FDA WARNING_LETTER - Rochester Smoke Shop Inc - October 05, 2023

The FDA issued a Warning Letter to Rochester Smoke Shop Inc. on October 5, 2023, following a review of inspection records. The FDA determined that the company manufactures and distributes e-liquid products, including "Blueberry Lemonade," which are considered tobacco products under section 201(rr) of the FD&C Act, as they contain nicotine and are intended for human consumption.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. These e-liquid products were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders or exemptions. 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 notices or information under section 905(j).

The letter states that the failure to provide such reports is a prohibited act under section 301(p) of the FD&C Act, and any act resulting in adulterated or misbranded products held for sale after interstate commerce shipment is prohibited under section 301(k).

Rochester Smoke Shop Inc. is required to submit a written response within 15 working days, detailing actions taken to address the violations, including discontinuation dates for violative sales and distribution, and