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WARNING LETTER
•www.cheapcigarettesone.com•September 15, 2015

www.cheapcigarettesone.com – FDA Warning Letter, Sep 15, 2015

Record Details

The FDA Center for Tobacco Products issued a Warning Letter to http://www.cheapcigarettesone.com after reviewing its website, which offers cigarette products for sale to U.S. customers. The FDA determined that several products are in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, the firm is selling or distributing modified risk tobacco products, such as "light" or "ultra light" cigarettes (e.g., Bond Special Selection, Marlboro Gold), without an FDA order in effect under section 911(g) of the FD&C Act. These products are therefore adulterated under section 902(8). Additionally, the website offers flavored cigarette products (e.g., Aroma Rich Apple, Kiss Mohito) which purport to contain a characterizing flavor. These are adulterated under section 902(5) of the FD&C Act, or misbranded under sections 903(a)(1) or 903(a)(7)(A) if the flavor representation is false or misleading. The FDA requires immediate correction of these violations and similar deficiencies to ensure full compliance with the FD&C Act and its implementing regulations across all promotional materials and sales platforms. A written response detailing corrective actions, including dates of discontinuing violative activities and a compliance plan, must be submitted within 15 working days. Failure to comply may lead to severe enforcement actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, injunction, and refusal of admission for imported products.

Company
www.cheapcigarettesone.com
Inspection date
September 15, 2015
Product type
Tobacco
Office
Center for Tobacco Products
Person
  • Ann Simoneau (Director)
View Company Profile

ID · e91c75f3-8d1f-46e4-9b3a-e69be4e9c323

Violation Codes10
21 U.S.C. 321(rr)21 U.S.C. 387a(b)21 U.S.C. 387b(8)21 U.S.C. 387b(5)21 U.S.C. 387c(a)(1)21 U.S.C. 387c(a)(7)(A)21 U.S.C. 387k(b)(2)(A)(ii)21 U.S.C. 387k(a)21 U.S.C. 387k(g)21 U.S.C. 387g(a)(1)(A)

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