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Shot of Joy LLC was warned for marketing unapproved new drug products, including kratom and kava shots and gummies, in violation of the Federal Food, Drug, and Cosmetic Act sections 301(d) and 505(a). The company made unsubstantiated disease claims on its website, specifically marketing kratom products for the treatment and cure of opioid addiction and withdrawal symptoms without FDA approval or evidence of safety and effectiveness. The FDA emphasized that these unapproved treatments posed a significant public health threat by potentially causing patients to forego or delay FDA-approved opioid addiction treatments during the ongoing national opioid crisis.