The FDA is again warning consumers about the dangers of kratom. This compound has not been approved for the treatment or cure of opiod use disorder and withdrawal symptoms. And the agency has received “concerning reports” about the use of kratom. Kratom is an extract from the leaves of an evergreen tree that grows in Southeast Asia.
The FDA is actively evaluating all scientific information about this compound and is warning consumers not to use kratom or essential oils. The agency recently sent five warning letters to companies that are selling this product: Herbsens Botanicals, Klarity Kratom, Kratom Exchange, Omni Consumer Products LLC d/b/a/ YoKratom, and MONQ, LLC.
The warning letters state that the kratom products are unapproved new drugs under the FD&C Act, because they are “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases, and/or are intended to affect the structure or any function of the body.”
These companies often make claims about the use of kratom that are not supported by research. Some claims include “Over ninety percent of patients suffering from rheumatoid arthritis … have reported partial or total improvement in their symptoms after using Kratom,” and “Red Bali Kratom … is great for heroin and opiate-withdrawal providing … sedative effects,” and “Overall Karatom is better and well tolerated compare [sic] to opiate painkiller.”
The kratom products are not generally recognized as safe and effective for those uses. New drugs may not be legally introduced or delivered for introduction into commerce without prior approval from the FDA. The companies that were sent letters received an FTC Cease and Desist Demand, that it is unlawful under the FTC Act to advertise that a product can prevent, treat, or cure human disease unless there is competent and and reliable scientific evidence substantiating that the claims are true at the time they are made.
If you have been using kratom, discontinue use and consult your doctor. The dangers of kratom are well known and may cause serious health effects.
