A new warning from the FDA reports multiple tests have found heavy metals in multiple kratom products. The alert comes after warnings and recalls this year because of a Salmonella outbreak traced to such products. 

Scott Gottlieb, FDA commissioner, said a stepped up testing program in response to the Salmonella outbreak revealed heavy metals, including lead and nickel, at dangerous levels. Scientists at the Food and Drug Administration tested 26 kratom products as part of the follow-up sampling program. 

“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 in the warning issued Nov. 27. 

“We are concerned that there may be other kratom products on the market that also contain heavy metals. As a result of our analysis, we’re contacting companies marketing these kratom products to make them aware of the heavy metal testing results. And we are putting out this advisory to warn consumers so that they can take steps to protect their health.”

Heavy metal poisoning may cause gastrointestinal tract symptoms, alopecia, mental disturbances such as irritability, concentration difficulties, and somnolence, and peripheral neuropathy, according to the Centers for Disease Control and Prevention. Lead poisoning is known to cause developmental and cognitive disorders in children.

Not a legal supplement
The FDA and CDC have been reviewing kratom products and the effect they have on people for several years. The substance, which is available in powder, tea, and capsule forms at retailers and online, is not legally marketed in the U.S. as a drug or dietary supplement.

Many of the recalled kratom products and others that remain on the market have labels claiming the substance, which is derived from the leaves of a plant native to Asia, has health benefits such as curing diabetes, lowering blood pressure, treating cancer, and reducing neuron damage caused by strokes. Some products are marketed as a non-opioid treatment for people who are addicted to opioids.

Public health officials say there is no evidence that kratom can help with any medical problems and that “certain substances in kratom have opioid properties and that one or more (of them) have the potential for abuse.”

The 41-state Salmonella outbreak traced to kratom products ended in May, with 199 people having contracted salmonellosis. Of the 199 laboratory-confirmed patients, more than a third — 38 percent — were so sick they had to be admitted to hospitals. The CDC reported no deaths were known of in relation to the outbreak.

“Despite all these risks, we know that kratom has grown in popularity in recent years due to unsubstantiated claims about its purported benefits,” Gottlieb said in the public warning.

“We know that many people have unmet needs when it comes to treating pain or addiction disorders. 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.”

FDA kratom timeline
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:

  • In September 2014, U.S. 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. in Van Nuys, CA.
  • In January 2016, U.S. Marshals, at the FDA’s request, seized nearly 90,000 bottles of dietary supplements labeled as containing kratom and worth more than $400,000. The product, manufactured for and held by Dordoniz Natural Products LLC, located in South Beloit, IL, is marketed under the brand name RelaKzpro.
  • In August 2016, U.S. Marshals, at the FDA’s request, seized more than 100 cases of products labeled as containing kratom and worth more than $150,000. The products are distributed by Nature Therapeutics LLC, which does business as Kratom Therapy and is located in Grover Beach, CA. The seized products are marketed under the brand name Kratom Therapy.

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