The U.S. Drug Enforcement Administration (DEA) recently proposed amendments on the Controlled Substances Act (CSA) citing additional rules for the hemp and cannabidiol products.
Conforming changes in the filed 2018 Farm Bill include the revision of the definition of marijuana’s active compound, tetrahydrocannabinoid (THC). According to the federal agency, hemp processing is not included in the bill legalizing hemp and hemp-derived products.
The regulatory gap skips on the relevant part of the manufacturing process, which for DEA is important to update. In the 2018 Farm Bill, hemp is defined to include all derivatives, extracts, and cannabinoids of hemp. With this definition, it is undeniable that cannabinoids are no longer controlled substances, but the interim ruling does not take into account the processing of the cannabis plant.
Any material or compound that contains greater than 0.3 percent of THC on a dry weight basis remains to be controlled and part of the Schedule I drugs. DEA said changes to the existing regulations would allow the public’s take and opinion for better enforcement. According to DEA, public comments will be accepted until Oct. 20, 2020.
Part of the amendment is removing any material, compound, mixture, or preparation that has been approved by the U.S. Food and Drug Administration. These must contain no more than 0.1 percent of the residual tetrahydrocannabinols. When the criteria are met, any CBD drug will be removed from the Schedule V status.
The modified definition of the marijuana extract must be observed by businesses operating in this sector. This helps to avoid conflicts and even penalties when the updated sections of the Farm Bill are approved.
Additionally, a green light was released to ease the controls over hemp importation and exportation. This also includes marijuana derivatives, which can aid the US economy.
“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,” stated on the filing. No additional costs are stated in the revision.
Removal of FDA-Approved Drugs
DEA is leaning towards the action of legalizing drugs that have been approved by the FDA. If a product is approved for safe consumption and with no drastic side effects for the consumers, the drug will be removed from the Schedule V status.
A testimony to this new ruling is the FDA-approved cannabidiol epilepsy medication called Epidiolex, which was taken out of the schedule. GW Pharmaceuticals announced the removal of the drug from the schedule last April, effective immediately. The CBD medication was no longer a controlled substance and is safe for public consumption.
FDA argued that Epidiolex made with CBD carries ‘minimal risks’ and proven to provide health benefits, so it shouldn’t be controlled. DEA looked into the drug and said FDA should warrant the control of the drug, and the agency must revisit the status of the drug as a controlled substance.
The World Health Organization also backed that CBD containing no more than 0.2 percent of THC is ‘not under international control.’ This statement helped clarify the conditions of the DEA when it comes to the new ruling.
FDA approved Epidiolex since 2018, and like many non-controlled drugs, people need a prescription to get it from the pharmacy. Prescriptions for this particular drug are only valid for up to a year.
A drug made for therapy, people suffering from the Lennox-Gastaut Syndrome, and Dravet Syndrome can get therapeutic benefits from the CBD drug.
THC Content Matters
Tetrahydrocannabinol or THC is a known compound responsible for the psychoactive effects, causing the high sensation. By controlling the dosing of this compound, abuse can be stopped, and authorities can control the compound.
DEA stated in the filing that in order to meet the definition of hemp, the derivative must not exceed to 0.3 percent limit. Going beyond this meter could provide an intense high sensation that affects the condition of a consumer.
When this happens, any substance, derivative, extract, or product exceeding this limit is labeled as a Schedule I controlled substance automatically. Even if the plant where the product is derived contained less than 0.3 percent, if the result weighs over the limit, then it’s already a controlled substance under the Schedule I drug.
Agriculture Secretary Sonny Purdue said formalizing the regulation on CBD and THC ‘hasn’t necessarily been an eager partner’ in the marijuana legalization. Purdue said this is only a pressure faced by the federal agency to develop its own set of regulations for hemp—leading to more restrictive rules.
Additionally, Purdue argued that right from the start, DEA didn’t like the whole marijuana reform program.
Meanwhile, DEA said it’s only following its obligations by coming with a new interim final rule. While there’s a public comment on the new regulations, the agency claimed that this isn’t necessary as they are only conforming to the new law.
“To the extent required by law, DEA will consider and respond to any relevant comments received in the 60-day deadline,” said in the filing.
Before coming with the new set of amendments for hemp, DEA has received complaints and was sued by scientists and veterans in May. Citing the unconstitutional labeling of cannabis in Schedule I of the CSA, scientists argued that a lot of studies were conducted on the effectiveness of the plant.
There’s also a separate lawsuit faced by the federal agency that dictates the prohibition of cannabis to medical patients. The patients asked the Supreme Court to take the case to lower courts to get to the final ruling.
In addition to this, manufacturers are also pressuring DEA to finalize the rules on the license of the marijuana growers. Without this approval, growers are kept in the dark whether to continue production or not, and it there are rules that are violated and considered unconstitutional.
Hemp advisory committee is yet to finalize the ruling. In Florida, a separate committee on marijuana advisory will meet on August 27.