October 21, 2018

FDA Sends Warning Letter To Three Companies Selling Unapproved Kratom Products

The FDA is warning companies that sell illegal, unapproved kratom products marketed for opioid cessation, pain treatment, and other medical uses to stop. Three corporations were issued warning letters on May 22, 2018: Front Range Kratom of Aurora, Colorado; Kratom Spot of Irvine, California, and Revibe, Inc., of Kansas City, Missouri.

FDA Warns Kratom Products Companies

The government states that those companies are illegally selling unapproved kratom-containing drug products and making unproven claims about their ability to help in the treatment of opioid addition and withdrawal. Other unproven claims the FDA alleges the companies are making including treating pain, lowering blood pressure, treating cancer, and reducing neuron damage caused by strokes.

The FDA has repeatedly warned consumers that no kratom product is safe. But companies continue to sell the product and do so “with deceptive medical claims for which there’s no reliable scientific proof to support their use,” said FDA Commissioner Dr. 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,” he continued.

The FDA is also telling consumers that Mitragyna species, commonly known as kratom, appears to expose users to risks of addiction, abuse, and dependence. There are no FDA-approved uses for kratom.

The FDA is evaluating all scientific information on this issue. The government is also encouraging more research to better understand kratom’s safety profile.

The companies making these claims use websites were they take orders for kratom products. Some examples of claims being made include “The mood elevation qualities of kratom reduces opiate withdrawal effects,” and “Kratom can be used as a remedy for stroke-related ailments and conditions as it is a powerful antioxidant that works to reduce neuron damage,” and “It is said, that kratom is very effective against cancer.”

These health fraud scams, the FDA says, can pose serious health risks. These products are not demonstrated as safe or effective, and make keep patients from seeking appropriate therapies for their health issues. Selling these unapproved products with claims that they can treat serious medical conditions is a violation of the Federal Food, Drug, and Cosmetics Act.

In addition, there is a Salmonella outbreak linked to kratom products that has sickened 132 people in 38 states. FDA testing found the pathogenic bacteria in kratom products distributed by Revibe, although no illnesses in the outbreak are definitely linked to the Revibe products. The company has not provided the FDA with information to confirm it has recalled the products it distributed.

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