Matt Dana, 27, was a police sergeant in the northern New York State town of Tupper Lake. Dana died from fluid in his lungs during the summer, but the report linking his death to kratom only surfaced this week.
Death linked to kratom use
A coroner’s report found that Dana died from hemorrhagic pulmonary edema, and that he did not suffer from any undisclosed health conditions. The report said the only unusual substance found in Dana’s blood was a high level of kratom. It is unclear why Dana was using the substance, but the AP story did note that some bodybuilders advocate for using the substance as a way to ‘push through the pain’ and for more mental focus in an attempt to get better workouts. The AP story also said Dana was making his own preparation of the herb by grinding it into a paste and consuming it that way, so there is no way to determine how much of the botanical he ingested.
The AP story, and another on Dana’s death that appeared on the Men’s Health magazine website, called kratom an ‘herbal supplement.’ One of the hallmarks of legal dietary ingredients that go into supplements is that there is typically a huge range between an efficacious dose and a toxic dose. That spread is undetermined for kratom, which has been ruled by FDA to be a New Dietary Ingredient for which no NDI is on file.
Despite FDA’s ruling, and an import ban placed on the botanical in 2014, the herb can still be found on the market. Earlier this year US Marshals, at FDA’s behest, seized more than 25,000 pounds of raw kratom material worth more than $5 million from Rosefield Management, Inc. in Van Nuys, CA. In 2016, the agency seized more that $500,000 worth of the botanical.
The undetermined safety envelope of kratom is not the only issue with the botanical. According to James Neal-Kababick of Flora Research Laboratories in Grants Pass, OR, some supplies of this botanical may be laced with dangerous undeclared pharmaceutical ingredients.
Kratom is the common name of the botanical Mitragyna speciosa, a tree that is a member of the coffee family native to Thailand, Malaysia, Indonesia and Papua New Guinea. FDA says Kratom is promoted on numerous websites in the United States for its psychoactive and opioid-like analgesic effects and for use in the treatment of morphine and heroin addiction, but it is not approved in the United States for any medical use.
Issue with missing NDI
In the Feb. 28, 2014 import alert, FDA said kratom could qualify as a dietary ingredient under federal law but is also clearly a New Dietary Ingredient. Presumably any dietary supplement manufacturer would have to file a NDI notification if it wanted to market the ingredient.
But it seems unlikely the agency would rule favorably on an NDI application. According to FDA’s review, far from having a history of safety, the literature on the ingredient shows, “Serious concerns regarding the toxicity of kratom in multiple organ systems. Consumption of kratom can lead to a number of health impacts, including respiratory depression, nervousness, agitation, aggression, sleeplessness, hallucinations, delusions, tremors, loss of libido, constipation, skin hyperpigmentation, nausea, vomiting, and severe withdrawal signs and symptoms.”
Dr Daniel Fabricant, PhD, president and executive director of the Natural Products Association, said kratom does not belong in a dietary supplement setting.
“If this was sold in the supplement channel it shouldn’t have been there,” Fabricant said. “Yes, it’s a natural product, but so is cocaine. There is a legal structure for bringing products to market that people have to abide by.”
Status remains unclear
In July of last year FDA attempted have the US Drug Enforcement Administration put kratom on the schedule 1 list of controlled substances via an emergency listing. NPA and other dietary supplement industry stakeholders objected to that move, as it was deemed to be unduly hasty and a violation of due process. The agency also received significant citizen pushback organized by the American Kratom Association, which advocates for continued access to the botanical. The process reverted to a more formal, protracted listing proceeding with a public comment period that closed on Dec. 1 of last year. To date, DEA has made no formal ruling on the botanical’s status.