FDA WARNING_LETTER - Firehouse Vapes LLC d/b/a Zaelynn’s Vape & CBD - July 07, 2022

On July 7, 2022, the FDA issued a Warning Letter to Firehouse Vapes LLC d/b/a Zaelynn’s Vape & CBD, based on a review of submissions and inspection records. The FDA determined that the company manufactures and distributes e-liquid products, specifically "FIREHOUSE JUICE Razzleberry e-liquid products," which are deemed tobacco products under section 201(rr) of the FD&C Act.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. These products were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders under section 910(c)(1)(A)(i) of the FD&C Act, nor are they exempt. Consequently, these products are considered adulterated under section 902(6)(A) and 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).

The FDA states that manufacturing, selling, or distributing such adulterated or misbranded products, or failing to provide required reports, constitutes prohibited acts under sections 301(k) and 301(p) of the FD&C Act. The company is a registered manufacturer with over 18,