On August 31 the Drug Enforcement Administration 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. 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.
DEA then backed off its emergency listing and announced it would hold an open comment period until December 1, 2016.
In formal comments submitted to DEA, Dr Dan Fabricant, NPA executive director and CEO, said: “Adding an untested and unregulated substance such as kratom to our food supply without the application of longstanding federal rules and guidelines would not only be illegal, it could likely be dangerous, leading to serious unintended consequences as our nation struggles with the crisis of opioid addiction.”
Dr 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. Dr Fabricant has previously said that there is not enough safety data available to be comfortable with kratom being on the shelf with more common dietary supplements.
“The safety record of the dietary supplement and natural products industry is far superior to prescription drugs or even conventional foods because of a strong federal regulatory regime, significant investment in product safety and quality, consumer demand and self-regulatory programs developed by the men and women of our industry, who want to help people lead healthier lifestyles,” wrote Dr Fabricant in the formal comments.
“NPA strongly supports the prosecution of criminal activity, and has robust internal measures and quality assurance programs to report bad actors to authorities.
“As former Food and Drug Administration (FDA) officials and regulators of the dietary supplement industry, we can tell you that finished kratom products and raw kratom botanical ingredients have not met the strict standards products and new ingredients must adhere to in order to be marketed to the public and deemed safe for regular use in either our food or our drug supply.”
“Self-medicating with kratom is dangerous without the necessary pre-market approval process set forth by our public health experts at FDA. Even if kratom were delivered as a food, kratom has never been filed as a new dietary ingredient to FDA’s Center for Food Safety and Applied Nutrition.”
The full comments can be viewed HERE.
Kratom
Kratom (Mitragyna speciosa) is an herb that is a member of the coffee family and that is native to Southeast Asia. It is noted for its pain relief properties and 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.
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.