On August 31 DEA proposed to temporarily place mitragynine and 7-hydroxymitragynine, the main psychoactive constituents of kratom (Mitragyna speciosa) into schedule I pursuant to the temporary scheduling provisions of the Controlled Substances Act. Those provisions provided a brief window for comment for such an action, and that opportunity was used by commenters from industry and Capitol Hill to the full.
Unusual procedure
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.
And 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.
More protracted proceeding
This is what the agency has agreed to do. In response to that backlash, the agency has agreed to halt the progress toward an immediate emergency listing and institute a more formal listing proceeding. The agency will also solicit from the Food and Drug Administration a “scientific and medical evaluation and scheduling recommendation for these substances, which DEA previously requested.”
Daniel Fabricant, PhD, CEO and executive director of the Natural Products Association, said that while he and his organization’s view of the botanical remains the same, he’s gratified that a rush to judgement on a natural product has been forestalled, even though during his stint at the helm of the Division (now Office) of Dietary Supplement Programs at FDA Fabricant was not keen on seeing kratom appear in dietary supplements.
“I think our view on the ingredient hasn’t changed. But DEA hadn’t used this particular emergency listing mechanism before, and due process is part of the issue,” Fabricant told NutraIngredients-USA.
Mark Blumenthal, executive director of the American Botanical Council, said DEA’s move is welcome in that it avoids what might be a troubling precedent for botanical medicines, whether they fit neatly into a dietary supplement definition or not. He said his organization’s publication HerbalGram has written an extensive, peer-reviewed article on kratom that it will be publish soon.
“DEA has heard from various sectors of the public that it is possible that their initial proposal may have been precipitous and not adequately thought out. I’m gratified that there might be some resolution in the schedule 1 treatment. Although there are some known tolerances and perhaps some addictive potential for some of the compounds of kratom, they seem to be lower in pharmacological activity than most opioids and there seems to be a reasonable potential for some people to use kratom to step down their opioids dependency,” he said.
Import ban
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 has in place an import ban dating from 2014 (Fabricant left the agency in April of that year), 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 claims to have successfully prevented moves to place additional legal restrictions on the plant in a number of states.
A new comment window has been opened with a deadline of Dec. 1. The agency said those who have already submitted comments on the (now more protracted) listing proposal do not have to submit new comments, but may do so if they want to provide additional information.
Speaking of submitting information, Fabricant said that his organization’s view on kratom rests on that notion. In NPA’s view, there has been a bum-rush to market, with proponents of the botanical bowling over legal barriers that are in place.
“I think our issue is that some people might have some of our position wrong. The position we took is that some people have this on the market without having filed a New Dietary Ingredient notification. If there is safety data on an NDI, then people have to file it, whether it’s kratom, or stevia or whatever,” he said.