Politics
FDA Misses Deadline To Publish Cannabinoid List And Define Hemp ‘Containers,’ Drawing Industry Criticism
The Food and Drug Administration (FDA) has missed a congressionally mandated deadline to publish a list of known cannabinoids as federal hemp laws are set to change later this year in a way that stakeholders argue will upend the existing market.
As part of appropriations legislation that President Donald Trump signed last year, many hemp products that were legalized during his first term in office under the 2018 Farm Bill will be prohibited once again starting in November. The spending measure included separate provisions, however, to have FDA and other relevant agencies study the cannabinoid marketplace and develop lists of cannabis components.
After the bill was signed, FDA was given 90 days to publish 1) a list of “all cannabinoids known to FDA to be capable of being naturally produced” by cannabis 2) a list of “all tetrahydrocannabinol class cannabinoids known to the agency to be naturally occurring in the plant” and 3) a list of “all other know cannabinoids with similar effects to, or marketed to have similar effects to, tetrahyrocannabinol class cannabinoids.”
Further, the agency was tasked with providing “additional information and specificity about the term ‘container’” with respect to hemp product THC serving sizes. In the bill, the term is defined as “the innermost wrapping, packaging, or vessel in direct contact with a final hemp-derived cannabinoid product in which the final hemp-derived cannabinoid product is enclosed for retail sale to consumers, such as a jar, bottle, bag, box, packet, can, carton, or cartridge.”
The lists and information was due last week, on February 10, but FDA did not follow through by the deadline.
A spokesperson for the U.S. Department of Health and Human Services (HHS), of which FDA is a component, told Marijuana Moment last week that it was the agency’s intention to provide the lists in time and that they would be published in the Federal Register. However, that’s yet to materialize—and officials did not provide clarification when asked for an update.
Hemp stakeholders say this missed deadline is all the more reason for Congress to pass legislation delaying the implementation of the pending hemp THC ban that’s set to take effect in November.
“We’re disappointed, but not surprised,” Jonathan Miller, general counsel of the U.S. Hemp Roundtable, told Marijuana Moment on Tuesday. “The FDA has been quite slow in meeting congressional deadlines when it comes to hemp in the past, and in some cases ignoring congressional deadlines.”
“But this just makes it even more imperative for Congress to pass an extension” of the hemp policy change, he said. “There is a whole lot of work to do, and the FDA is going to be in the middle of this, and there’s not enough time to come up with a thought-out regulatory regime to replace the ban.”
“This episode makes it clear why we need to have the extension,” Miller said.
The purpose of the FDA directive is related to how federal law will distinguish between legal hemp products under a new, narrower definition in the recently enacted legislation and marijuana, which remains illegal under U.S. law.
Since 2018, cannabis products have been considered legal hemp if they contain less than 0.3 percent delta-9 THC on a dry weight basis.
However, the law that is set to take effect in November specifies that, within one year of enactment, the weight would apply to total THC—including delta-8 and other isomers. It would also include “any other cannabinoids that have similar effects (or are marketed to have similar effects) on humans or animals as a tetrahydrocannabinol (as determined by the Secretary of Health and Human Services).”
The new definition of legal hemp would additionally ban “any intermediate hemp-derived cannabinoid products which are marketed or sold as a final product or directly to an end consumer for personal or household use” as well as products containing cannabinoids that are synthesized or manufactured outside of the cannabis plant or not capable of being naturally produced by it.
Legal hemp products would be limited to a per-container total of 0.4 milligrams of total THC or any other cannabinoids with similar effects.
Hemp stakeholders are paying particularly close attention to the “container” definition for cannabinoid products.
“It’s going to open up a window into how the FDA is thinking about these issues. And you know, one of the key issues here is, what is a container?” Miller said. “That could make a really big difference in terms of what products would be eligible.”
“We’re hopeful that the 0.4 milligrams per container does not stay. We’re hoping to see that change,” he said. “But, you know, defining what a container is is going to be very important for any regulatory solution.”
