FDA WARNING_LETTER - Mom and Pop Vapor Shop - November 09, 2021

On October 29, 2021, the FDA issued a Warning Letter to Tami Taucher of Mom and Pop Flavors, following a review of their website, https://www.momandpopflavors.com. The FDA determined that e-liquid products, specifically "Mom and Pop Vapor Shop Strawberry Milkshake" and "Mom and Pop Vapor Shop Krunchberry," were manufactured and offered for sale or distribution in the United States.

These e-liquid products are classified as "new tobacco products" under section 201(rr) of the FD&C Act because they were not commercially marketed in the U.S. as of February 15, 2007. The FDA found that these products lacked the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act, making them 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 5,500 products listed with FDA. The FDA noted that Premarket Tobacco Product Applications (PMTAs) STN PM0000981 (covering 595 products) and STN PM0003697 (covering 570 products) were submitted on September 4, 202