FDA WARNING_LETTER - Lake June Business, Inc. d/b/a ZennVapes Wholesale and Distribution - May 01, 2024

The FDA's Center for Tobacco Products issued a Warning Letter to ZennVapes (zennvapes.com) on April 30, 2024, after reviewing their website and determining they offer Electronic Nicotine Delivery System (ENDS) products for sale in the U.S. These products are classified as tobacco products under the FD&C Act, including those containing nicotine from any source, following a March 15, 2022, amendment.

The primary violation identified is the marketing of a "new tobacco product" without the required premarket authorization. Specifically, the "Elf Bar Airo Max 5000 Puffs Disposable Skittles Ice" is cited as a new tobacco product that was not commercially marketed in the U.S. as of February 15, 2007, and lacks FDA marketing authorization. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

ZennVapes 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.