FDA WARNING_LETTER - Smoke Shop Direct Dist, Inc. - May 30, 2024

The FDA Center for Tobacco Products issued a Warning Letter to Smoke Shop Direct Dist, Inc., following a review of inspection records, determining the company sells and/or distributes electronic nicotine delivery system (ENDS) products in the U.S. These products are classified as tobacco products under section 201(rr) of the FD&C Act, including those with nicotine from any source, and are subject to FDA jurisdiction and compliance requirements.

The primary violation identified is the marketing of a "new tobacco product" without the required premarket authorization order. Specifically, the product "DUMMY VAPES 5PCS/BRICK 8000 PUFFS ZESTY ZAZA 50mg/ml 18ml" was found to be a new tobacco product, as it was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, due to the absence of required notice or information under section 905(j).

The FDA requires the company to submit a written response within 15 working days detailing actions taken to address the violations, including discontinuing the sale and distribution of the violative products and a plan for maintaining compliance. Failure to comply