FDA WARNING_LETTER - Smoke and Vape LLC - June 22, 2023

The FDA's Center for Tobacco Products issued a Warning Letter to Jared Zigmond regarding the website https://smokesandvape.com, which offers electronic nicotine delivery system (ENDS) products for sale in the U.S. These products are classified as tobacco products under the FD&C Act, specifically section 201(rr), which now includes products with nicotine from any source.

The primary violation is the marketing of "new tobacco products" without required premarket authorization. The FDA identified specific ENDS products, including ELF Bar 5000 Puff Disposable Lemon Mint, ELF Bar 5000 Puff Disposable Sakura Grape, and ESCO Bar H2O 6000 Puff Disposable Mango Lassi, as new tobacco products because they were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization. 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 mandates a written response within 15 working days detailing actions taken to address the violations, including discontinuing sales and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction. The firm is responsible for ensuring all tobacco products, labeling, and advertising comply with the FD&C Act and FDA regulations