# FDA WARNING_LETTER - Belcorp of America - June 27, 2011

Source: https://www.keypedia.com/records/warning_letter/belcorp-of-america/fec857f2-bb75-4b20-a6ec-f65e43b8b711

> FDA WARNING_LETTER for Belcorp of America on June 27, 2011. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Belcorp of America
- Inspection Date: 2011-06-27
- Product Type: Tobacco
- Office Name: Department of Health and Human Services
- Summary: The FDA issued a Warning Letter to Belcorp of America on June 27, 2011, following a review of their website, http://www.belcorpfactorydirect.com, which promoted and offered cigarette products for sale in the U.S. The FDA determined that Belcorp's Galaxy Pro, Derby, Rich, and First One cigarettes were adulterated and misbranded.

The products were deemed 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 used descriptors like "Gold (Formerly Lights)," "Silver (Formerly Ultra Lights)," and "Green (Formerly Menthol Lights)," which classify them as 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)). Introducing such products into interstate commerce without an FDA order under section 911(g) (21 U.S.C. § 387k(g)) is a violation.

Additionally, the products were misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387

## Related Officers

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

Company: https://www.keypedia.com/companies/belcorp-of-america/e39e897d-0f3e-4c52-8560-03dc87836acf

Office: https://www.keypedia.com/offices/department-of-health-and-human-services/cecfcda4-4afa-4a1f-a7b7-a020b79f9861