From Prohibition to Prescription: DEA Releases Proposed Marijuana Rescheduling Rule

On May 21, 2024, the Drug Enforcement Administration (DEA) issued an order announcement proposed provisions of the above-mentioned Federal Register (FR) to amend the schedule of marijuana from Schedule I to Schedule III of the Controlled Substances Act (CSA). This announcement comes nearly a year after the U.S. Department of Health and Human Services (HHS)’s August 29, 2023 letter to the DEA recommending a change to the marijuana dispensation schedule. Also occurs on April 11, 2024 opinion letter from the Justice Department’s Office of Legal Counsel that U.S. international treaty obligations do not prevent marijuana from being rescheduled. The proposed rule represents the most significant change in marijuana policy since the passage of the CSA in 1970, which classified marijuana as a Schedule I controlled substance.

The DEA’s proposed rule is the first of many steps in the rescheduling process. France’s notification triggered a 60-day period to publicly respond to the request. Thus, interested persons can submit comments on the proposal until July 22, 2024. Moreover, since this is a formal regulation, interested persons can submit a request for a hearing. Although not required, the DEA Administrator may order an in-person hearing and select an Administrative Law Judge (ALJ) to preside over the hearing. After reviewing the file, the ALJ then forwards its recommendations to the Department of Justice, which makes the final rescheduling decision. It will likely be months, perhaps even longer, before a final decision is issued. During this time, marijuana will remain a Schedule I controlled substance.

Following the move to Schedule III, products containing marijuana will continue to be subject to different legal and regulatory requirements. Most importantly, such products would be subject to oversight by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act, and any medicinal product containing marijuana would require premarket approval from the FDA or an investigational new drug (IND) application. . for research use.

Consequences of changing the schedule

Marijuana is currently classified on Schedule I of the CSA, a category reserved for substances with a high potential for abuse and unsatisfactory medical uses in the United States. The Schedule I controlled substances list includes drugs such as heroin and ecstasy. On the other hand, Schedule III substances are viewed as having a lower potential for abuse and accepted medical use in the United States. Schedule III controlled substances include drugs such as acetaminophen with codeine.

Annex I classification imposes significant barriers to research. Rescheduling marijuana to Schedule III would expand research opportunities, allowing researchers in the United States to better understand the cannabis plant and potentially discover new therapeutic applications. However, changing the marijuana schedule to Schedule III would not automatically allow consumers to purchase marijuana products over the counter, including at pharmacies, convenience stores, gas stations or grocery stores. A prescription will likely be required, depending on the FDA’s classification of the product.

Rescheduling could result in favorable tax and banking reform for the cannabis industry. This could also result in a resumption of investment activity in the cannabis industry following the recent economic downturn and bankruptcy announcement of one of the larger legal cannabis companies. However, rescheduling marijuana to Schedule III would not legalize recreational marijuana programs at the state level because, under federal law, Schedule III substances cannot be sold or used recreationally. The proposed rule clearly states that rescheduling marijuana will not change “regulatory controls applicable to Schedule III controlled substances.” Cannabis/marijuana businesses that currently operate under state regulations governing the sale and marketing of marijuana products will continue to operate outside the current federal regulatory system. CSA restrictions on the production, distribution, dispensation and possession of controlled substances will remain in effect.

Importantly, even with the rescheduling, it may take some time before a new marijuana or cannabis-derived product, such as cannabidiols, becomes available for use in treatment. Specifically, under the proposed rule, “marijuana would continue to be subject to current (Federal Food, Drug, and Cosmetic Act (FDCA) regulations). For example, under the FDCA, a drug containing a substance within the CSA’s definition of “marijuana” would require FDA approval to be lawfully “introduced or furnished for introduction into interstate commerce,” unless an IND is in effect for this medicine.

