FDA WARNING_LETTER - zerocig - June 07, 2022

On June 3, 2022, the FDA issued a Warning Letter to David Moor regarding e-liquid products sold on zerocig.com and aristocigars.com. The FDA determined these e-liquid products are tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The primary violation is the marketing of "new tobacco products" without required premarket authorization, as mandated by section 910(a) of the FD&C Act. Specific examples cited include ARISTO Reserve E Cigar Juice Carmilla Clouds, ARISTO Reserve E Cigar Juice Cuban Robusto, and ARISTO Reserve E Cigar Juice CUBANO. These products were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization or exemption. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) 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 actions, including civil money penalties, seizure, and/or injunction. The company must submit a written response within 15 working days detailing actions taken to address violations, including discontinuing sales and distribution of violative products, and a plan for future compliance.