FDA Faces Deadline To Publish Cannabinoid Lists And Define Hemp Product ‘Containers’ Under Law Trump Signed

In about nine months, federal hemp laws are scheduled to significantly
change in a way that industry stakeholders say would effectively upend the
market by re-criminalizing most consumable cannabinoid products. But in the
interim, the Food and Drug Administration (FDA) is facing a deadline next
week to help inform future hemp policy.

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 are due by Tuesday. Whether FDA makes the
deadline is yet to be seen, however, as there are multiple examples of
federal agencies failing to meet congressionally mandated timelines,
including when it comes to marijuana-related policy issues.

The purpose of the FDA directive appears to be 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.

“No matter what they come up with, it won’t solve the intermediate issue,”
Adam Terry, CEO of the hemp beverage company Cantrip, told Marijuana Moment
on Thursday. “It may allow something like individually wrapped gummies with
0.4mg THC per piece, but the liquid used to pour into molds will still
break that container rule, which under statute applies to intermediates.”

“So the gummies would be illegal to make in the U.S. Full-spectrum CBD
needs a more comprehensive reform as the president said in his” recent
executive order, he said, adding that a bill introduced by Reps. Morgan
Griffith (R-VA) and Marc Veasey (D-TX) last month is “the best proposal for
that.”

Jim Higdon, the co-founder and chief communications officer at Cornbread
Hemp, said he is “eager for the FDA to finally provide some guidance on
hemp, which they have withheld since the passage of the 2018 Farm Bill.”

“If it remains unclear exactly which cannabinoids are outlawed, then the
McConnell hemp ban will just cause more confusion and chaos,” he said,
referring to Sen. Mitch McConnell (R-KY), who led the charge to both
initially legalize hemp in 2018 and the more recent push to recriminalize
hemp THC product.”

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.

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.

The post FDA Faces Deadline To Publish Cannabinoid Lists And Define Hemp
Product ‘Containers’ Under Law Trump Signed appeared first on Marijuana
Moment.