Kratom Recall Due to Dietary Supplement Claim
SNI National announced a voluntary recall of all Kratom products, including Kratom XL 4 Pack, Maeng Da Kratom 10 Pack, Max Kratom 20 Pack, and Bali Kratom 40 Pack due to the labeling of these products containing Kratom (Mitragyna Speciosa) as dietary supplements. Kratom is an μ-opioid receptor marketed for conditions such as chronic pain.
The FDA discovered that the products were distributed as dietary supplements despite Kratom being categorized as a dietary ingredient under section 201(ff)(1) of the Federal Food, Drug, and Cosmetic Act. Products labeled as dietary ingredients do not have adequate support regarding safety, unlike dietary supplements which are seemed as containing safe ingredients. The FDA warns that consumption of Kratom can lead to respiratory depression, nervousness, agitation, aggression, sleeplessness, hallucinations, delusions, tremors, loss of libido, constipation, skin hyperpigmentation, nausea, vomiting, and severe withdrawal signs and symptoms.
The Kratom products are packaged in bright green clamshell, zip sealed packets, and as 4-, 10-, 20-, and 40- count green pill bottles. The products were sold to wholesale distributors in Alabama, California, Illinois, Missouri, Kentucky, Florida, Oklahoma, Idaho, Colorado, Wisconsin, Massachusetts, and Ohio. SNI National has ceased all further distribution of the products and distributors and retailers that have purchased or are selling these products should halt distribution and return to the place of purchase. Consumers are also advised to return their products or discard them.For more information call (801) 388-4690 or visit FDA.gov.