FDA WARNING_LETTER - www.clovecigarettesonline.com - October 12, 2012
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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
ID · 2e0d45f5-75f2-4f02-b470-cd3a18e55392
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