FDA Warns Against Using Kratom, an Unregulated Drug, as Opioid Treatment

On June 30th, the U.S. Food and Drug Administration (FDA), working jointly with the Federal Trade Commission (FTC), issued warning letters to companies selling kratom products to treat or cure opioid use disorder and withdrawal symptoms.   

Mitragyna speciosa, or kratom, is a plant native to Southeast Asia with no FDA-approved uses. The FDA is concerned kratom users are susceptible to addiction, abuse, and dependence as the product affects the same opioid brain receptors as morphine. Between July 2016 and December 2017, the Centers for Disease Control and Prevention reported that 91 overdose deaths across the country were attributable to kratom.

The following businesses received warnings from the FDA and FTC regarding kratom sales:

In said letters, the FDA details that kratom is an unapproved drug:

Your kratom products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), 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…

Your kratom products are not generally recognized as safe and effective for their above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 355(a). FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective. There are no FDA-approved applications in effect for any of the above mentioned products.

Moreover, the FTC requested that the kratom sellers cease and desist their health claims:

In addition, it is unlawful under the FTC Act, 15 U.S.C. §§ 41–57, to advertise that a product can prevent, treat, or cure human disease, including addiction to alcohol, nicotine, or drugs, unless you possess competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made. For addiction, no such study is currently known to exist for kratom. Thus, any addiction treatment claims regarding such products are not supported by competent and reliable scientific evidence. You must immediately cease making all such claims and staff strongly suggests that you review all health-related claims that you or any of your affiliates are making in any medium to ensure that they are properly substantiated and do not violate the FTC Act

During the 2020 General Assembly Session, House Bill 283/Senate Bill 147 was introduced to prohibit kratom use, possession, and distribution in Maryland. The legislation did not advance, although several witnesses testified in support with anecdotes supporting kratom’s ability to treat substance use disorder. However, the Maryland Reporter noted significant opposition to kratom’s use:

Maryland Poison Center Medical Director Josh King told Capital News Service that it would be tough to regulate kratom without it going through clinical trials. King said he doesn’t recommend clinical trials due to concerns of abuse and the reported opium-like effects from kratom.

Additionally, county health officers objected to an unfunded mandate to enforce a kratom ban according to SB 147’s fiscal note:

The bill authorizes a sworn law enforcement officer, a county health officer, or a designee of a county health officer to issue a civil citation for a violation of the bill’s prohibition. To the extent local health departments enforce the bill, expenditures increase. The Maryland Association of County Health Officers (MACHO) advises that local health departments are unable to enforce the bill’s prohibition without additional funding for training, enforcement activities, and submission of violations. MACHO further advises that even if local health departments work with police officers to conduct enforcement, they will still have to conduct the processing and paperwork required for any violations.

Read the full FDA press release.

 

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