FDA WARNING_LETTER - Bogart Enterprises LLC d/b/a The Vapor Shop - December 27, 2021

The FDA issued a Warning Letter to Bogart Enterprises LLC d/b/a The Vapor Shop for manufacturing and distributing unapproved new tobacco products. The FDA determined that e-liquid products, specifically "The Vapor Shop Strawberry 3mg" and "The Vapor Shop Strawberry Kiwi 3mg," are "new tobacco products" as they were not commercially marketed in the U.S. before February 15, 2007.

These products lack the required FDA marketing 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). The failure to provide required reports under section 905(j) is also a prohibited act.

Bogart Enterprises is a registered manufacturer with over 800 listed products. Their Premarket Tobacco Product Application (PMTA), STN PM0002061, submitted September 3, 2020, received a Marketing Denial Order on September 16, 2021, covering 159 products. The FDA considers products without pending applications, including those with Marketing Denial Orders, as high enforcement priorities.

The company must submit a written response within 15 working days detailing actions to address violations, including discontinuing violative sales and a plan for compliance. Failure to comply may