Rockwall Vaporstop LLC – FDA Warning Letter, Jul 20, 2022

On July 20, 2022, the FDA issued a Warning Letter to Rockwall Vaporstop LLC, identifying violations related to the manufacture and distribution of e-liquid products. The FDA determined that Rockwall Vaporstop LLC manufactures and distributes e-liquid products, including "HY MAINTENANCE e-liquid products," which are considered tobacco products under section 201(rr) of the FD&C Act.

The primary violation is that these e-liquid products are "new tobacco products" because they were not commercially marketed in the United States as of February 15, 2007, and are being sold without the required premarket marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. This renders the products 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 under section 301(p).

Rockwall Vaporstop LLC is a registered manufacturer with over 4,400 products listed. The FDA received their Premarket Tobacco Product Application (PMTA), STN PM0002571, on September 9, 2020, but issued a Marketing Denial Order on September 15, 202