Turncoat Industries, Inc. – FDA Warning Letter, Apr 5, 2022

The FDA issued a Warning Letter to Khaled Aboabdo, operating shopjohnnyapple.com, for manufacturing and selling unapproved new tobacco products. The FDA reviewed the website and determined that e-liquid products, specifically "Johnny Be Fresh Cowabunga" and "Johnny Be Fresh Surf’s Up," are tobacco products under section 201(rr) of the FD&C Act and subject to FDA jurisdiction.

These e-liquid products are considered "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007. They lack the required FDA marketing 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 15 listed products. A Premarket Tobacco Product Application (PMTA), STN PM0001199, submitted on September 7, 2020, received a Marketing Denial Order on September 15, 2021, covering 43 products. The FDA emphasizes that new tobacco products without premarket authorization are unlawfully marketed and subject to enforcement actions, including civil money penalties, seizure, and injunction.

The company must submit a written response within