FDA WARNING_LETTER - Electric Smoke Vapor House - October 29, 2021

The FDA issued a Warning Letter to Electric Smoke Vapor House for manufacturing and distributing e-liquid products without required marketing authorization. The FDA determined that e-liquid products are tobacco products subject to FDA jurisdiction under the FD&C Act.

The violations identified include the commercial marketing of "new tobacco products" without premarket authorization. Specifically, the products "ELECTRIC SMOKE VAPOR HOUSE Best of Both Worlds 3 MG 15mL," "ELECTRIC SMOKE VAPOR HOUSE Kentucky Bourbon 12 MG 15mL," and "ELECTRIC SMOKE VAPOR HOUSE Banana Split 6 MG 15mL" were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders. This renders them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The failure to provide required reports under section 905(j) is also a prohibited act.

The company's Premarket Tobacco Product Application (PMTA), STN PM0003485, covering 6,959 products, received a Marketing Denial Order on September 8, 2021. The FDA states that products with Marketing Denial Orders or no submitted applications are high enforcement priorities.

Electric Smoke Vapor House must submit a written response within 15 working days detailing