The report by Jack Henningfield, PhD, was prepared for the American Kratom Association and was submitted in conjunction with the group’s comments on the Drug Enforcement Administration's recent move to place the herb on the schedule 1 list under the Controlled Substances Act (CSA), where it would join substances such as heroin and cocaine. Henningfield, who is a vice president at the pharmaceutical and consumer health care consulting firm PinneyAssociates, conducted an eight-point analysis of the herb that conformed to the factors laid out in the CSA for decided whether a substance needs to be added to the list. The eight factors are:
(1) Its actual or relative potential for abuse.
(2) Scientific evidence of its pharmacological effect, if known.
(3) The state of current scientific knowledge regarding the drug or other substance.
(4) Its history and current pattern of abuse.
(5) The scope, duration, and significance of abuse.
(6) What, if any, risk there is to the public health.
(7) Its psychic or physiological dependence liability.
(8) Whether the substance is an immediate precursor of a substance already controlled under this subchapter.
Low potential for abuse
In his 127-page report Henningfield concluded that “Kratom has a low potential for abuse and a low dependence liability and there is insufficient evidence of personal harm, adverse health effects or detriment to the public health to warrant control.”
Kratom (Mitragyna speciosa), an herb that is a member of the coffee family, has a long history of use in Southeast Asia where it is native and has been gaining in prominence in the United States in recent years. The botanical’s popularity is based on its purported analgesic effects and growing evidence for its utility in helping to wean prescription opiod abusers off of their addictions. But the herb has risen on the enforcement radar, too, and concerns about its abuse potential in its own right caused FDA to slap an import ban on the substance in 2014.
On August 31, DEA put out a letter of intent to temporarily add mitragynine and 7-hydroxymitragynine to the schedule 1 list. These are the main active components of kratom. As there are no kratom ingredients on the market in which these substances have been removed, the action would have the same effect as listing the whole plant on schedule 1, as had been done back in the day with cannabis.
Forestalling an emergency listing
The emergency listing procedure in the Controlled Substances Act gives DEA an authority that is unusual among regulatory bodies, according to the American Herbal Products Association. Putting a substances on the Schedule 1 list in this way is not subject to judicial review, the organization noted. Schedule 1, which includes drugs like heroin, LSD, cannabis and Ecstasy, is defined as substances that have a high risk of abuse, no current accepted medical use and a lack of accepted safety for use under medical supervision.
“Such unfettered discretion to criminalize conduct and effectively obstruct the availability of historically marketed items of commerce must be exercised sparingly and with great care for the legitimate interests of affected persons,” AHPA said in a statement issued in September.
DEA backed off that position after receiving letters signed by members of Congress including Sens. Cory Booker, D-NJ, Orrin Hatch, R-UT, and Bernie Sanders, D-VT, and Reps. Ted Poe, R-TX and Jared Polis, D-CO. The agency then moved to a more formal scheduling procedure with a comment period that ended on Dec. 1.
No evidence of public health risk
In its comments, AKA said that a schedule 1 listing (or a listing on one of DEA’s less restrictive lists) is inappropriate because the herb poses little risk and is being used safely by consumers.
“Scheduling kratom under the CSA would divert government resources from more critical initiatives, have a significant negative impact on a substantial number of small businesses and consumers who choose to use kratom products safely and responsibly, yet yield no positive impact on the public health,” the comments state.
“For both abuse potential and dependence liability, kratom's profile is comparable to or lower than that of unscheduled substances such as caffeine, nicotine-containing smoking cessation products, dextromethorphan, and many antihistamines, antidepressants, and other substances sold directly to consumers. Kratom's profile also resembles that of various botanical dietary supplements such as chamomile, lavender, St. John's Wort, kava, and hops,” the comments conclude.
Position as a dietary supplement
AKA states in its comments that FDA, not DEA, is the appropriate regulatory agency to deal with kratom. “Kratom can be appropriately regulated by the Food and Drug Administration (FDA) through existing authority under the Food, Drug, and Cosmetic Act (FDCA) to ensure the safe and appropriate use of consumer kratom products as traditionally marketed in the U.S.,” the comments state.
But when FDA slapped its import ban on kratom its objections centered on its concern about the herb’s abuse potential. While the agency said that kratom qualifies as a dietary ingredient, it remains unconvinced that enough evidence exists of kratom’s position on the market as an article of food prior to Oct. 15, 1994 (the DSHEA grandfather date) to warrant concluding that is its an Old Dietary Ingredient and thus judged to be safe on its face. And FDA says there is no sign that any marketer of kratom products has submitted a NDI notification on the herb that would include submitting a scientific dossier that could put the safety question to rest. Kratom advocates are making that case that the botanical should not be considered a drug like heroin, but if FDA at the moment does not consider kratom to be a legal dietary ingredient, it would seem to leave the botanical in a similar limbo to CBD supplements.
Mark Blumenthal, founder and executive director of the American Botanical Council, said if the advocates of kratom want the botanical to come fully out of the regulatory shade, there is really only one avenue, that being to go through process as laid out in DSHEA to bring a new ingredient to market.
“We support FDA in its attempts to fully implement exiting regulations and anyone who wants to market kratom as a dietary supplement should comply with those regulations,” he said.