The Agency named Nature Therapeutics LLC, which does business as Kratom Therapy and is located in Grover Beach, California, as the distributor. The Kratom Therapy products are reportedly worth approximately $150,000.
FDA originally issued an import alert on kratom in February, 2014. This allows US officials to detain imported dietary supplements and bulk dietary ingredients that are, or contain, kratom without physical examination. Despite this hurdle, some companies and individuals continue to run the risk of seizure, perhaps hoping they can slide in under the radar.
According to the FDA, kratom is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that it does not present a significant or unreasonable risk of illness or injury; therefore, dietary supplements containing kratom are adulterated under the FD&C Act. This de facto makes any product containing kratom to be adulterated under the act.
“The FDA will continue to take aggressive enforcement action to safeguard the public from harmful drug products illegally marketed as treatments for which they have not been studied or approved,” said Melinda Plaisier, the FDA’s associate commissioner for regulatory affairs.
What is kratom?
Mitragyna speciosa, commonly known as kratom, is a botanical substance that grows naturally in Thailand, Malaysia, Indonesia and Papua New Guinea. Serious concerns exist regarding the toxicity of kratom in multiple organ systems. According to FDA, 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 indicated to have both narcotic and stimulant-like effects and withdrawal symptoms may include hostility, aggression, excessive tearing, aching of muscles and bones and jerky limb movements.
Kratom contains two alkaloids, mitragynine and 7-hydroxymitragynine, that have analgesic and potentially psychedelic properties. It has been suggested that if a way were found to remove these that much of FDA’s concern about the ingredient would disappear.
This is the second time in 2016 that US Marshals have moved to seize kratom-containing products: 90,000 bottles worth more than $400,000 were seized at a facility in Illinois in January.
Over 25,000 pounds of raw kratom material worth more than $5 million were seized by US Marshals in Southern California in September 2014.