FDA WARNING_LETTER - La Crosse Smokes 4 Less 1 Inc. d/b/a SMOKES 4 LESS - September 29, 2022

The FDA issued a Warning Letter to La Crosse Smokes 4 Less 1 Inc. d/b/a SMOKES 4 LESS on September 29, 2022, following a review of submissions and inspection records. The company manufactures and distributes e-liquid products, specifically "BUTTER RUM e-liquid products," which are classified as tobacco products under section 201(rr) of the FD&C Act, including those containing nicotine from any source as per the Consolidated Appropriations Act, 2022.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. The "BUTTER RUM e-liquid 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 due to the failure to provide required information under section 905(j). Prohibited acts under sections 301(k) and 301(p) of the FD&C Act are cited.

The FDA requires a written response within 15 working days