FDA WARNING_LETTER - Vape.com - August 12, 2025

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to That 1 Vape Inc., located at 10 North Fairlane Drive, Suite 201, Joliet, IL, regarding their e-liquid products. The inspection, conducted by the FDA"s Center for Tobacco Products, identified that the company manufactures and sells e-liquid products, such as Banana Milk Shake and Funfetti flavors, without the required premarket authorization. These products are classified as "new tobacco products" under the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they were not commercially marketed in the U.S. as of February 15, 2007.

The FDA"s jurisdiction over these products is based on the FD&C Act, which requires new tobacco products to have a marketing authorization order. The products in question lack this authorization, rendering them adulterated and misbranded under sections 902(6)(A) and 903(a)(6) of the FD&C Act, respectively. The letter emphasizes that all tobacco products must comply with the FD&C Act and FDA regulations, including labeling and advertising standards.

That 1 Vape Inc. is required to submit a written response within 15 working days, detailing corrective actions taken to address the violations and ensure compliance. The FDA warns that failure to comply may result in enforcement actions, such as civil penalties or product seizures. The company is advised to visit the FDA"s Searchable Tobacco Products Database for a list of authorized products and ensure all future marketing complies with regulatory requirements.