July 30, 2021

elprincipelila

There's nothing like our health

FDA seizes ‘adulterated dietary supplements’ containing kratom worth $1.3 million

3 min read

Manufactured by Fort Myers, FL-based Atofil, LLC, a subsidiary of Premier Manufacturing Products, the seized products are marketed under the brand names Boosted Kratom, The Devil’s Kratom, Terra Kratom, Sembuh, Bio Botanical, and El Diablo.

“There is substantial concern regarding the safety of kratom, the risk it may pose to public health and its potential for abuse,”​ said Judy McMeekin, Pharm.D., the FDA’s Associate Commissioner for Regulatory Affairs.

“The FDA will continue to exercise our full authority under the law to take action against these adulterated dietary supplements as part of our ongoing commitment to protect the health of the American people. Further, there are currently no FDA-approved uses for kratom.”

NDI

Kratom (Mitragyna speciosa​) is a botanical native to Southeast Asia.  It has been used to treat chronic pain, PTSD and is alleged to have helped some individuals wean themselves from addiction to opioid pain killers.

According to the FDA, “serious concerns exist regarding the toxicity of kratom in multiple organ systems. 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.”

FDA first issued an import alert on kratom in 2014.  The import alert was reissued this year to update some details, including the companies on the so-called ‘Red List.’

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