FDA WARNING_LETTER - RTP Vapors LLC - February 24, 2022

The FDA issued a Warning Letter to RTP Vapors LLC on February 24, 2022, following a review of submissions and inspection records. The FDA determined that RTP Vapors LLC manufactures and distributes e-liquid products, which are classified as tobacco products under the FD&C Act.

The primary violation identified is the marketing of "RTP Vapor Vape Juice Blue Berry 3mg" e-liquid product without the required premarket authorization. This product is deemed a "new tobacco product" because it was not commercially marketed in the United States as of February 15, 2007, and lacks an FDA marketing authorization order or exemption.

Consequently, the product is 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.

RTP Vapors LLC, a registered manufacturer with over 1,100 listed products, is advised that all new tobacco products