Two distributors and marketers of kratom have been flagged by FDA for selling unapproved, misbranded drugs.
FDA on Tuesday announced warning letters were sent to Cali Botanicals of Folsom, California, and Kratom NC of Wilmington, North Carolina, because the companies claimed without proof to cure or treat opioid addiction and withdrawal symptoms.
The companies also make claims regarding the treatment of pain and other medical conditions such as anxiety, cancer and depression, according to an FDA news release.
Among some of the claims identified by FDA in the recent warning letters:
- "Kratom acts as a μ-opioid receptor-like morphine."
- "In fact many people use kratom to overcome opiate addiction."
- "Of course, people who are using kratom to overcome a preexisting opiate addiction may need to use kratom daily to avoid opiate withdrawal."
- Usage: It is for the management of chronic pain, as well as recreationally."
Cali Botanicals and Kratom NC did not immediately respond to emailed requests for comment.
FDA requested both companies respond to the letters within 15 working days, explaining their actions to address the agency’s concerns. Failure to correct the violations, FDA cautioned the firms, may result in a law enforcement action, such as a seizure or injunction, without further notice.
In several warnings in recent years, FDA has cautioned the public about certain risks related to the use of kratom, such as unapproved claims of treating diseases and the detection of heavy metals, including lead and nickel, in some kratom products at levels unsafe for human consumption.
“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," Acting FDA Commissioner Ned Sharpless, M.D., 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."