FDA WARNING_LETTER - Disposable Vapez - December 20, 2023

The FDA issued a Warning Letter to Disposablevapez.com on December 20, 2023, after reviewing their website and determining they offer unauthorized electronic nicotine delivery system (ENDS) products for sale in the U.S. These products are considered tobacco products under the FD&C Act, as amended to include nicotine from any source.

The specific violations involve "new tobacco products" lacking required premarket authorization. The identified products, including "Luckee - Vape Daniel Bottle Shape 8K Puffs" in various flavors (Frozen Strawberry Daiquiri, Cool Mojitos, Frozen Mangorita, Lush Mule), were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization. Consequently, these products 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 ENDS products imitate alcoholic drinks, potentially appealing to youth. The letter emphasizes that sales of such unauthorized products are prohibited and contribute to public health concerns.

Disposablevapez.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