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WARNING LETTER
•The Vapor Emporium, LLC•February 26, 2021

The Vapor Emporium, LLC – FDA Warning Letter, Feb 26, 2021

Record Details

The FDA Center for Tobacco Products issued a Warning Letter to Elmer P. Bailey, III, regarding e-liquid products sold on thevaporemporium.com. The FDA determined that e-liquid products, including TVE Bubblegum, TVE Blueberry Glazed, and TVE Banana Cream, are tobacco products under the FD&C Act and are subject to FDA jurisdiction.

The primary violation is the marketing of "new tobacco products" without the required premarket authorization order. These e-liquid products were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization, making them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The firm, a registered manufacturer with over 3,600 products listed with FDA, is responsible for ensuring compliance across all sales and advertising platforms. Failure to address these violations may result in civil money penalties, seizure, and/or injunction. The FDA requires a written response within 15 working days detailing corrective actions, including discontinuation of violative sales and a plan for future compliance.

Company
The Vapor Emporium, LLC
Inspection date
February 26, 2021
Product type
Tobacco
Office
Center for Tobacco Products
Person
  • Ann Simoneau (Director)
View Company Profile

ID · 247b5e29-ecb5-4da7-96c6-6a0494863c67

Violation Codes10
21 U.S.C. 321(rr)21 U.S.C. 387a(b)21 U.S.C. 387j(a)21 U.S.C. 387j(c)(1)(A)(i)21 U.S.C. 387e(j)21 U.S.C. 387e(j)(1)(A)(ii)21 U.S.C. 387e(j)(3)FD&C Act 201(rr)FD&C Act 901(b)FD&C Act 910(a

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