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WARNING LETTER
•www.cigs24x7.com

FDA WARNING_LETTER - www.cigs24x7.com

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Record Details

The FDA Center for Tobacco Products issued a Warning Letter to http://www.cigs24x7.com for offering violative cigarette products to U.S. customers. The review identified two main violations of the FD&C Act. First, several cigarette products (e.g., Camel Blue, Pall Mall Lights) were adulterated under section 902(8) because they were marketed with descriptors like "light," "mild," or implying reduced harm (e.g., "less harmful"). These are classified as modified risk tobacco products under section 911(b)(2)(A) and were sold without the required FDA order under section 911(g). Second, Richmond Cherry cigarettes were adulterated under section 902(5) or misbranded under sections 903(a)(1) or 903(a)(7)(A). This is due to purporting to contain a natural or artificial characterizing flavor, violating section 907(a)(1)(A) which prohibits such flavors in cigarettes. The FDA demands immediate correction of these and similar violations, ensuring all tobacco products and promotional materials comply with the FD&C Act. A written response detailing corrective actions, discontinuation dates, and a compliance plan is required within 15 working days. Non-compliance could result in severe enforcement actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, injunction, and refusal of admission for imported products.

Company
www.cigs24x7.com
Product Type
Tobacco
Office
Center for Tobacco Products
People
  • Ann Simoneau (Director)
  • Ele Ibarra-Pratt (Acting Director)
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ID · 540c03df-e2cf-4217-820e-f540dc8c17d7

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(b)(2)(A)(i)21 U.S.C. 387k(a)21 U.S.C. 387k(g)

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