Hemp Products Would Be Federally Regulated Instead Of Banned Under New Senate Bill

Democratic senators have introduced a new bill to create a federal
regulatory framework for hemp-derived cannabinoids and allow states to set
their own rules for products such as CBD.

The legislation, shared exclusively with Marijuana Moment ahead of its
introduction on Wednesday, is being sponsored by Sens. Ron Wyden (D-OR) and
Jeff Merkley (D-OR). It comes at a critical time for the industry, which is
facing significant upheaval after President Donald Trump signed a spending
bill last month that includes provisions to widely recriminalize consumable
cannabinoid products.

The senators’ proposal would set THC limits on hemp products, allowing up
to 5 milligrams per serving and a maximum of 50 milligrams per package
across all types other than beverages. Hemp drinks could have up to 10
milligrams of THC per package.

The Food and Drug Administration (FDA) would also be empowered to ensure
that certain safety standards are met in the marketplace—including making
sure that products aren’t marketed to children.

“There’s no question that more needs to be done to protect kids and
consumers from unsafe, untested hemp products,” Wyden told Marijuana Moment.

“We learned from the failed war on drugs that a one-size-fits all approach
that bans hemp products from the market outright does nothing to protect
kids and consumers, and will be a gut-punch to thousands of jobs and small
businesses across the country,” he said. “My legislation takes the
thoughtful and measured approach necessary to implement strong consumer
protection regulations while fostering growth and innovation in this
growing industry.”

Merkley said that “a blanket ban on hemp harms research and the entire
industry.”

“Instead, the FDA must establish clear, commonsense guidelines—as it does
for other foods, drinks, and products—to protect the health of all
Americans and prevent children from purchasing these hemp products,” he
said.

The new bill, the Cannabinoid Safety and Regulation Act, represents
something of a compromise between both sides of the hemp policy debate.
Rather than impose an outright ban as is currently set to take effect next
November, it would establish a regulatory pathway that many stakeholders
view as a more sensible alternative that wouldn’t threaten to dramatically
undermine the industry.

Businesses selling hemp cannabinoid items meant for human consumption would
need to register with FDA and comply with the agency’s safety regulations.
Such products could not be sold to people under 21, and they would need to
adhere to federal labeling requirements.

The measure would additionally create a $125 million cannabis use
prevention grant program under the U.S. Department of Health and Human
Services (HHS), with the intent of preventing underage consumption of
intoxicating cannabinoids.

The bill specifically preserves the rights of states to set tighter
regulations, including banning the products altogether as has played out in
certain markets. States that allow the products would need to abide by
federal packaging and labeling rules and they could not prevent companies
from transporting hemp cannabinoids through their state regardless of their
individual laws.

As part of the labeling requirement proposed under the measure, all
products would need to feature an internationally recognized symbol and
statement identifying them as containing cannabinoids. States could use
different symbols for intoxicating vs. non-intoxicating items.

FDA would be required to promulgate rules on the remote sale, marketing and
distribution of hemp cannabinoids to prevent youth use within 18 months of
the measure’s enactment. Within nine months, the agency would need to
establish good manufacturing processes for such products. In general, FDA
would have the authority to enact additional regulations on the sale and
production of hemp cannabinoids if they serve public health interests.

Hemp cannabinoids could be considered as, or included in, food items if
they meet Federal Food, Drug, and Cosmetic (FFD&C) Act standards laid out
in the bill. However, businesses couldn’t sell cannabinoid products if they
contain alcohol, tobacco or nicotine.

Vapes containing cannabinoids could not have natural or artificial flavors,
and they could contain no more than 6 percent terpenes.

The bill states that synthetically derived cannabinoids would be banned,
which is consistent with existing law but has generally gone without
federal enforcement. For example, delta-8 THC products are commonly
synthesized from legal CBD—something the Drug Enforcement Administration
(DEA) has said violates statute—but those products are still widely
available in loosely regulated state markets.

Wyden’s measure also adds a definition for what constitutes total THC
content, a measurement that determines whether a product is considered
federally legal hemp or illegal marijuana. The Farm Bill defines hemp as
cannabis containing up to 0.3 percent THC by dry weight, and that’s
conventionally been understood to refer to the most commonly known
intoxicating cannabinoid delta-9 THC. The new legislation stipulates that
THC refers to the total content of the cannabinoid in all forms, including
delta-8, delta-9, delta-10, THC-A and HHC, for example.

Additionally, the heads of the U.S. Department of Agriculture (USDA), FDA,
Justice Department and Alcohol and Tobacco Tax and Trade Bureau (TTB) would
be required to work together to create a report with recommendations on
regulating the sale of beverages containing THC.

The legislation also provides for mandatory recalls of any hemp cannabinoid
products that FDA determines to be unsafe.

On top of the regulatory provisions, the Cannabinoid Safety and Regulation
Act further calls for a series of agency directives and appropriations and
grant initiatives to support relevant public health objectives.

That includes $200 million in annual appropriations over five years for the
Centers for Disease Control and Prevention (CDC) to support data collection
on cannabis use trends and evidence-based prevention programs, mandatory
data collection on impaired driving and $40 million in grants over five
years for state agencies to combat driving under the influence and $30
million for research development to create a device capable of detected
impaired driving.

