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WARNING LETTER
•Yellowstone Tobacco Co, LLC.

Yellowstone Tobacco Co, LLC. – FDA Warning Letter

Record Details

The FDA issued a Warning Letter to Mr. Dixon, affiliated with Yellowstone Tobacco Co., LLC, based on a review of websites http://www.loosetobacco.com and http://www.rollingpapers.com. The FDA determined that cigarette tobacco and/or roll-your-own tobacco products were offered for sale to U.S. customers.

The violations include: 1. **Misclassification of Products**: Products labeled as "pipe tobacco" (e.g., Buoy, Criss Cross, Golden Harvest) were promoted as "cigarette tobacco" and/or "roll-your-own tobacco" through descriptions like "dual purpose," "Roll Your Own," or "Make Your Own." This makes them subject to FDA jurisdiction as cigarette tobacco or roll-your-own tobacco. 2. **Modified Risk Tobacco Product Violations**: Products like Buoy Silver were described using terms such as "mild," "light," "ultra light," or "lightest." These descriptors classify them as "modified risk tobacco products" under section 911(b)(2)(A)(ii) of the FD&C Act. Selling these without an FDA order under section 911(g) renders them adulterated under section 902(8) of the FD&C Act. 3. **Flavored Cigarette Violations**: Products like Criss Cross Black Cherry, Criss Cross Mint, and Golden Harvest Mint Blend

Company
Yellowstone Tobacco Co, LLC.
Product type
Tobacco
Office
Center for Tobacco Products
Person
  • Ann Simoneau (Director)
View Company Profile

ID · 4a84f9ed-f58a-471e-bb39-92381bf464c4

Violation Codes10
21 U.S.C. 321(rr)21 U.S.C. 387a(b)21 U.S.C. 387(4)21 U.S.C. 387(15)21 U.S.C. 387b(8)21 U.S.C. 387b(5)21 U.S.C. 387c(a)(1)21 U.S.C. 387c(a)(7)(A)21 U.S.C. 387k(b)(2)(A)(ii)21 U.S.C. 387k(a)

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