FDA WARNING_LETTER - Smoke-Free Planet, LLC d/b/a Smoke Free Nation - April 27, 2022

On April 27, 2022, the FDA issued a Warning Letter to Smoke-Free Planet, LLC d/b/a Smoke Free Nation, identifying violations related to the manufacture and distribution of e-liquid products. The FDA determined that the company's "Smoke Free Nation Meteor Menthol 3mg 120 ml e-liquid product" is a "new tobacco product" under section 910(a) of the FD&C Act because it was not commercially marketed in the U.S. as of February 15, 2007.

The product is deemed adulterated under section 902(6)(A) of the FD&C Act because it lacks the required FDA marketing authorization order under section 910(c)(1)(A)(i). Additionally, it is misbranded under section 903(a)(6) of the FD&C Act due to the failure to provide required notice or information under section 905(j). These actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act.

The FDA emphasized that all new tobacco products on the market without premarket authorization are unlawful and subject to enforcement actions, including civil money penalties, seizure, and/or injunction. The company, a registered manufacturer with over 150 listed products, must ensure all products comply with the