FDA WARNING_LETTER - Vegas Vapor Emporium - March 12, 2021
The FDA issued a Warning Letter to Michael Torsiello, Rod Rifkin, and Denise Kordelski of Vegas Vapor Emporium, LLC, following a review of their website, https://vegasvaporemporium.com. The FDA determined that e-liquid products, specifically "Vegas Vapor Emporium Dragon Picnic" and "Vegas Vapor Emporium Unicorn Farts," are manufactured and offered for sale or distribution in the United States.
These e-liquid products are classified as "tobacco products" under section 201(rr) of the FD&C Act, being derived from tobacco and intended for human consumption. Effective August 8, 2016, e-liquids became subject to FDA regulation. The identified products are considered "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007.
The primary violation is that these new tobacco products lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act, and are not otherwise exempt. Consequently, the 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).
Vegas Vapor Emporium is a registered manufacturer with
ID · b356220c-6f36-43e1-b9ac-b3a35032a95a
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