The Hemp Enforcement, Modernization, and Protection (HEMP) Act represents a potential alternative to the outright THC ban that was included in the spending bill Trump signed, affirmatively allowing the sale of consumable hemp products to adults 21 and older. That includes edibles, beverages and inhalable items.
If the legislation is enacted, there would be various regulatory restrictions for the market. For example, packaging couldn’t appeal to youth and would need to be tamper-proof. It would also need to list all cannabinoids present and include QR code linking to a certificate of analysis.
Hemp product makers would be prohibited from adding substances like alcohol, caffeine, tobacco, nicotine, melatonin or others “with effects that could interact with cannabinoids or enhance or alter their effects.”
There would also be manufacturing and testing requirements, and hemp businesses would need to register their facilities.
Additionally, there are provisions mandating the establishment of a total cannabinoid cap on hemp products. The U.S. Department of Health and Human Services (HHS) would be charged with proposing cannabinoid limits within 60 days of enactment.
Meanwhile, alcohol retailers recently came together to encourage Congress to delay the enactment of the law Trump signed to federally recriminalize hemp-derived THC beverages and other products.
The coalition is calling on lawmakers to pass recently introduced legislation, the Hemp Planting Predictability Act, that would give the hemp industry two more years before a federal ban on THC products would take effect—which stakeholders hope will better position them to negotiate a broader regulatory compromise.
House Oversight and Government Reform Committee Chairman James Comer (R-KY), who is cosponsoring the proposal, appeared at a press conference last month alongside farmers who are concerned about the looming federal hemp ban’s impact on their businesses.
For what it’s worth, four in five marijuana consumers say they oppose the recriminalization of hemp THC products under the spending bill Trump signed in November. However, it should be noted that that poll was conducted weeks before he issued a cannabis rescheduling order and took steps to protect access to full-spectrum CBD.
Trump signed an executive order last month directing the attorney general to complete the process of moving marijuana from Schedule I to Schedule III of the Controlled Substances Act (CSA).
Part of that announcement also hold implications for the forthcoming hemp law. The president’s order also urged Congress to examine updating the definition of hemp to ensure that full-spectrum CBD is accessible to patients.
A further redefinition of hemp would be part of a novel proposal to allow Medicare recipients to access non-intoxicating CBD that’d be covered under the federal health care plan.
To effectuate that, the Centers for Medicare & Medicaid Services (CMS) will be announcing “a model that will allow a number of CMS beneficiaries to benefit from receiving CBD under doctor recommendation at no cost,” a White House official said during a briefing that Marijuana Moment first reported leaked details from ahead of the signing event.
For what it’s worth, an executive with a hemp company that’s been collaborating with the agency on the initiative said the rules for CBD health care coverage were internally finalized weeks ago.
Trump seemed endorse a more flexible CBD policy last summer when he shared a video calling for that specific reform while promoting the health benefits of cannabidiol, particularly for seniors.
Meanwhile, a separate recently filed Republican-led congressional bill would stop the implementation of the hemp ban under the enacted appropriations legislation.
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Hemp businesses and industry groups have warned about the potential ramifications of the ban, but despite his support for states’ rights for cannabis and a recent social media post touting the benefits of CBD, Trump signed the underlying spending measure into law without acknowledging the hemp provisions.
GOP political operative Roger Stone said recently that Trump was effectively “forced” by Republican lawmakers to sign the spending bill with the hemp THC ban language.
However, a White House spokesperson said prior to the bill signing that Trump specifically supported the prohibition language.
The Democratic governor of Kentucky said that the hemp industry is an “important” part of the economy that deserves to be regulated at the state level—rather than federally prohibited, as Congress has moved to do.
Also, a leading veterans organization is warning congressional leaders that the newly approved blanket ban on consumable hemp products could inadvertently “slam the door shut” on critical research.
