The CDC says kratom, an herbal supplement, was a cause of deaths in 91 fatal overdoses in the United States from July 2016 to December 2017. USA TODAY
Cali Botanicals of Folsom, California, and Kratom NC of Wilmington, North Carolina, illegally sold product containing kratom that claimed to treat or cure opioid addiction and withdrawal symptoms as well as other health conditions the supplement is not proven to treat, the U.S. Food and Drug Administration says.
“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,” said Acting FDA Commissioner Ned Sharpless said in a statement.
“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 added.
USA TODAY has reached out to both companies for comment.
The warnings come amid increased attention from the FDA concerning kratom, a plant native to Southeast Asia and currently not FDA-approved for any medical use.
While the FDA says that kratom, like opioids, carries risks of abuse and addiction and has been linked to overdose deaths, its advocates say the risks have been blown out of proportion by health officials and that kratom can be used to help addicts wean themselves off harmful opioids.
In its warning letters, the FDA cites examples of both companies claiming that kratom can treat addiction and says that the FDA has not approved these products for such uses.
The FDA also said that the companies made unproven claims that their kratom products could treat other medical conditions such as pain, depression, anxiety and cancer. The agency gave the suppliers 15 days to respond or otherwise face law-enforcement action.
“Health fraud scams like these can pose serious health risks,” the FDA said in a statement. “These products have not been demonstrated to be safe or effective for any use and may keep some patients from seeking appropriate, FDA-approved therapies.”
The American Kratom Association, an advocacy organization for the supplement’s potential benefits, says that up to 5 million Americans are using kratom.
According to the National Institute on Drug Abuse, kratom interacts with opioid receptors in the brain to ease pain and produce sedation and pleasure.
It is commonly sold at smoke shops, gas stations or online as a powder or in a capsule. However, both the FDA and its advocates have raised concerns over kratom tainted with other harmful contaminants being available for sale.
According to the Centers for Disease Control and Prevention, kratom use has become increasingly popular in recent years.
A CDC study earlier this year found that kratom was behind at least 91 fatal overdoses in the United States from July 2016 to December 2017.
The CDC study said that in many of the overdose deaths, other drugs were also listed as contributing to the overdose, in addition to kratom.
A February study that tracked calls about kratom exposures to poison control centers also found that poisonings reported after taking kratom soared more than 50-fold, from 13 in 2011 to 682 in 2017.
Kratom supporters, however, cite past reports suggesting it has low toxicity and has milder withdrawal symptoms than opiates. They compare the addiction characteristics of kratom to caffeine in coffee.
The FDA says more research is needed on the safety of kratom, including how it interacts when mixed with other drugs.
Contributing: Joey Garrison
Read or Share this story: https://www.usatoday.com/story/news/health/2019/06/26/kratom-marketed-opioid-addiction-cure-fda-warnings/1568694001/