Proposed Rule2025-09988
Schedules of Controlled Substances: Placement of 4-Fluoroamphetamine in Schedule I
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 3, 2025
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
The Drug Enforcement Administration proposes placing the substance 4-fluoroamphetamine (4-FA; 1-(4-fluorophenyl)propan-2-amine), 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. If finalized, this action would impose 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.
Full Text
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<title>Federal Register, Volume 90 Issue 105 (Tuesday, June 3, 2025)</title>
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[Federal Register Volume 90, Number 105 (Tuesday, June 3, 2025)]
[Proposed Rules]
[Pages 23477-23483]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-09988]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA1180]
Schedules of Controlled Substances: Placement of 4-
Fluoroamphetamine in Schedule I
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Notice of proposed rulemaking.
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SUMMARY: The Drug Enforcement Administration proposes placing the
substance 4-fluoroamphetamine (4-FA; 1-(4-fluorophenyl)propan-2-amine),
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. If finalized, this action would
impose 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.
DATES: Comments must be submitted electronically or postmarked on or
before July 3, 2025.
Interested persons may file a request for a hearing or waiver of
hearing pursuant to 21 CFR 1308.44 and in accordance with 21 CFR
1316.47 and/or 1316.49, as applicable. Requests for a hearing and
waivers of an opportunity for a hearing or to participate in a hearing,
together with a written statement of position on the matters of fact
and law asserted in the hearing, must be received or postmarked on or
before July 3, 2025.
ADDRESSES: Interested persons may file written comments on this
proposal in accordance with 21 CFR 1308.43(g). The electronic Federal
Docket Management System will not accept comments after 11:59 p.m.
Eastern Time on the last day of the comment period. To ensure proper
handling of comments, please reference ``Docket No. DEA1180'' on all
electronic and written correspondence, including any attachments.
<bullet> Electronic comments: The Drug Enforcement Administration
(DEA) encourages commenters to submit comments electronically through
the Federal eRulemaking Portal, which provides the ability to type
short comments directly into the comment field on the web page or
attach a file for lengthier comments. Please go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and follow the online instructions at that site for
submitting comments. Upon completion of your submission, you will
receive a Comment Tracking Number. If you have received a Comment
Tracking Number, your comment has been successfully submitted and there
is no need to resubmit the same comment. Commenters should be aware
that the electronic Federal Docket Management System will not accept
comments after 11:59 p.m. Eastern Time on the last day of the comment
period.
<bullet> Paper comments: Paper comments that duplicate the
electronic submissions are not necessary and are discouraged. Should
you wish to mail a paper comment in lieu of an electronic comment, it
should be sent via regular or express mail to: Drug Enforcement
Administration, Attn: DEA Federal Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia 22152.
<bullet> Hearing requests: All requests for a hearing and waivers
of participation, together with a written statement of position on the
matters of fact and law asserted in the hearing, must be filed with the
DEA Administrator, who will make the determination of whether a hearing
will be needed to address such matters of fact and law in the
rulemaking. Such requests must be sent to: Drug Enforcement
Administration, Attn: Administrator, 8701 Morrissette Drive,
Springfield, Virginia 22152. For informational purposes, a courtesy
copy of requests for hearing and waivers of participation should also
be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/
OALJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug
Enforcement Administration, Attn: DEA Federal Register Representative/
DPW, 8701 Morrissette Drive, Springfield, Virginia 22152.
<bullet> Paperwork Reduction Act Comments: All comments concerning
collections of information under the Paperwork Reduction Act must be
submitted to the Office of Information and Regulatory Affairs, OMB,
Attention: Desk Officer for DOJ, Washington, DC 20503. Please state
that your comment refers to Docket No. DEA1180.
FOR FURTHER INFORMATION CONTACT: Dr. Terrence L. Boos, Drug and
Chemical Evaluation Section, Diversion Control Division, Drug
Enforcement Administration; Telephone: (571) 362-3249.
As required by 5 U.S.C. 553(b)(4), a summary of this proposed rule
may be found in the docket for this rulemaking at <a href="http://www.regulations.gov">www.regulations.gov</a>.
SUPPLEMENTARY INFORMATION: In this proposed rule, the Drug Enforcement
Administration (DEA) intends to place 4-fluoroamphetamine (4-FA; 1-(4-
fluorophenyl)propan-2-amine), including its salts, isomers, and salts
of isomers, in schedule I of the Controlled Substances Act (CSA).
