![]() The products are distributed by Nature Therapeutics LLC, which does business as Kratom Therapy and is located in Grover Beach, California. Marshals, at the FDA’s request, seized more than 100 cases of products labeled as containing kratom and worth more than $150,000. The product, manufactured for and held by Dordoniz Natural Products LLC, located in South Beloit, Illinois, is marketed under the brand name RelaKzpro. Marshals, at the FDA’s request, seized nearly 90,000 bottles of dietary supplements labeled as containing kratom and worth more than $400,000. Marshals, at the FDA’s request, seized more than 25,000 pounds of raw kratom material worth more than $5 million from Rosefield Management, Inc. Since identifying kratom on an import alert for unapproved drugs in 2012 and on a second import alert in February 2014 regarding kratom-containing dietary supplements and bulk dietary ingredients, FDA has taken a number of additional actions, including: FDA encourages more research to better understand kratom’s safety profile, including the use of kratom combined with other drugs. FDA is actively evaluating all available scientific information on this issue and continues to warn consumers not to use any products labeled as containing the botanical substance kratom or its psychoactive compounds, mitragynine and 7-hydroxymitragynine. There are no FDA-approved uses for kratom, and the agency has received concerning reports about the safety of kratom. FDA is concerned that kratom, which affects the same opioid brain receptors as morphine, appears to have properties that expose users to the risks of addiction, abuse, and dependence. Food and Drug Administration is warning consumers not to use Mitragyna speciosa, commonly known as kratom, a plant which grows naturally in Thailand, Malaysia, Indonesia, and Papua New Guinea.
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