FRANKFORT — The Kentucky Department for Public Health and the Kentucky Office of Drug Control Policy are advising the public not to consume 7-hydroxymitragynine (7-OH) and kratom products due to the risk of severe adverse reactions.
Kratom is a tropical tree native to Southeast Asia. Kratom leaves and 7-OH are made into a variety of products such as drinks, pills, teas, gummies and more, to self-treat conditions such as pain, coughing, diarrhea, anxiety, depression, opioid use disorder and opioid withdrawal.
Public health officials are warning the public that the use of 7-OH and kratom can lead to:
- Liver toxicity.
- Seizures.
- Addiction.
- Neonatal Abstinence Syndrome in newborns following prolonged exposure to kratom before birth.
Kratom has been identified as a drug of concern by the federal Drug Enforcement Administration (DEA), and it has not been approved by the U.S. Food & Drug Administration (FDA) for use in any drug or supplement products in the U.S. due to the risk of those serious negative health effects.
There are no guarantees that kratom products contain the ingredients that the packages claim, that active ingredients are present in the correct concentrations or that products are free from contaminants or other drugs. Kratom in its modern forms, especially 7-OH when concentrated or synthetically made, poses new and serious risks to the health and safety of consumers.
An estimated 1.7 million Americans aged 12 and older used kratom in 2021, according to the Substance Abuse and Mental Health Services Administration’s National Survey on Drug Use and Health.
The FDA says there are no drug products containing kratom or its two main chemical components that are legally on the market in the U.S. If a new drug application is submitted for kratom (or one of its components) to treat a specific medical condition, FDA will review the scientific data to determine if a drug product containing kratom (or its components) is safe and effective to treat that specific medical condition.
Consistent with FDA’s practice with unapproved substances, until the agency scientists can evaluate the safety and effectiveness of kratom (or its components) in the treatment of any medical conditions, FDA will continue to warn the public against the use of kratom for medical treatment. The agency will also continue to monitor emerging data trends to better understand the substance and its components.
