Victory Vapor Inc. – FDA Warning Letter, Feb 15, 2022
The FDA's Center for Tobacco Products issued a Warning Letter to Victory Vapor Inc. on February 4, 2022, following a review of their website, https://www.victoryvaporinc.com. The review determined that e-liquid products, specifically "White Bunny" and "Salted Caramel Apple," were manufactured and offered for sale or distribution in the U.S. These products are classified as "new tobacco products" under section 201(rr) of the FD&C Act because they were not commercially marketed in the U.S. as of February 15, 2007.
The primary violation is that these e-liquid products lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act, rendering them adulterated under section 902(6)(A) and misbranded under section 903(a)(6). While Victory Vapor Inc. is a registered manufacturer with over 32,000 products listed, their Premarket Tobacco Product Application (PMTA) STN PM0002511, covering 31,006 products, received a "Refuse to Accept" determination on June 30, 2021.
The FDA requires a written response within 15 working days detailing actions taken to address the violations, including discontinuing the sale and distribution
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