular Cannabinoid Products
The delayed guidance is central to how federal law will distinguish legal hemp from marijuana under the new policy.
Since 2018, hemp has been defined as cannabis containing less than 0.3 percent delta-9 THC by dry weight. The upcoming change expands that calculation to “total THC,” incorporating delta-8 and other isomers as well as cannabinoids with similar effects, as determined by federal health officials.
The revised law would also ban certain intermediate hemp-derived cannabinoid products marketed as finished consumer goods, along with compounds synthesized outside the plant or not naturally producible by cannabis.
Legal hemp products would face a strict cap of 0.4 milligrams of total THC—or similar cannabinoids—per container.
Debate Over ‘Container’ Definition Could Determine Viability Of Edibles, Beverages, And Inhalable Hemp Products
Industry stakeholders say FDA’s pending clarification of what constitutes a “container” could dramatically shape which products remain lawful.
Federal statute broadly defines the term as the innermost packaging in direct contact with a hemp product such as jars, bottles, bags, cartridges, or cartons but regulators were directed to provide additional specificity.
“It’s going to open up a window into how the FDA is thinking about these issues,” Miller said, noting that THC limits tied to container size could determine market eligibility for many products.
Alternative Federal Legislation Seeks Regulated Hemp Market Instead Of Outright THC Prohibition
Some lawmakers and industry groups are backing alternative legislation, including the Hemp Enforcement, Modernization, and Protection (HEMP) Act, which would allow adult sales of consumable hemp products while imposing regulatory safeguards.
Provisions would include youth-resistant packaging, mandatory cannabinoid labeling, QR-linked lab reports, manufacturing standards, and facility registration. The bill would also bar adding substances such as alcohol, nicotine, caffeine, or melatonin that could interact with cannabinoids.
Separately, the U.S. Department of Health and Human Services would be required to propose national cannabinoid caps within 60 days of enactment.
Retailers, Farmers, And Lawmakers Rally Behind Efforts To Delay Federal Hemp Ban Implementation
A coalition of alcohol retailers has urged Congress to postpone the THC crackdown, while farmers warn the ban could devastate hemp businesses.
The proposed Hemp Planting Predictability Act would delay enforcement for two years, giving regulators and industry time to negotiate a comprehensive framework.
Supporters include House Oversight Committee Chairman James Comer, who has appeared alongside farmers advocating for relief.
Broader Federal Cannabis Policy Shifts Including Rescheduling Push And CBD Healthcare Access Add Complexity To Hemp Debate
The hemp dispute is unfolding amid wider federal cannabis policy developments.
Trump recently ordered the attorney general to complete marijuana rescheduling from Schedule I to Schedule III and urged Congress to revisit hemp definitions to protect access to full-spectrum CBD.
The administration is also exploring a federal healthcare model allowing certain Medicare beneficiaries to receive non-intoxicating CBD under physician recommendation at no cost, according to officials.
Missed FDA Guidance Leaves Hemp Market In Regulatory Limbo As November Deadline Approaches
With cannabinoid classifications and container rules still unpublished, hemp businesses face mounting uncertainty over product legality, compliance thresholds, and market survival once federal restrictions take effect later this year.
Industry leaders say clarity whenever it arrives will be pivotal in determining whether the sector contracts sharply under prohibition or transitions into a tightly regulated marketplace.
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