Note regarding this rule – In light of questions that the Drug Enforcement Administration has received from members of the public following the publication of the Final Rule establishing a new Controlled Substance Code Number (drug code) for marijuana extract, DEA makes the following clarification:
The new drug code is a subset of what has always been included in the CSA definition of marijuana. By creating a new drug code for marijuana extract, the Final Rule divides into more descriptive pieces the materials, compounds, mixtures, and preparations that fall within the CSA definition of marijuana. Both drug code 7360 (marijuana) and new drug code 7350 (marijuana extract) are limited to that which falls within the CSA definition of marijuana.
Clarification of the New Drug Code (7350) for Marijuana Extract
As explained in the Final Rule, the creation of this new drug code was primarily intended to give DEA more precise accounting to assist the agency in carrying out its obligations to provide certain reports required by U.S. treaty obligations. Because the Final Rule did not add any substance to the schedules that was not already controlled, and did not change the schedule of any substance, it was not a scheduling action under 21 U.S.C. §§ 811 and 812.
Because recent public inquiries that DEA has received following the publication of the Final Rule suggest there may be some misunderstanding about the source of cannabinoids in the cannabis plant, we also note the following botanical considerations. As the scientific literature indicates, cannabinoids, such as tetrahydrocannabinols (THC), cannabinols (CBN) and cannabidiols (CBD), are found in the parts of the cannabis plant that fall within the CSA definition of marijuana, such as the flowering tops, resin, and leaves. 2 According to the scientific literature, cannabinoids are not found in the parts of the cannabis plant that are excluded from the CSA definition of marijuana, except for trace amounts (typically, only parts per million) 3 that may be found where small quantities of resin adhere to the surface of seeds and mature stalk. 4 Thus, based on the scientific literature, it is not practical to produce extracts that contain more than trace amounts of cannabinoids using only the parts of the cannabis plant that are excluded from the CSA definition of marijuana, such as oil from the seeds. The industrial processes used to clean cannabis seeds and produce seed oil would likely further diminish any trace amounts of cannabinoids that end up in the finished product. However, as indicated above, if a product, such as oil from cannabis seeds, consisted solely of parts of the cannabis plant excluded from the CSA definition of marijuana, such product would not be included in the new drug code (7350) or in the drug code for marijuana (7360), even if it contained trace amounts of cannabinoids. 5
The 2018 Farm Bill removed hemp, a lawful form of cannabis, from the CSA. Hemp is a versatile crop used to make a variety of products, including paper, food products and cosmetics. Hemp is perhaps best known as the source of CBD, a non-psychoactive ingredient in cannabis. To qualify as hemp, the plant must have 0.3% or less of delta-9 tetrahydrocannabinol concentration (THC) on a dry weigh basis. THC is the compound in cannabis that, when ingested at certain levels, can create a “high” sensation.
Business and consumers that may be impacted by the interim final rule should assess whether to participate in the comment period between now and October 20, 2020. Your comments could change the substance of the final rule published by the DEA.
The U.S. Drug Enforcement Administration (DEA) on August 20, 2020, published an interim final rule that, if adopted, would essentially criminalizes the hemp oil extraction process, contradicting the 2018 Farm Bill and potentially putting the entire CBD industry at risk.
The interim final rule will be open to public comment until 11:59 p.m. on October 20, 2020. As of this article’s publication, more than 750 comments have been submitted, many of which are from businesses in the hemp industry or hemp industry consumers expressing concern about the effect of the interim final rule.