FDA WARNING_LETTER - Apvapeshop Inc - September 14, 2023

On September 14, 2023, the FDA's Center for Tobacco Products issued a Warning Letter to Apvapeshop.com after reviewing their website and determining they offer for sale or distribution in the U.S. electronic nicotine delivery system (ENDS) products that are "new tobacco products" without the required premarket authorization.

The FDA cited specific ENDS products, including "EB Design Te5000 Disposable Vape Device - Cotton Candy," "EB Design Bc5000 Disposable Vape - Tropical Rainbow Blast," "EB Design TE6000 Disposable Vape Device - Lemon Drop," and "Lava Plus 2600 Puff Disposable Vape Device - Skittles." These products are considered "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007, and lack an FDA marketing authorization order or exemption.

The violations cited are that these products are adulterated under section 902(6)(A) of the FD&C Act and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required premarket authorization or notice. The letter emphasizes that all new tobacco products on the market without statutory premarket authorization are unlawful and subject to enforcement.

Apvapeshop.com is required to submit a written response within 15 working days from receipt of the letter, detailing actions