lonestar vapor shop, llc – FDA Warning Letter, Sep 2, 2021

The FDA issued a Warning Letter to LoneStar Vapor Shop, LLC d/b/a LoneStar Vapor, identifying violations related to the manufacturing and distribution of e-liquid products. The FDA determined that LoneStar Vapor's e-liquid products are tobacco products under section 201(rr) of the FD&C Act, subject to FDA jurisdiction and compliance requirements.

Specifically, the FDA found that LONESTAR VAPOR SHOP MLB 1.5 nicotine MG e-liquid product is a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007. This product lacks the required FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act, rendering it adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The failure to provide a required report under section 905(j) is also a prohibited act.

LoneStar Vapor is a registered manufacturer with over 8,200 products listed. Their Premarket Tobacco Product Application (PMTA), STN PM0002054, submitted on September 9, 2020, was refused on June 3, 2021, covering 2,114 products. The FDA emphasized that