FDA WARNING_LETTER - HRE Investments LLC d/b/a Vaporifics - October 28, 2021

The FDA issued a Warning Letter to HRE Investments LLC d/b/a Vaporifics for manufacturing and distributing e-liquid products, specifically "Vaporifics Double D 6mg e-liquid," without required premarket authorization. The FDA determined that this product is a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption.

Consequently, the product is deemed adulterated under section 902(6)(A) of the FD&C Act (21 U.S.C. § 387b(6)(A)) and misbranded under section 903(a)(6) of the FD&C Act (21 U.S.C. § 387c(a)(6)) 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 letter emphasizes that all new tobacco products on the market without premarket authorization are unlawful and subject to enforcement, including civil money penalties, seizure, and/or injunction. Vaporifics, a registered manufacturer with over 60 listed products, must submit a written response within 15 working days detailing corrective actions, including discontinuing viol