WASHINGTON, D.C. — The FDA is warning five companies that their claims of curing opioid use and withdrawal are unfounded.
On June 30, the FDA sent letters to four companies selling kratom products and one company selling essential oils. All of the companies claimed treatment or cure of opioid use disorder and withdrawal symptoms.
The companies that got warnings are:
- Herbsens Botanicals
- Klarity Kratom
- Kratom Exchange
- Omni Consumer Products LLC d/b/a YoKratom
- MONQ, LLC
In the letters, the FDA warned the companies that the claims on their websites make the products considered drugs because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body.
However, the FDA says the products have not been recognized as safe and effective for the uses the companies reference on their website. That makes the products “new drugs,” which can’t legally be introduced or delivered without FDA approval.
The warnings come as the Department of Health and Human Services determined that a public health emergency exists nationwide involving the opioid crisis. The FDA says it has not approved kratom products or essential oils for the treatment or cure of opioid use disorder and withdrawal symptoms.
“It’s very troubling to the FDA that patients believe they can use kratom to treat opioid withdrawal symptoms,” then FDA Commissioner Scott Gottlieb said in 2017.
The FDA says by marketing these products to treat opioid use disorder or withdrawals, it could cause people to forego or delay FDA-approved treatments. The administration also said it has received concerning reports about the safety of kratom.
Kratom is an herbal extract of Mitragyna speciosa, a plant native to Thailand, Malaysia, Indonesia, and Papua New Guinea. The FDA said in 2018 that there is evidence that certain substances found in kratom are opioids and data suggest that one or more may have a potential for abuse.
In 2019, the CDC reported that 152 kratom-involved overdose deaths occurred during July 2016-December 2017. This includes seven deaths where kratom was the only substance to test positive on postmortem toxicology.
The Mayo Clinic reports that kratom also adversely affects infant development. When the substance is used during pregnancy, the baby may be born with symptoms of withdrawal that require treatment.
The companies were given 15 working days to tell the FDA how they plan to correct the violations. If they continue to market them in the same way, they could face civil penalties up to $46,517 per violation.