FDA Seeking Public Comments on Kratom

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By Pat Anson, PNN Editor

The U.S. Food and Drug Administration is seeking public comments on the medical use and abuse of kratom. In a notice published Friday in the Federal Register, the FDA said the comments will be reviewed as it prepares a response to the World Health Organization (WHO), which is considering whether to place international restrictions on kratom and six other psychoactive substances.

Kratom comes from the leaves of the mitragyna speciosa tree in southeast Asia, where it has been used for centuries as a natural stimulant and pain reliever. In recent years, millions of Americans have discovered kratom and use it to self-treat pain, anxiety, depression and addiction. The FDA has tried — unsuccessfully so far – to schedule kratom as a controlled substance, which would effectively ban its sale and use in the United States.

Under international treaties, WHO is required to assess the use of psychoactive substances and advise the United Nations on whether they pose a public health risk and should be controlled. The annual assessment will begin in October and U.N. members have been invited to submit their recommendations.

Although the FDA said the U.S. will defer from making any immediate recommendations to WHO, the notice in the Federal Register makes plain that the agency still has a dim view of kratom. It makes no mention of the medical benefits many kratom users get from the herbal supplement.

“Kratom has a history of being used as an opium substitute in Southeast Asia. In the United States, kratom is misused to self-treat chronic pain and opioid withdrawal symptoms.”

— FDA

“Kratom is an increasingly popular drug of abuse and readily available on the recreational drug market in the United States. Evidence suggests that kratom is abused individually and with other psychoactive substances,” the FDA said.

“Kratom has a history of being used as an opium substitute in Southeast Asia. In the United States, kratom is misused to self-treat chronic pain and opioid withdrawal symptoms. Consumption of kratom can lead to a number of health impacts, including, among others, respiratory depression, vomiting, nervousness, weight loss, and constipation. Kratom has been reported to have both narcotic and stimulant-like effects.”

The American Kratom Association (AKA), a group of kratom vendors and consumers, said FDA instigated WHO’s review of kratom as a way to bypass the drug scheduling process in the U.S. The AKA is urging kratom consumers to submit positive comments about the herbal supplement.

“The comments should be focused on the experiences that kratom consumers have had with kratom and how it has benefited them in terms of improving their quality of life, to reduce pain, to reduce anxiety and depression, to wean off of opioids, and how kratom has saved their lives,” Mac Haddow, an AKA lobbyist, said in a video. “We want the WHO to know the powerful experiences that people have had. We want to protect kratom, not only here in the United States, but also around the world.”

There’s an August 9 deadline for comments, which can be submitted here.

Asked if the FDA requested WHO to review kratom, a spokesperson told PNN the agency “does not determine for the U.S. government which substances shall be proposed” for review. WHO reviews can be requested by any member countries that are signatories to international drug control treaties.

Kratom’s legal status varies around the world. Thailand recently decriminalized kratom and will make the plants legal to grow and export in August. Kratom use is banned domestically in Indonesia, but kratom farming is still permitted. Most kratom exports come from Indonesia, where it is considered an important cash crop.

Kratom sales are legal in most U.S. states, although some states and communities have banned it. The FDA recently seized 37 tons of kratom from a vendor in Florida for alleged violations of a federal law that prohibits the sale of adulterated dietary supplements.

A federal effort in 2016 to ban kratom nationwide failed due to a public outcry. Two years later, the Department of Health and Human Services (HHS) withdrew a request to classify kratom as a Schedule I controlled substance, citing lack of evidence it can be abused or posed a public health threat. A top HHS official later said the FDA request to schedule kratom was rejected because of “embarrassingly poor evidence & data.”

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