FDA WARNING_LETTER - www.guarde.info
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
ID · ce77b8f1-f5f9-4cf0-82a5-71f603d24d68
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.