Sunshine Trading Company, Inc. dba Nova Tea and Nova Kratom

Warning LetterOpen

Joshua Miller Sunshine Trading Company, Inc. dba Nova Tea and Nova Kratom 1510 Quail Lake Loop, Suite B Colorado Springs , CO 80906 United States support@novakratom.comFEI 3004254495Issued Jul 3, 2023Center for Drug Evaluation and Research | CDER

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3004254495.

Violations2

Issue DateJul 3, 2023

Product TypeDrugs

StatusOpen

Letter Details

Firm: Sunshine Trading Company, Inc. dba Nova Tea and Nova Kratom
Location: Joshua Miller Sunshine Trading Company, Inc. dba Nova Tea and Nova Kratom 1510 Quail Lake Loop, Suite B Colorado Springs , CO 80906 United States support@novakratom.com
FEI Number: 3004254495
Country: United States
Issue Date: July 03, 2023
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

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.

Sunshine Trading Company, Inc. dba Nova Tea and Nova Kratom FDA Warning Letter, July 3, 2023