FDA WARNING_LETTER - Osment Enterprises, LLC d/b/a The Vapor Apothecary - September 13, 2022

The FDA issued a Warning Letter to Osment Enterprises, LLC d/b/a The Vapor Apothecary on September 7, 2022, following a review of submissions and inspection records. The company manufactures and distributes e-liquid products, specifically "The Vapor Apothecary Rusty Tusk Happy Panda," which are deemed tobacco products under section 201(rr) of the FD&C Act.

The primary violation is the manufacturing, sale, and/or distribution of "new tobacco products" without the required premarket authorization. These products were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders under section 910(c)(1)(A)(i) of the FD&C Act, nor are they exempt. 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 notice or information under section 905(j).

The company's Premarket Tobacco Product Application (PMTA), STN PM0003454, submitted on September 8, 2020, received a Marketing Denial Order on September 8, 2021, covering 1,556 products. The FDA considers products with Marketing Denial Orders or no submitted applications as