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FDA Warns 2 Companies For Selling Unapproved Kratom Products


The U.S. Food and Drug Administration (FDA) sent out warning letters to two companies for marketing and distributing "unapproved, misbranded kratom-containing drug products."

Folsom, California-based Cali Botanicals and Wilmington, North Carolina-based Kratom NC were notified by the FDA for making unsubstantiated claims that their products have the ability to treat or cure opioid addiction and withdrawal symptoms. These claims are in violation of the Federal Food, Drug, and Cosmetic Act, the regulator said.

The FDA also warned them for making wrong claims of treating pain, as well as other medical conditions like depression, anxiety and cancer.

FDA is concerned that kratom, which affects the same opioid brain receptors as morphine, appears to have properties that could cause addiction, abuse, and dependence. Kratom is a botanical substance which contains psychoactive compounds, mitragynine and 7-hydroxymitragynine.

The FDA has sought responses from both companies within 15 working days. Failing this, the company may be subjected to law enforcement action such as seizure or injunction.

There are no FDA-approved uses for kratom, and the agency has been receiving concerning reports about the safety of it.

Kratom, an herbal supplement, has been linked to 91 deaths over 18 months from July 2016 to December 2017, according to a report by the U.S. Centers for Disease Control and Prevention. This was less than 1 percent of the 27,338 overdose fatalities analyzed for the report.

Although small, the numbers point to increasing numbers of people using the plant to combat pain, depression and opioid addiction.

The supplement is mashed leaves from the tropical tree Mitragyna speciosa, a coffee cousin that grows in the warm, wet forests of Southeast Asia. Pulverized leaves create a green powder that can be dissolved in tea, packed into pill capsules or extracted into alcohol.

As kratom is largely unregulated, products might also contain contaminants. Harmful levels of heavy metals and dangerous Salmonella bacteria have turned up in products.

Kratom is a controlled substance in sixteen countries and, the FDA banned importing and manufacturing of kratom as a dietary supplement in 2014. In February 2018, the regulator said there was no evidence for kratom's safety or effectiveness for treating any condition.

On April 2018, the FDA issued the first mandatory recall in its history over concerns of salmonella contamination of several kratom-containing products.

While the FDA is trying combat the opioid crisis, it says "unscrupulous vendors" are taking advantage of consumers by selling products with unsubstantiated claims of treating "opioid addiction or alleviate other medical conditions." They use websites and social media to illegally market kratom products.

Mitragyna speciosa, popularly called kratom, is made from the leaf of a tropical evergreen tree in the coffee family that grows in Thailand, Indonesia, Malaysia, Myanmar, and Papua New Guinea.

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