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WARNING LETTER
•http://www.cigs7.com

http://www.cigs7.com – FDA Warning Letter

Record Details

The FDA Center for Tobacco Products issued a Warning Letter to the operator of cigs7.com for distributing tobacco products to U.S. customers in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). A review of the website identified two main categories of violations. First, the firm sells or distributes modified risk tobacco products, including cigarettes, cigarette tobacco, and roll-your-own tobacco, without an FDA order. This encompasses products labeled with descriptors like "Light," "Mild," "Low," or similar terms, and those making claims of being "safer," "healthier," or "relatively harmless." These products are adulterated under section 902(8) of the FD&C Act. Second, the firm offers flavored cigarette products (e.g., Rum & Cherry, Mojito, Strawberry, Apple, Mint) purported to contain artificial or natural characterizing flavors, rendering them adulterated under section 902(5) of the FD&C Act. Alternatively, if these products lack the claimed flavors, their labeling is false or misleading, making them misbranded under sections 903(a)(1) or 903(a)(7)(A). The FDA demands immediate correction of all violations, cessation of violative sales and advertising, and a written response within 15 working days detailing corrective actions and a compliance plan. Non-compliance may lead to severe enforcement actions, including civil money penalties, no-tobacco-sale orders, and criminal prosecution.

Company
http://www.cigs7.com
Product type
Tobacco
Office
Center for Tobacco Products
People
  • Ann Simoneau (Director)
  • Wang Zheng
  • Irina Kuts
View Company Profile

ID · f941346e-b205-4299-952d-3021ea852cc5

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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