Statement from FDA Commissioner Scott Gottlieb, M.D., on new warning letters FDA is issuing to companies marketing kratom with unproven medical claims; and the agency's ongoing concerns about kratom

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Sep 11, 2018, 11:32 ET

SILVER SPRING, Md., Sept. 11, 2018 /PRNewswire/ -- Epidemics don't occur overnight. As we deal with the devastating crisis of opioid abuse and overdose plaguing our nation, the U.S. Food and Drug Administration must remain vigilant and aggressive against trends that threaten to reverse our progress, or substances that have the potential to cause new epidemics of abuse.

Mitragyna speciosa, known more commonly as kratom, is a plant native to Thailand, Malaysia, Indonesia and Papua New Guinea. While it is important to generate more evidence, there is evidence that certain substances found in kratom are opioids and data suggest that one or more may have a potential for abuse. And its use has been on the rise and is of concern to the FDA. We're not alone in our concern about the opioids found in kratom – it's already illegal or controlled in several other countries including Australia, Denmark, Germany, Malaysia and Thailand. The substance is also banned in a number of states and municipalities in the U.S.

Science and evidence matter in demonstrating medical benefit, especially when a product is being marketed to treat serious diseases like opioid use disorder (OUD). However, 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. Today's action is based on these concerns. The FDA issued warning letters to two more unscrupulous vendors, Chillin Mix Kratom and Mitra Distributing, for marketing kratom products with scientifically unsubstantiated claims including to "relieve opium withdrawals" and to "treat a myriad of ailments including but not limited to: diarrhea, depression, diabetes, obesity, high blood pressure, stomach parasites, diverticulitis, anxiety, alcoholism, and opiate withdrawal." Simply, selling these unapproved kratom products with claims that they can treat opioid withdrawal and addiction and other serious medical conditions is a violation of federal law.

Yet despite our warnings and previous regulatory and enforcement actions, we continue to find marketers actively selling kratom with unsubstantiated claims.

Fraudulent health claims can pose serious health risks. They may keep some patients from seeking appropriate, FDA-approved therapies. Reliance on products with unsubstantiated claims may delay those who suffer from OUD from entering recovery and may put them at greater risk of overdose and death. We know that patients receiving FDA-approved medication-assisted treatment (MAT) cut their risk of death in half, according to the Substance Abuse and Mental Health Services Administration.

As U.S. Department of Health and Human Services and the others in the federal government work to reduce the number of Americans who are addicted to opioids ad other substances, the FDA will continue to promote innovation and more widespread access to FDA-approved treatments for OUD. While HHS is taking new steps to make safe and effective MAT available to those who suffer from OUD, we must also work to reduce the stigma that is sometimes associated with use of these therapies. In parallel, we cannot allow kratom products with unsubstantiated claims to prevent those with OUD from seeking treatments that have been demonstrated to be safe and effective.

At HHS and within the FDA, we have great concern for the many Americans who misuse any drugs, especially opioids. In support of the public health, we continue to urge consumers not to consume kratom and to seek appropriate medical care from their health care provider. We will also continue to take action against those who put the safety of Americans at risk and who violate federal law by making unsubstantiated health claims about products that they seek to sell.

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The Food and Drug Administration, 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.

Media Inquiries: FDA Office of Media Affairs, 301-796-4540, [email protected]

SOURCE U.S. Food and Drug Administration