FDA Issues Warnings to Companies Illegally Selling Drugs Containing Kratom

The U.S. Food and Drug Administration (FDA) issued warning letters to two companies for illegally selling unapproved drug products that contain kratom, an herbal extract that has not been approved for use in the U.S.

The companies, Cali Botanicals of Folsom, Calif. and Kratom NC of Wilmington, N.C., were selling the products with claims that they could treat or cure opioid addiction and withdrawal symptoms, the FDA said. The companies also claimed that their products were effective at treating pain and other medical conditions, such as depression, anxiety and cancer. In its reprimand of the two companies selling the products, the FDA said they used websites and social media to illegally market the products and made unproven claims about the benefits of kratom to “cure, treat or prevent disease.” The FDA said examples of claims being made by these companies include:

• “In fact, many people use kratom to overcome opiate addiction.”
• “Kratom is frequently used as a natural alternative to treat depression, anxiety, addiction, diabetes, chronic pain and fatigue…Kratom has been reported to have taken the place of brand name drugs like Hydrocodone or Oxycodone for individuals, all the way to weaning people off of Heroin.”
• “Some researchers have even claimed that kratom can protect you against cancer!”

Acting FDA Commissioner Ned Sharpless said the regulatory agency has issued numerous warnings about the risks associated with the use of kratom. Among those risks are concerns over contamination of products that contain the extract, including high rates of salmonella that can put people at risk. High levels of heavy metals have also been found in kratom products tested by the FDA, Sharpless said. Pointing to Kratom NC’s kratom products, the FDA noted laboratory analysis of those products found various microorganisms that could cause serious illnesses.

The companies are directed to inform the agency of the specific actions taken to address each of the agency’s concerns within 15 working days. The warning letters also state that failure to correct violations may result in law enforcement action such as seizure or injunction.

“Despite our warnings, companies continue to sell this dangerous product and make deceptive medical claims that are not backed by science or any reliable scientific evidence. As we work to combat the opioid crisis, we cannot allow unscrupulous vendors to take advantage of consumers by selling products with unsubstantiated claims that they can treat opioid addiction or alleviate other medical conditions,” Sharpless said in a statement.

Sharpless added that as the FDA continues to combat the opioid crisis, it’s important that the agency tackle “unscrupulous vendors” who sell products with unproven claims “that they can treat opioid addiction or alleviate other medical conditions.”

Kratom is a plant that grows in parts of Southeast Asia. It can be ordered online as a dietary supplement and advocates claim that the extract has health benefits. However, there have been multiple reports of overdose deaths related to the use of kratom. In April, the U.S. Centers for Disease Control and Prevention released a report highlighting more than 1,800 overdoses related specifically to kratom from 2011 to 2017. The CDC noted that use of kratom “can produce stimulant effects in low doses and some opioid-like effects at higher doses when consumed.” The U.S. Drug Enforcement Administration has identified kratom as a drug of concern.

In its latest missive about kratom, the FDA noted that there are no FDA-approved uses for kratom, and the agency has received concerning reports about the safety of kratom. The FDA said it is evaluating scientific information on the extract and warns consumers not to use any products labeled as containing the botanical substance kratom or its psychoactive compounds, mitragynine and 7-hydroxymitragynine.