FDA WARNING_LETTER - Foundation Vapor LLC - January 18, 2022

The FDA issued a Warning Letter to Foundation Vapor LLC on December 16, 2021, following a review of submissions and inspection records. The FDA determined that Foundation Vapor LLC manufactures and distributes e-liquid products, which are classified as tobacco products under section 201(rr) of the FD&C Act and subject to FDA jurisdiction.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the products Foundation Vapor SourBerry Blast 3mg/ml 100ml, Foundation Vapor Grape Pom 3mg/ml 100ml, and Foundation Vapor Tropical Breeze 3mg/ml 100ml were found to be new tobacco products because they were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders or exemptions.

These products are cited as adulterated under section 902(6)(A) of the FD&C Act and misbranded under section 903(a)(6) for failure to provide required notice or information under section 905(j). Prohibited acts include holding for sale adulterated or misbranded products (section 301(k)) and failing to provide required reports (section 301(p)).

Foundation Vapor LLC, a registered manufacturer with over 1,300 listed products, is advised that