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WARNING LETTER
•Alexander Carter

FDA WARNING_LETTER - Alexander Carter

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Record Details

The FDA Center for Tobacco Products issued a Warning Letter to Mr. Carter for violations related to the sale and distribution of tobacco products via multiple websites, including cigarena.com and cigarettes-shop.com.

The inspection revealed three primary violations: 1. **Sales to Minors:** Camel Filters and American Legend cigarettes were sold to individuals under 18, violating 21 C.F.R. § 1140.14(a) and rendering the products misbranded under section 903(a)(7)(B) of the FD&C Act. 2. **Modified Risk Tobacco Products (MRTPs) without Authorization:** Numerous cigarette brands (e.g., Armada Blue, Beratt, Marlboro Silver Super Light) were advertised using descriptors like "light," "mild," or claims of reduced harm/exposure (e.g., "Less nicotine content," "low and ultra-low tar"). These are classified as MRTPs under section 911(b)(2)(A) of the FD&C Act and were sold without the required FDA order, making them adulterated under section 902(8) of the FD&C Act. 3. **Flavored Cigarettes:** Products like Aroma Rich Apple and Kiss Strawberry Superslims were offered, purporting to contain characterizing flavors. This violates section 907(a)(1)(A) of the FD&C

Company
Alexander Carter
Product Type
Tobacco
Office
Center for Tobacco Products
People
  • Ann Simoneau (Director)
  • Alexander Carter
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ID · 80439960-174c-4432-822a-7ae967ca304d

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

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