FDA warns two more kratom-makers to stop promising the life-threatening powder treats opioid addiction
- The Food and Drug Administration sent warning letters to Cali Botanicals and Kratom NC on Thursday
- Kratom, a powder made from a Southeast Asian, plant has opioid-like qualities and has been linked to 91 deaths
- Companies often sell the substance under the false pretense it can treat opioid addiction and withdrawals
The FDA has warned two kratom companies once more to stop illegally advertising and selling their products as opioid addiction treatments.
On Tuesday, the agency announced that it had sent letters to both Cali Botanicals and Kratom NC, which have made unproven claims that their kratom can alleviate opioid withdrawal symptoms, anxiety and more.
In fact, the Food and Drug Administration (FDA) has revealed that kratom behaves like an opioid and has been the cause of death for 91 people in the US.
The FDA’s warning letters demand that the two companies prove that they are taking steps to remove these false health claims from its products, stop selling them or face legal action.
The FDA has warned two more companies to stop selling kratom powder as an opioid withdrawal drug amid ongoing addiction crisis
Opioid withdrawal is described as hellacious, and that is one of the things that makes the drugs so difficult to quit.
Most public health officials agree that the most effective treatment for opioid addiction is medication-assisted therapy(MAT), which uses drugs like suboxone and buprenorphine to ease withdrawal symptoms.
Kratom is not one of the medications approved to help people overcome opioid addiction.
It is, unfortunately, more easily accessible than approved MAT drugs, for which patients need a prescription.
Some substances in the plant-derived supplement have opioid properties and the FDA considers it dangerous.
But there’s no data to suggest that kratom, a powder made from the Mitragyna speciosa plant, combats withdrawals or addiction.
The plant grows wild in Thailand, Indonesia and Malaysia. It was historically used ceremonially or chewed by workers as a stimulant.
Malaysia has actually made the drug illegal.
The US Drug Enforcement Agency (DEA) had plans to temporarily ban kratom and make it a schedule I drug as an emergency measure to try to stem overdoses linked to the drug and to bat back at the opioid epidemic.
Its plan was met with such public outcry and Congressional bristling that the DEA tabled the idea in 2016.
Since then, the FDA has tried to pick up where the government’s enforcement arm left off, going after any company making unfounded health claims related to the drug.
‘We have issued numerous warnings about the serious risks associated with the use of kratom, including warnings about the contamination of kratom products with high rates of salmonella that put people using kratom products at risk, and resulted in numerous illnesses and recalls,’ said acting FDA commissioner Ned Sharpless.
Dr Sharpless also said that some samples of kratom had tested positive for ‘high levels of heavy metal.
The FDA has given the Cali Botanicals and Kratom NC each 15 days to respond with their plans and actions to ‘address each of [the FDA’s] concerns,’ the agency said in its statement.
‘As we work to combat the opioid crisis, we cannot allow unscrupulous vendors to take advantage of consumers by selling products with unsubstantiated claims that they can treat opioid addiction or alleviate other medical conditions,’ said Dr Sharpless.