FDA WARNING_LETTER - Smoke Smart LLC - September 14, 2023

On September 14, 2023, the FDA's Center for Tobacco Products issued a Warning Letter to Smoke Smart LLC, located at 9923 Watson Road, St Louis, MO 63126. The letter states that a review of smokesmartllc.com revealed the sale of Electronic Nicotine Delivery System (ENDS) products, specifically "EB Design BC5000 Disposable – Miami Mint," to U.S. customers.

These products are classified as "tobacco products" under section 201(rr) of the FD&C Act, as amended by the Consolidated Appropriations Act, 2022, to include nicotine from any source. The FDA determined that the "EB Design BC5000 Disposable – Miami Mint" is a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007.

The primary violation is that this ENDS product is offered for sale without the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act, and is not otherwise exempt. Consequently, the product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the lack of required notice or information under section 905(