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•www.tobaccogeneral.com

FDA WARNING_LETTER - www.tobaccogeneral.com

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Record Details

The FDA Center for Tobacco Products reviewed TobaccoGeneral.com and found that cigarette and roll-your-own tobacco products offered for sale to U.S. customers violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). The website promotes "pipe tobacco" products like OHM and Golden Harvest as suitable for cigarettes, meeting the definition of "cigarette tobacco" or "roll-your-own tobacco."

Violations include selling "modified risk tobacco products" without FDA authorization, specifically products labeled "Light" or "Mild" (e.g., Golden Harvest Silver Blend, OHM Blue, OHM Gold Mint, OHM Silver). These are adulterated under section 902(8) of the FD&C Act.

Additionally, the company offers flavored cigarette tobacco and/or roll-your-own tobacco products (e.g., Golden Harvest Mint, OHM Mint, OHM Mild Mint, OHM Gold Mint) which are adulterated under section 902(5) of the FD&C Act, as they contain characterizing flavors other than tobacco or menthol, prohibited for cigarettes and cigarette tobacco since September 22, 2009. If these products do not contain characterizing flavors, they are misbranded under section 903(a)(1) or 903(a)(7)(A) for false or misleading labeling.

TobaccoGeneral.com must immediately correct these violations and ensure all tobacco

Company
www.tobaccogeneral.com
Product Type
Tobacco
Office
Center for Tobacco Products
Person
  • Ann Simoneau (Director)
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ID · 4cc83872-8274-4c72-863b-73bbda9e261d

Violation Codes10
21 U.S.C. 321(rr)21 U.S.C. 387a(b)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)21 U.S.C. 387k(g)21 U.S.C. 387g(a)(1)(A)

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