FDA WARNING_LETTER - Great American Vapes Shreveport - October 07, 2021

The FDA issued a Warning Letter to Great American Vapes LLC, identifying that the company manufactures and distributes e-liquid products, specifically "Great American VAPES Almond 3 mg 30 ml" and "Great American VAPES Big Top Cotton Candy 3 mg 30 ml," which are deemed tobacco products under the FD&C Act. These products are considered "new tobacco products" as they were not commercially marketed in the U.S. as of February 15, 2007.

The primary violation is the sale and distribution of these e-liquid products without the required premarket authorization from the FDA, as mandated by section 910(a) of the FD&C Act. Consequently, these products are adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, due to the lack of required marketing authorization orders or substantial equivalence reports. The failure to provide such reports is also a prohibited act under section 301(p).

The letter notes that Great American Vapes LLC is a registered manufacturer with over 25,500 listed products, and their Premarket Tobacco Product Application (PMTA) (STN PM0003726), covering 8,607 products, received a Marketing Denial Order on August 26, 2021. The FDA emphasizes