Schedules of Controlled Substances: Placement of 4-Fluoroamphetamine in Schedule I

<RULE> DEPARTMENT OF JUSTICE <SUBAGY>Drug Enforcement Administration</SUBAGY> <CFR>21 CFR Part 1308</CFR> <DEPDOC>[Docket No. DEA-1180]</DEPDOC> <SUBJECT>Schedules of Controlled Substances: Placement of 4-Fluoroamphetamine in Schedule I</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Drug Enforcement Administration, Department of Justice. <HD SOURCE="HED">ACTION:</HD> Final rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> With the issuance of this final rule, the Drug Enforcement Administration places 4-fluoroamphetamine (4-FA; 1-(4-fluorophenyl)propan-2-amine; <E T="03">para</E> -fluoroamphetamine), including its salts, isomers, and salts of isomers, in schedule I of the Controlled Substances Act. This action is being taken, in part, to enable the United States to meet its obligations under the 1971 Convention on Psychotropic Substances. This action imposes the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis with, or possess) or propose to handle 4-fluoroamphetamine. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> Effective February 17, 2026. </EFFDATE> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Dr. Terrence L. Boos, Drug and Chemical Evaluation Section, Diversion Control Division, Drug Enforcement Administration; Telephone: (571) 362-3249. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">Legal Authority</HD> The United States is a party to the 1971 United Nations Convention on Psychotropic Substances (1971 Convention), Feb. 21, 1971, 32 U.S.T. 543, 1019 U.N.T.S. 175, as amended. Procedures respecting changes in drug schedules under the 1971 Convention are governed domestically by 21 U.S.C. 811(d)(2)-(4). When the United States receives notification of a scheduling decision pursuant to Article 2 of the 1971 Convention indicating that a drug or other substance has been added to a schedule specified in the notification, the Secretary of Health and Human Services (Secretary), <SU>1</SU> <FTREF/> after consultation with the Attorney General, shall first determine whether existing legal controls under subchapter I of the Controlled Substances Act (CSA) and the Federal Food, Drug, and Cosmetic Act meet the requirements of the schedule specified in the notification with respect to the specific drug or substance. <SU>2</SU> <FTREF/> In the event that the Secretary did not so consult with the Attorney General, and the Attorney General did not issue a temporary order, as provided under 21 U.S.C. 811(d)(4), the procedures for permanent scheduling set forth in 21 U.S.C. 811(a) and (b) control. <FTNT> <SU>1</SU>  As discussed in a memorandum of understanding entered into by the FDA and the National Institute on Drug Abuse (NIDA), FDA acts as the lead agency within HHS in carrying out the Secretary's scheduling responsibilities under the CSA, with the concurrence of NIDA. 50 FR 9518 (Mar. 8, 1985). The Secretary has delegated to the Assistant Secretary for Health of HHS the authority to make domestic drug scheduling recommendations. 58 FR 35460 (July 1, 1993). </FTNT> <FTNT> <SU>2</SU>  21 U.S.C. 811(d)(3). </FTNT> Pursuant to 21 U.S.C. 811(a)(1) and (2), the Attorney General (as delegated to the Administrator of the Drug Enforcement Administration (DEA) pursuant to 28 CFR 0.100) may, by rule, and upon the recommendation of the Secretary, add to such a schedule or transfer between such schedules any drug or other substance, if she finds that such drug or other substance has a potential for abuse, and makes with respect to such drug or other substance the findings prescribed by 21 U.S.C. 812(b) for the schedule in which such drug or other substance is to be placed. <HD SOURCE="HD1">Background</HD> 4-Fluoroamphetamine (also known as 4-FA and <E T="03">para-</E> fluoroamphetamine) is a central nervous system stimulant and shares structural and pharmacological similarities with schedule II stimulants, such as amphetamine and methamphetamine, and the schedule I substance 3,4-methylenedioxymethamphetamine. (MDMA). On May 15, 2018, the Secretary-General of the United Nations advised the Secretary of State of the United States that the Commission on Narcotic Drugs (CND), during its 61st session held in March 2018, voted to place 4-FA in Schedule II of the 1971 Convention (CND Dec/61/12). As a signatory to the 1971 Convention, the United States is required, by scheduling under the CSA, to place appropriate controls on 4-FA to meet the minimum requirements of the treaty. Because the procedures in 21 U.S.C. 811(d)(3) and (4) for consultation and issuance of a temporary order for 4-FA, discussed in the above legal authority section, were not followed, DEA is utilizing the procedures for permanent scheduling set forth in 21 U.S.C. 811(a) and (b) to control 4-FA. Such scheduling would satisfy the United