FDA WARNING_LETTER - Absolute Vapor Lounge, LLC - December 16, 2021

On December 16, 2021, the FDA issued a Warning Letter to Absolute Vapor Lounge, LLC, following a review of submissions and inspection records. The FDA determined that Absolute Vapor Lounge manufactures and distributes e-liquid products, which are deemed "tobacco products" under section 201(rr) of the FD&C Act and subject to FDA regulation.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the products "Colorado Clouds Squeeze Please 0.6% nicotine 60ML e-liquid product," "Nefarious Lonely Hearts Killer 0.1% nicotine 60ML e-liquid product," and "Nefarious Lonely Hearts Killer 0.3% nicotine 60ML e-liquid product" were found to be new tobacco products not commercially marketed before February 15, 2007, and lacking FDA marketing authorization orders.

These products are cited as adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the lack of required premarket authorization or substantial equivalence reports. The introduction of adulterated or misbranded tobacco products into interstate commerce is a prohibited act under section 301(a), and failure to provide required reports is prohibited under section 301(p).

Absolute Vapor Lounge had submitted