The FDA later announced the voluntary destruction and recall of a large volume of kratom-containing dietary supplements manufactured and distributed nationwide under the brand names Botany Bay, Enhance Your Life and Divinity by Divinity Products Distribution of Grain Valley, Missouri. In cooperation with the FDA, the company has also agreed to stop selling all products containing kratom. "Based on the scientific evidence of the serious risks associated with the use of kratom, in the interest of public health, the FDA encourages all companies currently involved in the sale of products containing kratom intended for human consumption to take similar steps to take their products off the market and submit any necessary evidence, as appropriate, to the FDA to evaluate them based on the applicable regulatory pathway."
Kratom, (Mitragyna speciosa) is a plant that grows naturally in Thailand, Malaysia, Indonesia, and Papua New Guinea that is used as herb to provide relief from pain, depression and anxiety. But according to FDA, "evidence shows that kratom has similar effects to narcotics like opioids, and carries similar risks of abuse, addiction and in some cases, death. Thus, it’s not surprising that often kratom is taken recreationally by users for its euphoric effects. At a time when we have hit a critical point in the opioid epidemic, the increasing use of kratom as an alternative or adjunct to opioid use is extremely concerning."
According to the FDA, they aware of reports of 36 deaths associated with the use of misuse of kratom-containing products. So to what degree will people using this as a recreational mood enhancer worry about a Salmonella issue?
FDA Alert
https://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm597415.htm
FDA Investigates Multistate Outbreak of Salmonella Infections Linked to Products Reported to Contain Kratom
February 20, 2018
The U.S. Food and Drug Administration along with the Centers for Disease Control and Prevention (CDC) and state and local officials are investigating a multistate outbreak of Salmonella infections linked to products reportedly containing kratom.
Fast Facts
The FDA, CDC, and state and local officials are investigating a multistate outbreak of salmonellosis from a rare strain of Salmonella I 4,[5],12:b:-. CDC reports that epidemiologic evidence collected to date indicates that products reported to be kratom or contain kratom are a likely source of this outbreak. These products are marketed in many forms, including as leaves, pills, capsules, powder, and tea, and may not mention kratom on the labeling. Other names for kratom that have been identified by the U.S. Drug Enforcement Administration (DEA) are: Mitragyna speciosa, mitragynine extract, biak-biak, cratom, gratom, ithang, kakuam, katawn, kedemba, ketum, krathom, krton, mambog, madat, Maeng da leaf, nauclea, Nauclea speciosa, or thang.
During interviews conducted by health officials, ill people were asked about the foods they ate and other exposures before they became ill. Eight (73%) of 11 people interviewed reported consuming kratom in pills, powder, or tea. No common brands or suppliers of kratom associated with the outbreak have been identified at this time. The FDA is currently working with state and local health officials to identify specific brand names or suppliers of products reportedly containing kratom used by ill people to learn more about the source and route of Salmonella contamination.
As of February 16, the outbreak includes 28 people in 20 states [AL(1), AZ (1), CA (3), CO (1), FL (1), KS (1), KY (1), LA (1), MA(1), MI (1), NC (2), ND(1), NY(1), OH (2), OK (2), OR (2), PA (2), SC(1), TN(1), UT (2)]. Eleven of these people have been hospitalized and no deaths have been reported. Ill people range in age from 6 to 67 years.
All of the cases have been confirmed to have a rare strain of Salmonella I 4,[5],12:b:-. Whole genome sequencing performed to date on isolates from ill people are closely relatedly genetically. This means that people in this outbreak are more likely to share a common source of infection.
FDA Alert
https://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm597415.htm
FDA Investigates Multistate Outbreak of Salmonella Infections Linked to Products Reported to Contain Kratom
February 20, 2018
The U.S. Food and Drug Administration along with the Centers for Disease Control and Prevention (CDC) and state and local officials are investigating a multistate outbreak of Salmonella infections linked to products reportedly containing kratom.
Fast Facts
- The FDA is advising consumers to avoid kratom and kratom-containing products. These products have been linked to a multistate outbreak of salmonellosis from a rare strain of Salmonella. Mitragyna speciosa, commonly known as kratom, is a plant that grows naturally in Thailand, Malaysia, Indonesia, and Papua New Guinea.
- The CDC reports that 28 people in 20 states are infected with Salmonella I 4,[5],12:b:-. Eleven people have been hospitalized.
