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FDA seizes kratom supplements

Article-FDA seizes kratom supplements

kratom 2020
FDA's announcement that U.S. Marshals seized dietary supplements containing kratom ignited a war of words on Twitter between former high-ranking government officials.

Federal authorities recently seized dietary supplements and bulk dietary ingredients containing kratom over continuing concerns that the products pose risks to public health.

The seized products are worth roughly $1.3 million and the subject of a lawsuit filed in Florida by the U.S. Department of Justice (DOJ), according to an FDA news release. U.S. marshals at FDA's request seized more than 207,000 units of dietary supplements and bulk dietary ingredients that are or contain kratom, including more than 34,000 kilograms of bulk kratom, FDA announced.

Twitter war 

The announcement ignited a war of words on Twitter between former high-ranking government officials.

Dr. Scott Gottlieb, a former commissioner of FDA who resigned in 2019, said in a tweet that the U.S. Department of Health and Human Services (HHS) prevented FDA “from moving forward with the scheduling of kratom, and I’m convinced it’s fueling the opioid addiction crisis.”

In a 2018 letter made public earlier this year, HHS rescinded a request for DEA to classify two constituents of kratom as a Schedule I controlled substance under the Controlled Substances Act (CSA).

“The Biden Administration should follow through on efforts of FDA, NIH [National Institutes of Health] and DEA—and the new ASH [assistant secretary of health] should affirm health findings of these agencies,” Gottlieb said.

Responding to Gottlieb, Dr. Brett Giroir, former assistant secretary of health, clarified in a tweet that FDA recommends scheduling a substance but doesn’t schedule it. DEA is responsible for implementing and enforcing the CSA.

In the 2018 letter to then-DEA Acting Administrator Uttam Dhillon, Giroir recommended two constituents of kratom—mitragynine and 7-hydroxmitragynine—not be controlled either temporarily or permanently until such action is supported by scientific research.

“FDA's recommendation” to schedule kratom’s constituents “was rejected b/c of embarrassingly poor evidence & data, and a failure to consider overall public health,” Giroir tweeted in response to Gottlieb. “If #Kratom is fueling opioid addiction, prove it; and then @HHS_ASH should reconsider.”

Gottlieb then shot back a rebuttal: “It’s true: Brett Giroir unilaterally overruled a considered, multi-year, scientific effort by the NIH, FDA and DEA and a careful analysis in an act I found hasty and ill-conceived. He overruled the findings made by the prior career ASH. I believe public health suffered as result.”

'Poor science and data' 

Kratom advocates maintain FDA has an inherent bias against the botanical not grounded in science.

“FDA doesn’t like kratom” and has taken the position that since the botanical isn’t approved for any use, all kratom is adulterated, said C.M. (“Mac”) Haddow, senior fellow on public policy with the American Kratom Association (AKA). “That’s a seismic shift away from what the law says the FDA’s authority is and how it’s been actually applied.”

FDA can’t get kratom “scheduled because of the embarrassingly poor science and data,” and “without any claim that’s credible, they’re just now doing a de-facto ban on kratom,” Haddow said in an interview. “That’s their end game.”

Many users of kratom have maintained it helped them wean off heroin and other opioids. FDA, on the other hand, has continued to raised safety concerns over the botanical and previously asserted it could be exacerbating the opioid epidemic. According to DOJ’s lawsuit filed in the U.S. District Court in the Middle District of Florida, kratom’s major alkaloid—mitragynine—produces effects similar to morphine.

'Adulterated' kratom products 

“There is substantial concern regarding the safety of kratom, the risk it may pose to public health and its potential for abuse,” said Judy McMeekin, FDA’s associate commissioner for regulatory affairs, in the press release announcing the recent seizure. “The FDA will continue to exercise our full authority under the law to take action against these adulterated dietary supplements as part of our ongoing commitment to protect the health of the American people. Further, there are currently no FDA-approved uses for kratom.”

The seized products are made by Atofil LLC of Fort Myers, Florida, a subsidiary of Premier Manufacturing Products, which did not immediately respond to requests for comment for this article. FDA said the dietary supplements are marketed under the brand names Boosted Kratom, The Devil’s Kratom, Terra Kratom, Sembuh, Bio Botanical and El Diablo.

DOJ alleged in an amended complaint that defendant’s articles are “adulterated” because “they contain or are a new dietary ingredient [NDI], kratom, for which there is inadequate information to provide reasonable assurance that this ingredient does not present a significant or unreasonable risk of illness or injury.”

According to FDA, consumption of kratom can lead to such effects as constipation, nervousness, respiratory depression, vomiting and weight loss. “Kratom has been indicated to have both narcotic and stimulant-like effects, and withdrawal symptoms may include hostility, aggression, excessive tearing, aching of muscles and bones and jerky limb movements,” FDA cautioned in its news release.

FDA in February 2014 issued an import alert related to kratom. Updated from time to time, the import alert provides guidance to FDA field staff about detaining without physical examination imported dietary supplements and bulk dietary ingredients that are or contain kratom.

Echoing McMeekin, on May 21, FDA's acting commissioner Dr. Janet Woodcock added her thoughts on social media, tweeting, “There are currently no FDA-approved therapeutic uses for products containing kratom, and the FDA has identified significant safety concerns associated with its use.”

TAGS: Ingredients
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