• FDA Issues Warning Letters to Companies Illegally Selling Unapproved, Misbranded Kratom Products

    FDA Issues Warning Letters to Companies Illegally Selling Unapproved, Misbranded Kratom Products0

    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 unapproved, misbranded kratom-containing drug products with unproven claims about their ability to treat or cure opioid addiction and withdrawal symptoms. Additionally, FDA found that the companies also made claims about treating pain, as well as other medical conditions like depression, anxiety, and cancer.

    In FDA’s press release, Acting FDA Commissioner Ned Sharpless noted that there are no FDA-approved uses for kratom and the agency has been active in warning consumers about the serious risks associated with kratom.

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  • FDA Warns Chinese, Indian Drugmakers and US-Based Kratom Sellers

    FDA Warns Chinese, Indian Drugmakers and US-Based Kratom Sellers0

    The US Food and Drug Administration (FDA) earlier this month warned Chinese drugmaker Xi’an Livingbond Nonwoven Products Corp. and Indian homeopathic drugmaker Rxhomeo Private Limited over good manufacturing practice (GMP) violations stemming from inspections conducted earlier this year.
     
    Based on the observations identified during the inspections, FDA placed the firms on Import Alert in April and May, respectively.
     
    FDA also announced Tuesday that it has warned two US-based companies, Kratom NC and Cali Botanicals, for marketing kratom products through their websites and social media.
     
    Xi’an Livingbond
     
    In its warning letter to Xi’an Livingbond, FDA cites the company for failing to conduct identity and strength testing for some of its products and for lacking both an adequate quality control unit and an effective program for monitoring manufacturing operations.… Continue reading.

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  • Kratom-related deaths documented locally, as CDC says more U.S. deaths are linked to the herbal supplement

    Kratom-related deaths documented locally, as CDC says more U.S. deaths are linked to the herbal supplement0

    “Two in 2017, one was where kratom was actually listed as the cause of death and the other one it was an incidental finding. We had the exact same numbers in 2018 where we had one kratom death where it was listed as the cause of death, the other, it was an incidental finding on the autopsy,” said Jefferson Parish coroner Gerry Cvitanovich.… Continue reading.

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