FDA issues warning letters to companies selling kratom products
The U.S. Food and Drug Administration announced on Tuesday that it has issued warning letters to three marketers and distributors of kratom products for illegally selling unapproved kratom-containing drug products with unproven claims about their ability to help in the treatment of opioid addiction and withdrawal.
The companies are Front Range Kratom of Aurora, Colo.; Kratom Spot of Irvine, Calif.; and Revibe of Kansas City, Mo.
According to the FDA, the companies receiving warning letters use web sites where they take orders for kratom products or they use social media to make unproven claims about the ability of their kratom drug products to cure, treat, or prevent a disease, which is against the law. More specifically, the companies make claims about treating pain, as well as other medical conditions like lowering blood pressure, treating cancer and reducing neuron damage caused by strokes.
The FDA requested responses from each of the companies within 15 working days. The companies are directed to inform the agency of the specific actions taken to address each of the agency’s concerns. The warning letters also state that failure to correct violations may result in law enforcement action such as seizure or injunction.
“Despite our warnings that no kratom product is safe, we continue to find companies selling kratom and doing so with deceptive medical claims for which there’s no reliable scientific proof to support their use,” said Scott Gottlieb, FDA commissioner. “As we work to combat the opioid epidemic, we cannot allow unscrupulous vendors to take advantage of consumers by selling products with unsubstantiated claims that they can treat opioid addiction. Far from treating addiction, we’ve determined that kratom is an opioid analogue that may actually contribute to the opioid epidemic and puts patients at risk of serious side effects. If people believe that the active ingredients in kratom have drug-like effects that can treat pain or addiction, then the FDA is open to reviewing that data under our new drug approval process. In the meantime, I promised earlier this year that the FDA would step up our actions against unapproved and unsafe products that are being deceptively marketed for the treatment of opioid addiction and withdrawal symptoms. At the same time, we also promised to make the approval process more efficient for novel, safe and effective medical treatments aimed at the treatment of addiction; and to help more people suffering from addiction get access to approved therapies. In fulfilling these commitments, we’ll continue to take enforcement actions against unscrupulous products to protect the public health.”
The FDA continues to warn consumers not to use Mitragyna speciosa, commonly known as kratom, a plant which grows naturally in Thailand, Malaysia, Indonesia and Papua New Guinea. The FDA stated that it is concerned that kratom, which affects the same opioid brain receptors as morphine, appears to have properties that expose users to the risks of addiction, abuse and dependence. There are no FDA-approved uses for kratom, and the agency stated that it has received concerning reports about the safety of kratom.
The FDA is actively evaluating all available scientific information on this issue and continues to warn consumers not to use any products labeled as containing the botanical substance kratom or its psychoactive compounds, mitragynine and 7-hydroxymitragynine. The FDA also encourages more research to better understand kratom’s safety profile, including the use of kratom combined with other drugs.
Previous FDA testing also confirmed salmonella contamination in kratom products distributed by Revibe. In March, the FDA contacted Revibe regarding a recall of all Revibe kratom containing products that may be contaminated with salmonella. On April 3, the agency oversaw the destruction of products at Revibe’s facility, but, as of April 19, the company has not provided the FDA information to confirm that they have recalled the products it distributed.
The companies are Front Range Kratom of Aurora, Colo.; Kratom Spot of Irvine, Calif.; and Revibe of Kansas City, Mo.
According to the FDA, the companies receiving warning letters use web sites where they take orders for kratom products or they use social media to make unproven claims about the ability of their kratom drug products to cure, treat, or prevent a disease, which is against the law. More specifically, the companies make claims about treating pain, as well as other medical conditions like lowering blood pressure, treating cancer and reducing neuron damage caused by strokes.
The FDA requested responses from each of the companies within 15 working days. The companies are directed to inform the agency of the specific actions taken to address each of the agency’s concerns. The warning letters also state that failure to correct violations may result in law enforcement action such as seizure or injunction.
“Despite our warnings that no kratom product is safe, we continue to find companies selling kratom and doing so with deceptive medical claims for which there’s no reliable scientific proof to support their use,” said Scott Gottlieb, FDA commissioner. “As we work to combat the opioid epidemic, we cannot allow unscrupulous vendors to take advantage of consumers by selling products with unsubstantiated claims that they can treat opioid addiction. Far from treating addiction, we’ve determined that kratom is an opioid analogue that may actually contribute to the opioid epidemic and puts patients at risk of serious side effects. If people believe that the active ingredients in kratom have drug-like effects that can treat pain or addiction, then the FDA is open to reviewing that data under our new drug approval process. In the meantime, I promised earlier this year that the FDA would step up our actions against unapproved and unsafe products that are being deceptively marketed for the treatment of opioid addiction and withdrawal symptoms. At the same time, we also promised to make the approval process more efficient for novel, safe and effective medical treatments aimed at the treatment of addiction; and to help more people suffering from addiction get access to approved therapies. In fulfilling these commitments, we’ll continue to take enforcement actions against unscrupulous products to protect the public health.”
The FDA continues to warn consumers not to use Mitragyna speciosa, commonly known as kratom, a plant which grows naturally in Thailand, Malaysia, Indonesia and Papua New Guinea. The FDA stated that it is concerned that kratom, which affects the same opioid brain receptors as morphine, appears to have properties that expose users to the risks of addiction, abuse and dependence. There are no FDA-approved uses for kratom, and the agency stated that it has received concerning reports about the safety of kratom.
The FDA is actively evaluating all available scientific information on this issue and continues to warn consumers not to use any products labeled as containing the botanical substance kratom or its psychoactive compounds, mitragynine and 7-hydroxymitragynine. The FDA also encourages more research to better understand kratom’s safety profile, including the use of kratom combined with other drugs.
Previous FDA testing also confirmed salmonella contamination in kratom products distributed by Revibe. In March, the FDA contacted Revibe regarding a recall of all Revibe kratom containing products that may be contaminated with salmonella. On April 3, the agency oversaw the destruction of products at Revibe’s facility, but, as of April 19, the company has not provided the FDA information to confirm that they have recalled the products it distributed.