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Import and Export Restrictions on Two Opioids Postponed

Thursday, October 13, 2016
Sandler, Travis & Rosenberg Trade Report

The Drug Enforcement Administration has withdrawn its notice of intent to temporarily schedule the opioids mitragynine and 7-hydroxymitragynine into schedule I pursuant to the temporary scheduling provisions of the Controlled Substances Act.

Mitragynine and 7-hydroxymitragynine are the main active constituents of the plant commonly known as kratom, an indigenous plant of Southeast Asia. The temporary scheduling would have resulted in these substances being subject to the regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, reverse distribution, importation, exportation, research, conduct of instructional activities and chemical analysis, and possession of schedule I controlled substances.

However, the DEA states that it has received numerous public comments challenging its intent to place these substances into schedule I. The DEA’s proposal stemmed from its conclusion that these substances have a high potential for abuse and no currently accepted medical use in treatment in the U.S. According to press reports, however, advocates and researchers have disputed those findings, citing preliminary studies showing that these substances could be used to develop a beneficial new class of painkiller, and argued that subjecting the substances to the restrictions associated with a schedule I listing would preclude further research.

As a result, the DEA is soliciting comments through Dec. 1 and will consider those comments in determining whether to proceed with the temporary and/or permanent scheduling of these substances.

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