FDA orders seizure of US$1.3M kratom supplements, citing public health threats

25 May 2021 --- The US Food and Drug Administration (FDA) is seizing approximately US$1.3 million worth of dietary supplement products containing botanical ingredient kratom (Mitragyna speciosa), after determining they pose a potential threat to public health. 

The products were manufactured by Atofil, a subsidiary of Premier Manufacturing Products, which is located in Florida, US. The FDA requested US law enforcement to seize over 207,000 dietary supplements and bulk dietary ingredients containing kratom, including over 34,000 kg of bulk kratom. 

“There is substantial concern regarding the safety of kratom, the risk it may pose to public health and its potential for abuse,” says Judy McMeekin, associate commissioner for regulatory affairs at the FDA. 

“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.”

Research on kratom has shown both benefits and threats to human health.The seized dietary supplements are marketed under the brand names Boosted Kratom, The Devil’s Kratom, Terra Kratom, Sembuh, Bio Botanical and El Diablo. Suppliers tout the products for their ability to provide a range of physically and cognitively stimulatory effects.

Kratom’s murky waters 
Kratom is a plant that grows naturally in Thailand, Malaysia, Indonesia and Papua New Guinea. 

The plant has been used for centuries to relieve fatigue, anxiety, chronic pain, cough and diarrhea and, more recently, as an aid in opioid withdrawal. 

Serious concerns exist regarding the toxicity of kratom in multiple organ systems, however. 

Consumption of kratom can lead to a number of health impacts, including respiratory depression, vomiting, nervousness, weight loss and constipation. 

According to the FDA, kratom has also 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. 

In 2019, NutritionInsight spoke with experts, who found multiple uses for kratom as both a stimulant for fatigue and (at higher doses) a sedative for pain relief and insomnia.

However, a pronounced lack of evidence from human clinical trials makes it difficult to scientifically confirm the ingredient’s benefits, largely due to very little raw material in the US. 

A majority of kratom in the US is sourced from Asian countries, where it likely often goes treated and adulterated through unregulated processes, posing serious concerns over the safety of final products. 

Imposing regulations 
The FDA’s recent crackdown on kratom-containing products in the US is the latest in a line of legal action against the ingredient. 

In February 2014, the FDA issued an import alert providing information to FDA field staff about detaining, without physical examination, imported dietary supplements and bulk dietary ingredients that are or contain kratom. 

The US Department of Justice, on behalf of the FDA, filed a complaint in the US District Court for the Middle District of Florida alleging, among other things, that kratom is a new dietary ingredient for which there is inadequate information to provide assurance it does not present a significant or unreasonable risk of illness or injury. 

Edited

By Louis Gore-Langton