Posting of Public Comments
All comments received in response to this docket are considered
part of the public record. DEA will make comments available for public
inspection online at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Such information
includes personal or business identifying information (such as name,
address, State or Federal identifiers, etc.) voluntarily submitted by
the commenter. All information voluntarily submitted by the commenter,
unless clearly marked as Confidential Information in the method
described below, will be publicly posted. Comments may be submitted
anonymously
Commenters submitting comments which include personal identifying
information (PII), confidential, or proprietary business information
that the commenter does not want made publicly available should submit
two copies of the comment. One copy must be marked ``CONTAINS
CONFIDENTIAL INFORMATION'' and should clearly identify all PII or
business information the commenter does not want to be made publicly
available, including any supplemental materials. DEA will review this
copy, including the claimed PII and confidential business information,
in its consideration of comments. The second copy should be marked ``TO
BE PUBLICLY POSTED'' and must have all claimed confidential or
proprietary business information redacted. DEA will
[[Page 23478]]
post only the redacted comment on <a href="https://www.regulations.gov">https://www.regulations.gov</a> for
public inspection. DEA generally will not redact additional information
contained in the comment marked ``TO BE PUBLICLY POSTED.'' The Freedom
of Information Act applies to all comments received.
For easy reference, an electronic copy of this document and
supplemental information to this proposed rule are available at <a href="https://www.regulations.gov">https://www.regulations.gov</a> for easy reference.
Request for Hearing or Appearance; Waiver
Pursuant to 21 U.S.C. 811(a), this action is a formal rulemaking
``on the record after opportunity for a hearing.'' Such proceedings are
conducted pursuant to the provisions of the Administrative Procedure
Act (APA), 5 U.S.C. 551-559.\1\ Interested persons, as defined in 21
CFR 1300.01(b), may file requests for a hearing in conformity with the
requirements of 21 CFR 1308.44(a) and 1316.47(a), and such requests
must:
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\1\ 21 CFR 1308.41 through 1308.45; 21 CFR part 1316, subpart D.
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(1) state with particularity the interest of the person in the
proceeding;
(2) state with particularity the objections or issues concerning
which the person desires to be heard; and
(3) state briefly the position of the person with regard to the
objections or issues.
Any interested person may file a waiver of an opportunity for a
hearing or to participate in a hearing in conformity with the
requirements of 21 CFR 1308.44(c), together with a written statement of
position on the matters of fact and law involved in any hearing.\2\
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\2\ 21 CFR 1316.49.
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All requests for a hearing and waivers of participation, together
with a written statement of position on the matters of fact and law
involved in such hearing, must be sent to DEA using the address
information provided above. The decision whether a hearing will be
needed to address such matters of fact and law in the rulemaking will
be made by the Administrator. If a hearing is needed, DEA will publish
a notice of hearing on the proposed rulemaking in the Federal
Register.\3\ Further, once the Administrator determines a hearing is
needed to address such matters of fact and law in rulemaking, he will
then designate an Administrative Law Judge (ALJ) to preside over the
hearing. The ALJ's functions shall commence upon designation, as
provided in 21 CFR 1316.52.
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\3\ 21 CFR 1308.44(b), 1316.53.
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In accordance with 21 U.S.C. 811 and 812, the purpose of a hearing
would be to determine whether 4-fluoroamphetamine meets the statutory
criteria for placement in schedule I, as proposed in this rulemaking.
Legal Authority
The CSA provides that proceedings for the issuance, amendment, or
repeal of the scheduling of any drug or other substance may be
initiated by the Attorney General (delegated to the Administrator of
DEA pursuant to 28 CFR 0.100) on her own motion, at the request of the
Secretary of Health and Human Services (HHS), or on the petition of an
interested party.\4\ This proposed action is initiated on the Acting
Administrator's own motion and supported by, inter alia, a
recommendation from the then-Assistant Secretary for Health of the
Department of Health and Human Services (HHS).
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\4\ 21 U.S.C. 811(a).
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In addition, the United States is a party to the 1971 United
Nations Convention on Psychotropic Substances (1971 Convention),
February 21, 1971, 32 U.S.T. 543, 1019 U.N.T.S. 175, as amended.
Domestic procedures respecting changes in drug schedules under the 1971
Convention are set forth in 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 HHS (Secretary),\5\ after consultation with the
Attorney General, shall first determine whether existing legal controls
under subchapter I of the 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.\6\ In the event that
the Secretary did not 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) remain available and can be used to meet the
United States' international obligations under the Convention.
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\5\ 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).
\6\ 21 U.S.C. 811(d)(3).
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Pursuant to 21 U.S.C. 811(a)(1) and (2), the Attorney General (as
delegated to the Administrator of DEA) 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.
Background
4-Fluoroamphetamine (4-FA) 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.