- During interviews conducted by health officials, ill people were asked about the foods they ate and other exposures before they became ill. Eight (73%) of 11 people interviewed reported consuming kratom in pills, capsules, powder, or tea.
- Kratom is marketed in many forms, including as leaves, pills, capsules, powder, and tea. No common brands or suppliers of products reportedly containing kratom associated with this outbreak have been identified at this time. The FDA is working with state and local health officials and CDC to identify specific brand names or suppliers of products to learn more about the possible source and route of Salmonella contamination and will share more information as it becomes available.
The FDA, CDC, and state and local officials are investigating a multistate outbreak of salmonellosis from a rare strain of Salmonella I 4,[5],12:b:-. CDC reports that epidemiologic evidence collected to date indicates that products reported to be kratom or contain kratom are a likely source of this outbreak. These products are marketed in many forms, including as leaves, pills, capsules, powder, and tea, and may not mention kratom on the labeling. Other names for kratom that have been identified by the U.S. Drug Enforcement Administration (DEA) are: Mitragyna speciosa, mitragynine extract, biak-biak, cratom, gratom, ithang, kakuam, katawn, kedemba, ketum, krathom, krton, mambog, madat, Maeng da leaf, nauclea, Nauclea speciosa, or thang.
During interviews conducted by health officials, ill people were asked about the foods they ate and other exposures before they became ill. Eight (73%) of 11 people interviewed reported consuming kratom in pills, powder, or tea. No common brands or suppliers of kratom associated with the outbreak have been identified at this time. The FDA is currently working with state and local health officials to identify specific brand names or suppliers of products reportedly containing kratom used by ill people to learn more about the source and route of Salmonella contamination.
As of February 16, the outbreak includes 28 people in 20 states [AL(1), AZ (1), CA (3), CO (1), FL (1), KS (1), KY (1), LA (1), MA(1), MI (1), NC (2), ND(1), NY(1), OH (2), OK (2), OR (2), PA (2), SC(1), TN(1), UT (2)]. Eleven of these people have been hospitalized and no deaths have been reported. Ill people range in age from 6 to 67 years.
All of the cases have been confirmed to have a rare strain of Salmonella I 4,[5],12:b:-. Whole genome sequencing performed to date on isolates from ill people are closely relatedly genetically. This means that people in this outbreak are more likely to share a common source of infection.
What are the Symptoms of Salmonella Infection?
Salmonella bacteria cause the foodborne illness salmonellosis. Most people infected with Salmonella develop diarrhea, fever, and abdominal cramps. The illness usually lasts 4 to 7 days, and most people recover without treatment. However, in the current outbreak, an unusually high rate of cases have been hospitalized for their illness.
How Soon After Exposure do Symptoms Appear?
Most people infected with Salmonella develop diarrhea, fever, and abdominal cramps 12 to 72 hours after infection.
What are the Complications of Salmonella Infections?
In some people, the diarrhea may be so severe that they need to be hospitalized. In these patients, the Salmonella infection may spread from the intestines to the blood stream and then to other body sites and can cause death unless the person is treated promptly with antibiotics.
Who is at Risk?
Children are the most likely to get salmonellosis, although other groups are also at risk. Children younger than five, the elderly, and those people with weakened immune systems are more likely to have severe infections. It is estimated that approximately 400 persons in the United States with acute salmonellosis die each year.
What Do Consumers Need To Do?
Consumers who have symptoms of salmonellosis should contact their health care provider. If you are diagnosed with salmonellosis, be sure to tell your health care provider about all products you may be using, including products reported to contain kratom. Consumers should be aware that some products may not list kratom on the labeling.
The FDA advises consumers to avoid kratom in any form. In addition to the public health concerns raised by this outbreak, kratom affects the same opioid brain receptors as morphine and appears to have properties that expose people who consume kratom to the risks of addiction, abuse, and dependence.
There are no FDA-approved uses for kratom, and the agency has received concerning reports about the safety of kratom, including deaths associated with its use. 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. FDA encourages more research to better understand kratom’s safety profile, including the use of kratom combined with other drugs.
Who Should be Contacted?
The FDA encourages consumers with questions about food safety to call 1-888-SAFEFOOD or
consult the fda.gov website: http://www.fda.gov.
