FDA WARNING_LETTER - Rocky Mountain Ecigs, LLC - January 18, 2022

On January 11, 2022, the FDA issued a Warning Letter to Keith Petterson regarding e-liquid products manufactured and sold by Rocky Mountain Ecigs, specifically citing products found on https://www.rockymountainecigs.com and https://rmevape.com. The FDA determined these e-liquid products are "tobacco products" under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization order, as mandated by section 910(a) of the FD&C Act. The e-liquid products, including "Mile High Drip Pair," "Mile High Drip Bacco Supreme," and "Mile High Drip JaMakin Clouds," were deemed new tobacco products because they were not commercially marketed in the U.S. as of February 15, 2007, and lack the necessary FDA marketing authorization. This renders them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The letter notes that the firm is a registered manufacturer with over 6,500 products listed with FDA. A Premarket Tobacco Product Application (PMTA) (STN PM0003748) submitted on September 9, 2