Article 2, paragraph 7(b), of the 1971 Convention sets forth the
minimum requirements that the United States must meet when a substance
has been added to Schedule II of the 1971 Convention. Pursuant to the
1971 Convention, the United States must require licenses for the
manufacture, export and import, and distribution of 4-FA. This license
requirement is accomplished by the CSA's registration requirement as
set forth in 21 U.S.C. 822, 823, 957, and 958, and in accordance with
21 CFR parts 1301 and 1312.
In addition, the United States must adhere to specific export and
import provisions set forth in the 1971 Convention. This requirement is
accomplished by the CSA with the export and import provisions
[[Page 23479]]
established in 21 U.S.C. 952, 953, 957, and 958, and in accordance with
21 CFR part 1312. Likewise, under Article 13, paragraphs 1 and 2, of
the 1971 Convention, a party to the 1971 Convention may notify through
the U.N. Secretary-General another party that it prohibits the
importation of a substance in Schedule II, III, or IV of the 1971
Convention. If such notice is presented to the United States, the
United States shall take measures to ensure that the named substance is
not exported to the notifying country. This requirement is also
accomplished by the CSA's export provisions mentioned above.
Under Article 16, paragraph 4, of the 1971 Convention, the United
States is required to provide annual statistical reports to the
International Narcotics Control Board (INCB). Using INCB Form P, the
United States shall provide the following information: (1) In regard to
each substance in Schedule I and II of the 1971 Convention, quantities
manufactured, exported to, and imported from each country or region as
well as stocks held by manufacturers; (2) in regard to each substance
in Schedule III and IV of the 1971 Convention, quantities manufactured,
as well as quantities exported and imported; (3) in regard to each
substance in Schedule II and III of the 1971 Convention, quantities
used in the manufacture of exempt preparations; and (4) in regard to
each substance in Schedule II-IV of the 1971 Convention, quantities
used for the manufacture of non-psychotropic substances or products.
Lastly, under Article 2 of the 1971 Convention, the United States
must adopt measures in accordance with Article 22 to address violations
of any statutes or regulations that are adopted pursuant to its
obligations under the 1971 Convention. Persons acting outside the legal
framework established by the CSA are subject to administrative, civil,
and/or criminal action; therefore, the United States complies with this
provision.
DEA notes that there are differences between the schedules of
substances in the 1971 Convention and the CSA. The CSA has five
schedules (schedules I-V) with specific criteria set forth for each
schedule. Schedule I is the only possible schedule in which a drug or
other substance may be placed if it has high potential for abuse and no
currently accepted medical use in treatment in the United States.\7\ In
contrast, the 1971 Convention has four schedules (Schedules I-IV) but
does not have specific criteria for each schedule. The 1971 Convention
simply defines its four schedules, in Article 1, to mean the
correspondingly numbered lists of psychotropic substances annexed to
the Convention, and altered in accordance with Article 2.
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\7\ See 21 U.S.C. 812(b).
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Proposed Determination to Schedule 4-FA
Pursuant to 21 U.S.C. 811(b), DEA gathered the necessary data on 4-
FA and on September 6, 2019, submitted it to the then-Assistant
Secretary for Health of HHS with a request for a scientific and medical
evaluation of available information and a scheduling recommendation for
4-FA.
On March 2, 2021, HHS provided DEA a scientific and medical
evaluation entitled ``Basis for the Recommendation to Place 4-
Fluoroamphetamine in Schedule I of the Controlled Substances Act'' and
a scheduling recommendation. Pursuant to 21 U.S.C. 811(b), following
consideration of the eight factors and findings related to the
substance's abuse potential, legitimate medical use, safety, and
dependence liability, HHS recommended that 4-FA be controlled in
schedule I of the CSA under 21 U.S.C. 812(b). Upon receipt of the
scientific and medical evaluation and scheduling recommendation from
HHS, DEA reviewed the documents and all other relevant data and
conducted its own eight-factor analysis in accordance with 21 U.S.C.
811(c).
Included below is a brief summary of each factor as analyzed by HHS
and DEA, and as considered by DEA in its proposed scheduling action.
Please note that the detailed DEA and HHS eight-factor analyses
supporting this proposed rule are both available in their entirety
under the tab ``Supporting Documents'' of the public docket of this
rulemaking action at <a href="https://www.regulations.gov">https://www.regulations.gov</a>, under docket number
``DEA1180.''
