FDA WARNING_LETTER - thevaporshoppeusa.com

The U.S. Food and Drug Administration (FDA) issued a warning letter on September 19, 2025, to The Vapor Shoppe USA LLC, The Vapor Shoppe Inc, and TVS Distributors LLC, regarding their nicotine pouch and e-liquid products. The inspection, conducted by the FDA"s Center for Tobacco Products, revealed that these products are being manufactured, sold, or distributed in the United States without the necessary premarket authorization, as required under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The main violations identified include the marketing of new tobacco products, such as NOAT Nicotine Pouches and The Vapor Shoppe E-Liquids, without FDA marketing authorization. These products are deemed adulterated and misbranded under sections 902(6)(A) and 903(a)(6) of the FD&C Act, respectively, due to the absence of proper authorization and required notices.

The regulatory framework mandates that all new tobacco products, defined as those not commercially marketed in the U.S. as of February 15, 2007, must have a premarket authorization order. The FDA"s jurisdiction extends to products containing nicotine from any source, following amendments to the FD&C Act in 2022.

The FDA requires The Vapor Shoppe and its associated entities to take immediate corrective actions to comply with the FD&C Act. This includes ceasing the sale and distribution of the violative products and submitting a written response within 15 working days detailing the actions taken to address the violations. Failure to comply may result in regulatory actions, including penalties, seizure, or injunction.