FDA claims there is no scientific evidence to back medical claims made by suppliers of kratom.
Three distributors of kratom, a popular and controversial herbal supplement, were issued warning letters from the Food and Drug Administration (FDA). According to the agency, the companies made deceptive marketing claims about the potential health benefits of kratom.
As reported by Reuters, the FDA is accusing Front Range Kratom, Revibe Inc., and Kratom Spot of engaging in “health fraud scams” by selling kratom products with unconfirmed medical claims. Without evidence to back it up, the companies marketed several health benefits of kratom, including pain relief, blood pressure reduction, and as an opioid addiction treatment, according to the agency.
Over 65 kratom products with names such as “Super Green Indo” and “50x Black Diamond Extract” were named in the FDA letter. The three companies have yet to comment about the administration’s letter.
The FDA has yet to approve kratom for any medical use, making it a crime to sell it using claims of specific health benefits. Since kratom is considered an herbal supplement derived from leaves of a plant native to Southeast Asia, the substance does not fall under the Federal Controlled Substances Act nor the jurisdiction of the FDA.
However, this did not keep the agency from sending letters earlier this year to kratom suppliers about the potentially addictive nature of the substance. As reported by the Washington Examiner, the “extensive scientific data” quoted by the agency claimed kratom could be just as habit-forming as opioids.
Two years ago, the Drug Enforcement Administration threatened to categorize kratom as a Schedule I drug, essentially making it illegal like heroin and ecstasy. After a substantial outcry from the public and pushback from some members of Congress, the agency backed down and has yet to revisit a potential kratom ban.
Advocates of kratom claim the supplement helps people get over opioid addiction because it activates some of the same brain receptors. Some scientists, including a group that asked the Trump administration to keep it legal, fear the nation’s current opioid epidemic will only get worse without legal access to kratom. Many users say they take kratom for the relief of chronic pain and anxiety.
Often sold as a powder or in pill form, kratom is generally available to purchase online or in many convenience stores. The supplement is currently banned in Alabama, Arkansas, Indiana, Tennessee, and Wisconsin.
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