The FDA is cracking down on kratom, and has ordered US Marshalls to seize nearly 90,000 bottles of dietary the dietary supplements RelaKzpro manufactured for and held by Dordoniz Natural Products LLC, of South Beloit, Illinois. The raid came as a result of a complaint filed by the Department of Justice (on behalf of the Food and Drug Administration) in the US District Court for the Northern District of Illinois alleging (among other things), that kratom is a “new dietary ingredient for which there is inadequate information to provide reasonable assurance that it does not present a significant or unreasonable risk of illness or injury; therefore, dietary supplements containing kratom are adulterated under the FD&C Act. The action allows authorities to keep certain products off the marketplace for up to 30-days while they investigate its safety.
Although relatively new to the United States, kratom was been long used by natives of Thailand as a substitute for opium to treat chronic pain and alter moods until outlawed by the government there more than 70-years ago. The plant (aka Mitragyna speciosa ), which is a deciduous and evergreen related to coffee, is also found in. Malaysia, Indonesia and Papua New Guinea.
“We have identified kratom as a botanical substance that could pose a risk to public health and have the potential for abuse,” stated the FDA’s associate commissioner for regulatory affairs.Melinda Plaiser. “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.”
Side effects associated with chronic kratom use include loss of appetite and weight loss, delayed ejaculation, constipation, and darkening of the skin color of the face, respiratory depression, vomiting, and nervousness. The plant has also 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. As a result, the FDA is warning consumers not to use any products labeled as containing kratom. Health care professionals and consumers should report any adverse events related to products containing kratom to the FDA’s MedWatch programKratom Starter Pack