For Immediate Release: November 27, 2018 Statement From: Statement Author Leadership Role Commissioner of Food and Drugs - Food and Drug Administration Scott Gottlieb M.D.

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. These include warnings about the contamination of kratom products with extremely high rates of salmonella that put people using kratom products at risk, and resulted in numerous illnesses and recalls and the agency’s first-ever mandatory recall order after a rigorous investigation. As part of our efforts to assess kratom for contamination in the products tested, we also found disturbingly high levels of heavy metals in kratom products.

FDA scientists tested 26 separate kratom products obtained by our field investigators. These products were obtained as part of the efforts related to the multistate outbreak of salmonella infections or in connection with regulatory actions we’ve taken to protect consumers from companies selling unapproved kratom products with unsubstantiated claims about treating serious medical conditions. Among the heavy metals we found were lead and nickel at levels not considered safe 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. 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.

Kratom is not legally marketed in the U.S. as a drug or dietary supplement. While it is important to gather more evidence, data suggest that certain substances in kratom have opioid properties and that one or more have the potential for abuse.

Certain kratom products have been found to contain salmonella and cause infections. And now, there’s the potential for heavy metal exposure at unacceptable levels posing even more risk to consumers.

Despite all these risks, we know that kratom has grown in popularity in recent years due to unsubstantiated claims about its purported benefits. 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. 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. There are three drugs (buprenorphine, methadone, and naltrexone) approved by the FDA for the treatment of opioid use disorder, and the agency is committed to promoting more widespread innovation and access to these treatments to help those suffering from opioid use disorder transition to lives of sobriety. There are also safer, non-opioid options to treat pain. We’re deeply committed to these patients, and to advancing new, safe and effective options for those suffering from these conditions. I assure you that we’ll continue to pursue innovation in these areas.

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. To date, there have been no adequate and well-controlled scientific studies involving the use of kratom as a treatment for opioid use withdrawal or other diseases in humans. Nor have there been studies on how kratom, when combined with other substances, may impact the body, its dangers, potential side effects, or interactions with other drugs.

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.

###