FDA News Release
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm597649.htm
FDA oversees destruction and recall of kratom products; and reiterates its concerns on risks associated with this opioidFor Immediate Release
February 21, 2018
Summary
FDA oversees destruction and recall of kratom products; and reiterates its concerns on risks associated with this opioid
Release
The U.S. Food and Drug Administration today announced the voluntary destruction and recall of a large volume of kratom-containing dietary supplements manufactured and distributed nationwide under the brand names Botany Bay, Enhance Your Life and Divinity by Divinity Products Distribution of Grain Valley, Missouri. In cooperation with the FDA, the company has also agreed to stop selling all products containing kratom. Based on the scientific evidence of the serious risks associated with the use of kratom, in the interest of public health, the FDA encourages all companies currently involved in the sale of products containing kratom intended for human consumption to take similar steps to take their products off the market and submit any necessary evidence, as appropriate, to the FDA to evaluate them based on the applicable regulatory pathway.
“The extensive scientific data we’ve evaluated about kratom provides conclusive evidence that compounds contained in kratom are opioids and are expected to have similar addictive effects as well as risks of abuse, overdose and, in some cases, death. At the same time, there’s no evidence to indicate that kratom is safe or effective for any medical use,” said FDA Commissioner Scott Gottlieb, M.D. “To protect the public health, we’ll continue to affirm the risks associated with kratom, warn consumers against its use and take aggressive enforcement action against kratom-containing products. We appreciate the cooperation of companies currently marketing any kratom product for human consumption to take swift action to remove these products from circulation to protect the public.”
When intended for use as or in a dietary supplement, the FDA considers kratom to be a new dietary ingredient. Generally, any dietary supplement containing kratom would need to be the subject of a New Dietary Ingredient Notification demonstrating that the product will reasonably be expected to be safe. To date, the FDA is not aware of any evidence of safety establishing that kratom (or any compounds derived from kratom) will reasonably be expected to be safe as a dietary ingredient. Additionally, kratom should not be used to treat any medical conditions, nor should it be used as an alternative to prescription opioids. There are currently no FDA-approved therapeutic uses of kratom and importantly, the FDA has evidence to show that there are significant safety issues associated with its use. Before it can be legally marketed for therapeutic uses in the U.S., kratom’s risks and benefits must be evaluated as part of the regulatory process for drugs established by Congress.
“We know that some patients are using kratom because they believe it can help treat their opioid dependency, but there’s no reliable evidence to support kratom’s effectiveness for this use; and we’re deeply committed to making sure patients have access to safe, effective treatment options,” Commissioner Gottlieb added. “There are three FDA-approved products that are safe and effective for the treatment of opioid use disorder and we encourage patients to seek advice from their health care professional and pursue treatment for addiction. Additionally, the FDA is taking new steps to bring new, safe and effective, FDA-approved therapies to the market for treatment of opioid use disorder. We understand that patients suffering from opioid addiction need access to effective treatment options. Creating an efficient pathway for the development of these treatments is a very high priority of mine.”
The FDA recommends that consumers not use these or any kratom products and dispose of any products currently in their possession. While the FDA is not aware of recent reports of illness specifically associated with the use of Divinity Products Distribution’s kratom-containing products, the agency asks health care professionals and consumers to report adverse events or quality problems associated with the use of Divinity Products Distribution’s products or any kratom product to the agency’s online Safety Reporting Portal.
Today’s action follows previous warnings from the FDA regarding kratom – a plant that grows in Thailand, Malaysia, Indonesia and Papua New Guinea. Recently, the FDA also communicated about a computational model developed by agency scientists, which – along with other scientific evidence evaluated by the agency – led to the FDA’s conclusion that compounds in kratom share the most structural similarities with controlled opioid analgesics, such as morphine derivatives, thus making kratom-containing products opioids. The agency has also been assessing peer-reviewed research and a growing number of adverse event reports associated with kratom use, including 44 reported deaths.
Additionally, the FDA and the U.S. Centers for Disease Control and Prevention are carefully monitoring an active nationwide outbreak across 20 states of a rare type of salmonella associated with kratom products. The agencies will continue to communicate with the public as more information becomes available. This outbreak associated with kratom-containing capsules, teas and powders, underscores the risk that harmful bacteria may contaminate these products when not subjected to manufacturing controls to eliminate that risk, in addition to the overall safety concerns for kratom itself.
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.
