The Food and Drug Administration has issued a public health warning about kratom, an herbal supplement used by some to treat chronic pain, help with opioid withdrawals, and is used recreationally.
In the United States, there are no FDA-approved uses for kratom, which grows naturally in Southeast Asia. Serious side effects associated with kratom include seizures, liver damage, and withdrawal symptoms. Calls to poison control centers regarding kratom have increased 10-fold from 2010 to 2015.
Advocates say kratom can ease pain and make it easier to get through opioid withdrawals.
Until it is tested like any other drug and shown to be safe and effective, Gottlieb said the FDA would work to keep marketers from selling it.
Importers, organized crime or others in the supply chain could be part of conspiracies to distribute illegal opioids, Sharfstein says.
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"The FDA is concerned about harmful unapproved products that have been crossing our borders in increasing numbers", Gottlieb wrote in a statement.
Kratom has similar effects to narcotics like opioids and carries similar risks of abuse, addiction and in worst cases, death, the FDA noted.
Meanwhile, a similarly troubling trend has been seen with kratom.
Gottlieb also acknowledged that if proponents are right, and kratom could be used alternatively as a tool to treat opioid addiction, the agency owes them clear, reliable evidence to support those benefits.
More than 340 million shipments of kratom reach the USA each year, even though the FDA has seized hundreds more.
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"If they find people here who are opening the gates to these drugs, there may be opportunities for the FDA to investigate at a high level", former principal deputy FDA commissioner under the Obama administration, Joshua Sharfstein, told the news site. Instead, Gottlieb mentioned that kratom is already a controlled substance in 16 countries, and that several states have pending legislation to ban it.
"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", Gottlieb added.
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. "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.
For now, the FDA said it is working to prevent shipments of kratom from entering the country.
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