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Imports and Exports of Two Opioids to be Restricted

Wednesday, August 31, 2016
Sandler, Travis & Rosenberg Trade Report

The Drug Enforcement Administration has announced its intent to temporarily schedule the opioids mitragynine and 7-hydroxymitragynine 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 Sept. 30, which will mark the end of the 30-day notice period. Upon the issuance of that order, mitragynine and 7-hydroxymitragynine will be 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. 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 U.S., 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 labeled 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 Food and Drug Administration has issued and updated two import alerts that allow for detention without physical examination of (a) dietary supplements and bulk ingredients that are or contain kratom and (b) unapproved new drugs promoted in the U.S., which includes kratom products that make false health claims. Since 2014, 121 firms have been added to these import alerts for importing kratom products.

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