(RxWiki News) The US Food and Drug Administration (FDA) has issued warnings to two companies for illegally selling kratom products.
These companies, Cali Botanicals of Folsom, California, and Kratom NC of Wilmington, North Carolina, are under fire for selling unapproved, misbranded kratom products.
Furthermore, these companies are marketing their products as a way to treat or cure opioid addiction and withdrawal symptoms, but these claims are unproven. These companies are also making claims about treating pain, depression, anxiety and cancer.
Kratom has gained popularity in the United States over the past few years. It has been marketed as a “safe” treatment for pain, anxiety and depression, as well as to treat or cure opioid addiction and withdrawal symptoms. These are all serious conditions that require proper diagnosis and treatment, according to the FDA.
But kratom products have also had negative press. Last year, warnings about the contamination of kratom products with high rates of salmonella hit the news. Furthermore, the FDA found high levels of heavy metals in kratom products.
To read more about the warnings associated with kratom, read "FDA Warns of Kratom Risks."
"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 Dr. Ned Sharpless in a press release.
Kratom is not legally marketed in the US as a drug or dietary supplement, and there are no FDA-approved uses for kratom. And the FDA continues to warn consumers not to use Mitragyna speciosa, which is commonly known as kratom. Kratom is a plant that grows naturally in places like Indonesia, Malaysia, Thailand and Papua New Guinea.
Other compounds to look out for when reading a product label include mitragynine and 7-hydroxymitragynine.
Research suggests that kratom contains certain substances with opioid properties that can expose users to the risks of abuse and addiction. The FDA called for additional studies to understand the safety profile of kratom, as well as information about the substance when combined with other medications.
The claims these companies are making are considered health fraud scams that can pose serious health risks to consumers, the FDA stated.
This is because of the following:
- These products have not been shown to be safe or effective for any use.
- These products may delay consumers from seeking appropriate treatment in a timely manner.
The FDA said it continues to take steps to reduce the number of Americans who are addicted to opioids.
Consumers are encouraged to report any adverse events related to kratom products to the FDA’s MedWatch Adverse Event Reporting program.
Speak with your health care provider about any questions you may have.
Written by Anyssa Garza PharmD, BCMAS