Menu
×
News
Get Involved
About Us
Our Members

ABC states that potentialmedical/therapeutic uses of kratom warrant further scientific research

(AUSTIN, Texas, December 5, 2016) On December 1, 2016, the nonprofit American BotanicalCouncil 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 intoSchedule I of the Controlled Substances Act (CSA).

ABC set forthto the DEA in its comments that emerging science supports viable potentialmedical uses of the alkaloids mitragynine and 7-hydroxymitragynine in kratom, andthat scheduling these substances into Schedule I of the CSA may impede currentand future medical research efforts. ABC also acknowledged the actions that theUS Food and Drug Administration (FDA) — the principal federal agency withenforcement authority over food, dietary supplement, and drug products — has initiatedto remove kratom products labeled as dietary supplements from the marketplace.1ABC emphasized that these FDA enforcement efforts should continue to ensure thatonly kratom products that comply with FDA regulations are available in themarket.

On August 31,2016, the DEA filed a Notice of Intent to temporarily schedule the twosubstances, mitragynine and 7-hydroxymitragynine, into Schedule I of the CSA.2These substances are found in kratom, a tree native to Southeast Asia, and havebeen the subject of increased media headlines over the past two years.

Due to the almost15,000 comments received from the public, Congressional members, and thescientific community, the DEA withdrew its original notice to temporarilyschedule kratom alkaloids, and instead, opened a comment period until December1, 2016.3 The DEA intended to use this time to consider theextensive comments already received, to solicit additional information from thepublic, and to request FDA’s expedited scientific and medical evaluation andscheduling recommendation for these substances.  

ABC has beenreviewing the scientific literature related to kratom and recently published anextensive peer-reviewed article on this plant and the various issues related toits use.4 ABC’s review explores the complex science of kratom, andexamines the data that the DEA cited to support the temporary scheduling ofmitragynine and 7-hydroxymitragynine. The article also served as the foundationto ABC’s comments to the DEA.

ABC’s commentsto the DEA stated that there is a body of evidence on kratom that demonstrates themedical and therapeutic potential of the plant and its constituents, inparticular the potential benefits to alleviate the symptoms of opioidwithdrawal and the management of pain. ABC noted that further research isneeded to fully discover kratom’s medicinal value and to understand more fully thepotential risks and safety considerations, such as addiction potential.However, ABC referenced medical research suggesting that kratom’s addictivepotential is significantly less than that of conventional opiates.

ABC alsoemphasized that by putting these substances on Schedule I, the medical researchcommunity will be subject to additional hurdles — such as obtaining aregistration from the DEA (and likely a state registration), along with othersecurity, inventory, and recordkeeping requirements5 — that may impedeand/or curtail current and future research efforts.

“ABC realizes that there are compellingscientific data to support kratom’s potential therapeutic use; there is also confusionabout its safety profile,” said Mark Blumenthal, founder and executive directorof ABC. “Our comments to DEA are intended to help ensure that appropriatescientific and medical research on this interesting plant and its biologicallyactive constituents can continue with minimal regulatory hurdles.”   

To add furthersupport to ABC’s position that DEA should not list these substances in ScheduleI, ABC raised concerns regarding the data cited by the DEA to support thetemporary scheduling. Specifically, ABC believes the safety profile of theplant is not wholly known, and that a more thorough investigation of thecausality between kratom and adverse event reports provided by the poisoncontrol call center needs to be performed. For example, some of the data onadverse events cited by the DEA include use of kratom with various analgesic orsedative pharmaceutical drugs. Also, ABC noted that, in many cases, there was alack of analytical testing of commercial kratom products to identify the possiblepresence of other substance(s) that may have contributed to the adversereaction.

ABCbelieves that the potential benefits of kratom warrant further scientific andmedical investigation, and that putting kratom compounds on Schedule I would createexcessive obstacles to research on a plant that may be beneficial to a largenumber of people.

References

  1. Food,Drug, and Cosmetic Act (FDCA) §413 (21 USC §350b).
  2. TheDEA has the authority to temporarily schedule a substance if it finds that suchaction is necessary to avoid an imminent hazard to the public safety. (21 USC 811(h)(1)).
  3. Thepossible outcomes post December 1, 2016, include DEA proceeding with atemporary or permanent scheduling (or both) of these substances. If the DEAdetermines a permanent scheduling is warranted, the DEA will publish a noticeof proposed rulemaking in the FederalRegister which will allow the public another opportunity to providecomments and request a hearing.
  4. YearsleyC. Kratom: Medicine or Menace? HerbalGram.November 2016;112:46-59.
  5. 21CFR §1301, Registration ofManufacturers, Distributors, and Dispensers of Controlled Substances.