ABC states that potential
medical/therapeutic uses of kratom warrant further scientific research
(AUSTIN, Texas, December 5, 2016) On December 1, 2016, the nonprofit American Botanical
Council filed comments in response to the US Drug Enforcement Administration (DEA)
Solicitation of Comments regarding the scheduling of two compounds in the kratom
(Mitragyna speciosa) plant into
Schedule I of the Controlled Substances Act (CSA).
ABC set forth
to the DEA in its comments that emerging science supports viable potential
medical uses of the alkaloids mitragynine and 7-hydroxymitragynine in kratom, and
that scheduling these substances into Schedule I of the CSA may impede current
and future medical research efforts. ABC also acknowledged the actions that the
US Food and Drug Administration (FDA) — the principal federal agency with
enforcement authority over food, dietary supplement, and drug products — has initiated
to remove kratom products labeled as dietary supplements from the marketplace.1
ABC emphasized that these FDA enforcement efforts should continue to ensure that
only kratom products that comply with FDA regulations are available in the
market.
On August 31,
2016, the DEA filed a Notice of Intent to temporarily schedule the two
substances, mitragynine and 7-hydroxymitragynine, into Schedule I of the CSA.2
These substances are found in kratom, a tree native to Southeast Asia, and have
been the subject of increased media headlines over the past two years.
Due to the almost
15,000 comments received from the public, Congressional members, and the
scientific community, the DEA withdrew its original notice to temporarily
schedule kratom alkaloids, and instead, opened a comment period until December
1, 2016.3 The DEA intended to use this time to consider the
extensive comments already received, to solicit additional information from the
public, and to request FDA’s expedited scientific and medical evaluation and
scheduling recommendation for these substances.
ABC has been
reviewing the scientific literature related to kratom and recently published an
extensive peer-reviewed article on this plant and the various issues related to
its use.4 ABC’s review explores the complex science of kratom, and
examines the data that the DEA cited to support the temporary scheduling of
mitragynine and 7-hydroxymitragynine. The article also served as the foundation
to ABC’s comments to the DEA.
ABC’s comments
to the DEA stated that there is a body of evidence on kratom that demonstrates the
medical and therapeutic potential of the plant and its constituents, in
particular the potential benefits to alleviate the symptoms of opioid
withdrawal and the management of pain. ABC noted that further research is
needed to fully discover kratom’s medicinal value and to understand more fully the
potential risks and safety considerations, such as addiction potential.
However, ABC referenced medical research suggesting that kratom’s addictive
potential is significantly less than that of conventional opiates.
ABC also
emphasized that by putting these substances on Schedule I, the medical research
community will be subject to additional hurdles — such as obtaining a
registration from the DEA (and likely a state registration), along with other
security, inventory, and recordkeeping requirements5 — that may impede
and/or curtail current and future research efforts.
“ABC realizes that there are compelling
scientific data to support kratom’s potential therapeutic use; there is also confusion
about its safety profile,” said Mark Blumenthal, founder and executive director
of ABC. “Our comments to DEA are intended to help ensure that appropriate
scientific and medical research on this interesting plant and its biologically
active constituents can continue with minimal regulatory hurdles.”
To add further
support to ABC’s position that DEA should not list these substances in Schedule
I, ABC raised concerns regarding the data cited by the DEA to support the
temporary scheduling. Specifically, ABC believes the safety profile of the
plant is not wholly known, and that a more thorough investigation of the
causality between kratom and adverse event reports provided by the poison
control call center needs to be performed. For example, some of the data on
adverse events cited by the DEA include use of kratom with various analgesic or
sedative pharmaceutical drugs. Also, ABC noted that, in many cases, there was a
lack of analytical testing of commercial kratom products to identify the possible
presence of other substance(s) that may have contributed to the adverse
reaction.
ABC
believes that the potential benefits of kratom warrant further scientific and
medical investigation, and that putting kratom compounds on Schedule I would create
excessive obstacles to research on a plant that may be beneficial to a large
number of people.
References
- Food,
Drug, and Cosmetic Act (FDCA) §413 (21 USC §350b).
- The
DEA has the authority to temporarily schedule a substance if it finds that such
action is necessary to avoid an imminent hazard to the public safety. (21 USC 811(h)(1)).
- The
possible outcomes post December 1, 2016, include DEA proceeding with a
temporary or permanent scheduling (or both) of these substances. If the DEA
determines a permanent scheduling is warranted, the DEA will publish a notice
of proposed rulemaking in the Federal
Register which will allow the public another opportunity to provide
comments and request a hearing.
- Yearsley
C. Kratom: Medicine or Menace? HerbalGram.
November 2016;112:46-59.
- 21
CFR §1301, Registration of
Manufacturers, Distributors, and Dispensers of Controlled Substances.