SUPPLEMENTARY INFORMATION:

Hexahydrocannabinol Control

Hexahydrocannabinol (also known as 6,6,9-trimethyl-3-pentyl-6a,7,8,9,10,10a-hexahydro-6 H -benzo[ c]chromen-1-ol, and HHC) is a synthetic substance that is structurally related to tetrahydrocannabinols. Hexahydrocannabinol is currently controlled in schedule I as a tetrahydrocannabinol.

The Agriculture Improvement Act of 2018 (AIA), Public Law 115-334, amended the CSA to remove “tetrahydrocannabinols in hemp” from control.^[1] Importantly, the AIA defined the term “hemp” to mean “the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9-tetrahydrocannabinol ( printed page 23914) concentration of not more than 0.3 percent on a dry weight basis.” ^[2] Thus, only tetrahydrocannabinols in or derived from the cannabis plant—not synthetic tetrahydrocannabinols—are excluded from control as “tetrahydrocannabinols in hemp.” To clarify further, tetrahydrocannabinols produced through chemical conversion, even when hemp derived are considered synthetically produced for purposes of the CSA, do not qualify as “tetrahydrocannabinols in hemp” under the AIA.

Legal Authority

This rule is prompted by a letter dated June 9, 2025, in which the Secretariat of the United Nations informed the United States government that hexahydrocannabinol had been added to Schedule II of the United Nations Convention on Psychotropic Substances of 1971 (1971 Convention), February 21, 1971, 32 U.S.T. 543, 1019 U.N.T.S. 175, as amended. This letter was provoked by a decision at the 68th Session of the Commission on Narcotic Drugs (CND) in March 2025 to schedule hexahydrocannabinol under Schedule II of the 1971 Convention (CND Decision 68/5). After receiving official notice of this decision, DEA sent a letter to the Department of Health and Human Services (HHS) dated October 9, 2025, outlining its intention to specifically list hexahydrocannabinol in schedule I of the Controlled Substances Act (CSA) pursuant to treaty obligations. HHS responded in a letter dated December 3, 2025, that there are no approved new drug applications or investigational new drug applications for hexahydrocannabinol. In addition, HHS concurs with the direct listing and drug code assignment of hexahydrocannabinol in the CSA.

As discussed above, hexahydrocannabinol—by meeting the definition of “tetrahydrocannabinols” and being synthetically produced—has been controlled in schedule I of the CSA. Therefore, all regulations and criminal sanctions applicable to schedule I substances have been and remain applicable to hexahydrocannabinol. Drugs controlled in schedule I of the CSA satisfy and exceed the required controls of Schedule II under Article 2 of the 1971 Convention.

Effect of Action

As previously stated, this rule does not affect the continuing status of hexahydrocannabinol as a schedule I controlled substance in any way. This action, as an administrative matter, establishes a separate, specific listing for hexahydrocannabinol in schedule I of the CSA and assigns a DEA drug code for this substance. This action will allow DEA to establish an aggregate production quota and grant individual manufacturing and procurement quotas to DEA-registered manufacturers of hexahydrocannabinol, who had previously been granted individual quotas for such purposes under the drug code for tetrahydrocannabinols.

Regulatory Analyses

Administrative Procedure Act

An agency may find good cause to exempt a rule from certain provisions of the Administrative Procedure Act (APA), including notice of proposed rulemaking and the opportunity for public comment, if it is determined to be unnecessary, impracticable, or contrary to the public interest.^[3]

Pursuant to 5 U.S.C. 553(b)(B), DEA finds that notice-and-comment rulemaking is unnecessary as hexahydrocannabinol is currently controlled in schedule I as it meets the definition of tetrahydrocannabinols. The addition of a separate listing for hexahydrocannabinol and its DEA drug code number in the list of schedule I substances in 21 CFR 1308.11(d) makes no substantive difference in the status of this drug as a schedule I controlled substance, but instead is “a minor or merely technical amendment in which the public is not particularly interested.” ^[4] This rule is a “technical amendment” to 21 CFR 1308.11(d) as it is “insignificant in nature and impact, and inconsequential to the industry and public.” Therefore, DEA finds that publishing a notice of proposed rulemaking and soliciting public comment are unnecessary and good cause exists to dispense with these procedures.

In addition, DEA is concerned that delaying the effective date of this rule potentially could cause confusion regarding the regulatory status of hexahydrocannabinol. With hexahydrocannabinol currently controlled as a schedule I controlled substance, and with no additional requirements being imposed through this action, DEA finds good cause exists to make this rule effective immediately upon publication in accordance with 5 U.S.C. 553(d)(3).

Executive Orders 12866, 13563, 14192, and 14294 (Regulatory Review)

This regulation has been drafted and reviewed in accordance with the principles of Executive Orders (E.O.) 12866 and 13563. The Office of Information and Regulatory Affairs has determined that this rule is not a significant regulatory action under section 3(f) of E.O. 12866. Hexahydrocannabinol is already a controlled substance in the United States under schedule I as a tetrahydrocannabinol. In this final rule, DEA is making an administrative change by amending its regulations to separately list hexahydrocannabinol in schedule I and to assign a DEA controlled substances code number to this substance. Separately listing hexahydrocannabinol and its DEA drug code will not alter the status of this substance as a schedule I controlled substance. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB). DEA scheduling actions are not subject to either E.O. 14192, Unleashing Prosperity Through Deregulation, or E.O. 14294, Fighting Overcriminalization in Federal Regulations.

Executive Order 12988, Civil Justice Reform

This regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of E.O. 12988 to eliminate drafting errors and ambiguity, provide a clear legal standard for affected conduct, and promote simplification and burden reduction.

Executive Order 13132, Federalism

This rulemaking does not have federalism implications warranting the application of E.O. 13132. The rule does not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.

Executive Order 13175, Consultation and Coordination With Indian Tribal Governments

This rule does not have Tribal implications warranting the application of E.O. 13175. It does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and Indian tribes, or on the distribution of ( printed page 23915) power and responsibilities between the Federal government and Indian tribes.

Regulatory Flexibility Act

The Regulatory Flexibility Act (RFA) applies to rules that are subject to the notice-and-comment requirements under the APA or other laws.^[5] As noted in the above section regarding the applicability of the APA, DEA determined that there was good cause to exempt this final rule from notice and comment. Consequently, the RFA does not apply.

Paperwork Reduction Act of 1995

This action does not impose a new collection of information requirement under the Paperwork Reduction Act of 1995.^[6] This action would not impose recordkeeping or reporting requirements on State or local governments, individuals, businesses, or organizations. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

Unfunded Mandates Reform Act of 1995

In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995, 2 U.S.C. 1532, DEA has determined that this action would not result in any Federal mandate that may result “in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any 1 year. . . .” Therefore, neither a Small Government Agency Plan nor any other action is required under UMRA of 1995.

Congressional Review Act

The Office of Information and Regulatory Affairs has determined that this rule is not a major rule as defined by the Congressional Review Act (CRA), 5 U.S.C. 804. However, pursuant to the CRA, DEA is submitting a copy of this rule to both Houses of Congress and to the Comptroller General.

For the reasons set out above, DEA amends 21 CFR part 1308 as follows:

Signing Authority

This document of the Drug Enforcement Administration was signed on April 22, 2026, by DEA Administrator Terrance C. Cole. That document with the original signature and date is maintained by DEA. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DEA Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of DEA. This administrative process in no way alters the legal effect of this document upon publication in the Federal Register .

91 FR 23913