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Sunshine Trading Company, Inc. dba Nova Tea and Nova Kratom was cited for marketing unapproved new drug products—specifically multiple kratom varieties including Red Vein, White Vein, Green Vein, and Yellow Vein Kratom powders—in violation of sections 301(d) and 505(a) of the FD&C Act. The company violated FDA regulations by marketing these kratom products for the treatment or cure of opioid addiction and withdrawal symptoms without FDA approval, despite these products not being determined safe and effective for any medical use. The FDA emphasized that these unapproved opioid addiction treatments pose a significant public health threat, particularly given the nationwide opioid crisis, as they could cause patients to forego or delay FDA-approved addiction treatments.