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WARNING LETTER
•http://www.okcigarettes.com

http://www.okcigarettes.com – FDA Warning Letter

Record Details

The FDA Center for Tobacco Products issued a Warning Letter to the operator of http://www.okcigarettes.com after reviewing the website and determining that cigarette products were offered for sale or distribution in the U.S. The FDA identified two primary violations. First, Pall Mall Lights (Blue) cigarettes were deemed adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)). These products are considered modified risk tobacco products due to the use of "light" descriptors on the website, and they are being sold without the required FDA order under section 911(g) of the FD&C Act (21 U.S.C. § 387k(g)). Second, Richmond Cherry cigarettes were found to be adulterated under section 902(5) (21 U.S.C. § 387b(5)) or misbranded under sections 903(a)(1) or 903(a)(7)(A) (21 U.S.C. § 387c(a)(1) or § 387c(a)(7)(A)). This is because they purport to contain a characterizing flavor (cherry), which violates section 907(a)(1)(A) of the FD&C Act (21 U.S.C. § 387g(a)(1)(A)) prohibiting such flavors in cigarettes (other than tobacco or menthol). The firm is required to immediately correct these violations, discontinue the sale and distribution of these products, and submit a written response within 15 working days detailing corrective actions and a compliance plan. Failure to comply could lead to civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, or injunction, and import refusal.

Company
http://www.okcigarettes.com
Product type
Tobacco
Office
Center for Tobacco Products
Person
  • Ann Simoneau (Director)
View Company Profile

ID · e2a8887a-c5cd-4dee-8363-ac7744b2a6b0

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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