FDA Warns Companies Against Selling Kratom For Opioid Addiction

It may seem completely illogical that a particular herbal supplement with proven opioid compounds according to research by the U.S. Food and Drugs Administration (FDA) in 2018 should be used to counter the very addiction it may also trigger. This thought process does not align with two companies that are promoting tall claims on the use of kratom, a substance from a tree of the same name typically found in Malaysia, Indonesia and Thailand. The substance is apparently being marketed as a product that could be used to treat opioid addiction-related withdrawal symptoms. 

The two companies indulging in the questionable promotion are Cali Botanicals, which is located in Folsom, California, and Kratom NC in Wilmington, North Carolina. Both companies have been issued notices, instructing them to explain themselves within the next 15 days. Failure to comply with The Federal Food, Drug and Cosmetic Act could end up in involuntary confiscation of goods and property, the warnings stated. 

The FDA’s MedWatch Adverse Event Reporting program can be used by the public to report any side effects of using kratom, so they could warn other people and help them recover using the right medication. Employing an integrated approach with therapy and familial support and taking one of the agency’s three approved drugs (buprenorphine, methadone, and naltrexone) is recommended. Medical assisted treatment (MAT) was successfully able to reduce the risk of overdose and death to half according to the Substance Abuse and Mental Health Services Administration.

“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,” said acting FDA Commissioner Ned Sharpless in a press release issued on June 25.

Opioid Epidemic A man uses heroin under a bridge where he lives with other addicts in the Kensington section which has become a hub for heroin use on January 24, 2018 in Philadelphia, Pennsylvania. The FDA warns drug companies against marketing the herbal supplement, kratom, as an alternate medication to deal with withdrawal symptoms. Spencer Platt/Getty Images

Since kratom comes directly from a plant, the advocates of the alternative medicine believe that it is a completely benign substance. Scientists at the FDA argue that heroin is considered one of the most dangerous opioids despite being extracted from the seeds of opium poppy plants. In the agency’s press release, they warned consumers against products containing the botanical substance kratom as well as two harmful psychoactive compounds: mitragynine and 7-hydroxymitragynine. 

The companies are not legally allowed to market these harmful herbal supplements on social media. They claim that kratom is an opioid receptor similar to the function of morphine and that many people have used it in the past to beat addiction to opioids. “Of course, people who are using kratom to overcome a preexisting opiate addiction may need to use kratom daily to avoid opiate withdrawal,” read one of the promotional materials for kratom. 

A public health advisory issued by the agency in November 2017 also encouraged consumers to be aware of companies selling the questionable products, specifically kratom and its compounds, with the use of unproven claims. So far there is no evidence to suggest that kratom is an alternative treatment to combat addiction to opiates, because past research by the U.S. government conclusively points to the contrary. 

The Centers for Disease Control and Prevention carried out an 18-month study by analyzing toxicology reports of drug-related deaths. In a government report released in April 2019 based on this analysis, it was suggested that 91 deaths could have been possibly caused by kratom consumption. In most of the cases, there were traces of other harmful drugs such as heroin or fentanyl, and they were found to be the direct cause of death in seven cases.  

Since more than 2 million Americans suffer from opioid use disorder, the FDA is always trying its best to research and innovate new treatment methods.  For now, they are focused on making MAT more accessible and affordable to the general public.