FDA WARNING_LETTER - Xhale Vapor N Smoke - August 28, 2025

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Xhale Vapor N Smoke, located at 5 Lake Street, Kirkland, WA, on August 28, 2025. The FDA"s Center for Tobacco Products conducted a review and found that the company sells e-liquid products in the U.S. without the required premarket authorization, violating the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The inspection revealed that Xhale Vapor N Smoke distributes e-liquid products, such as Coastal Clouds Caramel Brulée 60ML 0.3%, 3MG/ML, which are classified as "new tobacco products" under the FD&C Act. These products lack the necessary marketing authorization, making them adulterated and misbranded. The FD&C Act mandates that new tobacco products, not marketed in the U.S. before February 15, 2007, must have premarket authorization to be legally marketed.

The FDA requires Xhale Vapor N Smoke to take immediate corrective actions to comply with the FD&C Act. This includes ceasing the sale and distribution of unauthorized products and submitting a written response within 15 working days detailing the actions taken to address the violations. The company must ensure all products and advertising comply with FDA regulations to avoid potential enforcement actions, such as civil penalties or product seizures.

For further guidance, Xhale Vapor N Smoke is directed to review the FD&C Act and FDA regulations and submit their response to the FDA"s Office of Compliance and Enforcement.