1. The Drug's Actual or Relative Potential for Abuse
In addition to considering the information HHS provided in its
scientific and medical evaluation document for 4-FA, DEA also
considered all other relevant data regarding actual or relative
potential for abuse of 4-FA. The term ``abuse'' is not defined in the
CSA; however, the legislative history of the CSA suggests the following
four prongs in determining whether a particular drug or substances has
a potential for abuse: \8\
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\8\ Comprehensive Drug Abuse Prevention and Control Act of 1970,
H.R. Rep. No. 91-1444, 91st Cong., Sess. 1 (1970); reprinted in 1970
U.S.C.C.A.N. 4566, 4603.
a. There is evidence that individuals are taking the drug or drugs
containing such a substance in amounts sufficient to create a hazard to
their health or to the safety of other individuals or of the community;
or
b. There is a significant diversion of the drug or substance from
legitimate drug channels; or
c. Individuals are taking the drug or drugs containing such a
substance on their own initiative rather than on the basis of medical
advice from a practitioner licensed by law to administer such drugs in
the course of his professional practice; or
d. The drug or drugs containing such a substance are new drugs so
related in their action to a drug or drugs already listed as having a
potential for abuse to make it likely that the drug will have the same
potentiality for abuse as such drugs, thus making it reasonable to
assume that there may be significant diversions from legitimate
channels, significant use contrary to or without medical advice, or
that it has a substantial capability of creating hazards to the health
of the user or to the safety of the community.
Both DEA and HHS eight-factor analyses found that 4-FA produces
pharmacological effects that are similar to those produced by schedule
I and II substances, such as amphetamine, methamphetamine, and MDMA. 4-
FA produces amphetamine-like features in a number of in vivo and in
vitro assays, including the induction of locomotor activity and
associated dopamine release. Data also demonstrate that 4-FA is self-
administered and produces discriminative stimulus effects that are
similar to those of the schedule II substances methamphetamine and
cocaine. These pharmacological characteristics of 4-FA are predictive
of substances that have a high potential for abuse.
4-FA does not have an approved medical use in the United States,
but evidence indicates that 4-FA is being abused and trafficked in the
United States. Because this substance is not an approved drug product,
a practitioner may not legally prescribe it, and it cannot be dispensed
to an individual. However, case reports, coroner/medical examiner
reports, and law enforcement data \9\ demonstrate that 4-FA is being
abused because it is being used without medical advice. 4-FA has been
identified during the toxicological screening of human urine or serum
samples indicating that it is being
[[Page 23480]]
abused by individuals. In humans, stimulant effects, like that of
amphetamine, were observed following the oral administration of 4-FA.
Non-fatal intoxications and overdoses have also been associated with
the abuse of 4-FA.
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\9\ While law enforcement data is not direct evidence of abuse,
it can lead to an inference that a drug has been diverted and
abused. See Schedules of Controlled Substances: Placement of
Carisoprodol Into Schedule IV, 76 FR 77330, 77332 (Dec. 12, 2011).
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Law enforcement data show that 4-FA has been encountered in the
United States' illicit drug market. From January 2011 to December 2023,
National Forensic Laboratory Information System (NFLIS)-Drug registered
269 reports \10\ pertaining to the trafficking, distribution, and abuse
of 4-FA. These encounters of 4-FA by law enforcement indicate that this
substance is being trafficked and abused by individuals in the United
States as a recreational drug of abuse.
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\10\ NFLIS-Drug is a national forensic laboratory reporting
system that systematically collects results from drug chemistry
analyses conducted by State and local forensic laboratories in the
United States. NFLIS-Drug data were queried on October 15, 2024.
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Overall, these data demonstrate that 4-FA has a high potential for
abuse. Thus, based on these data, it is reasonable to conclude that 4-
FA, having no medical use, and thus no therapeutic value, presents a
hazard to the health and safety of individuals and the community.
2. Scientific Evidence of the Drug's Pharmacological Effects, if Known
As explained in the 8-factor analyses by HHS and by DEA, the
available pharmacology data indicate that 4-FA produces pharmacological
effects that are similar to those produced by schedule I and II
substances, such as methamphetamine, cocaine, and MDMA. Similar to
these schedule I and II stimulants, 4-FA affects monoamine
neurotransmission. Briefly, 4-FA promotes the release of dopamine,
norepinephrine, and serotonin, and blocks the reuptake of these
substances at nerve terminals. Data also demonstrate that 4-FA produces
locomotor behavior and discriminative stimulus effects that are similar
to those of the schedule I and II substances MDMA, methamphetamine, and
cocaine. In a self-administration study, 4-FA produced rewarding
properties. Furthermore, in humans, stimulant effects, like that of
amphetamine, were observed following the oral administration of 4-FA.
Non-fatal intoxications and overdoses have also been associated with
the abuse of 4-FA. These pharmacological characteristics of 4-FA are
predictive of substances that have a high potential for abuse. Overall,
these data indicate that 4-FA produces pharmacological effects and
stimulant-like behaviors that are similar to those of the amphetamine
and MDMA.
