FDA WARNING_LETTER - Titan Star Resources Sdn Bhd. d/b/a Vape Vandal Ltd. - August 23, 2023

On August 23, 2023, the FDA's Center for Tobacco Products issued a Warning Letter to Vape Vandal (vapevandal.com) for offering unauthorized electronic nicotine delivery system (ENDS) products for sale in the U.S. The FDA determined that products listed on the website are "tobacco products" under section 201(rr) of the FD&C Act, as amended to include nicotine from any source.

The identified violations include marketing "new tobacco products" without required premarket authorization, making them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. Specific products cited are "Vape Tape 8000 Puffs Disposable Vape Pod - Strawberry Vanilla," "Vape Tape 12,000 Puffs Disposable Vape Pod - Lemon Cola," "Elf Bar BC3000 Puffs Disposable Vape Pod, Cranberry Grape," and "Elf Bar TE6000 Puffs Disposable Vape Pod, Pop Corn Caramel." These products were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization.

The FDA expressed particular concern that the "Vape Tape" products' labeling and design imitate cassette tapes, potentially promoting youth use and concealing their nature as tobacco products.

Vape Vandal must submit a