FDA WARNING_LETTER - Main Smoke Shop Inc. - September 14, 2023

On September 14, 2023, the FDA's Center for Tobacco Products issued a Warning Letter to Karam Goro regarding the sale of Electronic Nicotine Delivery System (ENDS) products on mainsmokes.com. The FDA determined that ENDS products, specifically "Bang XL Disposable Vape – Red Apple" and "Bang XL Disposable Vape – Banana Ice," were offered for sale or distribution 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 found these ENDS products to be "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007, and lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. 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 absence of required notice or information under section 905(j).

The letter requires a written response within 15 working days detailing actions taken to address violations, including discontinuation of sales and a plan for future compliance. Failure to comply may result in