3. The State of Current Scientific Knowledge Regarding the Drug or
Other Substance
4-FA is a halogenated amphetamine, which can be produced by a
variety of synthetic methods that are commonly utilized for the
preparation of amphetamine. After oral ingestion, 4-FA is excreted in
the urine mainly as an unchanged drug, but three metabolites, in low
concentrations, have also been identified. Available pharmacology data
demonstrate that the effects of 4-FA after oral administration,
generally, occurred approximately 30 to 60 minutes post-ingestion and
lasted for 4 to 8 hours after exposure. In addition, maximum blood
concentrations of 4-FA occurred 2 hours after administration of 4-FA
with both clinical and recreational uses. Data also show that 4-FA is
eliminated from the body approximately 8 to 9 hours with a variation of
5.5 to 16.8 hours after administration. In the HHS report, United
States Food and Drug Administration (FDA) concluded that 4-FA has no
currently accepted medical use in the United States. Similarly, DEA
concludes 4-FA has no currently accepted medical use according to
established DEA procedure and case law.\11\
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\11\ To place a drug or other substance in schedule I under the
CSA, DEA must consider whether the substance has a currently
accepted medical use in treatment in the United States. 21 U.S.C.
812(b)(1)(B). There is no evidence suggesting that 4-FA has a
currently accepted medical use in treatment in the United States. To
determine whether a drug or other substance has a currently accepted
medical use, DEA has traditionally applied a five-part test to a
drug that has not been approved by FDA: i. The drug's chemistry must
be known and reproducible; ii. there must be adequate safety
studies; iii. there must be adequate and well-controlled studies
proving efficacy; iv. the drug must be accepted by qualified
experts; and v. the scientific evidence must be widely available.
Marijuana Scheduling Petition; Denial of Petition; Remand, 57 FR
10499 (Mar. 26, 1992), pet. for rev. denied, Alliance for Cannabis
Therapeutics v. Drug Enforcement Admin., 15 F.3d 1131, 1135 (D.C.
Cir. 1994). DEA and HHS applied the traditional five-part test for
currently accepted medical use in this matter. In a recent published
letter in a different context, HHS applied an additional two-part
test to determine currently accepted medical use for substances that
do not satisfy the five-part test: (1) whether there exists
widespread, current experience with medical use of the substance by
licensed health care practitioners operating in accordance with
implemented jurisdiction-authorized programs, where medical use is
recognized by entities that regulate the practice of medicine, and,
if so, (2) whether there exists some credible scientific support for
at least one of the medical conditions for which the part 1 is
satisfied. On April 11, 2024, the Department of Justice's Office of
Legal Counsel (OLC) issued an opinion, which, among other things,
concluded that HHS's two-part test would be sufficient to establish
that a drug has a currently accepted medical use. Office of Legal
Counsel, Memorandum for Merrick B. Garland Attorney General Re:
Questions Related to the Potential Rescheduling of Marijuana at 3
(April 11, 2024). For purposes of this proposed rule, there is no
evidence that health care providers have widespread experience with
medical use of 4-FA, or that the use of 4-FA is recognized by
entities that regulate the practice of medicine under either the
traditional five-part test or the two-part test.
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4. History and Current Pattern of Abuse
4-FA is a recreational drug that has been identified in the United
States' illicit drug market. Evidence indicates that 4-FA has been
substituted for MDMA and amphetamines. Thus, it is highly likely that
this substance is abused in the same manner as these stimulant
substances. That is, 4-FA, similar to other stimulant substances, is
most likely ingested by swallowing capsules or tablets or snorted by
nasal insufflation of the powder. Demographic data collected from
toxicology analyses suggest that the main users of 4-FA are young
adults. In addition, there is evidence that 4-FA being ingested with
other substances, including schedule I synthetic cathinones, common
cutting agents, or other substances of abuse.
5. Scope, Duration and Significance of Abuse
Evidence shows that 4-FA is a recreational drug of abuse. According
to HHS, based on the pharmacological properties of 4-FA, the scope,
duration, and significance of abuse of 4-FA would be similar to
stimulants that are scheduled under the CSA, including the schedule I
substance MDMA, as well as the schedule II stimulants cocaine and
methamphetamine, if uncontrolled. Evidence of 4-FA abuse is confirmed
by law enforcement encounters of this substance. According to analyses
by forensic laboratories, drug exhibits received from State, local, or
Federal law enforcement agencies were found to contain 4-FA. Between
January 2011 and December 2023, NFLIS registered 269 reports from
Federal, State, and local forensic laboratories identifying this
substance in drug-related exhibits from 27 States. These encounters of
4-FA by law enforcement indicate that this substance is being
trafficked and abused in the United States. Furthermore, evidence also
indicate that 4-FA is abused internationally. According to the European
Monitoring Centre for Drugs and Drug Addiction, 4-FA has also been
seized abroad, indicating it is being abused internationally. Taken
together, these data indicate that the abuse of 4-FA is widespread.
