FDA WARNING_LETTER - SAS Technologies, Inc d/b/a Save A Smoker - January 25, 2022

The FDA issued a Warning Letter to Erick Slaick of Save A Smoker on January 21, 2022, following a review of their website, https://www.saveasmoker.com. The FDA determined that e-liquid products, specifically "Save A Smoker – Buttery Waffle" and "Save A Smoker – Vanilla Cinnamon Roll," are manufactured and offered for sale or distribution in the U.S. These products are classified as tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The primary violation is the marketing of "new tobacco products" without the required premarket authorization order, as mandated by section 910(a) of the FD&C Act. These e-liquid products were not commercially marketed in the U.S. as of February 15, 2007, and lack the necessary FDA marketing authorization. Consequently, they are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The firm is a registered manufacturer with over 5,900 products listed with FDA. A Premarket Tobacco Product Application (PMTA) (STN PM0001270) submitted on September 8, 2020, covering 1,662 products, received a Ref