FDA WARNING_LETTER - Vape-X Club - December 20, 2023

On December 20, 2023, the FDA issued a Warning Letter to Vapexclub.com for offering unauthorized electronic nicotine delivery system (ENDS) products for sale in the U.S. The FDA reviewed the website and determined that products like "Luckee Vape Daniel’s – Cool Mojitos," "Frozen Mangorita," and "Lush Mule" are tobacco products under the FD&C Act, including the expanded definition covering nicotine from any source.

These ENDS products are considered "new tobacco products" as they were not commercially marketed in the U.S. before February 15, 2007, and lack the required premarket authorization order from the FDA. Consequently, they are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The FDA expressed particular concern that the product labeling and advertising for the "Luckee Vape Daniel's" products imitate alcoholic beverages, potentially appealing to youth.

Vapexclub.com is required to submit a written response within 15 working days detailing actions taken to address the violations, including discontinuing sales and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction.