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WARNING LETTER
•Vapor4Less Inc.•March 24, 2020

FDA WARNING_LETTER - Vapor4Less Inc. - March 24, 2020

Record Details

On January 14, 2020, the FDA issued a Warning Letter to Ari Levy regarding the website https://www.vapor4less.com. The FDA determined that the electronic nicotine delivery system (ENDS) and e-liquid products advertised and sold on the website are tobacco products under section 201(rr) of the FD&C Act.

The primary violation identified is that the advertising for ENDS and e-liquid products on the website, such as "Cherry Flavor Disposable Electronic Cigar" and "10ml Blueberry Flavor e-liquid," fails to include the required nicotine warning statement: "WARNING: This product contains nicotine. Nicotine is an addictive chemical." This omission renders the products misbranded under sections 903(a)(7)(B) and 903(a)(7)(A) of the FD&C Act, and in violation of 21 C.F.R. § 1143.3(b). The FDA considers the lack of this material fact to make the advertising false or misleading.

The letter requires immediate correction of these violations and similar issues across all advertising platforms. Failure to comply may result in further FDA actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. The company must submit a written response within 15 working days detailing corrective actions, including dates of discontinued violative activities and a plan for ongoing

Company
Vapor4Less Inc.
Inspection date
March 24, 2020
Product type
Tobacco
Office
Center for Tobacco Products
Person
  • Ann Simoneau (Director)
View Company Profile

ID · 60c93f4a-c6e9-414d-8385-b2c1b0395c90

Violation Codes10
21 U.S.C. 321(rr)21 U.S.C. 387a(b)21 U.S.C. 387c(a)(7)(B)21 U.S.C. 387c(a)(7)(A)21 U.S.C. 321(n)21 CFR 1143.3(b)21 CFR 1143.3(b)(1)21 CFR 1143.3(b)(2)21 CFR 1143.121 CFR 1100.2

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