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WARNING LETTER
•www.clovecigarettesonline.com•October 12, 2012

www.clovecigarettesonline.com – FDA Warning Letter, Oct 12, 2012

Record Details

The FDA issued a Warning Letter to Derwin Yonarta of www.clovecigarettesonline.com on October 12, 2012, following a review of the website which offered cigarette products for sale to U.S. customers. The FDA determined that several products were 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, products like "Sampoerna Avolution Slim" and "Djarum LA Light" were described using terms such as "mild," "low," or "lower in tar and nicotine," which classify them as modified risk tobacco products under section 911(b)(2)(A) of the FD&C Act (21 U.S.C. § 387k(b)(2)(A)).

Additionally, numerous clove and flavored cigarettes, including "Sampoerna A Mild Menthol 16" and "Djarum Black Cappuccino," were found to be adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)) for containing characterizing flavors other than tobacco or menthol, which is prohibited for cigarettes as of September 22, 2009, under section 90

Company
www.clovecigarettesonline.com
Inspection date
October 12, 2012
Product type
Tobacco
Office
Department of Health and Human Services
People
  • Ann Simoneau (Director)
  • Ele Ibarra-Pratt (Acting Director)
View Company Profile

ID · 2e0d45f5-75f2-4f02-b470-cd3a18e55392

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. 387k(b)(2)(A)(ii)21 U.S.C. 387k(b)(2)21 U.S.C. 387k(a)21 U.S.C. 387k(g)21 U.S.C. 387g(a)(1)(A)

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