[[Page 23481]]
6. What, if Any, Risk There Is to the Public Health
Available evidence on the overall public health risks associated
with the use of 4-FA suggests that 4-FA can cause acute health problems
leading to emergency department admissions and death. Indeed, 4-FA has
been associated with numerous overdoses and at least five deaths. Acute
effects of 4-FA are those typical of sympathomimetic agents (e.g.,
cocaine, methamphetamine, amphetamine) and include, among other
effects, tachycardia, headache, palpitations, agitation, anxiety,
mydriasis, tremor, fever or sweating, and hypertension. In addition,
products containing 4-FA often do not bear labeling information
regarding their ingredients, and if they do, such labels may not
contain the expected active ingredient or identify the health risks and
potential hazards associated with these products. These factors
demonstrate that 4-FA is a serious public health threat.
7. Its Psychic or Physiological Dependence Liability
According to HHS, there is reason to suspect that 4-FA will have
psychic dependence liability even though studies have not specifically
examined physical dependence with respect to 4-FA. While there may be
no studies examining the psychic and physiological dependence of 4-FA,
its dependence liability can be inferred by case reports. Self-reports
by users of 4-FA indicate that 4-FA produces typical stimulant-like
effects, including euphoria, and psychological and psychomotor
stimulation. These reports, combined with the pharmacological profile
of 4-FA in animals, indicate that 4-FA produces stimulant effects that
are similar to those produced by psychomotor stimulants in schedule II,
such as amphetamine and methamphetamine. Thus, as HHS notes, it is
likely that 4-FA will produce similar psychic dependence to these
schedule II psychomotor stimulant drugs.
8. Whether the Substance Is an Immediate Precursor of a Substance
Already Controlled Under the CSA
4-FA is not an immediate precursor of any substance controlled
under the CSA, as defined in 21 U.S.C. 802(23).
Conclusion
After considering the scientific and medical evaluation conducted
by HHS, HHS's scheduling recommendation, and DEA's own eight-factor
analysis, DEA finds that the facts and all relevant data constitute
substantial evidence of the potential for abuse of 4-FA. As such, DEA
hereby proposes to permanently schedule 4-FA as a schedule I controlled
substance under the CSA. This action would enable the United States to
meet its obligations under the 1971 Convention on Psychotropic
Substances.
Proposed Determination of Appropriate Schedule
The CSA establishes five schedules of controlled substances known
as schedules I, II, III, IV, and V. The CSA also outlines the findings
required to place a drug or other substance in any particular
schedule.\12\ After consideration of the analysis and recommendation of
the Assistant Secretary for Health of HHS and review of all other
available data, the Acting Administrator of DEA, pursuant to 21 U.S.C.
811(a) and 812(b)(1), finds that:
---------------------------------------------------------------------------
\12\ 21 U.S.C. 812(b).
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1. 4-FA Has a High Potential for Abuse
According to HHS, 4-FA is structurally and chemically similar to
schedule I and II stimulant substances, such as amphetamine,
methamphetamine, and MDMA. An assessment of all available in vitro and
in vivo pharmacology studies (i.e., drug discrimination and intravenous
self-administration studies) as well as clinical and human anecdotal
data support that the abuse potential of 4-FA is similar to that of
schedule I and II stimulant substances. Furthermore, 4-FA has been
detected in various drug seizures across the United States and in
various European countries; thus, there is significant evidence that
individuals are using 4-FA for abuse purposes. Overall, these data
provide supportive evidence that 4-FA has a high potential for abuse
that is similar to substances in schedule I or II of the CSA.
2. 4-FA Has No Currently Accepted Medical Use in Treatment in the
United States
HHS stated that FDA has not approved a marketing application for a
drug product containing 4-FA for any indication. Moreover, there are no
clinical studies or petitioners, of which HHS is aware, that claim an
accepted medical use in the United States. DEA further notes that
according to established DEA procedure and case law, 4-FA has no
currently accepted medical use. Thus, evidence demonstrates that 4-FA
has no currently accepted medical use in treatment in the United
States.
3. There Is a Lack of Accepted Safety for Use of 4-FA Under Medical
Supervision
Currently, 4-FA does not have an accepted medical use as noted by
HHS. Because 4-FA has no approved medical use in treatment in the
United States and has not been investigated as a new drug, its safety
for use under medical supervision has not been determined. Thus, there
is a lack of accepted safety for use of 4-FA under medical supervision.
