FDA WARNING_LETTER - Shijin Vapor, LLC - November 09, 2021

The FDA issued a Warning Letter to Shijin Vapor, LLC on November 9, 2021, following a review of submissions and inspection records. The company manufactures and distributes e-liquid products, which are deemed tobacco products under the FD&C Act and subject to FDA regulation.

The primary violation identified is the marketing of SHIJIN VAPOR Pixy SERIES MANGO LIME 3MG 100ML e-liquid without the required premarket authorization. This product is considered a "new tobacco product" as it was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption. Consequently, the product is adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the lack of required notice or information.

The FDA noted that Shijin Vapor is a registered manufacturer with over 1,500 listed products. A Premarket Tobacco Product Application (PMTA), STN PM0002319, submitted on September 9, 2020, covering 147 products, received a Marketing Denial Order on September 3, 2021. Products with Marketing Denial Orders or no applications are high enforcement priorities.

Shijin Vapor must submit a written response within 15