Both ABC and AHPA are reacting to the plan announced by the Drug Enforcement Administration to place the two active compounds of kratom (Mitragyna speciosa)— mitragynine and 7-hydroxymitragynine—onto the schedule 1 list of controlled substances, where they would join drugs such as heroin and cocaine. DEA first proposed on Aug. 31 of this year to make this move immediately under an emergency provision, but after significant pushback from Capitol Hill and thousands of comments from the public the agency backed down and instituted a more formal listing procedure that included a comment period that ended Dec. 1.
Chilling effect on research
In its comments, ABC focused on the wide array of research being conducted on the botanical. The group recently published a peer-reviewed article on the botanical that formed the basis for ABC’s comments. As well as summing up the complex science of kratom, the article also examined 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 (Drug Enforcement Administration) 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 founder and executive director Mark Blumenthal said the issue with placing kratom or any other herb on the schedule 1 list is that it then becomes almost impossible to conduct further research as access to the study material becomes so problematic and approvals become difficult to get. Cannabis, for instance, has been on the schedule 1 list for decades with only one legal source—a field at the University of Mississippi—for study material. As a result, research in this country slowed to a trickle while it proceeded elsewhere.
“Our main thesis is that we want to see appropriate medical and scientific research on the mitragynines in the plant on and the plant itself. Schedule 1 status would seriously inhibit this research,” Blumenthal told NutraIngredients-USA.
Statistical deficiencies
ABC also cited what it characterized as flaws in the data DEA used to back it scheduling intent. The agency cited 660 calls over a six year period to poison control centers associated with kratom use. ABC pointed out that when ranked against the potential number of kratom users (estimated to be as many as 3.5 million) and the total number of calls to poison control centers during the relevant time period (in the millions), that 660 figure fades to statistical insignificance. Only 49 of the calls were associated with life-threatening symptoms, and of those other substances could have been involved.
ABC’s comments do address a secondary issue with kratom, that being that FDA has placed an import ban on the botanical. The reason for this action is that in that agency’s opinion, marketers of kratom need to have a NDI notification in their pocket before going to market. FDA has concluded that while kratom fits the definition of a dietary ingredient, it is not an Old Dietary Ingredient.
“ABC supports FDA’s current enforcement activities to ensure that any kratom products are compliant with the applicable regulatory framework. Additionally, a few states have taken legislative action to control and monitor the sales of products containing kratom within their respective state. Hence, there are other agencies with enforcement authority that are actively engaged in monitoring the market,” the comments state.
AHPA: Abuse of discretion
AHPA, for its part, objected in its comments to the proposed listing of the two chemicals because to do so would have the effect of banning the entire plant which has been on the market for some time. Sans an obvious public health crisis, AHPA said there is no justification for this action.
“As a general principle, AHPA is opposed to DEA using its scheduling authority in a manner that would have the effect of removing from the existing marketplace an herbal article simply because of the naturally occurring presence of one or more constituents that have become subject to scheduling under the broad standards established in the CSA. In AHPA’s view, such scheduling would be an abuse of discretion,” the group wrote.
In concord with ABC, AHPA cited the chilling effect placing the kratom constituents onto the schedule 1 list would have. DEA should look at potential benefits and not just focus on potential dangers, AHPA maintained.
“As a general matter, AHPA believes that in any consideration by DEA of placing a substance in any schedule under the CSA, and especially a substance that is a botanical ingredient or product currently or traditionally used for a recognized health benefit, DEA should abstain from any decision that would restrict future research that may discover new medical uses, health benefits, or other uses of the subject substance. AHPA believes such restrictions are not only contrary to the interests of science and industry but ultimately are also detrimental to the public interest.” the group wrote.