FDA WARNING_LETTER - Alexander Carter
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
ID · 80439960-174c-4432-822a-7ae967ca304d
Full citation text and observation details available on the Dashboard.