FDA WARNING_LETTER - Moore Cigarettes - May 01, 2025

On May 1, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to Moore Cigarettes, located at 521 Southwest 4th Street, Moore, OK 73160. The letter states that Moore Cigarettes sells and/or distributes electronic nicotine delivery system (ENDS) products in the United States, which are classified as tobacco products under section 201(rr) of the FD&C Act.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization order. Specifically, the product "Flow Bar Twist Triple Cherry/Exotic Mango 5% Nicotine" was cited. This product is considered a new tobacco product because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks the necessary FDA marketing authorization under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, this product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The letter emphasizes that all new tobacco products on the market without statutory premarket authorization are unlawfully marketed and subject to enforcement actions, including civil money penalties, seizure, and/or injunction. Moore Cigarettes is required to submit a written response within 15 working days, detailing