# FDA WARNING_LETTER - Cigs365.com - September 28, 2012

Source: https://www.globalkeysolutions.net/records/warning_letter/cigs365com/addfb191-56f6-4c96-be7f-6a4de17328d5

> FDA WARNING_LETTER for Cigs365.com on September 28, 2012. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Cigs365.com
- Inspection Date: 2012-09-28
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: The FDA's Center for Tobacco Products issued a Warning Letter to Cigs365.com after reviewing their website, http://www.cigs365.com, and determining that cigarette products were offered for sale to U.S. customers. The FDA found that several products were adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)) because they were promoted as modified risk tobacco products without an FDA order.

Specifically, the website described products as "Lights" or "Ultra-Lights" in advertising and product names, which are considered descriptors for modified risk tobacco products under section 911(b)(2)(A)(ii) of the FD&C Act (21 U.S.C. § 387k(b)(2)(A)(ii)). Products listed with "Lights" descriptors included Bond Special Selection, Camel Blue, Marlboro Gold, and others. Products listed with "Ultra-Lights" descriptors included Bond Fine Selection, Camel Silver, Marlboro Silver, and others.

Under section 911(a) of the FD&C Act (21 U.S.C. § 387k(a)), modified risk tobacco products cannot be introduced into interstate commerce without an FDA order. Since Cigs365.com offered these products to U.S. customers without such

## Related Officers

- [Director](https://www.globalkeysolutions.net/people/ann-simoneau/155ef03c-6b60-4063-b35d-75522fa67d2b)

Company: https://www.globalkeysolutions.net/companies/cigs365com/f5e40102-4550-4dc0-97c4-23b2bf5334d2

Office: https://www.globalkeysolutions.net/offices/center-for-tobacco-products/65f73cae-ef6f-4e9f-a311-a111daa67374