Pharmaceutical

FDA cracks down on kratom marketers, distributors

kratom plant FDA cracks down on kratom marketers, distributorsThree marketers and distributors of kratom products were slapped with warning letters by the Food and Drug Administration (FDA) for illegally selling the herbal supplement with unproven claims about its ability to help ease symptoms of opioid addiction and withdrawal. The companies – Front Range Kratom of Aurora, Colorado; Kratom Spot of Irvine, California; and Revibe Inc., of Kansas City, Missouri – also claim that the controversial supplement can treat pain, lower blood pressure, treat cancer, and reduce neuron damage caused by strokes.

“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, M.D. “As we work to combat the opioid epidemic, we cannot allow unscrupulous vendors to take advantage of consumes by selling products with unsubstantiated claims that they can treat opioid addiction.”

Earlier this year, the FDA reported that it had determined that kratom is an opioid analogue that may actually contribute to the opioid epidemic and put consumers at risk for serious side effects. The agency said it is open to reviewing any data from those who believe that the supplement can offer benefits. Until then, the FDA said it would continue to step up its actions against unapproved and unsafe products that are being deceptively marketed for the treatment of opioid addiction and withdrawal symptoms.

The companies that received the warning letters promoted their kratom supplements for a variety of conditions, which the FDA said is a health fraud scam. “These products have not been demonstrated as safe or effective and may keep some patients from seeking appropriate, FDA-approved therapies,” the agency said in a News Release.

The warning letters included more than 65 kratom products. The FDA gave the companies 15 working days to respond to the claims made in the warnings.

Earlier this year, the FDA warned the public of an outbreak of salmonella infections linked to contaminated kratom products, which led to the recall of numerous brands of kratom from several distributors nationwide. Testing confirmed that kratom from Revibe, one of the companies that received an FDA warning letter, was contaminated with salmonella. On April 3, 2018, FDA officials oversaw the destruction of Revibe kratom products, but the company has yet to show evidence that it recalled the product.

Source: FDA News Release