US health officials are urging the Drug Enforcement Agency (DEA) to make kratom, the opioid supplement linked to scores of deaths, a schedule 1 drug.
At least 36 people have died of apparent overdoses after ingesting kratom, a controversial herb used in capsules, teas and powders.
The products are not FDA-approved or regulate and have been sold as supplements promising slight euphoria. Kratom has been marketed and become popular as an unapproved opioid withdrawal aid.
But scientists have recently discovered that compounds in the plant-derived substance actually are opioid substances in kratom.
Now, Health and Human Services (HHS) is pleading with the DEA to give kratom the same illegal status as heroin, according to a letter obtained by Stat News.
Kratom has gained popularity in the US as an unapproved herbal supplement to treat opioid withdrawal. A Florida mother’s use of the controversial herb gave her newborn withdrawals
Kratom, derived from a Southeast Asian plant, has long been used there as a stimulant for workers or to give those who chewed, smoke or drank it as a tea a feeling of euphoria.
But in Thailand, the plant’s country of origin, it’s since been outlawed.
Here in the US, products made from it have only recently emerged.
Because they were plant-based, natural, substances, kratom powders, teas and capsules did not require approval from the FDA before they could be marketed and sold in the US.
Manufacturers and sellers pushed it as a cheaper natural alternative to opioid addiction withdrawal assistance drugs like methodone.
Kratom gained quite a following. The American Kratom Association estimated that between three and five million Americans have used the supplement.
After reports of ER visits and even deaths surged, doctors called on the FDA to investigate the supplement.
Case reports of babies born with drug withdrawals from kratom – nearly identical to those caused by mothers’ use of opioids during pregnancy – have even begun to emerge.
When FDA scientists tested it, they found that substances in kratom behave like pharmarceutical opioid drugs, meaning the substance should be regulated as such.
Commissioner Scott Gottlieb warned in a statement in September that because kratom has never substantiated its many claims of medical benefits with scientific study, its manufacturers are already breaking federal law.
In his statement, Gottlieb stressed the need for the FDA and HHS to work together to make sure that approved, proven and effective medications for use disorder are accessible to people fighting opioid addiction, that unproven ones are not marketed, and that new potentially safe and effective drugs are brought to market.
The agency has called on several manufacturers to stop making their kratom products and recalled, but ultimately HHS itself has not formally taken any action against the substance, and in order for the drug to be outlawed and seized, the DEA must get involved.
In a letter obtained by Stat and dated October 1 of last year, the HHS urged the DEA to do just that.
According to the letter, the DEA requested scientific review of kratom’s potential for abuse back in 2014.
Now, the HHS has detailed the results of those investigations in 15 pages summarizing negative health effects and addictive qualities.
As a result of the FDA’s studies, the agency’s parent organization, HHS and the National Institute on Drug Abuse (NIDA) made concurrent recommendations that kratom be classified as a schedule 1 substance.
That would designate kratom as a substance with no accepted medical value and a high risk for addiction and abuse.
But over a year later, the DEA has ostensibly not made a decision about kratom.
The HHS was none too pleased that Stat obtained the letter and spokeswoman Caitlin Oakley told Daily Mail Online that the document ‘should have been withheld’ after being ‘inadvertently disclosed.’
She added that deliberations over kratom’s status are ongoing.