States' international obligations. <HD SOURCE="HD1">DEA and HHS Eight Factor Analyses</HD> In a letter dated March 2, 2021, in accordance with 21 U.S.C. 811(b), and in response to DEA's September 6, 2019, request, the Department of Health and Human Services (HHS) provided to DEA a scientific and medical evaluation and scheduling recommendation for 4-FA. DEA reviewed the scientific and medical evaluation and scheduling recommendation for schedule I placement provided by HHS, and all other relevant data, pursuant to 21 U.S.C. 811(b) and (c), and conducted its own analysis under the eight factors stipulated in 21 U.S.C. 811(c). DEA found, under 21 U.S.C. 812(b)(1), that this substance warrants control in schedule I. Both DEA's and HHS' Eight-Factor analyses are available in their entirety under the tab Supporting Documents of the public docket for this action at <E T="03">https://www.regulations.gov</E> under docket number DEA-1180. <HD SOURCE="HD1">Notice of Proposed Rulemaking to Schedule 4-FA</HD> On June 3, 2025, DEA published a notice of proposed rulemaking (NPRM) to permanently control 4-FA in schedule I. <SU>3</SU> <FTREF/> Specifically, DEA proposed to add 4-FA to the list of stimulant substances under 21 CFR 1308.11(f). The NPRM provided an opportunity for interested persons to file a request for hearing in accordance with DEA regulations on or before July 3, 2025. DEA did not receive any requests for such a hearing. The NPRM also provided an opportunity for interested persons to submit comments on or before July 3, 2025. <FTNT> <SU>3</SU>  Schedules of Controlled Substances: Placement of 4-Fluoroamphetamine in Schedule I, 90 FR 23477 (June. 3, 2025). </FTNT> <HD SOURCE="HD1">Comments Received</HD> DEA received nine comments in response to the NPRM for the placement of 4-FA into schedule I of the CSA. The submissions were from individuals or anonymous commenters. Two commenters supported the placement of 4-FA in schedule I of the CSA, five commenters were against the placement of 4-FA in schedule I of the CSA, and two commenters expressed statements that were neither for nor against the proposed rule (one of which noted 4-FA has helped them feel calmer). <E T="03">Support of Rulemaking:</E> DEA received two comments in support of the placement of 4-FA in schedule I. <E T="03">DEA Response:</E> DEA appreciates these comments in support of this rulemaking. <E T="03">Opposition to Rulemaking:</E> DEA received five comments against the placement of 4-FA in schedule I of the CSA. Of these comments, one asserted that 4-FA is already controlled under schedule II of the CSA under the Controlled Substances Analogue Act, and that criminal illicit use is already illegal. Three of these comments noted that placing 4-FA in schedule I would negatively impact the ability to do research. One commenter asserted 4-FA could be an effective treatment for PTSD and depression and should not be controlled until additional studies have been conducted. The following is DEA's response to the comments against the proposed rulemaking. <E T="03">DEA Response:</E> DEA appreciates these comments and would like to emphasize that 4-FA is not currently scheduled under the CSA and to provide further clarification regarding the control of 4-FA. 4-FA has been placed under international control. In order to comply with treaty obligations, DEA must place 4-FA under the most appropriate schedule, taking into consideration all appropriate scientific data. Additionally, as set forth in the NPRM, 4-FA has no currently accepted medical use in treatment in the United States, nor were there any New Drug Applications. Therefore, 4-FA must be placed in schedule I of the CSA along with other substances which have no currently accepted medical use, lack accepted safety for use under medical supervision, and possess a high potential for abuse. With respect to research for potential medical use, the placement of substances in schedule I of the CSA does not preclude academic research on these substances. <SU>4</SU> <FTREF/> Those wishing to conduct research on 4-FA must seek permission to do so with the DEA. <SU>5</SU> <FTREF/> <FTNT> <SU>4</SU>  21 U.S.C. 822(h); 21 U.S.C. 823(g)(2)(A); 21 U.S.C. 823(n). </FTNT> <FTNT> <SU>5</SU>   <E T="03">https://apps.deadiversion.usdoj.gov/webforms2/spring/login?execution=e1s1.</E> </FTNT> <HD SOURCE="HD1">Scheduling Conclusion</HD> After consideration of the public comments, scientific and medical evaluation and accompanying scheduling recommendation from HHS, and after its own eight-factor evaluation, DEA finds that these facts and all relevant data constitute substantial evidence of potential for abuse of 4-FA. As such, DEA is permanently scheduling 4-FA as a controlled substance under schedule I of the CSA. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 26k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━