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

By Hank Schultz contact

- Last updated on GMT

Kratom - Mitragyna speciosa. Image © iStock / frank600
Kratom - Mitragyna speciosa. Image © iStock / frank600

Related tags: Controlled substances act, Drug enforcement administration

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.”

Related news

Show more

Related products

show more

 Furosap® - An Innovative Approach to Men's Health

Furosap® - An Innovative Approach to Men's Health

Chemical Resources (CHERESO) | 18-Jun-2018 | Case Study

FUROSAP®, a natural extract is versatile in men’s health goals. It contains protodioscin (20%), which promotes healthy testosterone levels as well as healthy...

Are you a 40 + Man?

Are you a 40 + Man?

Chemical Resources (CHERESO) | 11-Jun-2018 | Data Sheet

PROSMANTM is an innovative product derived from Prunus Domestica that has anti-inflammatory effects by inhibiting production of pro-inflammatory prostaglandins...

Powerful heart health benefits from aronia

Powerful heart health benefits from aronia

Naturex | 07-Jun-2018 | Technical / White Paper

Aronox® is an extract of aronia that delivers heart health benefits supported by several published peer-reviewed clinical trials, with significant improvements...

Related suppliers

5 comments

Show more

Yes, take a look at the scientific evidence

Posted by Carol,

If the DEA really does take the scientific evidence into consideration, they will find that Kratom is a safe, natural, plant herb and has a lower rate of poison control calls than many things like laundry soap packets. The only confirmed deaths reported of people who used Kratom were also found to have other harmful drugs in their systems. They need to consider the scientific evidence and encourage new studies rather than banning it under the false premise that it is dangerous to the American people. The only danger Kratom poses is to Big Pharma! If The DEA doesn't want the public to know they are in bed with the pharmaceutical companies, they need to leave medicinal plants alone.

Report abuse

keep kratom legal

Posted by Danyon,

I'm not sure if these comments make a difference but we have:) so I'm going to say what I think, they should just leave it alone it is already classified, it's a leaf beneficialleaf and we are suppose to be free :( it's helping ppl not hurting please leave it alone.. Peace and Love to us all.. We are not walking around like zombies or freaks we are just trying to live the most comfortable life we can... We are productive members of society thanks to KRATOM....

Report abuse

GRAS

Posted by Andrew,

Kratom has been in the USA for decades, before October 1994, if anything it should be considered GRAS by the FDA

Report abuse

Follow us

Products

View more

Webinars