The Drug Enforcement Administration (DEA) on Thursday unveiled proposed rules for hemp and CBD to put the federal agency officially in compliance with the 2018 Farm Bill.
While DEA stressed that the policies laid out in this interim final rule have already been in effect since hemp was federally legalized, it said the new filing to be published in the Federal Register on Friday will codify those regulations. These “conforming changes to DEA’s existing regulations” will be open to public comment.
DEA is revising the definition of THC and marijuana extracts under the Controlled Substances Act (CSA) to exclude substances that are considered legal hemp (containing no more than 0.3 percent THC).
It is also making it so any CBD-based drugs approved by the Food and Drug Administration (FDA) are removed from Schedule V.
Finally, the proposed regulations remove restrictions on importing and exporting hemp and its derivatives.
“This interim final rule merely conforms DEA’s regulations to the statutory amendments to the CSA that have already taken effect, and it does not add additional requirements to the regulations,” the filing says. “Accordingly, there are no additional costs resulting from these regulatory changes.”
The removal of FDA-approved CBD medications is consistent with an action that DEA seemed to take prior to the release of this interim final rule. GW Pharmaceuticals announced in April that its FDA-approved cannabidiol epilepsy medication Epidiolex was taken of that schedule.
When it comes to excluding a broader class of newly legal hemp products from the federal definition of still-illegal marijuana, DEA clarified how THC content comes into play.
“The definition of hemp does not automatically exempt any product derived from a hemp plant, regardless of the Δ,9 -THC content of the derivative,” it said. “In order to meet the definition of ‘hemp,’ and thus qualify for the exemption from schedule I, the derivative must not exceed the 0.3% Δ,9-THC limit.”
“As a result, a cannabis derivative, extract, or product that exceeds the 0.3% Δ9 -THC limit is a schedule I controlled substance, even if the plant from which it was derived contained 0.3% or less Δ9 -THC on a dry weight basis,” the agency said.
While DEA is formalizing these regulations for hemp and CBD, it hasn’t necessarily been an eager partner in the crop’s legalization, according to Agriculture Secretary Sonny Purdue.
He said on a couple occasions this year that the U.S. Department of Agriculture (USDA) faced pressure from the federal agency as it developed its own set of regulations for hemp, leading to more restrictive policies that stakeholders are pushing back on.
Purdue said DEA “really didn’t like the whole program to begin with,” referring to hemp reform.
In any case, DEA says it is following through on its statutory obligations with this new interim final rule. The agency wrote that while asking for public comment on the proposed regulation is “unnecessary in this instance” because they are simply conforming with the new law and DEA “has no discretion” over it, it will still be soliciting input after the notice is published.
“To the extent required by law, DEA will consider and respond to any relevant comments received” during the 60-day window, it said.
While DEA is complying with the federal policy change on hemp and its derivatives, it is actively fighting lawsuits concerning its marijuana regulations.
Scientists and veterans sued the federal agency in May, arguing that the legal basis DEA has used to justify keeping cannabis in Schedule I of the CSA is unconstitutional. A federal appeals court on Tuesday denied the agency’s request to dismiss the lawsuit.
In a separate lawsuit against DEA, medical cannabis patients challenging the federal prohibition of marijuana are asking the U.S. Supreme Court to take their case after a series of rulings in lower courts since the original lawsuit was filed in 2017.
DEA is also facing pressure to approve additional marijuana manufacturers for research purposes. A bipartisan coalition of lawmakers demanded that the agency “expeditiously” finalize rules to license more growers in a letter this week.
Photo courtesy of Brendan Cleak.