FDA WARNING_LETTER - We Vape USA, Inc. d/b/a Eliminator Vapes - October 06, 2020

On August 27, 2020, the FDA issued a Warning Letter to Kelcy Edmondson regarding the sale and distribution of Electronic Nicotine Delivery System (ENDS) products on the website https://www.wevapeusa.com. The FDA determined that products like MYLE Pods - Summer Strawberry, Tropical Mango, and Lush Ice (Iced Watermelon) are tobacco products under section 201(rr) of the FD&C Act and are subject to FDA regulation.

The primary violation is the offering of "new tobacco products" without the required premarket authorization, as mandated by section 910(a) of the FD&C Act. These products were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders or exemptions. Consequently, these ENDS products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, due to the absence of required notice or information under section 905(j).

The letter emphasizes the company's responsibility to ensure compliance across all advertising and sales platforms. Failure to correct these violations may lead to regulatory action, including detention and refusal of admission for imported products. A written response detailing corrective actions, including discontinuation of violative sales and a plan for future compliance, is required within 1