Based on these findings, the Acting Administrator concludes that 4-
fluoroamphetamine (4-FA; 1-(4-fluorophenyl)propan-2-amine), including
its salts, isomers, and salts of isomers, warrants control in schedule
I of the CSA. More precisely, because of its stimulant-like effects,
DEA is proposing to place 4-FA in 21 CFR 1308.11(f) (the stimulants
category of schedule I).
Requirements for Handling 4-FA
If this rulemaking is finalized as proposed, 4-FA would be subject
to the CSA's schedule I regulatory controls and administrative, civil,
and criminal sanctions applicable to the manufacture, distribution,
reverse distribution, importation, exportation, engagement in research,
and conduct of instructional activities or chemical analysis with, and
possession of schedule I controlled substances, including the
following:
1. Registration. Any person who handles (manufactures, distributes,
reverse distributes, imports, exports, engages in research, or conducts
instructional activities or chemical analysis with, or possesses) 4-FA,
or who desires to handle 4-FA, would need to be registered with DEA to
conduct such activities pursuant to 21 U.S.C. 822, 823, 957, and 958,
and in accordance with 21 CFR parts 1301 and 1312, as of the effective
date of a final scheduling action. Any person who currently handles 4-
FA, and is not registered with DEA, would need to submit an application
for registration and may not continue to handle 4-FA as of the
effective date of a final scheduling action, unless DEA has approved
that application for registration pursuant to 21 U.S.C. 822, 823, 957,
and 958, and in accordance with 21 CFR parts 1301 and 1312.
2. Disposal of stocks. Any person who does not desire or is not
able to obtain a schedule I registration would be required to surrender
all quantities of currently held 4-FA or to transfer all quantities of
currently held 4-FA to a person registered with DEA before the
effective date of a final scheduling action, in accordance with all
applicable
[[Page 23482]]
Federal, State, local, and Tribal laws. As of the effective date of a
final scheduling action, 4-FA would be required to be disposed of in
accordance with 21 CFR part 1317, in addition to all other applicable
Federal, State, local, and Tribal laws.
3. Security. 4-FA would be subject to schedule I security
requirements and would need to be handled and stored pursuant to 21
U.S.C. 821, 823, and 871(b), and in accordance with 21 CFR 1301.71
through 1301.76, as of the effective date of a final scheduling action.
Non-practitioners handling 4-FA would also need to comply with the
employee screening requirements of 21 CFR 1301.90 through 1301.93.
4. Labeling and Packaging. All labels, labeling, and packaging for
commercial containers of 4-FA would need to comply with 21 U.S.C. 825
and 958(e), and be in accordance with 21 CFR part 1302, as of the
effective date of a final scheduling action.
5. Quota. Only registered manufacturers would be permitted to
manufacture 4-FA in accordance with a quota assigned pursuant to 21
U.S.C. 826 and in accordance with 21 CFR part 1303 as of the effective
date of a final scheduling action.
6. Inventory. Every DEA registrant who possesses any quantity of 4-
FA on the effective date of a final scheduling action would need to
take an inventory of 4-FA on hand at that time, pursuant to 21 U.S.C.
827 and 958 and in accordance with 21 CFR 1304.03, 1304.04, and
1304.11.
Any person who becomes registered with DEA to handle 4-FA on or
after the effective date of a final scheduling action would need to
take an initial inventory of all stocks of controlled substances
(including 4-FA) on hand on the date the registrant first engages in
the handling of controlled substances, pursuant to 21 U.S.C. 827 and
958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.
After the initial inventory, every DEA registrant would need to
take an inventory of all controlled substances (including 4-FA) on hand
every two years, pursuant to 21 U.S.C. 827 and 958, and in accordance
with 21 CFR 1304.03, 1304.04, and 1304.11.
7. Records and Reports. Every DEA registrant would need to maintain
records and submit reports with respect to 4-FA pursuant to 21 U.S.C.
827 and 958(e), and in accordance with 21 CFR parts 1304 and 1312, as
of the effective date of a final scheduling action. Manufacturers and
distributors would be required to submit reports regarding 4-FA to the
Automation of Reports and Consolidated Order System (ARCOS) pursuant to
21 U.S.C. 827, and in accordance with 21 CFR parts 1304 and 1312, as of
the effective date of a final scheduling action.
8. Order Forms. Every DEA registrant who distributes 4-FA would
need to comply with the order form requirements, pursuant to 21 U.S.C.
828, and in accordance with 21 CFR part 1305, as of the effective date
of a final scheduling action.
9. Importation and Exportation. All importation and exportation of
4-FA would need to be comply with 21 U.S.C. 952, 953, 957, and 958, and
in accordance with 21 CFR part 1312, as of the effective date of a
final scheduling action.
