DEA appears to waver on kratom listing in face of pressure from lawmakers

04-Oct-2016 - Last updated on 05-Oct-2016 at 15:17 GMT

Kratom - Mitragyna speciosa. Image © iStock / frank600

The federal Drug Enforcement Administration's plan to move kratom to the Schedule 1 list via an emergency filing has spurred significant pushback from industry stakeholders and from lawmakers. But even within the herbal sphere not everyone agrees the botanical ought to be sold as a supplement.

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 (Mitragyna speciosa), an herb that is a member of the coffee family and that is native to Southeast Asia. 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.

The main thread of the reaction coming from industry and Capitol Hill is that there is not a big enough public health concern to mandate an emergency listing and that a formal listing procedure with adequate time for input and adequate provisions for review should be followed.

Unusually broad authority

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.

“My understanding is that this was really unusual and it seemed like DEA was doing FDA’s dirty work. If FDA really believes there is an issue, why don’t they take an enforcement action? I don’t know if that is an appropriate use of DEA’s power,” Marc Ullman, an attorney at counsel with the firm Rivkin Radler told NutraIngredients-USA.

A number of US Senators and Representatives apparently agreed with that assessment, and the reaction to DEA’s attempted emergency listing drew broad bipartisan support. Two letters were sent to DEA by Senators, one signed by nine Senators including Orrin Hatch, R-UT and Bernie Sanders, D-VT and the other signed by three, including Cory Booker, D-NJ. A letter also came from the House that was signed by 45 Representatives including Ted Poe, R-TX and Jared Polis, D-CO. The content of the three letters was similar, with lawmakers urging DEA to follow the formal procedure which would allow adequate time for stakeholders to weigh in and would require DEA to outline the evidence that caused it to take this decision. While the listing was already supposed to go into effect, according to a report from Forbes a DEA spokesman has said that there is now no formal timetable for the listing.

Pain relief indications

Kratom is noted for its pain relief properties and has a long history of use in Southeast Asia. In North America it has been mentioned as being helpful in weaning people away from addiction to opiod pain killers. FDA placed a ban on the import of the herb in 2014, but reportedly large quantities are still showing up on the market and being sold as dietary supplements. Proponents of the herb have come together to form an industry association, the American Kratom Association, and an advocacy group called the Botanical Education Alliance, which was previously known as Botanical Legal Defense. The group has worked to advocate for the legality of the kratom trade and the use of the herb at the state level and successfully forestalled a move to criminalize the herb in Florida.

While not weighing in on the appropriateness of DEA’s action, Dan Fabricant, PhD, CEO and executive director of the Natural Products Association, did have an opinion on kratom itself. Fabricant was not in favor of kratom as a dietary ingredient during his stint as director of the Division (now Office) of Dietary Supplements at FDA and even though he’s now on the industry side of the fence, his attitude hasn’t changed. Given kratom’s demonstrated strong effects, Fabricant said that there is not enough safety data available to be comfortable with it being on the shelf with more common dietary supplements.

“I think everyone gets that the kratom people are upset,” Dr Fabricant said. “What you always hear from people who advocate for this or other botanicals is that they are passionate about it. That’s fine, but at the end of the day people are going to fall back onto the scientific data, and in the case of kratom there is a lack of company-level data for its safety. If you are going to use it as a supplement you should just go through the NDI gate.”