FDA reprimands suppliers of opioid substitute kratom products
pharmafile | May 23, 2018 | News story | Research and Development, Sales and Marketing | FDA, kratom, opioid crisis, opioids, pharma
The ongoing opioid epidemic in the US has seen the rise of the sale and use of kratom (mitragyna speciose), a plant with opiate effects, as a means for treating opioid addiction.
Despite this, the FDA’s line has been that such purported treatments are not supported by scientific evidence and cannot deliver on its promises of effective treatment and other benefits, and now the agency is doubling down by targeting three marketers and distributors of such products.
The three bodies in question are Front Range Kratom of Aurora, Colorado; Kratom Spot of Irvine, California; and Revibe, of Kansas City, Missouri, and each has received a warning letter over their involvement in the supply of kratom products. Specifically, the companies have been reprimanded over their sale and for making uncertified claims on their ability to cure, treat or prevent a range of conditions including chronic pain, drug addiction, high blood pressure, diabetes, anxiety and even cancer.
Kratom acts on the same receptors in the brain as morphine, and the FDA has concerns that the product can expose users to the risks of addiction, abuse and dependence as well as other safety issues. No FDA-approved kratom products currently exist for these reasons, and the agency actively warns against the use of such products or its psychoactive compounds mitragynine and 7-hydroxymitragynine until more research can be conducted.
“Despite our warnings that no kratom product is safe, we continue to find companies selling kratom and doing so with deceptive medical claims for which there’s no reliable scientific proof to support their use,” said FDA Commissioner Scott Gottlieb. “As we work to combat the opioid epidemic, we cannot allow unscrupulous vendors to take advantage of consumers by selling products with unsubstantiated claims that they can treat opioid addiction. Far from treating addiction, we’ve determined that kratom is an opioid analogue that may actually contribute to the opioid epidemic and puts patients at risk of serious side effects. If people believe that the active ingredients in kratom have drug-like effects that can treat pain or addiction, then the FDA is open to reviewing that data under our new drug approval process.”
Matt Fellows
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