News, musings and commentary on dietary supplements & pharmaceutical law issues, technology, and litigation.
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Sunday, March 16, 2014
SNI National Recalls Kratom XL, Maeng Da Kratom, Max Kratom
2 bottles of kratom (Mitragyna speciosa) extract (Thai Kratom Red Veine), each bottle 20ml. (Photo credit: Wikipedia)
NI National is recalling all Kratom products,including Kratom XL 4 Pack, Maeng Da Kratom 10 Pack, Max Kratom 20 Pack, and Bali Kratom 40 Pack, from distributors and retail locations. These products contain Kratom (Mitragyna Speciosa).
Kratom is a botanical that qualifies as a dietary ingredient under section 201(ff)(1) of the Federal Food, Drug, and Cosmetic Act . When marketed as a dietary ingredient, FDA considers kratom to be a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury. Furthermore, scientific literature discloses serious concerns regarding the toxicity of Kratom in multiple organ systems. Consumption of Kratom can lead to a number of health impacts, including respiratory depression, nervousness, agitation, aggression, sleeplessness, hallucinations, delusions, tremors, loss of libido, constipation, skin hyperpigmentation, nausea, vomiting, and severe withdrawal signs and symptoms.