FDA WARNING_LETTER - Jungle Nation Inc. - April 12, 2022

On January 21, 2022, the FDA issued a Warning Letter to Tyler Burg and Troy Lanie of JnglNation.com after reviewing their website and determining they manufacture and offer for sale e-liquid products in the U.S. These products are deemed "tobacco products" under section 201(rr) of the FD&C Act and are subject to FDA regulation.

The FDA found that "The Glory Days Melon Blackberry" and "The Glory Days Peach Orange Mango" e-liquid products are "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007. These products lack the required FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act, rendering them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

While the firm is a registered manufacturer with 350 products listed, their Premarket Tobacco Product Application (PMTA) (STN PM0002407), covering 180 products, received a Marketing Denial Order on September 15, 2021. The FDA emphasizes that new tobacco products without premarket authorization are marketed unlawfully and are high enforcement priorities.

The letter requires a written response within 15