The Food and Drug Administration is appealing against several companies that manufacture and distribute kratom, a psychoactive and pain-relieving supplement that has been linked to a recent Salmonella outbreak.
In a letter released on Tuesday, FDA Commissioner Scott Gottlieb called on three companies in different states to stop selling unauthorized kratom products with unproven health claims. In a statement, Gottlieb said that companies were dealing with "fraud scams in the healthcare sector" that "pose serious health risks".
Kratom is derived from a Southeast Asian plant and is often sold in the US as a pills, powder or tea. Advocates say it helps stem the symptoms of opioid degradation, which has led to people hurrying to Kratom in recent years to refrain from using stronger drugs like Vicodin.
However, as Kratom is classified as a dietary supplement and was not developed as a drug, it is not subject to much federal regulation. This means that spoiled kratom pills and powders can easily find their way onto the shelves. This seems to have happened in a recent salmonella outbreak that has so far affected more than 1
Extraordinary Claims and Little Scientific Research
The recent raid by the FDA appears to be the latest step in a growing gap between advocates and regulators regarding the use of kratom. The companies named by the agency are Front Range Kratom of Aurora, Colorado; Kratom Spot by Irvine, California and Revibe, Inc., of Kansas City, Missouri.
The allegations made by these three companies include marketing the supplement as "very effective against cancer," suggesting that their products may help reduce the symptoms of opioid dependence.
But there are few scientific studies that support these claims. However, research on kratom has shown that the drug enters some of the same receptors in the brain as opioids. This led the FDA to classify it as an opioid in February.
Experts say it makes sense for people with opioid use to use kratom as a remedy to alleviate their symptoms and refrain from using more powerful medications such as Vicodin.
But taking supplements that have not been tested for safety by medical professionals can be dangerous.
The Risks of Taking Kratom
Earlier FDA tests revealed that several products marketed by Revibe, one of the three companies named in the FDA letter, were contaminated with salmonella. Last month, at the request of the agency, Revibe destroyed a number of spoiled products still in its factory, but the company still has to confirm that it has recalled products that have already been delivered to stores.
Last month, the FDA issued the first compulsory recall of Kratom products after it was found that the products manufactured by Triangle Pharmanaturals of Las Vegas were contaminated with Salmonella.
By April 5, 132 people in 38 states were suffering from the bacteria, which can lead to diarrhea and abdominal pain for up to a week.
Apart from the risk that kratom products can carry harmful bacteria, those taking the product do not have a reliable way of determining the right dose. It is also difficult to find a complete ingredient list Verify Kratom supplement or account for potentially harmful interactions with other drugs or medications.
Kratom is currently banned in Australia, Malaysia, Myanmar, Thailand and several US states (Alabama, Arkansas, Indiana, Tennessee and Wisconsin). In the US, several death and dependency reports led to the drug agency placing Kratom on its list of "worrying drugs and chemicals". In 2016, the DEA proposed a ban on kratom, but pulled back under pressure from some members of Congress and an outcry from Kratom advocates.