FDA News Release
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm584970.htm
Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA advisory about deadly risks associated with kratom
For Immediate Release
November 14, 2017
Summary
The FDA has issued a public health advisory related to mounting concerns regarding risks associated with the use of kratom.
Statement
The FDA is concerned about harmful unapproved products that have been crossing our borders in increasing numbers. The agency has a public health obligation to act when we see people being harmed by unapproved products passed off as treatments and cures for serious conditions.
Salmonella bacteria cause the foodborne illness salmonellosis. Most people infected with Salmonella develop diarrhea, fever, and abdominal cramps. The illness usually lasts 4 to 7 days, and most people recover without treatment. However, in the current outbreak, an unusually high rate of cases have been hospitalized for their illness.
How Soon After Exposure do Symptoms Appear?
Most people infected with Salmonella develop diarrhea, fever, and abdominal cramps 12 to 72 hours after infection.
What are the Complications of Salmonella Infections?
In some people, the diarrhea may be so severe that they need to be hospitalized. In these patients, the Salmonella infection may spread from the intestines to the blood stream and then to other body sites and can cause death unless the person is treated promptly with antibiotics.
Who is at Risk?
Children are the most likely to get salmonellosis, although other groups are also at risk. Children younger than five, the elderly, and those people with weakened immune systems are more likely to have severe infections. It is estimated that approximately 400 persons in the United States with acute salmonellosis die each year.
What Do Consumers Need To Do?
Consumers who have symptoms of salmonellosis should contact their health care provider. If you are diagnosed with salmonellosis, be sure to tell your health care provider about all products you may be using, including products reported to contain kratom. Consumers should be aware that some products may not list kratom on the labeling.
The FDA advises consumers to avoid kratom in any form. In addition to the public health concerns raised by this outbreak, kratom affects the same opioid brain receptors as morphine and appears to have properties that expose people who consume kratom to the risks of addiction, abuse, and dependence.
There are no FDA-approved uses for kratom, and the agency has received concerning reports about the safety of kratom, including deaths associated with its use. 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. FDA encourages more research to better understand kratom’s safety profile, including the use of kratom combined with other drugs.
Who Should be Contacted?
The FDA encourages consumers with questions about food safety to call 1-888-SAFEFOOD or
consult the fda.gov website: http://www.fda.gov.
FDA News Release
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm597649.htm
FDA oversees destruction and recall of kratom products; and reiterates its concerns on risks associated with this opioidFor Immediate Release
February 21, 2018
Summary
FDA oversees destruction and recall of kratom products; and reiterates its concerns on risks associated with this opioid
Release
The U.S. Food and Drug Administration today announced the voluntary destruction and recall of a large volume of kratom-containing dietary supplements manufactured and distributed nationwide under the brand names Botany Bay, Enhance Your Life and Divinity by Divinity Products Distribution of Grain Valley, Missouri. In cooperation with the FDA, the company has also agreed to stop selling all products containing kratom. Based on the scientific evidence of the serious risks associated with the use of kratom, in the interest of public health, the FDA encourages all companies currently involved in the sale of products containing kratom intended for human consumption to take similar steps to take their products off the market and submit any necessary evidence, as appropriate, to the FDA to evaluate them based on the applicable regulatory pathway.
“The extensive scientific data we’ve evaluated about kratom provides conclusive evidence that compounds contained in kratom are opioids and are expected to have similar addictive effects as well as risks of abuse, overdose and, in some cases, death. At the same time, there’s no evidence to indicate that kratom is safe or effective for any medical use,” said FDA Commissioner Scott Gottlieb, M.D. “To protect the public health, we’ll continue to affirm the risks associated with kratom, warn consumers against its use and take aggressive enforcement action against kratom-containing products. We appreciate the cooperation of companies currently marketing any kratom product for human consumption to take swift action to remove these products from circulation to protect the public.”
When intended for use as or in a dietary supplement, the FDA considers kratom to be a new dietary ingredient. Generally, any dietary supplement containing kratom would need to be the subject of a New Dietary Ingredient Notification demonstrating that the product will reasonably be expected to be safe. To date, the FDA is not aware of any evidence of safety establishing that kratom (or any compounds derived from kratom) will reasonably be expected to be safe as a dietary ingredient. Additionally, kratom should not be used to treat any medical conditions, nor should it be used as an alternative to prescription opioids. There are currently no FDA-approved therapeutic uses of kratom and importantly, the FDA has evidence to show that there are significant safety issues associated with its use. Before it can be legally marketed for therapeutic uses in the U.S., kratom’s risks and benefits must be evaluated as part of the regulatory process for drugs established by Congress.
