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etvfutures.com November 22, 2017


FDA Issues Warning Against Kratom, A Naturally Occurring but Unapproved Plant

15 November 2017, 02:07 | Lena Norman

FDA Issues Warning Against Kratom, A Naturally Occurring but Unapproved Plant

FDA warns against using kratom for opioid addiction

Kratom is a common name for a plant that grows in several countries in Southeast Asia including Thailand, Malaysia, Indonesia and Papua New Guinea. "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", FDA Commissioner Scott Gottlieb stated in a press release. But the DEA almost made kratom a Schedule 1 drug, the same as heroin and marijuana, last year, and the FDA is now trying to stop shipments of kratom from entering the United States while it works on increasing regulatory oversight.

Importers, organized crime or others in the supply chain could be part of conspiracies to distribute illegal opioids, Sharfstein says.

"There are now no FDA-approved therapeutic uses of kratom", said Gottlieb.

The FDA said that some of the adverse risks of opioids also appear with kratom use, including "abuse, addiction and in some cases, death". Others use kratom for its euphoric effects, or to wean addicts off opioids such as prescription painkillers or heroin, also without medical say-so.

These two uses are what Gottlieb appears to see as the most troubling.

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For now, kratom is widely available online and in some stores. Finally, the use of kratom is associated with serious side effects like seizures, liver damage and withdrawal symptoms, he wrote. The FDA says that review is underway.

Previous year the Drug Enforcement Administration planned to make kratom a Schedule I drug, a category that includes marijuana and LSD, but decided against it after an outcry of opposition.

Specifically, Gottlieb noted, poison control centers received ten times more calls about kratom in 2015 than they did in 2010. "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", Gottlieb said in the statement. That includes a stronger presence at ports of entry and working alongside Customs and Border Patrol. Hundreds of shipments have already been detained and many are seized. "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".

Gottlieb said he was sympathetic but said distributors have to show that kratom does work as advertised.

Whether kratom will eventually be banned, however, depends on the Drug Enforcement Administration.



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