DFW Vapor Holdings Inc. d/b/a Vapor Lakes, Inc. – FDA Warning Letter, Nov 17, 2021

The FDA issued a Warning Letter to DFW Vapor Holdings Inc. d/b/a Vapor Lakes, Inc. on November 17, 2021, following a review of submissions and inspection records. The company manufactures and distributes e-liquid products, which are deemed tobacco products under 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, VAPOR LAKES Blueberry 3MG/30ML, VAPOR LAKES Lemonade 3MG/30ML, and VAPOR LAKES Strawdairy 3MG/30ML were found to be new tobacco products not commercially marketed before February 15, 2007, and lacking 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 cited as a prohibited act under section 301(p).

The company is a registered manufacturer with over 14,500 products listed. While Premarket Tobacco Product Applications (PMTAs) were submitted for some products (STNs PM0003453, PM0003786, PM0003530