FDA WARNING_LETTER - Texas Wholesale

On October 5, 2009, the FDA reviewed the website http://www.texaswholesale.us and found it was offering for sale various Djarum, Dreams, and Zanzibar brand products. These products, including Djarum Bali Hai Natural Clove Box and Zanzibar Cherry Clove Cigarettes, are classified as tobacco products under section 201(rr) of the FFDCA.

The FDA determined these products are represented as cigarettes containing artificial or natural characterizing flavors such as clove, cherry, vanilla, chocolate mocha, chardonnay, cafe latte, or citrus. This violates Section 907(a)(1)(A) of the FFDCA, which prohibits cigarettes from containing characterizing flavors other than tobacco or menthol.

Consequently, if these products contain the stated characterizing flavors, they are adulterated under section 902(5) of the FFDCA. If they do not contain these flavors, their labeling is false and misleading, rendering them misbranded under section 903(a)(1) of the FFDCA.

Texas Wholesale must immediately cease marketing and selling these products or take other corrective actions to achieve compliance. Failure to do so may result in regulatory actions, including seizure and injunction. A written response detailing the plan for discontinuing sales or relabeling is required within 15 working days, addressed to Ann Simoneau at the Center for Tobacco Products.