FDA WARNING_LETTER - Everything Vapor Aztec - June 29, 2023

On June 29, 2023, the FDA issued a Warning Letter to Everything Vapor, located at 1409 West Aztec Boulevard, Aztec, NM, 87410. The FDA's Center for Tobacco Products determined that Everything Vapor manufactures and distributes e-liquid products, including "House Juice # 11," which are considered 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 deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because required notices or information were not provided under section 905(j).

The FDA cited prohibited acts under section 301(k) for holding for sale adulterated or misbranded tobacco products, and section 301(p) for failing to provide required reports. Everything Vapor is required to submit a written response within 15 working days detailing actions taken to address the violations, including discontinuing the sale