FDA WARNING_LETTER - wetvapes.com - August 12, 2025

The FDA issued a Warning Letter to Wet Vapes Inc., headquartered in Amherst, NY, on August 1, 2025, following a review of their website, https://www.wetvapes.com. The inspection identified that Wet Vapes is offering electronic nicotine delivery system (ENDS) products for sale in the U.S. without the necessary premarket authorization. These products include the EB Design TE6000 Disposable – Apple Peach and Spaceman Prism 20K Puff Disposable – Triple Strawberry, which are classified as "new tobacco products" under the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they were not marketed before February 15, 2007.

The main violations include the sale of these products without FDA marketing authorization, rendering them adulterated and misbranded under sections 902(6)(A) and 903(a)(6) of the FD&C Act. The regulatory framework requires that all new tobacco products must have a premarket authorization order to be legally marketed in the U.S., as stipulated under section 910 of the FD&C Act.

The FDA has requested Wet Vapes Inc. to submit a written response within 15 working days, detailing actions taken to address the violations and ensure compliance with the FD&C Act. Failure to comply may result in enforcement actions, including civil penalties, seizure, or injunction. The letter emphasizes the importance of adhering to all applicable provisions of the FD&C Act and FDA regulations to avoid further regulatory actions.