FDA WARNING_LETTER - www.serenawholesaler.com

The FDA Center for Tobacco Products reviewed serenawholesaler.com and found cigarettes and smokeless tobacco products offered for sale in the U.S. are adulterated and misbranded.

**Violations:**

1. **Modified Risk Tobacco Product Violations:** Cigarette products like "Rave Menthol Light 100's," "Rave Menthol Light King," and "Silver Menthol Light King" are promoted using the descriptor "Light." Under section 911(b)(2)(A)(ii) of the FD&C Act, this makes them "modified risk tobacco products." Introducing or delivering such products into interstate commerce without an FDA order under section 911(g) is prohibited, rendering them adulterated under section 902(8) of the FD&C Act.

2. **Health Warning Statement Violation:** Numerous smokeless tobacco products, including "Bloodhound Thick Cut 15ct" and "Grizzly L/C Mint 5ct," are advertised without required warning label statements. This violates section 3 of the Comprehensive Smokeless Tobacco Health Education Act of 1986 (15 U.S.C. § 4402), as amended, and causes the products to be misbranded under section 903(a)(7)(A) of the FD&C Act. The Smokeless Tobacco Act mandates specific warnings and their quarterly rotation.

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