FDA WARNING_LETTER - E-Cig Mania LLC - October 19, 2021

The FDA issued a Warning Letter to E-Cig Mania LLC, identifying violations related to the manufacturing and distribution of e-liquid products. The FDA determined that E-Cig Mania MENTHOL 3mg e-liquid 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 primary violation is that this product is being sold without the required premarket authorization order from the FDA, as mandated by section 910(c)(1)(A)(i) of the FD&C Act. Consequently, the product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as the required notice or information under section 905(j) was not provided. These actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act.

E-Cig Mania LLC is a registered manufacturer with over 1700 products listed with the FDA. The FDA emphasizes that all new tobacco products marketed without statutory premarket authorization are unlawful and subject to enforcement. The company must submit a written response within 15 working days detailing corrective actions, including discontinuing violative sales and distribution, and a