The bill is largely identical to a prior version of the hemp legislation
filed last Congress, with select changes.

Arguably the most notable revision is the imposition of THC limits for hemp
products, which represents a departure from the earlier iteration of the
proposal and seems to serve as a compromise agains the broad ban that is
set to take effect next November under the newly enacted appropriations
legislation.

Under the new measure, testing facilities would need to be approved at the
state level and registered with either DEA, FDA or USDA. The previous bill
stipulated that testing facilities could have either state or federal
approval.

The earlier version of the measure also sought to create a new Center for
Cannabinoid Products at FDA, which was removed from the current legislation.

“We are deeply grateful to Senators Wyden and Merkley for their continued
leadership on behalf of hemp farmers, consumers and businesses,” Jonathan
Miller, general counsel at the U.S. Hemp Roundtable, told Marijuana Moment
on Wednesday.

“Introduction of their bill is a key first step to developing consensus
around a robust regulatory framework that can replace the impending ban,”
he said. “We are hopeful that Congress will extend the ban moratorium for
at least another year to provide adequate time to consider, improve upon
and resolve efforts such as Wyden/Merkley.”


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Meanwhile, the Congressional Research Service (CRS) recently released a
report describing the significant uncertainty around how the pending
federal hemp ban will ultimately be enforced, but “divergent federal and
state marijuana laws may provide some guidance,”

Hemp was federally legalized under the 2018 Farm Bill that Trump signed
during his first term, with then-Senate Majority Leader Mitch McConnell
(R-KY) leading the push to end criminalization of the crop at the time. But
the senator has insisted that the policy change wasn’t intended to allow
consumable products with THC, so he’s been determined to close what he
describes as a “loophole” in the law.

Sen. Rand Paul (R-KY) attempted to remove the hemp ban language from the
spending bill Trump signed last month, but a majority of members voted to
table his amendment.

Industry stakeholders, advocates and lawmakers are stressing the urgency of
the situation. While the hemp ban won’t take effect until one year after
enactment, that still leaves little time in the congressional calendar to
reverse course or create an alternative regulatory framework for products
set to be banned.

Paul, meanwhile, said last month that he’ll soon file a bill to protect the
hemp industry from the impending hemp ban. And he also called out alcohol
and marijuana interests for allegedly “join[ing] forces” to lobby in favor
of the prohibitionist policy change, which will restrict access to a plant
and its derivatives that are often used therapeutically.

The senator said the forthcoming legislation would make it so state policy
regulating hemp cannabinoid products—with basic safeguards in place to
prevent youth access, for example—”supersedes the federal law.”

On the other end of the debate, Rep. Andy Harris (R-MD), who helped secure
the hemp re-criminalization language, said last month that he’s not
concerned about attempts to undercut the enacted law, brushing off
arguments about the possible consequences of the policy change as
“desperate mistruths from an industry that stands to lose billions of
dollars by selling intoxicants to children.”

Overall, there’s been widespread outcry over the pending hemp
re-criminalization law, drawing criticism from parents of cannabis patients
, veterinarians and influencers like Joe Rogan, for example.

In response to the hemp ban, Rep. Nancy Mace (R-SC) filed a bill that would strike
the contested provisions of the appropriations legislation. But some
stakeholders worry that approach could backfire, and they’re hoping to see
bipartisan bills introduced in he near future that would provide a robust
regulatory model for intoxicating hemp products as a viable alternative to
blanket prohibition.

Meanwhile, GOP political operative Roger Stone said last month 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 last month 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.

While many hemp stakeholders say the ban would effectively eradicate the
industry–even applying to nonintoxicating CBD products that people use for
medical reasons—there’s latent hope that they can strike a compromise deal
with lawmakers before the prohibition is implemented this time next year.

Lawmakers such as Sen. Chris Van Hollen (D-MD) also say that window could
provide an opportunity to advance legislation to create an alternative
regulatory model for consumable hemp products.

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.

The new legislation specifies that, within one year of enactment, the
weight will apply to total THC—including delta-8 and other isomers. It will
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 will 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 will be limited to a total of 0.4 milligrams per
container of total THC or any other cannabinoids with similar effects.

Within 90 days of the bill’s enactment, the Food and Drug Administration
(FDA) and other agencies will need to publish list of “all cannabinoids
known to FDA to be capable of being naturally produced by a Cannabis sativa
L. plant, as reflected in peer reviewed literature,” “all
tetrahydrocannabinol class cannabinoids known to the agency to be naturally
occurring in the plant” and “all other known cannabinoids with similar
effects to, or marketed to have similar effects to, tetrahyrocannabinol
class cannabinoids.”

The language slightly differs from provisions included in legislation that
had previously advanced out of the House and Senate Appropriations panels,
which would have banned products containing any “quantifiable” amount of
THC, to be determined by the HHS secretary and secretary of agriculture.

*Read the full text of the new Senate bill below:*

*Photo courtesy of Brendan Cleak.*

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New Senate Bill appeared first on Marijuana Moment.