FDA warns two 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 properties and has been associated with 91 deaths
- Companies often sell the substance under the false pretenses that it can treat opioid addiction and withdrawals
The FDA has again warned two kratom companies to advertise illegally and sell their products as opioid addiction treatments.
On Tuesday, the agency announced it had sent letters to both Cali Botanicals and Kratom NC, who have made unproven claims that their kratom can relieve opiate withdrawal symptoms, anxiety and more.
In fact, the Food and Drug Administration (FDA) has revealed that kratom behaves like an opioid and was the cause of death for 91 people in the US.
The warning letters from the FDA require the two companies to prove that they are taking steps to remove these false health claims from their products, to stop selling or to take legal action.
The FDA has warned two more companies to stop selling crate powder as an opioid withdrawal drug during the ongoing addiction crisis
Opioid withdrawal is described as hellacious and that is one of the things that makes the drugs so hard to stop.
Most public health officials agree that the most effective treatment for opioid addiction is drug therapy (MAT), which uses drugs such as suboxone and buprenorphine to ease withdrawal symptoms.
Kratom is not one of the approved drugs to help people overcome their opioid addiction.
Unfortunately, it is easier to access than approved MAT medicines, for which patients need a prescription.
Some substances in the plant-derived supplement have opioid properties and the FDA considers it dangerous.
But there is no data to suggest that kratom, a powder made from the Mitragyna speciosa plant, prevents withdrawals or addiction.
The plant grows wild in Thailand, Indonesia and Malaysia. It was historically used ceremonially or chewed by employees as a stimulant.
Malaysia has even made the substance illegal.
The US Drug Enforcement Agency (DEA) planned to temporarily ban kratom and make it an I-drug schedule as an emergency measure to try to stop drug-related overdoses and to return to the opioid epidemic .
The plan was met with so much public outrage and the convulsions of Congress that the DEA presented the idea in 2016.
Since then, the FDA has tried to pick up where the government's enforcement arm had stopped, and went after every business unfounded health claims related to the drug.
& # 39; We have issued numerous warnings about the serious risks associated with the use of kratom, including warnings about the contamination of high salmonella kratom products that endanger people using kratom products, and resulted in numerous diseases and recall actions, & # 39; said acting FDA commissioner Ned Sharpless.
Dr. Sharpless also said that some samples of kratom had tested positive for & # 39; high levels of heavy metals.
The FDA has given the Cali Botanicals and Kratom NC every 15 days to respond with their plans and actions to address & # 39; address each of the FDA concerns, & quot; the agency said in its statement.
"While we are working to combat the opioid crisis, we cannot allow unscrupulous sellers to misuse consumers by selling products with unsubstantiated claims that they can treat opioid addiction or alleviate other medical conditions," Dr said. . Sharpless.
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