DEA took this action based on the Administrator’s finding that placement of these opioids into CSA’s schedule I was “necessary to avoid an imminent hazard to the public safety.” Thus, any final order would impose administrative, civil, and criminal sanctions and regulatory controls applicable to schedule I controlled substances on the manufacture, distribution, possession, importation, and exportation of, and research and conduct of instructional activities of these substancesAs DEA’s August 31st Notice of Intent stated, 21 U.S.C. § 811(h)(4), requires the Administrator to notify the Secretary of HHS of his intention to temporarily place a substance into schedule I of the CSA. The Administrator transmitted notice of his intent to place mitragynine and 7-hydroxymitragynine in schedule I on a temporary basis to the Assistant Secretary on May 6, 2016.

e manufacture, distribution, or possession of marijuana, except when used in federally-approved research studies.Notably, Schedule I and II substances are subject to Internal Revenue Code 280E, which prohibits tax deduction or credit for any amount that is incurred in carrying on a business if it consists of “trafficking in controlled substances (within the meaning of Schedule I and II of the CSA) which is prohibited by Federal law…” (IRS Tax Code Section 280E – Expenditures In Connection With The Illegal Sale Of Drugs). This means that marijuana businesses effectively pay taxes on their entire gross income. By contrast, non-marijuana businesses may deduct certain business expenses (such as payroll, rent, marketing, and research and development expenses), thereby reducing their taxable income and overall effective tax rate.Rescheduling a Scheduled Drug SubstancePursuant to the CSA, there are various ways in which a substance can be added, removed, or moved to a different schedule (see 21 USC § 811 and Congressional Research Service, The Controlled Substances Act (CSA): A Legal Overview for the 118th Congress (Jan. 19, 2023)). Congress may pass legislation to place or remove a substance under control or to move its classification. This method does not require the incorporation of scientific or medical findings and is not subject to the Administrative Procedures Act. This method has been used to respond to urgent drug matters such as the addition of synthetic cathinones and certain cannabimimetic substances to Schedule I, and the placement of fentanyl analogies in Schedule I on a temporary basis.Alternatively, DEA may make scheduling decisions through the administrative process. This is the process that the potential rescheduling of marijuana is currently undergoing. This avenue may be initiated by DEA, HHS, or any “interested party” (21 USC 811(a)). Upon receiving a scheduling petition, DEA must determine whether there are sufficient grounds for the request and, if so, pass it a

al, where he promised to enforce California’s cannabis laws in light of former U.S. Attorney Jeff Sessions’ decision to rescind the Cole Memorandum in 2018. As far back as 2017, Becerra told the Los Angeles Times that the federal government had to “catch up” regarding marijuana law. While these statements are relevant to Becerra’s opinion on marijuana reform, as HHS Secretary, he will need to follow the CSA protocols and base any recommendation on medical and scientific findings.When Can We Expect a Decision on Marijuana Scheduling?If HHS and the FDA do, in fact, report their findings by the end of 2023, it does not mean that a final decision will be made at that time. The Attorney General would then need to review the recommendation, make a determination, and finally initiate the rulemaking process pursuant to the Administrative Procedures Act. If Becerra’s statements are true, and everything goes according to plan, marijuana could have a new federal status in 2024. 21 USC 812(b)(1). 21 USC 811(a)(1)(B). 21 USC 811(a)(2). 21 USC 811(c). 21 USC 811(b).See 5 USC 551-559.

Congress carved hemp, which it defined (roughly) as cannabis with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis, out of the definition of “marihuana” under the federal Controlled Substances Act in the 2018 Farm Bill. In doing so, Congress transformed hemp from a criminalized schedule I controlled substance into a fully legal agricultural commodity.Notably, however, Congress did not amend another provision of the Controlled Substances Act—21 U.S.C. § 811(d)(1)—that arguably obligates DEA to reschedule much if not all hemp. Section 811(d)(1) provides that “[i]f control is required by United States obligations under [the Single Convention], [DEA] shall issue an order controlling such drug under the [Controlled Substances Act] schedule [it] deems most appropriate to carry out such [treaty] obligations.”

The action is based on a finding by the DEA Administrator that the substances mephedrone (methylcathinone), methylone (3,4-methylenedioxy-N-methylcathinone), and MDPV (3,4-methylenedioxypyrovalerone) are an imminent hazard to the public safety.As reported here in December 2010 and March 2011, DEA has authority (as delegated by the U.S. Attorney General) to temporarily place a substance into Schedule I of the CSA for a one-year period (subject to a six-month extension) without having to comply with the usual scheduling requirements under 21 U.S.C. § 811(b) if the agency makes a finding that such action necessary to avoid imminent hazard to the public health. DEA last invoked its temporary scheduling authority in December 2010 when it published a notice of intent to temporarily schedule five synthetic cannabinoids in Schedule I, and finalized that temporary scheduling in March 2011.

