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WARNING LETTER
•az-smokes.com

FDA WARNING_LETTER - az-smokes.com

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Record Details

The FDA Center for Tobacco Products issued a Warning Letter to az-smokes.com and az-smokes.net after reviewing their websites, which offer cigarette products for sale in the U.S. The FDA determined these products are tobacco products under the FD&C Act.

The company is in violation of several regulations: 1. **Sales to Minors:** An FDA investigation revealed a minor purchased Lucky Strike Red cigarettes from az-smokes.com, violating 21 C.F.R. § 1140.14(a). This renders the products misbranded under section 903(a)(7)(B) of the FD&C Act. 2. **Modified Risk Tobacco Products (MRTP) Violations:** The websites sell products described with terms like "light," "ultra light," "extra light," "super light," or "mild" (e.g., Camel Mild, Davidoff Lights, Marlboro Gold Lights, Parliament Lights, Winston Lights), or as "low nicotine" (Gala brand). These descriptors classify them as MRTPs under section 911(b)(2)(A) of the FD&C Act. Selling these without an FDA order in effect, as required by section 911(a), makes them adulterated under section 902(8) of the FD&C Act. 3. **Flavored Cigarette Violations

Company
az-smokes.com
Product Type
Tobacco
Office
Center for Tobacco Products
Person
  • Ann Simoneau (Director)
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ID · f9f01e3d-0174-41be-90f9-257811f371f8

Violation Codes10
21 U.S.C. 321(rr)21 U.S.C. 387a(b)21 U.S.C. 387c(a)(7)(B)21 CFR 1140.14(a)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)

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