WASHINGTON — Seeking to short-circuit any possible regulation by the U.S. Food and Drug Administration amid increasing reports of overdose deaths, the American Kratom Association is urging kratom users and sellers to call their representatives in support of new legislation.
“We want a tsunami wave to hit Congress,” says AKA chairman Matt Salmon, a former Republican congressman from Arizona, during an Oct. 18 instructional webinar. He urged kratom users to enlist friends and family to use the AKA’s website to send letters and even automatically dial the telephones of their congressional representatives and voice their support.
Kratom is a southeast Asian tree that produces leaves that can be chewed, eaten or brewed in tea. In low doses it increases stamina and in high doses acts as a painkiller and mood relaxer. More than a million Americans use it and scientists are studying its effects for use in medicine.
Nominally illegal to import for human consumption since the FDA established an “Import Alert” a decade ago, kratom remains legal to possess in 45 states, with age restrictions in some states and bans in a few counties. There is a gray market of online sellers, kava bars and convenience store vendors serving users who take the drug for chronic pain, opioid withdrawal symptoms and for other reasons, although as yet no studies have proven its efficacy.
The AKA, a nonprofit advocacy group funded by kratom vendors and consumers, took the lead in beating back an effort to schedule kratom as an illegal drug in 2016. The group claims the federal regulators, whose responsibility extends to all drugs, all supplements and much of the food processed, manufactured, marketed and sold in the country, have waged a vendetta against kratom.
The bill, introduced by Republican Senator Mike Lee of Utah and cosponsored by Democratic Senator Cory Booker of New Jersey, would legalize the importation of kratom into the U.S., prohibit the FDA from regulating it as a new dietary ingredient, and establish a “Kratom Research Task Force” charged with reporting kratom’s benefits and drawbacks within 90 days of the law’s adoption. Representative Mark Pocan, a Wisconsin Democrat, has introduced a companion bill in the House, which is currently deadlined by the Republican majority’s inability to elect a speaker.
If enacted, the new law would “make FDA accountable for all of the disinformation” it has promulgated against kratom, Mac Haddow, AKA’s principal lobbyist, said in the webinar. The FDA recently updated its web page on the substance, reiterating that kratom is an unapproved new dietary ingredient with no medical use.
“Consistent with FDA’s practice with unapproved substances, until the agency scientists can evaluate the safety and effectiveness of kratom (or its components) in the treatment of any medical conditions, FDA will continue to warn the public against the use of kratom for medical treatment. The agency will also continue to monitor emerging data trends to better understand the substance and its components.”
But in an email, Haddow said the FDA is cracking down due to the transgressions of a few
“The FDA has improperly used import alerts and claims that all kratom or kratom products are adulterated products under the Federal Food, Drug, and Cosmetic Act (FDCA) because some kratom vendors make illegal marketing claims on their products,” Haddow wrote. “These regulatory actions have intentionally circumvented the requirements of the CSA and interfered with the freedom of Americans to make informed decisions about kratom products that they choose to use to maintain their health and well-being. This legislation will allow the FDA to focus its limited resources to address food contamination, including kratom, that poses a public health risk from salmonella, e-coli, heavy metals, and other contaminants.”
Meanwhile, a lawyer who has sued kratom vendors on behalf of the families of overdose victims said the proposed legislation is dangerous.
“The timing here is critical, not for my case, but for public safety,” says Talis Abolins, an attorney with the Washington firm MCTLaw, which in July won an $11 million award for the kratom death of Krystal Talavera in Florida and a $2.5 million jury award for the death of Patrick Coyne in Washington state. “They’re literally going for the jugular.”
Kratom vendors have tried and failed to get the product approved under existing law, Abolins said, and “they haven’t met the standards of showing premarket safety. How could they? So now they’re putting all their resources into Congress to eliminate the law that says they have to prove it’s safe before they sell it.”
Using court filings, news reports and other public records, Courthouse News detailed eight overdose deaths — including those of Talavera and Coyne — by kratom in a 2022 series about the drug and the industry that pushes it. Despite the rulings of medical examiners in many states, and toxicology reports showing no significant levels of other drugs in these victims’ otherwise healthy bodies, and now judges and jury awards, the AKA says that these deaths are not proven to be from kratom.
“The number of REPORTED kratom overdoses are increasing,” Haddow said in an email, “but that has nothing to do with whether there are actual kratom overdose deaths occurring. The FDA’s bully pulpit, and the accompanying interest in kratom, likely accounts for those increased reports.”
A study of overdose deaths between 2020 and 2021 in Florida found more than 500 from kratom, 21 of which were attributed to kratom alone.
“It’s almost a full-time job doing kratom cases,” Abolins says. “We have 10 of them now and we turn down about 10 times that many.”
Read the 2022 series on kratom:
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