- A class action lawsuit filed earlier this year against Mitra-9 Brands, LLC, alleged that the company’s Kratom-containing seltzers, powders, and shots were falsely and misleadingly advertised, primarily because they failed
Kratom
FDA Continues Enforcement Action Against Kratom
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- FDA has warned consumers for years against using products containing Mitragyna speciosa, a plant from Southeast Asia that is commonly known as kratom, or its psychoactive compounds, mitragynine and
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CSPI Urges FDA to Take Further Action on Tianeptine Products
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- On August 25, 2020, the Center for Science in the Public Interest (CSPI) sent a letter urging FDA to take further enforcement against manufacturers, distributors, and retailers that sell products
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FDA Issues Warning Letters to Companies Illegally Selling Unapproved, Misbranded Kratom Products
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- On June 25, FDA issued warning letters to two marketers and distributors of kratom products – Cali Botanicals and Kratom NC. FDA determined that the companies were illegally selling
FDA Releases Heavy Metal Test Results in Kratom
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- In November 2018, FDA announced that it had tested 26 kratom products with “disturbingly” high heavy metal levels. Also known as Mitragyna speciose, kratom grows naturally in Southeast Asia
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FDA Finds High Levels of Heavy Metals in Kratom Products
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- In a press announcement released on November 27, 2018, FDA Commissioner Scott Gottlieb revealed that FDA scientists found “disturbingly” high levels of heavy metals in kratom products. Kratom, also known
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FDA Announces Continued Kratom Safety Concerns and Issues Warning Letters to Kratom Marketers
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- In a press announcement released on September 11, 2018, FDA Commissioner Scott Gottlieb, M.D., emphasized the Agency’s continuing concerns about kratom products. Our readers may remember our previous posts about
FDA Continues its Enforcement Efforts Aimed at Companies Marketing Kratom Products
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- On May 22, 2018 FDA announced that it had issued warning letters to three companies marketing kratom products with medical claims. FDA’s letter asserts that the claims that the products
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FDA Issues First Ever Mandatory Recall Order for Kratom Products
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- On April 2, 2018, FDA issued a mandatory recall order for all products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC, after several tested positive for
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