AHPA- Legal Alert

8 years ago
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Editor’s Note: The Drug Enforcement Agency (DEA) announced it is withdrawing a Notice of Intent to temporarily place two active constituents of kratom into schedule I of the Controlled Substances Act (CSA). The agency is now soliciting comments on the scheduling of this plant. This DEA pathway was requested by the public, members of congress, and organizations (including AHPA) to consider submitted comments and accompanying information before taking action to make kratom a scheduled substance under the CSA. If during this process, the DEA determines kratom presents an imminent hazard to public health, it would need to issue a new Notice of Intent and wait 30 days before placing kratom into schedule I under CSA’s temporary scheduling provisions. FDA has issued an import alert to detain kratom coming into the U.S. and has taken seizure action against kratom found in California and Illinois.

Federal Register
October 13, 2016

Withdrawal of Notice of Intent to Temporarily Place Mitragynine and 7- Hydroxymitragynine into Schedule I

AGENCY: Drug Enforcement Administration, Department of Justice

ACTION: Withdrawal of Notice of Intent; Solicitation of Comments.

SUMMARY: On August 31, 2016, the Drug Enforcement Administration (DEA) published in the Federal Register a notice of intent to temporarily place mitragynine and 7-hydroxymitragynine, which are the main psychoactive constituents of the plant Mitragyna speciosa, also referred to as kratom, into schedule I pursuant to the temporary scheduling provisions of the Controlled Substances Act. Since publishing that notice, DEA has received numerous comments from members of the public challenging the scheduling action and requesting that the agency consider those comments and accompanying information before taking further action. In addition, DEA will receive from the Food and Drug Administration (FDA) a scientific and medical evaluation and scheduling recommendation for these substances, which DEA previously requested. DEA is therefore taking the following actions: DEA is withdrawing the August 31, 2016 notice of intent; and soliciting comments from the public regarding the scheduling of mitragynine and 7-hydroxymitragynine under the Controlled Substances Act.

DATES: The notice of intent that was published on August 31, 2016 (81 FR 59929) is withdrawn as of [October, 13, 2016]. The comment period will be open until December 1, 2016. All comments for the public record must be submitted electronically or in writing in accordance with the procedures outlined below. Electronic comments must be submitted, and written comments must be postmarked, on or before December 1, 2016. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after 11:59 p.m. Eastern Time on the last day of the comment period. Please note that if you previously submitted a comment via email or regular mail following the August 31, 2016 notice, that comment is being considered by DEA – it is not necessary to resubmit the same comment unless you wish to provide additional information, or you wish to have your comment posted for public view in accordance with the instructions provided below.

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Editor’s Note: The Drug Enforcement Agency (DEA) announced it is withdrawing a Notice of Intent to temporarily place two active constituents of kratom into schedule I of the Controlled Substances Act (CSA). The agency is now soliciting comments on the scheduling of this plant. This DEA pathway was requested by the public, members of congress, and organizations (including AHPA) to consider submitted comments and accompanying information before taking action to make kratom a scheduled substance under the CSA.  If during this process, the DEA determines kratom presents an imminent hazard to public health, it would need to issue a new Notice of Intent and wait 30 days before placing kratom into schedule I under CSA’s temporary scheduling provisions. FDA has issued an import alert to detain kratom coming into the U.S. and has taken seizure action against kratom found in California and Illinois.  
Federal Register
October 13, 2016
AGENCY: Drug Enforcement Administration, Department of Justice
ACTION: Withdrawal of Notice of Intent; Solicitation of Comments.
SUMMARY: On August 31, 2016, the Drug Enforcement Administration (DEA) published in the Federal Register a notice of intent to temporarily place mitragynine and 7-hydroxymitragynine, which are the main psychoactive constituents of the plant Mitragyna speciosa, also referred to as kratom, into schedule I pursuant to the temporary scheduling provisions of the Controlled Substances Act. Since publishing that notice, DEA has received numerous comments from members of the public challenging the scheduling action and requesting that the agency consider those comments and accompanying information before taking further action. In addition, DEA will receive from the Food and Drug Administration (FDA) a scientific and medical evaluation and scheduling recommendation for these substances, which DEA previously requested. DEA is therefore taking the following actions: DEA is withdrawing the August 31, 2016 notice of intent; and soliciting comments from the public regarding the scheduling of mitragynine and 7-hydroxymitragynine under the Controlled Substances Act.
DATES: The notice of intent that was published on August 31, 2016 (81 FR 59929) is withdrawn as of [October, 13, 2016]. The comment period will be open until December 1, 2016. All comments for the public record must be submitted electronically or in writing in accordance with the procedures outlined below. Electronic comments must be submitted, and written comments must be postmarked, on or before December 1, 2016. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after 11:59 p.m. Eastern Time on the last day of the comment period. Please note that if you previously submitted a comment via email or regular mail following the August 31, 2016 notice, that comment is being considered by DEA – it is not necessary to resubmit the same comment unless you wish to provide additional information, or you wish to have your comment posted for public view in accordance with the instructions provided below.
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