U.S. Marshals seized more than 207,000 units of dietary supplements and bulk dietary ingredients that are or contain kratom, including over 34,000 kilograms of bulk kratom, the U.S. Food and Drug Administration, or FDA, said in a statement.
The dietary supplements were manufactured by Fort Myers, Florida-based Atofil, LLC, which is a subsidiary of Premier Manufacturing Products.
The dietary supplements were marketed under the brand names Boosted Kratom, The Devil’s Kratom, Terra Kratom, Sembuh, Bio Botanical, and El Diablo. The seized products are worth approximately $1.3 million.
Kratom is an herbal supplement, made from Mitragyna speciosa, a tropical evergreen tree native to Southeast Asia. Most people take Kratom as a pill, capsule, or extract. Some people chew Kratom leaves or brew the dried or powdered leaves as a tea. Sometimes the leaves are smoked or eaten in food.
Kratom contains the alkaloid mitragynine, which is said to produce stimulant effects in low doses and some opioid-like effects at higher doses when consumed. It affects the same opioid brain receptors as morphine.
This herbal supplement is touted as an alternative to treat pain in place of opioids and as a “cure” for heroin addiction and withdrawal symptoms. Kratom is available in various internet forums.
FDA is concerned that kratom, which affects the same opioid brain receptors as morphine, appears to have properties that expose users to the risks of addiction, abuse, and dependence. It has regularly warned consumers not to use kratom products as well as warned marketers and distributors for illegally selling unapproved, misbranded kratom-containing drug products with unproven claims.
There are serious concerns regarding the toxicity of kratom in multiple organ systems. The consumption of kratom can lead to a number of health impacts, including, among others, respiratory depression, vomiting, nervousness, weight loss and constipation.
There are no FDA-approved uses for kratom, and the agency has received concerning reports about the safety of kratom. The FDA continues to warn consumers not to use any products labeled as containing kratom.
According to the FDA, dietary supplements and bulk dietary ingredients that are or contain kratom are adulterated under the Federal Food, Drug, and Cosmetic Act, as there is inadequate information to provide reasonable assurance that it does not present a significant or unreasonable risk of illness or injury.
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