“We know that some patients are using kratom because they believe it can help treat their opioid dependency, but there’s no reliable evidence to support kratom’s effectiveness for this use; and we’re deeply committed to making sure patients have access to safe, effective treatment options,” Commissioner Gottlieb added. “There are three FDA-approved products that are safe and effective for the treatment of opioid use disorder and we encourage patients to seek advice from their health care professional and pursue treatment for addiction. Additionally, the FDA is taking new steps to bring new, safe and effective, FDA-approved therapies to the market for treatment of opioid use disorder. We understand that patients suffering from opioid addiction need access to effective treatment options. Creating an efficient pathway for the development of these treatments is a very high priority of mine.”
The FDA recommends that consumers not use these or any kratom products and dispose of any products currently in their possession. While the FDA is not aware of recent reports of illness specifically associated with the use of Divinity Products Distribution’s kratom-containing products, the agency asks health care professionals and consumers to report adverse events or quality problems associated with the use of Divinity Products Distribution’s products or any kratom product to the agency’s online Safety Reporting Portal.
Today’s action follows previous warnings from the FDA regarding kratom – a plant that grows in Thailand, Malaysia, Indonesia and Papua New Guinea. Recently, the FDA also communicated about a computational model developed by agency scientists, which – along with other scientific evidence evaluated by the agency – led to the FDA’s conclusion that compounds in kratom share the most structural similarities with controlled opioid analgesics, such as morphine derivatives, thus making kratom-containing products opioids. The agency has also been assessing peer-reviewed research and a growing number of adverse event reports associated with kratom use, including 44 reported deaths.
Additionally, the FDA and the U.S. Centers for Disease Control and Prevention are carefully monitoring an active nationwide outbreak across 20 states of a rare type of salmonella associated with kratom products. The agencies will continue to communicate with the public as more information becomes available. This outbreak associated with kratom-containing capsules, teas and powders, underscores the risk that harmful bacteria may contaminate these products when not subjected to manufacturing controls to eliminate that risk, in addition to the overall safety concerns for kratom itself.
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.
FDA News Release
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm584970.htm
Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA advisory about deadly risks associated with kratom
For Immediate Release
November 14, 2017
Summary
The FDA has issued a public health advisory related to mounting concerns regarding risks associated with the use of kratom.
Statement
The FDA is concerned about harmful unapproved products that have been crossing our borders in increasing numbers. The agency has a public health obligation to act when we see people being harmed by unapproved products passed off as treatments and cures for serious conditions.
Over the past several years, a botanical substance known as kratom has raised significant concerns given its increasing prevalence and potential safety risks. Today, the agency issued a public health advisory related to the FDA’s mounting concerns regarding risks associated with the use of kratom.
Kratom is a plant that grows naturally in Thailand, Malaysia, Indonesia and Papua New Guinea. It has gained popularity in the U.S., with some marketers touting it as a “safe” treatment with broad healing properties. Proponents argue that it’s a safe substance largely because it’s a plant-based product. The FDA knows people are using kratom to treat conditions like pain, anxiety and depression, which are serious medical conditions that require proper diagnosis and oversight from a licensed health care provider. We also know that this substance is being actively marketed and distributed for these purposes. Importantly, evidence shows that kratom has similar effects to narcotics like opioids, and carries similar risks of abuse, addiction and in some cases, death. Thus, it’s not surprising that often kratom is taken recreationally by users for its euphoric effects. At a time when we have hit a critical point in the opioid epidemic, the increasing use of kratom as an alternative or adjunct to opioid use is extremely concerning.
It’s very troubling to the FDA that patients believe they can use kratom to treat opioid withdrawal symptoms. The FDA is devoted to expanding the development and use of medical therapy to assist in the treatment of opioid use disorder. However, an important part of our commitment to this effort means making sure patients have access to treatments that are proven to be safe and effective. There is no reliable evidence to support the use of kratom as a treatment for opioid use disorder. Patients addicted to opioids are using kratom without dependable instructions for use and more importantly, without consultation with a licensed health care provider about the product’s dangers, potential side effects or interactions with other drugs.
