US health officials are urging the Drug Enforcement Agency (DEA) to do kratom, the opioid supplement linked to dozens of deaths, a 1 drug program.
At least 36 people died of overdose evident after ingesting kratom, a controversial herb used in capsules, teas and powders.
The products are not approved or approved by the FDA and have been sold as supplements promising a slight euphoria. Kratom has been marketed and popularized as an unapproved opioid withdrawal aid.
But scientists have recently discovered that compounds in the plant-derived substance are actually opioids 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 from Stat News.
Kratom has gained popularity in the United States as an unapproved herbal supplement for the treatment of opioid withdrawal. The controversial use of a mother in Florida has given her samples to newborns
Kratom, derived from a plant of Southeast Asia, has long been used as a stimulant for workers or to give those who chewed, smoked or drank like tea a feeling of euphoria.
But in Thailand, the country of origin of the plant, has been outlawed.
Here in the United States, the products made from it have only recently emerged.
Because they were plant, natural, kratom, powders, teas and capsules, they did not need approval from the FDA before they could be marketed and sold in the United States.
Manufacturers and salespeople have passed it off as a cheaper natural alternative to opioid-dependency withdrawal medications such as the method.
Kratom has gained enough following. The American Kratom Association estimated that between three and five million Americans have used the supplement.
After reports of visits to the ER and even deaths, doctors asked the FDA to investigate the supplement.
The clinical cases of children born with kratom drugs – almost identical to those caused by the use of opioids by mothers during pregnancy – have even started to emerge.
When the FDA scientists tested it, they found that the substances in kratom behave like pharmaceutical opioid drugs, which means that the substance must be regulated as such.
Commissioner Scott Gottlieb warned in a statement in September that since kratom has never shown its many claims of medical benefits with scientific studies, its producers are already breaking federal law.
In his statement, Gottlieb underlined the need for FDA and HHS to work together to make sure that approved and proven use medications are accessible to people who fight opioid dependence, that unproven drugs are not marketed and that potentially new and safe effective drugs are introduced on the market.
The agency has invited several manufacturers to stop manufacturing their kratom products and to recall them, but in the end 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 be involved.
In a letter obtained from Stat and dated October 1 last year, HHS urged the DEA to do just that.
According to the letter, the DEA requested a scientific review of the potential for Kratom abuse in 2014.
Now, the HHS has detailed the results of these surveys in 15 pages summarizing negative effects on health and addiction quality.
As a result of FDA studies, the agency's parent organization, the HHS and the National Drug Abuse Institute (NIDA) made competing recommendations that the Kratom is classified as a substance of list 1.
This would designate kratom as a substance with no accepted medical value and a high risk of addiction and abuse.
But over a year later, the DEA apparently did not make a decision on Kratom.
The HHS was not at all happy that Stat got the letter and spokeswoman Caitlin Oakley told the Daily Mail Online that the document "should have been suspended" after being "inadvertently disclosed".
He added that the deliberations on the state of Kratom are ongoing.