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DEA Proposes Rule to Place 4-Fluoroamphetamine in Schedule I

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On June 3, 2025, the Drug Enforcement Administration (DEA) announced a proposed rule to place the substance 4-fluoroamphetamine (4-FA) in Schedule I of the Controlled Substances Act (CSA).

What Is 4-Fluoroamphetamine (4-FA)?

4-FA is a central nervous system stimulant. It is similar to amphetamine and methamphetamine, which are already controlled substances. 4-FA has no approved medical use in the United States.

Why Is the DEA Proposing This Rule?

This proposal is partly to help the United States meet its requirements under the 1971 Convention on Psychotropic Substances. The United Nations international body placed 4-FA in Schedule II of its convention in 2018. The DEA is acting to control 4-FA following these international decisions and U.S. law.

What Evidence Did the DEA Review?

The DEA and the Department of Health and Human Services (HHS) reviewed scientific studies, medical information, case reports, and law enforcement data. Their findings show that 4-FA:

  • Acts like powerful stimulant drugs.
  • Is being abused in the United States and elsewhere.
  • Is found in illegal drug markets.
  • Can cause serious health problems, including death.
  • Has no accepted medical use.

Details From the Scientific Review

4-FA produces effects similar to those of schedule I and II drugs such as amphetamine, methamphetamine, cocaine, and MDMA. It increases levels of certain chemicals in the brain and produces feelings of euphoria and high energy. People have taken it without medical advice, and it has been abused in many states.

Law enforcement tested drug samples and found 269 reports of 4-FA in drug exhibits from January 2011 to December 2023. Most users are young adults. The drug can be taken by swallowing or snorting.

4-FA has caused emergency department visits, overdoses, and at least five deaths. Common effects include fast heartbeat, high blood pressure, headache, agitation, and fever.

No studies show that it has accepted medical use or that it is safe for use with medical supervision.

Proposed Rule Details

If the rule is finalized, 4-FA will become a Schedule I controlled substance. This means:

  • Only DEA-registered persons can manufacture, distribute, import, export, research, or possess 4-FA.
  • Those who wish to handle 4-FA will need DEA registration.
  • Those who do not register must surrender or transfer their 4-FA stock.
  • 4-FA will need to be stored securely.
  • Quotas will limit manufacturing.
  • Inventories must be taken and records kept.
  • Reports must be submitted to the DEA.
  • Order forms must be used for transactions.
  • Import and export rules will apply.

Activities with 4-FA not allowed under the law may lead to criminal, civil, or administrative penalties.

Comment Period and Hearing Requests

Comments about the proposed rule must be submitted to the DEA by July 3, 2025. People may also request a hearing by that date, showing their interest and objections.

Regulatory Effects

This proposal will not have a big economic impact on small businesses. There is no evidence of legitimate use for 4-FA, except in some scientific research.

The DEA says this rule does not add new paperwork requirements for businesses or government agencies, but existing recordkeeping rules must be followed.

How to Comment

Comments can be sent electronically through the Federal eRulemaking Portal at www.regulations.gov. Paper comments can be mailed to the DEA in Springfield, Virginia.

All comments are part of the public record unless marked as confidential.

Conclusion

The DEA is proposing full control of 4-FA due to high potential for abuse and no accepted medical use. If the rule becomes final, 4-FA and related substances will be placed in Schedule I and subject to strict regulations.


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