If a marijuana product were advertised or otherwise represented as having the potential to treat any disease or related condition, it would be a new drug and would be subject to FDA approval requirements before it could be marketed. In the case of food products and dietary supplements containing marijuana derivatives, although the FDA’s current position is that the introduction of such products into interstate commerce is a prohibited act, with the change in the schedule we can expect that the FDA will also take its own regulatory actions with respect to marijuana and marijuana . marijuana-derived products. For example, the Agency could seek to create a new category of regulation emphasizing a harm reduction regulatory pathway, as it has done for tobacco products, which would allow the sale and marketing of marijuana products with clear caveats and warnings regarding the potential harmful effects of these products . However, such action would require a resolution of Congress, which, given the current political situation, is unlikely to happen in the near future.

How rescheduling works: An eight-factor analysis

The CSA provides the Attorney General, through the DEA, with the authority to make regulations to add, remove, or amend the schedule of a controlled substance. The CSA specifies the detailed findings that are required for substances to be classified in Schedule I, II, III, IV, or V. For Schedule III, the following findings are required in accordance with 21 USC § 812(b)(3):

(A) The drug or other substance has a lower potential for abuse than Schedule I and II drugs or other substances.

(B) The drug or other substance has a currently accepted medical use for treatment in the United States.

The substance rescheduling process may be initiated by the DEA, HHS, or by a petition submitted by an interested party. To reschedule a controlled substance, HHS must have it reviewed by the FDA and prepare a recommendation to the Attorney General based on scientific and medical considerations and the potential impact on public health. When considering rescheduling the use of a controlled substance, the DEA conducts an eight-factor analysis to assess the abuse potential, medical use and safety of the substance. DEA considers the HHS recommendation to be part of its overall eight-factor analysis and must show significant deference to HHS’s scientific and medical findings. The eight factors analyzed are:

Actual or relative potential for abuse: Epidemiological studies, case reports, and data from law enforcement and medical sources are used to assess patterns of substance abuse, including the number of users, frequency of use, and severity of addiction.
Scientific Evidence of Pharmacological Actions and General Pharmacology: Preclinical and clinical studies, scientific literature, and expert reviews aim to understand the pharmacodynamics and pharmacokinetics of substances.
State of current scientific knowledge about a controlled substance: Existing scientific knowledge about the substance, including its chemical structure, stability, pharmacological properties and toxicology.
History and current pattern of abuse: Historical context and contemporary patterns of substance use and abuse, including geographic and demographic trends.
Scope, duration and severity of harassment: the scope and seriousness of the harassment, taking into account the number of people affected, the duration of the harassment and the impact on public health and safety.
Public health risks, if any: potential public health risks associated with the substance, including adverse health effects, overdoses and burden on healthcare systems.
Liability for psychological or physiological dependence: the ability of a substance to cause psychological or physical dependence, taking into account withdrawal symptoms, tolerance and addictive behaviors.
Whether the substance is a direct precursor of an already controlled substance: use of the substance as a basic chemical in the production of a controlled substance.

DEA comprehensively considers these eight factors to determine whether rescheduling the use of a controlled substance is warranted.

Key takeaways

Rescheduling marijuana from a Schedule I controlled substance to a Schedule III controlled substance would allow for greater research opportunities into the medicinal uses of marijuana. It would also potentially create a legal marketing avenue for new categories of marijuana products as the FDA issues regulations and guidance on these products and potentially approves new drug products containing marijuana. That said, rescheduling marijuana use would not legalize recreational marijuana programs at the state level, and the exact impact of rescheduling at the patient level may not be visible for some time.

Because the proposed rule is subject to the notice and comment rulemaking process, it is likely to receive a significant number of comments and hearing requests from interested parties. Historically, the rescheduling process has been lengthy, but President Biden has stated that his administration intends to prioritize reviewing DEA-proposed regulations, especially in an election year when there could be a change in administration.

Public comment will be open for 60 days from the date of publication Federal Register. You can submit comments Protocol No. DEA-1362