The FDA seizes $1.3M worth of Kratom included in dietary supplements alongside bulk dietary ingredients also containing Kratom. The Food and Drugs Administration’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.

Kratom Ingredients

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.

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In a 2018 letter made public earlier this year, HHS rescinded a request for DEA to classify two constituents of kratom as a Schedule I controlled substance under the Controlled Substances Act (CSA).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

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

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.

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.

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