There’s clear data on the increasing harms associated with kratom. Calls to U.S. poison control centers regarding kratom have increased 10-fold from 2010 to 2015, with hundreds of calls made each year. The FDA is aware of reports of 36 deaths associated with the use of kratom-containing products. There have been reports of kratom being laced with other opioids like hydrocodone. The use of kratom is also associated with serious side effects like seizures, liver damage and withdrawal symptoms.
Given all these considerations, we must ask ourselves whether the use of kratom – for recreation, pain or other reasons – could expand the opioid epidemic. Alternatively, if proponents are right and kratom can be used to help treat opioid addiction, patients deserve to have clear, reliable evidence of these benefits.
I understand that there’s a lot of interest in the possibility for kratom to be used as a potential therapy for a range of disorders. But the FDA has a science-based obligation that supersedes popular trends and relies on evidence. The FDA has a well-developed process for evaluating botanical drug products where parties seek to make therapeutic claims and is committed to facilitating development of botanical products than can help improve people’s health. We have issued guidance on the proper development of botanical drug products. The agency also has a team of medical reviewers in the FDA’s Center for Drug Evaluation and Research that’s dedicated to the proper development of drug applications for botanicals. To date, no marketer has sought to properly develop a drug that includes kratom.
We believe using the FDA’s proven drug review process would provide for a much-needed discussion among all stakeholders. Until then, I want to be clear on one fact: there are currently no FDA-approved therapeutic uses of kratom. Moreover, the FDA has evidence to show that there are significant safety issues associated with its use. Before it can be legally marketed for therapeutic uses in the U.S., kratom’s risks and benefits must be evaluated as part of the regulatory process for drugs that Congress has entrusted the FDA with. Moreover, Congress has also established a specific set of review protocols for scheduling decisions concerning substances like kratom. This is especially relevant given the public’s perception that it can be a safe alternative to prescription opioids.
The FDA has exercised jurisdiction over kratom as an unapproved drug, and has also taken action against kratom-containing dietary supplements. To fulfill our public health obligations, we have identified kratom products on two import alerts and we are working to actively prevent shipments of kratom from entering the U.S. At international mail facilities, the FDA has detained hundreds of shipments of kratom. We’ve used our authority to conduct seizures and to oversee the voluntary destruction of kratom products. We’re also working with our federal partners to address the risks posed by these imports. In response to a request from the Drug Enforcement Administration (DEA), the FDA has conducted a comprehensive scientific and medical evaluation of two compounds found in kratom. Kratom is already a controlled substance in 16 countries, including two of its native countries of origin, Thailand and Malaysia, as well as Australia, Sweden and Germany. Kratom is also banned in several states, specifically Alabama, Arkansas, Indiana, Tennessee and Wisconsin and several others have pending legislation to ban it.
We’ve learned a tragic lesson from the opioid crisis: that we must pay early attention to the potential for new products to cause addiction and we must take strong, decisive measures to intervene. From the outset, the FDA must use its authority to protect the public from addictive substances like kratom, both as part of our commitment to stemming the opioid epidemic and preventing another from taking hold.
As a physician and FDA Commissioner, I stand committed to doing my part to prevent illegal substances that pose a threat to public health from taking their grip on Americans. While we remain open to the potential medicinal uses of kratom, those uses must be backed by sound-science and weighed appropriately against the potential for abuse. They must be put through a proper evaluative process that involves the DEA and the FDA. To those who believe in the proposed medicinal uses of kratom, I encourage you to conduct the research that will help us better understand kratom’s risk and benefit profile, so that well studied and potentially beneficial products can be considered. In the meantime, based on the weight of the evidence, the FDA will continue to take action on these products in order to protect public health.
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.
Kratom is a plant that grows naturally in Thailand, Malaysia, Indonesia and Papua New Guinea. It has gained popularity in the U.S., with some marketers touting it as a “safe” treatment with broad healing properties. Proponents argue that it’s a safe substance largely because it’s a plant-based product. The FDA knows people are using kratom to treat conditions like pain, anxiety and depression, which are serious medical conditions that require proper diagnosis and oversight from a licensed health care provider. We also know that this substance is being actively marketed and distributed for these purposes. Importantly, evidence shows that kratom has similar effects to narcotics like opioids, and carries similar risks of abuse, addiction and in some cases, death. Thus, it’s not surprising that often kratom is taken recreationally by users for its euphoric effects. At a time when we have hit a critical point in the opioid epidemic, the increasing use of kratom as an alternative or adjunct to opioid use is extremely concerning.
