FDA Warns of 'Disturbingly' High Levels of Heavy Metals in Kratom Products

Megan Brooks

Disclosures

November 27, 2018

Some kratom products contain "disturbingly" high levels of heavy metals, the US Food and Drug Administration (FDA) warned today.

"Among the heavy metals we found were lead and nickel at levels not considered safe for human consumption," FDA Commissioner Scott Gottlieb, MD, said in a statement.

FDA scientists tested 26 different kratom products. "While the levels of the specific products we've tested so far are not likely to result in immediate acute heavy metal poisoning from a single use, some of these products included levels that, with chronic use, could cause some people to suffer from heavy metal poisoning," Gottlieb said.

The agency is concerned that there may be other kratom products on the market that also contain heavy metals.

No Approved Use

Kratom is derived from the leaves from the kratom tree (Mitragyna speciosa), which is native to Thailand, Indonesia, and Papua New Guinea. The botanical's popularity has been increasing in the United States, with those who take it and manufacturers claiming it can help treat pain, anxiety, depression, and more recently, opioid withdrawal.

Earlier this year, an analysis of kratom by FDA scientists found that its compounds act like prescription-strength opioids, as reported by Medscape Medical News.

The scientific data and adverse event reports have "clearly revealed" that compounds in kratom make it "not just a plant — it's an opioid," Gottlieb, MD, said in a statement back in February. "Claiming that kratom is benign because it's 'just a plant' is short-sighted and dangerous," he added.

Kratom has been linked to numerous deaths in the United States. There are currently no FDA-approved uses for kratom, and the agency has advised against using kratom or its psychoactive compounds mitragynine and 7-hydroxymitragynine in any form and from any manufacturer. 

The FDA continues to crackdown on companies selling unapproved kratom products with unsubstantiated claims about its purported benefits.

Over the past year, the agency issued numerous warnings about the serious risks associated with the use of kratom, including risks because of the variability in how kratom products are formulated, sold, and used both recreationally and by those seeking to self-medicate for pain or opioid withdrawal symptoms.  

Kratom products have also been found to be contaminated with Salmonella resulting in numerous illnesses and product recalls.

Health providers are encouraged to report any adverse reactions related to kratom products to MedWatch, the FDA's safety information and adverse event reporting program.

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