DEA Announces Intent to Temporarily Schedule Seven Benzimidazole-Opioids as Schedule I Substances

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Background

The Drug Enforcement Administration (DEA) plans to temporarily place seven benzimidazole-opioids into Schedule I of the Controlled Substances Act (CSA). This move follows concerns that these synthetic opioids pose an imminent danger to public safety.

• Ethyleneoxynitazene
• Methylenedioxynitazene (also called 3′,4′-methylenedioxynitazene)
• 5-methyl etodesnitazene
• N-desethyl etonitazene
• N-desethyl protonitazene
• N,N-dimethylamino etonitazene
• N-pyrrolidino isotonitazene

When the temporary scheduling order is published after July 28, 2025, these substances will be subject to all regulations, civil, and criminal penalties applicable to Schedule I controlled substances.

Legal Framework

Under 21 U.S.C. 811(h), the DEA may schedule substances temporarily for two years if it is necessary to avoid an imminent hazard to public safety. This can be extended for up to one year if certain proceedings are initiated.

A substance can only be temporarily scheduled in Schedule I if it is not already scheduled elsewhere, and if there is no FDA approval for its medical use. According to the DEA and Health and Human Services (HHS), none of these seven substances are approved for medical use in the United States.

History and Pattern of Abuse

Benzimidazole-opioids were first created in the 1950s for pain relief but were never approved for medical use. Since 2019, these opioids—also called “nitazenes”—started showing up in illegal drug markets in the U.S. They are usually found as powders or tablets, often mixed with other drugs.

These substances have been linked to a growing number of overdose deaths. Reports have found them in both drug seizures and in biological samples from fatal cases.

Current Abuse and Law Enforcement Encounters

Since 2023, there have been 184 reports related to these seven substances in the National Forensic Laboratory Information System (NFLIS-Drug) database. Here are the reported state encounters:

• Ethyleneoxynitazene: 14 encounters in 5 states
• Methylenedioxynitazene: 19 encounters in 5 states
• 5-methyl etodesnitazene: 4 encounters in 1 state
• N-desethyl etonitazene: 114 encounters in 14 states
• N-desethyl protonitazene: 9 encounters in 6 states
• N,N-dimethylamino etonitazene: 12 encounters in 4 states
• N-pyrrolidino isotonitazene: 12 encounters in 9 states

These drugs are often abused along with other powerful substances such as fentanyl, heroin, or designer benzodiazepines.

Public Health Risks

These benzimidazole-opioids act like other strong opioids, affecting mu-opioid receptors in the brain. They can cause serious health effects, including respiratory depression and death. In 2024, these substances were found in at least 37 toxicology cases.

They have no accepted medical use. People who use drugs from unknown sources may be at higher risk since the exact content and strength are uncertain. The spread of these substances makes the ongoing opioid crisis even worse.

Regulatory Process and Next Steps

The DEA followed all legal steps:

• Gave notice to the HHS, who did not object.
• Is giving the public 30 days’ notice before the order is published.

Once the temporary order is in effect, these seven substances will:

• Be illegal to make, distribute, or possess except as allowed by law.
• Be regulated with the same controls as other Schedule I substances.

This action will last for two years, with the possibility of a one-year extension as DEA works on permanent scheduling rules.

Federal Rulemaking

Temporary scheduling is issued as an “order” and not a “rule.” Regular rulemaking, which takes longer and allows more public input, will continue to determine if these drugs should be permanently scheduled.

Summary Table of Scheduled Substances

Authority

This action was signed on June 17, 2025, by Acting DEA Administrator Robert J. Murphy.

For more details, the public can review the full notice and supporting material under Docket Number DEA-1494 at www.regulations.gov.

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This article includes content collected from the Federal Register (federalregister.gov). The content is not an official government publication. This article is for informational purposes only and does not constitute legal advice. For case-specific consultation, please contact us. Read our full Legal Disclaimer, which also includes information on translation accuracy.