On April 3, 2019, the FDA released the results of its tests that found dangerous levels of lead and nickel in certain kratom products. The agency tested 30 products sold on websites such as krakenkratom.com and by retailers such as Gaia Ethnobotanicals, Sunstone Organics LLC and Happy Hippo LLC. The newly released test results include product and retailer names and websites, and the exact amounts of lead and nickel found in each product.
Levels of lead in the products ranged from less than 0.2 mcg per gram to as much as 2.7 mcg per gram. In comparison, the State of California's Prop 65 limit for lead in dietary supplements is 0.5 mcg per recommended daily serving, or slightly higher for supplements containing substantial amounts of mineral such as calcium and magnesium. Levels of nickel in the tested kratom products ranged from 0.57 mcg per gram to as much as 29 mcg per gram. The FDA calculated that, "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."
FDA Commissioner Scott Gottlieb, M.D. called the levels of heavy metals found in the products "disturbingly high" and stated that the agency has 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."
In fact, the FDA first warned consumers that some kratom products contain high levels of lead and nickel in November 2018.
Earlier in 2018, the FDA urged consumers not to use kratom due to its opioid-like effects and side effects, and pointing to least 44 deaths that have been linked with the use of kratom products.
Kratom products have also been the subject of numerous recalls over the past year due to an outbreak of illness associated with Salmonella contamination in kratom products.
For other Recalls and Warnings click HERE.For information about reporting serious reactions and problems with medical products to the U.S. Food and Drug Administration through its MedWatch reporting program, please go to http://www.fda.gov/medwatch/how.htm.
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