FDA WARNING_LETTER - The Vape Lounge, Inc. d/b/a The Vape Lounge 760 - November 02, 2021

The FDA issued a Warning Letter to Marino Younan and Marlow Younan, owners of The Vape Lounge 760, on October 29, 2021, following a review of their website, https://thevapelounge760.com. The FDA determined that the company was manufacturing and selling electronic nicotine delivery system (ENDS) products, specifically e-liquids, without the required premarket authorization.

The identified violations include the sale of "new tobacco products" without a marketing authorization order, rendering them adulterated under section 902(6)(A) of the FD&C Act and misbranded under section 903(a)(6). Specifically, products like "TVL VapeSauce – Grape Koolaide" and "TVL VapeSauce – Raspberry Lemonade" were cited as new tobacco products not commercially marketed before February 15, 2007, and lacking FDA authorization.

Although the firm is a registered manufacturer with over 1,000 products listed, their Premarket Tobacco Product Application (PMTA) STN PM0003417, submitted on September 4, 2020, received a Marketing Denial Order on September 15, 2021, covering 88 products. The FDA emphasized that products without pending applications or those with Marketing Denial Orders are high enforcement priorities.

The letter requires a written response within 15