FDA WARNING_LETTER - Wayan Sumartini Saraswati - August 25, 2011

The FDA issued a Warning Letter to Wayan Sumartini Saraswati after reviewing their websites, http://www.balicigarette.com and http://www.clovecigarettesmarket.com, which offer cigarette products for sale to U.S. customers. The FDA determined that numerous products, including a wide range of clove and clove/cappuccino flavored cigarettes, are either adulterated or misbranded. Specifically, under section 907(a)(1)(A) of the FD&C Act, cigarettes are prohibited from containing artificial or natural characterizing flavors other than tobacco or menthol. The firm's promotion of these products as "clove cigarettes" violates this ban, effective September 22, 2009, rendering them adulterated under section 902(5). Alternatively, if the products lack these characterizing flavors, their labeling is false and misleading, making them misbranded under section 903(a)(1). The FDA demands immediate corrective action to ensure compliance with the FD&C Act. A written response detailing corrective actions, including the discontinuation of violative promotion and sales, must be submitted within 15 working days. Non-compliance may result in severe enforcement actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, injunction, and refusal of admission for imported products.