The FDA announced today that it issued warning letters to Cali Botanicals of Folsom, California, and Kratom NC of Wilmington, North Carolina, for “illegally selling unapproved, misbranded kratom-containing drug products with unproven claims about their ability to treat or cure opioid addiction and withdrawal symptoms.”
The companies also make claims about treating anxiety, cancer, depression and pain, the FDA said.
According to the release, the FDA letters request that Cali Kratom and Kratom NC respond within 15 working days with details of how they will address agency’s concerns. The warning letters also state that failure to correct violations may result in law enforcement action such as injunction or seizure.
The announcement is the latest of many the FDA has made regarding kratom, a plant with no FDA-approved uses that cannot legally be marketed in the U.S. as a drug or dietary supplement, Ned Sharpless, MD, acting FDA commissioner said in a press release.
“We have issued numerous warnings about the serious risks associated with the use of kratom, including warnings about the contamination of kratom products with high rates of salmonella that put people using kratom products at risk, and resulted in numerous illnesses and recalls. ... We also found high levels of heavy metals in kratom products,” he said.
“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 continued.
The FDA announced today that it issued warning letters to two companies for “illegally selling unapproved, misbranded kratom-containing drug products with unproven claims about their ability to treat or cure opioid addiction and withdrawal symptoms.”
Though the FDA and some other research suggests kratom is harmful, others in the medical community disagree.
Healio Primary Care reported in 2018 that some kratom supporters take issue with the FDA’s stance in classifying the substance.
“The FDA has taken the position that since the compounds in kratom can bind to opioid receptors, kratom is an opioid. [But] Narcan, which is used to treat opioid poisoning binds to opioid receptors, but no one calls Narcan an opioid,” Walter C. Prozialeck, PhD, professor and chair of the department of pharmacology, Chicago College of Osteopathic Medicine at Midwestern University, said in an interview last year.
Other advocates in the story touted kratom’s use to treat opioid use disorder, mood elevation and anxiety reducer.
However, for the time being, kratom remains on the Drug Enforcement Agency’s drugs of concern list, where it has been since 2011. As part of last year’s coverage, a DEA spokesperson told Healio Primary Care there is no “timetable to share on when a scheduling decision regarding kratom will be made.” – by Janel Miller
Disclosures: Sharpless is acting FDA commissioner.