Import alerts, warning letters, and seizures by U.S. Marshals involving the U.S. Food and Drug Administration (FDA) are not uncommon where Kratom is involved. The tropical tree native to Southeast Asia is not approved for any medical use by the FDA but is often mentioned for one kind of caution or another.
And court action now has the industry crying out for regulation.
A Florida jury on July 31 awarded $11 million for the wrongful death of a Florida woman. She died due to “acute mitragynine intoxication.” Mitragynine, one of two main chemical compounds in kratom, produces classic opioid-like effects at high concentrations, such as sedation, nausea, vomiting, addiction, and difficulty breathing, which may be fatal.
FDA has not approved kratom for sale in the U.S., but the herb operates in a grey area of the law and is often sold online or at convenience stores and gas stations, usually in the form of capsules or loose powder.
Kratom leaves produces both stimulant effects (in low doses) and sedative effects (in high doses) and can lead to psychotic symptoms and psychological and physiological dependence. Kratom leaves contain two primary psychoactive ingredients (mitragynine and 7-hydroxy mitragynine).
The leaves are crushed, smoked, brewed with tea, or placed into gel capsules. Kratom has a long history of use in Southeast Asia, where it is commonly known as thang, kakuam, thom, ketum, and biak. In the U.S., kratom abuse has increased markedly in recent years.
However, Kratom is not controlled under the Controlled Substances Act, although there are some state regulations or prohibitions against the possession and use of kratom.
The Drug Enforcement Agency has listed kratom as a Drug and Chemical of Concern.
It may surprise some that the American Kratom Association (AKA) issued a Consumer Advisory in response to recent wrongful death jury awards in Florida and elsewhere. The industry group:
1. Urges the FDA to immediately publish product manufacturing standards for kratom products that are sold to consumers and encourage the removal of kratom products that do not contain adequate labeling with recommended serving sizes, product ingredients, and appropriate warnings on conditions of use.
2. Until the FDA implements a set of standards to protect consumers, the AKA advises kratom consumers not to purchase or consume kratom products that:
a. Have not been certified by an independent third-party lab to be free of dangerous contaminants or contain adulterants that could be dangerous to consume.
b. Are offered for sale from a vendor that markets its product with illegal therapeutic claims.
c. Do not contain the name of the product distributor so that a consumer can file an adverse event report if required.
d. Are delivered in unprofessional packaging, such as zip-close bags, or that have handwritten product information.
“Recent reports of product liability awards for irresponsibly manufactured or marketed kratom products are the direct result of the FDA’s failure to regulate the kratom marketplace and, in some cases, the exploitive behavior of trial attorneys who do nothing to compel the FDA to act responsibly,” said Mac Haddow, the AKA’s Senior Fellow on Public Policy.
Based on the AKA’s review of litigation reports, Haddow claims the product liability awards by the courts have been based on the failure of the product manufacturers to provide labeling instructions for responsible use and little or no information on the contents of the potentially contaminated products.
“The safety and addiction profile of pure, unadulterated kratom is well-documented by science and there is no known level of kratom use that would cause any fatality unless it is irresponsibly consumed, adulterated with a toxic drug or used concurrently with a deadly drug substance,” Haddow added. “The AKA supports congressional action to compel the FDA to develop and implement a set of standards for the manufacturing and marketing of kratom products to protect consumers in the United States.”
AKA calls itself “a consumer-based, nonprofit organization, focuses on setting the record straight about kratom and gives a voice to those suffering by protecting their rights to possess and consume safe and natural kratom.” It claims to represent “millions of Americans, each of whom has a unique story to tell about the virtues of kratom and its positive effects on their lives.”
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