FDA WARNING_LETTER - smokewonderland.com - March 18, 2025

The FDA's Center for Tobacco Products issued a Warning Letter to smokewonderland.com on March 13, 2025, after reviewing their website and determining they offer electronic nicotine delivery system (ENDS) products for sale in the United States. These products are considered tobacco products under section 201(rr) of the FD&C Act, as amended on March 15, 2022, to include nicotine from any source.

The primary violation identified is the marketing of a "new tobacco product," specifically "Elf Bar Airo Max 5,000 Puffs Disposable Vapes – Yummy Bear Ice," without the required premarket authorization order. A new tobacco product is defined as one not commercially marketed in the U.S. as of February 15, 2007, or a modified product marketed after that date. Since this product lacks an FDA marketing authorization order and is not otherwise exempt, it is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The FDA requires the firm to submit a written response within 15 working days detailing actions taken to address the violations, including discontinuing the sale/distribution of the violative product and a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.