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WARNING LETTER
•www.guarde.info

FDA WARNING_LETTER - www.guarde.info

Record Details

The FDA's Center for Tobacco Products reviewed guarde.info, determining the website offers cigarettes, cigarette tobacco, and roll-your-own tobacco products for sale in the U.S. These products are subject to FDA jurisdiction under the FD&C Act.

The FDA identified several violations: 1. **Misleading Product Descriptions:** Products like Drum Blue, Captain Black White, Old Holborn Yellow, Samson Halfzware, and Van Nelle Halfzware are marketed as "Rolling Tobacco" and explicitly linked to cigarette use, meeting the definition of cigarette tobacco and/or roll-your-own tobacco. 2. **Modified Risk Tobacco Products (MRTPs) Sold Without Authorization:** Numerous cigarette and tobacco products (e.g., Camel White, Davidoff ID Blue, Silk Cut Purple, Drum Blue Rolling Tobacco) are described as "light," "ultra-light," "mild," or imply reduced harm/substance levels (e.g., "low tar," "low nicotine"). These are considered MRTPs under section 911(b)(2)(A) of the FD&C Act and are adulterated under section 902(8) because they lack an FDA order for sale. 3. **Flavored Cigarette Violations:** Dunhill International is advertised as containing "plum extract," a characterizing flavor. This violates section 907(a)(1)(A) of the FD&C Act, making

Company
www.guarde.info
Product type
Tobacco
Office
Center for Tobacco Products
Person
  • Ann Simoneau (Director)
View Company Profile

ID · ce77b8f1-f5f9-4cf0-82a5-71f603d24d68

Violation Codes10
21 U.S.C. 321(rr)21 U.S.C. 387a(b)21 U.S.C. 387(4)21 U.S.C. 387(15)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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