US health officials urge the Drug Enforcement Agency (DEA) to make kratom, the opioid supplement linked to dozens of deaths, a schedule 1 drug.
At least 36 people have died of obvious overdoses after taking kratom, a controversial herb used in capsules, teas and powders.
The products are not approved or regulated by the FDA and are sold as supplements that promise light euphoria. Kratom has been marketed and has become popular as an unapproved opioid removal aid.
But scientists have recently discovered that compounds in the plant-derived substance are actually opioid substances in kratom.
Now, Health and Human Services (HHS) begs the DEA to give Kratom the same illegal status as heroin, according to a letter from Stat News.
Kratom has become popular in the US as an unapproved herbal supplement for the treatment of opioid withdrawal. The use of a controversial herb by a mother in Florida gave her baby's childbirths
Kratom, derived from a Southeast Asian plant, has long been used there as a stimulant for workers or to give those who chewed, smoked or drank like a tea a feeling of euphoria.
But in Thailand, the country of origin of the plant, it has since been banned.
Here in the US, products that have been made from it have only recently emerged.
Because they were plant-based, natural substances, Kratom powders, teas and capsules did not require FDA approval before they could be marketed and sold in the US.
Manufacturers and sellers pushed it as a cheaper natural alternative to drug-addicted help with opioid addiction, such as methodone.
Kratom got a lot of supporters. The American Kratom Association estimated that between three and five million Americans used the supplement.
After reports of ER visits and even deaths, doctors called on the FDA to investigate the supplement.
Cases reports of babies born with the taking of medicines from the kratom – almost identical to those of mothers who use opioids during pregnancy – have even started to show up.
When FDA scientists tested it, they discovered that 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, because Kratom never substantiated his many claims of medical benefits with scientific research, the manufacturers have already violated federal law.
In his statement, Gottlieb stressed the need for the FDA and the HHS to work together to ensure that approved, proven and effective medication for user-related problems are accessible to people who fight opioid addiction, that unproven drugs are not sold and that new potentially safe and effective medicines are being marketed.
The agency has called upon a number of manufacturers to stop making their kratom products and recalled it, but in the end HHS itself formally took no action against the content, and to banish and seize the drug, the DEA must be involved. touch.
In a letter obtained by Stat and dated on 1 October last year, the HHS urged the DEA to do exactly that.
According to the letter, the DEA asked for a scientific assessment of the potential of kratom for abuse in 2014.
Well, the HHS has detailed the results of these studies in 15 pages with a summary of negative health effects and addictive properties.
As a result of the FDA investigations, the agency's parent organization, HHS and the National Institute on Drug Abuse (NIDA) made simultaneous recommendations that kratom be classified as substance from scheme 1.
That would indicate kratom as a substance with no accepted medical value and with a high risk of addiction and abuse.
But more than a year later, the DEA apparently did not make a decision about kratom.
The HHS was not so happy that Stat had received the letter and spokeswoman Caitlin Oakley told Daily Mail Online that the document ought to have been withheld & # 39; after it was unintentionally disclosed & # 39 ;.
She added that talks about the status of Kratom are under way.