FDA News

FDA announces new concerns regarding kratom

FDA Commissioner Scott Gottlieb, MD, has issued a new warning about kratom, stating that the agency found “disturbingly high levels of heavy metals” in 26 kratom products.

“Among the heavy metals we found were lead and nickel at levels not considered safe for human consumption,” Gottlieb said in today’s announcement.

“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,” he added.

The FDA is in the process of notifying the companies that made the kratom products of the test results, according to Gottlieb. Kratom has not been approved for use by the FDA.

Today’s announcement is the latest the FDA has made regarding kratom.

In April, Gottlieb, citing concerns about Salmonella contamination, announced a mandatory recall for all food products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC — saying it was the first-ever mandatory recall because a company failed to comply with the agency’s request to conduct a voluntary recall to protect Americans from contaminated food products.

A few months earlier, Gottlieb said a computational model produced “stronger evidence of kratom compounds’ opioid properties,” announced that a large number of kratom-containing dietary substances were recalled by a Missouri-based manufacturer and destroyed. He also encouraged other companies who make products with kratom to remove them from the market and have them go through the FDA regulatory process and also accused a California-based company that produces kratom products of making “misleading statements about its compliance with FDA regulations.”

The FDA and Gottlieb have continuously stated that they base their actions on the fact that kratom is not legally marketed in the U.S. as a drug or dietary supplement and data that suggest that certain substances in kratom have opioid properties and that one or more have the potential for abuse.

Not all medical professionals agree with the FDA, and say the agency is missing an opportunity to turn the tide with the opioid epidemic by issuing kratom-related warnings and recalls.

Kratom 
FDA Commissioner Scott Gottlieb, MD, has issued a new warning about kratom, stating that the agency found “disturbingly high levels of heavy metals” in 26 kratom products.

Source:Shutterstock

Jack E. Henningfield, PhD, adjunct professor at Johns Hopkins University and consultant to the American Kratom Association, told Healio Family Medicine earlier this year that “for the FDA to deny people the chance to use kratom in spite of the evidence is flat out ignoring the reality and very scary.”

Others, such as Walter C. Prozialeck, PhD, professor and chair of the department of pharmacology, Chicago College of Osteopathic Medicine at Midwestern University, said in an interview he has a problem with what the FDA calls “sound science,” and compared it to “a game of semantics.”

Gottlieb acknowledged kratom’s other uses in today’s announcement and strongly recommended patients and health care providers seek alternative approaches that include, but not limited to the three drugs — buprenorphine, methadone, and naltrexone — approved by the FDA for the treatment of opioid use disorder

“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,” he said. – by Janel Miller

Disclosures: Gottlieb is FDA commissioner. Healio Family Medicine was unable to determine Henningfield’s and Prozialeck’s relevant disclosures prior to publication.

 

FDA Commissioner Scott Gottlieb, MD, has issued a new warning about kratom, stating that the agency found “disturbingly high levels of heavy metals” in 26 kratom products.

“Among the heavy metals we found were lead and nickel at levels not considered safe for human consumption,” Gottlieb said in today’s announcement.

“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,” he added.

The FDA is in the process of notifying the companies that made the kratom products of the test results, according to Gottlieb. Kratom has not been approved for use by the FDA.

Today’s announcement is the latest the FDA has made regarding kratom.

In April, Gottlieb, citing concerns about Salmonella contamination, announced a mandatory recall for all food products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC — saying it was the first-ever mandatory recall because a company failed to comply with the agency’s request to conduct a voluntary recall to protect Americans from contaminated food products.

A few months earlier, Gottlieb said a computational model produced “stronger evidence of kratom compounds’ opioid properties,” announced that a large number of kratom-containing dietary substances were recalled by a Missouri-based manufacturer and destroyed. He also encouraged other companies who make products with kratom to remove them from the market and have them go through the FDA regulatory process and also accused a California-based company that produces kratom products of making “misleading statements about its compliance with FDA regulations.”

The FDA and Gottlieb have continuously stated that they base their actions on the fact that kratom is not legally marketed in the U.S. as a drug or dietary supplement and data that suggest that certain substances in kratom have opioid properties and that one or more have the potential for abuse.

Not all medical professionals agree with the FDA, and say the agency is missing an opportunity to turn the tide with the opioid epidemic by issuing kratom-related warnings and recalls.

Kratom 
FDA Commissioner Scott Gottlieb, MD, has issued a new warning about kratom, stating that the agency found “disturbingly high levels of heavy metals” in 26 kratom products.

Source:Shutterstock

Jack E. Henningfield, PhD, adjunct professor at Johns Hopkins University and consultant to the American Kratom Association, told Healio Family Medicine earlier this year that “for the FDA to deny people the chance to use kratom in spite of the evidence is flat out ignoring the reality and very scary.”

Others, such as Walter C. Prozialeck, PhD, professor and chair of the department of pharmacology, Chicago College of Osteopathic Medicine at Midwestern University, said in an interview he has a problem with what the FDA calls “sound science,” and compared it to “a game of semantics.”

Gottlieb acknowledged kratom’s other uses in today’s announcement and strongly recommended patients and health care providers seek alternative approaches that include, but not limited to the three drugs — buprenorphine, methadone, and naltrexone — approved by the FDA for the treatment of opioid use disorder

“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,” he said. – by Janel Miller

Disclosures: Gottlieb is FDA commissioner. Healio Family Medicine was unable to determine Henningfield’s and Prozialeck’s relevant disclosures prior to publication.

 

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