April 3, 2019
FDA Office of Media Affairs
"Over the last year, the FDA has issued numerous warnings about the serious risks associated with the use of kratom, including novel risks due to the variability in how kratom products are formulated, sold and used both recreationally and by those who are seeking to self-medicate for pain or to treat opioid withdrawal symptoms. Among these warnings are the extremely high rates of contamination of kratom products with salmonella that have resulted in numerous illnesses and recalls, leading to the agency’s first-ever mandatory recall order after a rigorous investigation. Our most recent warning was about disturbingly high levels of heavy metals found in kratom products," said FDA Commissioner Scott Gottlieb, M.D. "After FDA scientists conducted an analysis of these metals, we’ve been attempting to work with the companies whose products were found to contain high levels of heavy metals, and we’ve warned consumers of the risks associated with kratom in general. To help make sure consumers are fully informed of these risks, we’re releasing our final laboratory test results. The data from these results support our public warning about the risk of heavy metals in kratom products. Data suggest that certain substances in kratom have opioid properties and that one or more have the potential for abuse. The findings of identifying heavy metals in kratom only strengthen our public health warnings around this substance and concern for the health and safety of Americans using it."
The U.S. Food and Drug Administration today released the results of laboratory testing performed by the agency of 30 kratom products from a variety of sources to determine if they contain heavy metals. The analysis found significant levels of lead and nickel at concentrations that exceed safe exposure for oral daily drug intake. The FDA first warned of the risk of heavy metals, including lead and nickel, in kratom products at levels not considered safe for human consumption in November 2018.
Based on reported kratom usage patterns, heavy kratom users may be exposed to levels of lead and nickel many times greater than the safe daily exposure. The test results show that the typical long-term kratom user could potentially develop heavy metal poisoning, which could include nervous system or kidney damage, anemia or high blood pressure and/or increased risk of certain cancers.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.