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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.

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:

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

Clarification of the New Drug Code (7350) for Marijuana Extract

This interim final rule is not a major rule as defined by the Congressional Review Act (CRA) (5 U.S.C. 804). DEA is submitting the required reports with a copy of this interim final rule to both Houses of Congress and to the Comptroller General.

Administrative practice and procedure; Drug traffic control; Exports; Imports; Reporting and recordkeeping requirements.

Removal of Import/Export Provisions Involving FDA-Approved Products Containing CBD

Executive Orders 12866 (Regulatory Planning and Review), 13563 (Improving Regulation and Regulatory Review), and 13771 (Reducing Regulation and Controlling Regulatory Cost)

[FR Doc. 2020-17356 Filed 8-20-20; 8:45 am]

Removal of Schedule V Control of FDA-Approved Products Containing Cannabidiol

DEA finds there is good cause within the meaning of the APA to issue these amendments as an interim final rule and to delay comment procedures to the post-publication period, because these amendments merely conform the implementing regulations to recent amendments to the CSA that have already taken effect. DEA has no discretion with respect to these amendments. This rule does no more than incorporate the statutory amendments into DEA’s regulations, and publishing a notice of proposed rulemaking or soliciting public comment prior to publication is unnecessary. See 5 U.S.C. 553(b)(B) (relating to notice and comment procedures). "[W]hen regulations merely restate the statute they implement, notice-and-comment procedures are unnecessary." Gray Panthers Advocacy Committee v. Sullivan, 936 F.2d 1284, 1291 (D.C. Cir. 1991); see also United States v. Cain, 583 F.3d 408, 420 (6th Cir. 2009) (contrasting legislative rules, which require notice-and-comment procedures, "with regulations that merely restate or interpret statutory obligations," which do not); Komjathy v. Nat. Trans. Safety Bd., 832 F.2d 1294, 1296 (D.C. Cir. 1987) (when a rule "does no more than repeat, virtually verbatim, the statutory grant of authority" notice-and-comment procedures are not required).

marihuana, cannabis and cannabis-derived material must both fall within the pre-AIA CSA definition of marihuana and contain more than 0.3 percent Δ 9 -THC on a dry weight basis. Pursuant to the AIA, unless specifically controlled elsewhere under the CSA, any material previously controlled under Controlled Substance Code Number 7360 (marihuana) or under Controlled Substance Code Number 7350 (marihuana extract), that contains 0.3% or less of Δ 9 -THC on a dry weight basis–i.e., "hemp" as that term defined under the AIA–is not controlled. Conversely, any such material that contains greater than 0.3% of Δ 9 -THC on a dry weight basis remains controlled in schedule I.

Note that CBD in a mixture with a Δ 9 -THC concentration greater than 0.3% by dry weight is not exempted from the definition of "marihuana" or "tetrahydrocannabinols." Accordingly, all such mixtures exceeding the 0.3% limit remain controlled substances under schedule I.

Information contained in this alert is for the general education and knowledge of our readers. It is not designed to be, and should not be used as, the sole source of information when analyzing and resolving a legal problem. Moreover, the laws of each jurisdiction are different and are constantly changing. If you have specific questions regarding a particular fact situation, we urge you to consult competent legal counsel.

The DEA is accepting comments on its hemp IFR until Oct. 20, 2020. For additional information or assistance with the regulatory specifics and comment process, please contact the authors.

Under the Administrative Procedures Act (APA), agencies normally must publish a proposed rule, receive comments and then issue a final rule. However, agencies are authorized to promulgate IFRs if the agency finds that it has “good cause” to skip the normal rulemaking process. IFRs are generally effective when issued, which is the case with the DEA’s hemp IFR. In addition, IFRs often provide a comment period — in this case, 60 days — for industry and individuals to provide feedback before the agency imposes its final rule. The final rule might (or might not) incorporate changes to address any concerns raised by commentators.

Although the DEA’s IFR ostensibly codified the “derivative” theory of hemp products (the legality of products derived from hemp so long as they contain less than 0.3 percent delta-9 THC), the rule also raised three significant concerns for the hemp and CBD industries.

What Is an “Interim Final Rule”?

Notes

The brief and pro forma petition, which was filed on Sept. 18, 2020, evidences that the petitioners will also file a case in the U.S. District Court for the District of Columbia to make their initial arguments.

The DEA made six changes based on the Farm Bill in its hemp IFR:

What Does DEA’s Hemp Rule Say?

The D.C. Circuit petition challenges the IFR on the basis that: 1) the DEA did not follow the appropriate notice and comment procedures, 2) the DEA does not have authority under the Farm Bill to issue the IFR, and 3) the DEA’s acting administrator lacks authority to issue the IFR.

While Congress makes laws, it often tasks Executive Branch agencies, such as the U.S. Department of Justice (the DEA’s parent organization), with promulgating rules and regulations that interpret laws and have the force of law themselves. These rules, codified in the Code of Federal Regulations, provide regulatory guidance to industries and individuals. Violation of these rules can carry civil and criminal penalties.