HS submitted its new recommendation to ultimately move HCPs from Schedule III to Schedule II.In the case of marijuana rescheduling, several months have already passed since the DEA received HHS’s recommendation to move marijuana to Schedule III. There is no way to know exactly how long the process will take for the DEA to determine if it will initiate rulemaking. It could happen in days, weeks, months, or even years. However, the politics involved in rescheduling indicate that a decision will likely be made in the next few months, not years. President Biden has already campaigned on marijuana reform, and he’ll likely want to highlight rescheduling when courting voters in 2024.Step 2: DEA Initiates Rulemaking or Issues Order to Reschedule MarijuanaFollowing a determination by the DEA, the next step will be either a rulemaking proceeding or the issuance of an order to reschedule cannabis.Federal law outlines the authority and criteria for the classification of substances. Section (a) of 21 USC 811 states that “rules relating to this statute subsection shall be made on the record after opportunity for a hearing pursuant to the rulemaking procedures prescribed by [the APA, specifically 5 USC 553].” The APA requires that the DEA provide interested persons an opportunity to submit comments, which the DEA must consider when issuing any rules related to the CSA. This is commonly referred to as the notice and comment period. The public must have at least 30 days to provide comments, with some exceptions, including when a matter relates to the foreign affairs functions of the U.S., which is relevant here.There is precedent for the DEA to side-step the notice and comment period by claiming that the scheduling of a drug containing cannabis is a matter of foreign affairs. In 2018, the epilepsy drug containing cannabidiol became the first FDA-approved drug containing marijuana extract. The DEA placed Epidiolex in Schedule V without providing an opportunity for notice and comment because th

n and has legitimate medical use. In the past, it has been difficult to fund and publish research on marijuana because, generally, the federal government has not considered even state-legal medical marijuana use legal. In this letter, HHS has clearly started to take into account the decades of data that has come from the medical use of marijuana.According to the letter, “[t]he current review is largely focused on modern scientific considerations on whether marijuana has a CAMU and on new epidemiological data related to abuse of marijuana in the years since the 2015 HHS [eight factor analysis] on marijuana.” This references the last time that HHS reviewed marijuana’s status in 2015, upon request by the governors of Rhode Island and Washington, which was ultimately denied by the DEA.HHS Eight Factor AnalysisIn determining where marijuana should be scheduled, the HHS Letter focuses on the following eight factor analysis test (8FA) required by the Controlled Substances Act (CSA) listed in 21 USC 811(b). Below is a brief analysis and summary of each factor as set forth in the HHS Letter:1. Marijuana’s actual or relative potential for abuse – HHS found that marijuana has the potential to create hazards for health; however, when compared to Schedule I and II substances, marijuana is less likely to result in incidences of adverse outcomes or severity of substance use disorder.2. Scientific evidence of marijuana’s pharmacological effect, if known – HHS discusses how cannabinoids interact with the endocannabinoid system. The HHS reviewed studies of marijuana use in animals and humans. Pages 16 and 17 of the HHS Letter list recorded clinical responses to marijuana use as positive subjective, sedative, anxiety and negative, perceptual, psychiatric, social and cognitive, and physiological.3.The state of current scientific knowledge regarding marijuana – This section focuses on the state of scientific knowledge on marijuana, including its chemistry and interaction with the human body. The HHS

Placement of a drug in one of the four schedules (II-V) where there has been a finding of accepted medical use relative to its potential for abuse and potential for psychological or physical dependence. Moreover, prior to initiating rescheduling proceedings, 21 U.S.C. § 811(b) requires DEA to seek an opinion from HHS and determine whether the “scheduling recommendation, scientific and medical evaluation, and ‘all other relevant data’ constitute substantial evidence that the drug should be rescheduled as proposed.” Id. at 53,739, 53,820.

By Karla L. Palmer & Larry K. Houck –The Drug Enforcement Administration (“DEA”) published a Final Rule on July 30th (77 Fed. Reg. 44,456 (July 30, 2012) placing prostanozol and methasterone into Schedule III of the federal Controlled Substances Act (“CSA”) as anabolic steroids. DEA’s administrative scheduling of prostanozol and methasterone, along with their salts, esters and ethers, becomes effective August 29, 2012.According to the CSA, DEA schedules drugs according to statutory procedures set forth in 21 U.S.C. § 811, which mandates a detailed, eight factor scheduling analysis set forth in 21 U.S.C. § 811(b). In the case of anabolic steroids, however, the DEA uses another, simpler process drawn from the Anabolic Steroid Control Act of 1990.

See generally 72 Fed. Reg. 54228-29.Based on industry comments, the 2007 proposed rescheduling rule hit a road block in 2008. The DEA opted instead to require the application of the formal eight-factor statutory analysis set forth in 21 U.S.C. §811(c) for each generic version of dronabinol approved by FDA, and for transferring each approved dronabinol product from Schedule I to Schedule III based on that eight factor analysis. DEA also withdrew the 2007 proposed rule out of a concern that administrative appeals of any final rule could take years to resolve -- with no final regulation ever taking effect until well after the approval of generic forms of Marinol®.