UIS Manufacturing, LLC d/b/a UIS Vapes – FDA Warning Letter, Nov 19, 2021

On November 19, 2021, the FDA issued a Warning Letter to UIS Manufacturing, LLC d/b/a UIS Vapes, identifying violations related to the manufacture and distribution of e-liquid products. The FDA determined that UIS Vapes manufactures and distributes e-liquid products, which are considered tobacco products under section 201(rr) of the FD&C Act and subject to FDA jurisdiction.

The primary violation is the marketing of "new tobacco products" without the required premarket authorization. Specifically, UIS Vapes Apple Jacks 3mg 30 ML, UIS Vapes Jolly Green 3mg 30ML, and UIS Vapes Dark Matter 3mg 30ML were identified as new tobacco products that 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 company's Premarket Tobacco Product Application (PMTA), STN PM0002774, submitted on September 8, 2020, received a Marketing Denial Order on September 14, 2021, covering 320 products. The FDA emphasized that all new tobacco products on the market without statutory premarket authorization are