# FDA WARNING_LETTER - http://www.premium-smokes.com - Unknown Date

Source: https://www.keypedia.com/records/warning_letter/httpwwwpremium-smokescom/38727e3c-c166-4ab7-b1ce-b80c1f5d3977

> FDA WARNING_LETTER for http://www.premium-smokes.com on Unknown Date. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: http://www.premium-smokes.com
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: The FDA's Center for Tobacco Products reviewed the website http://www.premium-smokes.com and determined that the cigarette products offered for sale are subject to FDA jurisdiction. The company was cited for multiple violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and related regulations.

Firstly, Pall Mall Red cigarettes were found to be misbranded under section 903(a)(7)(B) of the FD&C Act because they were sold to a person younger than 18 years of age, violating 21 C.F.R. § 1140.14(a).

Secondly, numerous cigarette products, including American Legend White, Camel Milds Orange, and Winston Silver, were deemed adulterated under section 902(8) of the FD&C Act. These products were described using terms like "light," "ultra-light," "mild," or similar descriptors, or claimed reduced levels of substances (e.g., "low nicotine," "low-tar"), classifying them as "modified risk tobacco products" under section 911(b)(2)(A) of the FD&C Act. These products were sold without an FDA order in effect as required by section 911(a).

Thirdly, Dunhill International (plum) cigarettes were found to be adulterated under section 902(5) or misbranded under section 90

## Related Officers

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

Company: https://www.keypedia.com/companies/httpwwwpremium-smokescom/bab01448-6fc3-4820-a558-b7af10e917de

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