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WARNING LETTER
•www.buy-sigaretts.com

FDA WARNING_LETTER - www.buy-sigaretts.com

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Record Details

The FDA's Center for Tobacco Products issued a Warning Letter to the operator of http://www.buy-sigaretts.com after reviewing the website and determining that cigarette products were offered for sale to U.S. customers. The letter identifies two primary categories of violations. Firstly, the firm is selling or distributing modified risk tobacco products (MRTPs) without the required FDA order. This includes cigarettes described as "light," "super light," "extra light," "ultra light," or those advertised as "less harmful" than other products. Such products are deemed adulterated under section 902(8) of the FD&C Act because they lack an FDA order under section 911(g). Secondly, the firm offers flavored cigarettes, specifically "Aroma Rich Apple" and "Aroma Rich Rum & Cherry," which purport to contain characterizing flavors (other than tobacco or menthol), violating section 907(a)(1)(A) of the FD&C Act. Alternatively, if these products do not contain the claimed flavors, they are misbranded under sections 903(a)(1) or 903(a)(7)(A) due to false or misleading labeling. The FDA requires immediate correction of all referenced violations, including discontinuing the violative promotion, advertising, sale, and distribution of these tobacco products. A written response detailing corrective actions and a compliance plan must be submitted within 15 working days. Failure to comply could 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.buy-sigaretts.com
Product Type
Tobacco
Office
Center for Tobacco Products
Person
  • Ann Simoneau (Director)
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ID · e59ca44c-c46a-4a9a-a109-c70820d6e85b

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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