FDA WARNING_LETTER - Venture Concepts Group LLC d/b/a High Light Vape Co. - August 23, 2023

The FDA Center for Tobacco Products issued a Warning Letter to Amnon Arama on August 23, 2023, following a review of the website https://highlightvape.com. The review determined that Electronic Nicotine Delivery System (ENDS) products were offered for sale or distribution to U.S. customers. These products are classified as tobacco products under section 201(rr) of the FD&C Act, as amended by the Consolidated Appropriations Act, 2022, to include nicotine from any source.

The primary violation identified is the marketing of "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. Specifically, the products "High Light Vape Office 4 – Lush Ice," "High Light Vape Office 6 – Blueberry Ice," and "High Light Vape Office 6 - Mango" were cited as lacking marketing authorization orders and not being commercially marketed in the U.S. as of February 15, 2007.

The FDA expressed particular concern that the product labeling and/or advertising for High Light Vape products imitate highlighter markers, which is likely to promote youth use and conceal the product's nature as a tobacco product from adults.

The letter requires a written response within 15 working days detailing actions taken to address violations, including