FDA WARNING_LETTER - ABS Distribution Inc. - July 27, 2023

The FDA issued a Warning Letter to ABS Distribution Inc. following a review of inspection records, determining the company distributes Electronic Nicotine Delivery System (ENDS) products, specifically Puff Max brand products, for commercial distribution in the U.S. These products are considered tobacco products under section 201(rr) of the FD&C Act, as amended on March 15, 2022, to include nicotine from any source.

The core violation is the marketing of "new tobacco products" without required premarket authorization. The identified products—Puff Max Aloe Grape 5%, Banana Ice 5%, Blueberry Ice 5%, Cool Mint 5%, Mango Peach Watermelon 5%, Mystery 5%, and Pineapple Mango Orange 5%—are deemed "new tobacco products" because they 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 adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required marketing authorization or notification. The introduction of adulterated or misbranded tobacco products into interstate commerce, and the failure to provide required reports, are prohibited acts under sections 301(a) and 301(p) of the FD&C Act.

ABS Distribution Inc.