FDA finds heavy metals in some kratom products

FDA’s top official revealed this week that his agency identified heavy metals, including lead and nickel, in some kratom products at levels unsafe for human consumption.

Josh Long, Associate editorial director, Natural Products Insider

November 29, 2018

3 Min Read
FDA finds heavy metals in some kratom products

FDA’s top official revealed this week that his agency identified heavy metals, including lead and nickel, in some kratom products at levels unsafe for human consumption.

“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,” FDA Commissioner Scott Gottlieb, M.D., said in a Nov. 27 statement. “We are concerned that there may be other kratom products on the market that also contain heavy metals.”

The revelation is just the latest warning from FDA that kratom, a botanical from Southeast Asia, poses risks to human health.

Gottlieb said FDA scientists tested 26 separate kratom products obtained by the agency’s field investigators as part of efforts related to a multistate outbreak of salmonella infections or concerning actions taken by FDA to protect consumers from unsubstantiated claims from marketers that their unapproved kratom products treat serious medical conditions.

Lyndsay Meyer, an FDA spokeswoman, confirmed all 26 products contained lead and/or nickel.

Kratom is consumed for various purposes, experts said, including treatment of minor pain, to relieve anxiety and for respite from withdrawal symptoms associated with use of opioids. The botanical--otherwise known as Mitragyna speciosa--has been used for more than a century in Southeast Asia, and an estimated three to five million Americans use kratom.

FDA has described certain compounds in kratom as opioids, and Gottlieb said the botanical is not legally marketed in the United States as either a drug or dietary supplement.

“For individuals seeking treatment for opioid use disorder who are being told that kratom can be an effective treatment, I urge you to seek help from a health care provider,” he said. “More widespread adoption of treatment with safe and effective FDA-approved medications, coupled with relevant social, medical and psychological services, has the highest probability of being the most effective way to help those suffering from opioid addiction transition to lives of sobriety.”

As reported earlier this month by STAT, the U.S. Department of Health and Human Services (HHS) through FDA has recommended to the Drug Enforcement Administration (DEA) that two compounds in kratom—mitragynine and 7-hydroxymitragynine—be controlled as Schedule I drugs under the Controlled Substances Act.

If adopted by DEA through a scheduling action, HHS’ recommendation would place kratom in the same drug category as heroin, peyote and LSD, making the botanical unlawful to purchase in the United States and forcing consumers who wanted it to turn to the black market.

On Nov. 28, a group of researchers and scientists sent a letter to federal agencies including FDA expressing “major concerns” regarding HHS’ “conclusions, the actions that could be based upon it, and the implications for public health.”

An eight-factor analysis conducted by FDA, the researchers proclaimed, neglected to “include the serious public health consequences that will result from scheduling kratom, including potential exacerbation of the opioid epidemic.”











About the Author(s)

Josh Long

Associate editorial director, Natural Products Insider, Informa Markets Health and Nutrition

Josh Long directs the online news, feature and op-ed coverage at Natural Products Insider, which targets the health and wellness industry. He has been reporting on developments in the dietary supplement industry for over a decade, with a focus on regulatory issues, including at the Food and Drug Administration.

He has moderated and/or presented at industry trade shows, including SupplySide East, SupplySide West, Natural Products Expo West, NBJ Summit and the annual Dietary Supplement Regulatory Summit.

Connect with Josh on LinkedIn and ping him with story ideas at [email protected]

Education and previous experience

Josh majored in journalism and graduated from Arizona State University the same year "Jake the Snake" Plummer led the Sun Devils to the Rose Bowl against the Ohio State Buckeyes. He also holds a J.D. from the University of Wyoming College of Law, was admitted in 2008 to practice law in the state of Colorado and spent a year clerking for a state district court judge.

Over more than a quarter century, he’s written on various topics for newspapers and business-to-business publications – from the Yavapai in Arizona and a controversial plan for a nuclear-waste incinerator in Idaho to nuanced issues, including FDA enforcement of the Dietary Supplement Health and Education Act of 1994 (DSHEA).

Since the late 1990s, his articles have been published in a variety of media, including but not limited to, the Cape Cod Times (in Massachusetts), Sedona Red Rock News (in Arizona), Denver Post (in Colorado), Casper Star-Tribune (in Wyoming), now-defunct Jackson Hole Guide (in Wyoming), Colorado Lawyer (published by the Colorado Bar Association) and Nutrition Business Journal.

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