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WARNING LETTER
•http://www.wholesalecigarettetobacco.com

http://www.wholesalecigarettetobacco.com – FDA Warning Letter

Record Details

The FDA Center for Tobacco Products reviewed http://www.wholesalecigarettetobacco.com and determined that cigarette tobacco and roll-your-own tobacco products, specifically "Canadian Flue Cured" and "Smokers Choice Blend," are offered for sale to U.S. customers. These products are defined as tobacco products under section 201(rr) of the FD&C Act.

The website's presentation, including product listings under "Cigarette Tobacco Rolling Leaf," sales with cigarette tubes and shredders, and descriptions like "the best cigarettes on the market," indicates these are intended for cigarette use, meeting the definitions of "cigarette tobacco" and/or "roll-your-own tobacco" under sections 900(4) and 900(15) of the FD&C Act.

The FDA found these products to be adulterated under section 902(8) of the FD&C Act because they are modified risk tobacco products sold without an FDA order. This is due to labeling and advertising claims such as "mild tobacco leaves," "light (Canadian) tobacco leaves," and "lower in nicotine content," which classify them as modified risk tobacco products under section 911(b)(2)(A) of the FD&C Act. Section 911(a) prohibits the introduction of such products into interstate commerce without an FDA order.

The letter requires immediate correction of

Company
http://www.wholesalecigarettetobacco.com
Product type
Tobacco
Office
Center for Tobacco Products
People
  • Ann Simoneau (Director)
  • Michael Schnetzler
  • Chris Boulton
View Company Profile

ID · 9656cb0f-12f7-4f28-b448-c3a8fb64e149

Violation Codes9
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. 387k(b)(2)(A)(ii)21 U.S.C. 387k(b)(2)(A)(i)21 U.S.C. 387k(a)21 U.S.C. 387k(g)

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