HR5415-119

1. Short title This Act may be cited as the Nitazene Control Act of 2025.

2. Findings Congress finds the following: 2-Benzylbenzimidazole opioids are a class of synthetic opioids first synthesized in the 1950s. They exhibit significant potency at the mu-opioid receptor, with some substances exceeding the potency of fentanyl. The Drug Enforcement Administration (DEA) has temporarily or permanently scheduled multiple 2-benzylbenzimidazole opioid compounds under Schedule I of the Controlled Substances Act due to their high abuse potential and lack of accepted medical use. Nitazenes and related compounds have emerged in the illicit drug supply as designer drugs and contribute to overdose and fatal poisonings in the United States. A class-wide permanent scheduling of 2-benzylbenzimidazole opioids is necessary to preemptively address the proliferation of new analogs, streamline enforcement, and protect public health. The HALT Fentanyl Act created pathways for research using Schedule I controlled substances which apply to scheduled nitazenes.

3. Schedule i classification of nitazenes Section 202(c) of the Controlled Substances Act (21 U.S.C. 812(c)) is amended by adding at the end of Schedule I the following: 2-Benzylbenzimidazole opioids, commonly referred to as nitazenes, their isomers, esters, ethers, salts and salts of isomers, esters, and ethers, including: Is structurally related to 2-benzylbenzimidazole with the following modifications: At the 1-position, substitution with an alkyl linker connected to a substituted amine group containing hydrogen, alkyl, alkenyl, and/or heteroaryl group (e.g. morphilino, pyrrolidino, or piperidinyl groups), whether or not further substituted. At the 2-position: Substitution on the phenyl portion of the benzimidazole ring with a hydrogen atom, halogen, nitro, cyano, substituted or unsubstituted amide, amine, alkyl, alkoxy, aryl, and/or heteroaryl groups. At the 6-position, substitution with hydrogen, nitro, trifluoromethyl, methoxy, trifluoromethoxy, cyano, and halogen groups.; and Exhibits agonist activity at the mu-opioid receptor. Any substance included in the amendment to section 202(c) of the Controlled Substances Act made by this section that was temporarily scheduled under section 201(h) of the Controlled Substances Act shall be deemed permanently scheduled and subject to the requirements of Schedule I as of the date of enactment of this Act. Nothing in this section or the amendments made by this section shall be construed to authorize the initiation of new research using substances described in the amendment made by subsection (a) without proper registration and scheduling compliance. (f)2-Benzylbenzimidazole opioids, commonly referred to as nitazenes, their isomers, esters, ethers, salts and salts of isomers, esters, and ethers, including: (1)Is structurally related to 2-benzylbenzimidazole with the following modifications: (A) At the 1-position, substitution with an alkyl linker connected to a substituted amine group containing hydrogen, alkyl, alkenyl, and/or heteroaryl group (e.g. morphilino, pyrrolidino, or piperidinyl groups), whether or not further substituted. (B) At the 2-position: i. Replacement of the alkyl portion of the benzyl group with a substituted or unsubstituted alkyl, alkoxy, carbamates group, nitrogen, sulfur, and/or oxygen atoms. ii. Replacement of the phenyl portion of the benzyl group with an aryl or heteroaryl group. (C)Substitution on the phenyl portion of the benzimidazole ring with a hydrogen atom, halogen, nitro, cyano, substituted or unsubstituted amide, amine, alkyl, alkoxy, aryl, and/or heteroaryl groups. (D) At the 6-position, substitution with hydrogen, nitro, trifluoromethyl, methoxy, trifluoromethoxy, cyano, and halogen groups.; and (2)Exhibits agonist activity at the mu-opioid receptor.Such substances include, but are not limited to: etonitazene, clonitazene, metonitazene, isotonitazene, protonitazene, butonitazene, etodesnitazene, flunitazene, N-pyrrolidino etonitazene, N-desethyl isotonitazene, and N-piperidinyl etonitazene..