23 Sept 2016
U.S. Targets Imports of Certain Cannabinoids and Opioids
The Drug Enforcement Administration has issued a final rule that permanently places the following substances, including their salts, isomers and salts of isomers whenever their existence is possible, into schedule I of the Controlled Substances Act.
- quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate (PB-22; QUPIC)
- quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate (5-fluoro-PB-22; 5F-PB-22)
- N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide (ABFUBINACA)
- N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (ADB-PINACA)
The DEA states that these substances have a high potential for abuse comparable to other schedule I substances and have no currently accepted medical use in treatment in the United States. These substances were previously temporarily placed in schedule I. As a result, this rule continues on a permanent basis the regulatory controls and administrative, civil and criminal sanctions applicable to schedule I controlled substances on persons who handle (import, export, manufacture, distribute, reverse distribute, engage in research, conduct instructional activities or chemical analysis, or possess) any of these substances. These include the following.
- all importation and exportation of these substances must continue to be in compliance with 21 USC 952, 953, 957 and 958 and in accordance with 21 CFR part 1312
- any activity involving these substances that is not authorised by, or is in violation of, the Controlled Substances Act or its implementing regulations continues to be unlawful and may subject the person to administrative, civil or criminal sanctions
- any person who handles or desires to handle one of these substances must be registered with the DEA to conduct such activities
- all labels, labelling, and packaging for commercial containers of these substances must comply with 21 USC 825 and 958(e) and be in accordance with 21 CFR part 1302
- only registered manufacturers are permitted to manufacture these substances in accordance with an assigned quota
- every DEA registrant whose registration currently authorises handling of these substances and who possesses any quantity of these substances is required to continue to maintain an inventory of all stocks on hand
The DEA has also announced its intent to temporarily schedule (1) the opioids mitragynine and 7-hydroxymitragynine and (2) the synthetic opioid 3,4-dichloro-N-[2-(dimethylamino)cyclohexyl]-N-methylbenzamide (also known as U-47700) into schedule I pursuant to the temporary scheduling provisions of the Controlled Substances Act. The DEA intends to issue a final order effecting this change as soon as possible after 30 September and 7 October, respectively, which will mark the end of the 30-day notice period. Upon the issuance of that order, the opioids will be subject to the regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, possession, importation, exportation, research, and conduct of instructional activities of schedule I controlled substances. This order will be effective for two years, with a possible extension of one year, pending completion of the regular scheduling process.
According to the DEA, available data and information indicate that these substances have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. Mitragynine and 7-hydroxymitragynine are the main active constituents of the plant commonly known as kratom, an indigenous plant of Southeast Asia that is abused for its ability to produce opioid-like effects. Kratom is available in several different forms, including dried/crushed leaves, powder, capsules, tablets, liquids and gum/resin. The DEA states that attempted importations of kratom are routinely misdeclared and falsely labelled and that the amount of kratom material seized by law enforcement for the first half of 2016 greatly exceeds any previous year totals and easily accounts for millions of dosage units intended for the recreational market.
The FDA has issued and updated two import alerts that allow for detention without physical examination of (i) dietary supplements and bulk ingredients that are or contain kratom and (ii) unapproved new drugs promoted in the United States, which includes kratom products that make false health claims. Since 2014, 121 firms have been added to these import alerts for importing kratom products.
Seizures of U-47700 have been encountered in powder form and in counterfeit tablets that mimic pharmaceutical opioids. It has also been encountered in glassine bags and envelopes and knotted corners of plastic bags, which demonstrates the abuse of this substance as a replacement for heroin or other opioids, either knowingly or unknowingly. U-47700 has been encountered as a single substance as well as in combination with other substances, including heroin, fentanyl and furanyl fentanyl.