It’s very troubling to the FDA that patients believe they can use kratom to treat opioid withdrawal symptoms. The FDA is devoted to expanding the development and use of medical therapy to assist in the treatment of opioid use disorder. However, an important part of our commitment to this effort means making sure patients have access to treatments that are proven to be safe and effective. There is no reliable evidence to support the use of kratom as a treatment for opioid use disorder. Patients addicted to opioids are using kratom without dependable instructions for use and more importantly, without consultation with a licensed health care provider about the product’s dangers, potential side effects or interactions with other drugs.
There’s clear data on the increasing harms associated with kratom. Calls to U.S. poison control centers regarding kratom have increased 10-fold from 2010 to 2015, with hundreds of calls made each year. The FDA is aware of reports of 36 deaths associated with the use of kratom-containing products. There have been reports of kratom being laced with other opioids like hydrocodone. The use of kratom is also associated with serious side effects like seizures, liver damage and withdrawal symptoms.
Given all these considerations, we must ask ourselves whether the use of kratom – for recreation, pain or other reasons – could expand the opioid epidemic. Alternatively, if proponents are right and kratom can be used to help treat opioid addiction, patients deserve to have clear, reliable evidence of these benefits.
I understand that there’s a lot of interest in the possibility for kratom to be used as a potential therapy for a range of disorders. But the FDA has a science-based obligation that supersedes popular trends and relies on evidence. The FDA has a well-developed process for evaluating botanical drug products where parties seek to make therapeutic claims and is committed to facilitating development of botanical products than can help improve people’s health. We have issued guidance on the proper development of botanical drug products. The agency also has a team of medical reviewers in the FDA’s Center for Drug Evaluation and Research that’s dedicated to the proper development of drug applications for botanicals. To date, no marketer has sought to properly develop a drug that includes kratom.
We believe using the FDA’s proven drug review process would provide for a much-needed discussion among all stakeholders. Until then, I want to be clear on one fact: there are currently no FDA-approved therapeutic uses of kratom. Moreover, the FDA has evidence to show that there are significant safety issues associated with its use. Before it can be legally marketed for therapeutic uses in the U.S., kratom’s risks and benefits must be evaluated as part of the regulatory process for drugs that Congress has entrusted the FDA with. Moreover, Congress has also established a specific set of review protocols for scheduling decisions concerning substances like kratom. This is especially relevant given the public’s perception that it can be a safe alternative to prescription opioids.
The FDA has exercised jurisdiction over kratom as an unapproved drug, and has also taken action against kratom-containing dietary supplements. To fulfill our public health obligations, we have identified kratom products on two import alerts and we are working to actively prevent shipments of kratom from entering the U.S. At international mail facilities, the FDA has detained hundreds of shipments of kratom. We’ve used our authority to conduct seizures and to oversee the voluntary destruction of kratom products. We’re also working with our federal partners to address the risks posed by these imports. In response to a request from the Drug Enforcement Administration (DEA), the FDA has conducted a comprehensive scientific and medical evaluation of two compounds found in kratom. Kratom is already a controlled substance in 16 countries, including two of its native countries of origin, Thailand and Malaysia, as well as Australia, Sweden and Germany. Kratom is also banned in several states, specifically Alabama, Arkansas, Indiana, Tennessee and Wisconsin and several others have pending legislation to ban it.
We’ve learned a tragic lesson from the opioid crisis: that we must pay early attention to the potential for new products to cause addiction and we must take strong, decisive measures to intervene. From the outset, the FDA must use its authority to protect the public from addictive substances like kratom, both as part of our commitment to stemming the opioid epidemic and preventing another from taking hold.
As a physician and FDA Commissioner, I stand committed to doing my part to prevent illegal substances that pose a threat to public health from taking their grip on Americans. While we remain open to the potential medicinal uses of kratom, those uses must be backed by sound-science and weighed appropriately against the potential for abuse. They must be put through a proper evaluative process that involves the DEA and the FDA. To those who believe in the proposed medicinal uses of kratom, I encourage you to conduct the research that will help us better understand kratom’s risk and benefit profile, so that well studied and potentially beneficial products can be considered. In the meantime, based on the weight of the evidence, the FDA will continue to take action on these products in order to protect public health.
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.
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