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Supplements Containing Kratom Seized by US Marshals
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Nearly 90,000 bottles of dietary supplements containing kratom have been seized by US Marshals, according to the FDA.
Nearly 90,000 bottles of dietary supplements containing kratom have been seized by US Marshals, according to the FDA.
Health care providers and consumers may know the product as RelaKzpro, which is worth more than $400,000 and manufactured by Illinois-based Dordoniz Natural Products, LLC.
Kratom, which grows naturally in Thailand, Malaysia, Indonesia, and Papua New Guinea, can lead to respiratory depression, vomiting, nervousness, weight loss, and constipation.
The substance can also act like a narcotic and produce stimulant and withdrawal symptoms, including hostility, aggression, excessive tearing, aching of muscles and bones, and jerky limb movements.
“We have identified kratom as a botanical substance that could pose a risk to public health and have the potential for abuse,” said Melinda Plaisier, the FDA’s associate commissioner for regulatory affairs, in a press release. “The FDA will continue to exercise our full authority under law to take action on these new dietary ingredients, especially if they ignore the notification requirements, as part of our commitment to protecting the health of the American people.”
Back in 2014, the FDA allowed US officials to detain imports of dietary supplements and ingredients that contained kratom without physical examination.
Now, the FDA has administratively detained the product under the Federal Food, Drug and Cosmetic Act, as amended by the Food Safety Modernization Act.
This means that the FDA can restrict the products from entering the marketplace for 30 days while it takes further action.
According to an FDA press release, the US Department of Justice filed a complaint that there is not sufficient evidence that kratom does not pose significant risks, so products containing the substance are considered adulterated under the Federal Food, Drug and Cosmetic Act.
Patients should not use any products containing kratom, and health care professionals and consumers may report adverse events to the FDA’s MedWatch program.