10. Liability. Any activity involving 4-FA not authorized by, or in
violation of, the CSA or its implementing regulations would be
unlawful, and may subject the person to administrative, civil, and/or
criminal sanctions.
Regulatory Analyses
Executive Orders 12866, 13563, and 14192 (Regulatory Review)
In accordance with 21 U.S.C. 811(a), this proposed scheduling
action is subject to formal rulemaking procedures performed ``on the
record after opportunity for a hearing,'' which are conducted pursuant
to the provisions of 5 U.S.C. 556 and 557. The CSA sets forth the
criteria for scheduling a drug or other substance. Such actions are
exempt from review by the Office of Management and Budget (OMB)
pursuant to section 3(d)(1) of Executive Order (E.O.) 12866 and the
principles reaffirmed in E.O. 13563. DEA scheduling actions are not
subject to E.O. 14192, Unleashing Prosperity Through Deregulation,
Executive Order 12988, Civil Justice Reform
This proposed 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, minimize litigation, provide a clear legal standard for
affected conduct, and promote simplification and burden reduction.
Executive Order 13132, Federalism
This proposed rulemaking does not have federalism implications
warranting the application of E.O. 13132. The proposed rule does not
have substantial direct effects on the States, on the relationship
between the National Government and the States, or the distribution of
power and responsibilities among the various levels of government.
Executive Order 13175, Consultation and Coordination With Indian Tribal
Governments
This proposed 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 power and
responsibilities between the Federal Government and Indian tribes.
Regulatory Flexibility Act
The Acting Administrator, in accordance with the Regulatory
Flexibility Act, 5 U.S.C. 601-602, has reviewed this proposed rule and,
by approving it, certifies that it will not have a significant economic
impact on a substantial number of small entities.
DEA proposes placing the substance 4-fluoroamphetamine (4-FA, 1-(4-
fluorophenyl)propan-2-amine), including its salts, isomers, and salts
of isomers, in schedule I of the CSA. This action is being taken to
enable the United States to meet its obligations under the 1971
Convention on Psychotropic Substances. If finalized, this action would
impose 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-FA.
According to HHS, 4-FA has a high potential for abuse, has no
currently accepted medical use in treatment in the United States, and
lacks accepted safety for use under medical supervision. There appear
to be no legitimate sources for 4-FA as a marketed drug in the United
States, but DEA notes that this substance is available for purchase
from legitimate suppliers for scientific research. There is no evidence
of significant diversion of 4-FA from legitimate suppliers. As such,
the proposed rule, if finalized, is not expected to result in a
significant economic impact on a substantial number of small entities.
Unfunded Mandates Reform Act of 1995
In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995,
2 U.S.C. 1501 et seq., DEA has determined and certifies 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 million or more
[[Page 23483]]
(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.
Paperwork Reduction Act of 1995
This proposed rule would not impose a new collection of information
under the Paperwork Reduction Act of 1995.\13\ Also, this proposed rule
would not impose new or modify existing recordkeeping or reporting
requirements on State or local governments, individuals, businesses, or
organizations. However, this proposed rule would require compliance
with the following existing OMB collections: 1117-0003, 1117-0004,
1117-0006, 1117-0008, 1117-0009, 1117-0010, 1117-0012, 1117-0014, 1117-
0021, 1117-0023, 1117-0029, and 1117-0056. 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.
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\13\ 44 U.S.C. 3501-3521.
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List of Subjects in 21 CFR Part 1308
Administrative practice and procedure, Drug traffic control,
Reporting and recordkeeping requirements.
For the reasons set out above, DEA proposes to amend 21 CFR part
1308 as follows:
PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES
0
1. The authority citation for part 1308 continues to read as follows:
Authority: 21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise
noted.
0
2. In Sec. 1308.11:
0
a. Redesignate paragraphs (f)(8) through (13) as (f)(9) through (14);
and
0
b. Add a new paragraph (f)(8).
The addition reads as follows:
Sec. 1308.11 Schedule I.
* * * * *
(f) * * *
------------------------------------------------------------------------
------------------------------------------------------------------------
* * * * * * *
(8) 4-Fluoroamphetamine (4-FA, 1-(4-fluorophenyl)propan- 1476
2-amine)...............................................
* * * * * * *
------------------------------------------------------------------------
* * * * *
Signing Authority
This document of the Drug Enforcement Administration was signed on
May 27, 2025, by Acting Administrator Robert J. Murphy. 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.
Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2025-09988 Filed 6-2-25; 8:45 am]
BILLING CODE 4410-09-P
</pre></body>
</html>Indexed from Federal Register on June 3, 2025.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.