FDA WARNING_LETTER - Cosco International, Inc. - September 15, 2020

This FDA Warning Letter, dated August 26, 2020, addresses Cosco International, Inc. regarding violations related to the manufacture and distribution of e-liquid products. The FDA determined that Cosco International, Inc. manufactures and distributes e-liquid products that are considered tobacco products under the FD&C Act.

The primary violations identified are: 1. **New Tobacco Products Without Required Marketing Authorization:** Three specific e-liquid products (Infuze Salts Tan Lines - Baja Ice, Infuze Salts Basilisk - Iced Dragon Fruit, and Infuze Salts Labyrinth - Shortbread Cookie) are deemed "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007, and lack required FDA marketing authorization orders. This renders them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The introduction of such products into interstate commerce is a prohibited act under section 301(a), and failure to provide required reports under section 905(j) is a prohibited act under section 301(p).

2. **Tobacco Products Without Required Ingredient Listing Submissions:** Cosco International, Inc. failed to provide an ingredient listing to the FDA for 48 listed e-liquid products, as required by section 904(