FDA WARNING_LETTER - Beyond Vape Boston LLC d/b/a Beyond Vape - July 28, 2020

The FDA Center for Tobacco Products issued a Warning Letter to Wen Wei of Beyond Vape on March 27, 2020, following a review of their website, https://beyondvape.com. The review determined that the company was offering Electronic Nicotine Delivery System (ENDS) products for sale or distribution in the United States without the required premarket authorization.

The identified violations pertain to specific ENDS products: Blue Razz Caesar Juice Pods, Mango Iced Caesar Juice Pods, Passion Fruit Guava Caesar Juice Pods, and Strawberry Watermelon Iced Caesar Juice Pods. These products are classified as "new tobacco products" under section 910(a) of the FD&C Act because they were not commercially marketed in the U.S. as of February 15, 2007.

The FDA states that these products lack the necessary marketing authorization orders under section 910(c)(1)(A)(i) of the FD&C Act and are not otherwise exempt. Consequently, these ENDS products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as required notice or information was not provided under section 905(j).

Beyond Vape is required to ensure all tobacco products and associated labeling/advertising comply with the FD&C Act and FDA regulations. Failure to correct