FDA WARNING_LETTER - ATL Vaping Inc. - October 07, 2021

The FDA issued a Warning Letter to Tracy Shelnutt and Donald Shelnutt regarding e-liquid products sold on shopatlvaping.com. The FDA determined that products like "Grizzly Grahams" and "Cap’n Munch" are tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction. These e-liquids are considered "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007.

The primary violation is the marketing of these new tobacco products without the required premarket authorization order, as mandated by section 910(a) 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.

Although the firm is a registered manufacturer with over 15,500 products listed, their Premarket Tobacco Product Application (PMTA), STN PM0003483, received a Marketing Denial Order on September 8, 2021, covering 3,012 products. The FDA emphasizes that all new tobacco products on the market without premarket authorization are unlawful and subject to enforcement action, with products lacking pending applications or those with Marketing Denial Orders being high enforcement priorities.

The firm must submit a