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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Texas Wholesale 11/3/09

   

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
  Center for Tobacco Products
9200 Corporate Boulevard
Rockville MD 20850-3229

                                                                 NOV 03 2009

VIA FEDERAL EXPRESS

Mike Wazir
Owner
Texas Wholesale
11409 Denton Dr
Dallas, TX 75229-6070

WARNING LETTER

 

Re: Djarum Bali Hai Natural Clove Box, Djarum Black Kretek Clove 10 Count Box, Djarum Cherry, Djarum Splash Clove 10 Count Box, Djarum Vanilla Filter Kretek 10 Count Box, Dreams Assorted Flavors 5 Pack Box, Dreams Cherry Filter 5 Pack Box, Dreams Chocolate Mocha Filter 5 Pack Box, Dreams Natural Vanilla 5 Pack Box, Dreams Vanilla Filter 5 Count Box, Zanzibar Chardonnay Clove Cigarettes, 10 count, Zanzibar Cherry Clove Cigarettes, 10 count, Zanzibar Crossfire Clove Cigarettes, 10 count, Zanzibar Lights Clove Cigarettes, 10 count, Zanzibar Ultimate Clove Cigarettes, 10 count, Zanzibar Vanilla Clove Cigarettes, 10 count, Zanzibar Xtreme Clove Cigarettes, 10 count, Zanzibar Zanzilatte Cafe Latte Clove Cigarettes, 10 count, and Zanzibar Zanzitwist Citrus Clove Cigarettes, 10 count

Dear Mr. Wazir:

The Food and Drug Administration (FDA) reviewed your website at http://www.texaswholesale.us. on October 5, 2009, and determined that your website has been offering for sale Djarum Bali Hai Natural Clove Box, Djarum Black Kretek Clove 10 Count Box, Djarum Cherry, Djarum Splash Clove 10 Count Box, Djarum Vanilla Filter Kretek 10 Count Box, Dreams Assorted Flavors 5 Pack Box, Dreams Cherry Filter 5 Pack Box, Dreams Chocolate Mocha Filter 5 Pack Box, Dreams Natural Vanilla 5 Pack Box, Dreams Vanilla Filter 5 Count Box, Zanzibar Chardonnay Clove Cigarettes, 10 count, Zanzibar Cherry Clove Cigarettes, 10 count, Zanzibar Crossfire Clove Cigarettes, 10 count, Zanzibar Lights Clove Cigarettes, 10 count, Zanzibar Ultimate Clove Cigarettes, 10 count, Zanzibar Vanilla Clove Cigarettes, 10 count, Zanzibar Xtreme Clove Cigarettes, 10 count, Zanzibar Zanzilatte Cafe Latte Clove Cigarettes, 10 count, and Zanzibar Zanzitwist Citrus Clove Cigarettes, 10 count to consumers in the United States. Under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Family Smoking Prevention and Tobacco Control Act (FSPTCA), 21 U.S.C. § 321(rr), these products are tobacco products because they are made or derived from tobacco and intended for human consumption.

According to the information and materials on your website we reviewed, your products listed above are represented as cigarettes that contain artificial or natural flavors that are characterizing flavors of the products and, as such, are adulterated and/or misbranded. Section 907(a)(1 )(A) of the FFDCA, 21 U.S.C. § 387g(a)(1 )(A), provides, as part of the tobacco product standards, a "special rule for cigarettes" as follows:

[A] cigarette or any of its component parts (including the tobacco, filter, or paper) shall not contain, as a constituent (including a smoke constituent) or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice, including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee, that is a characterizing flavor of the tobacco product or tobacco smoke.

After the September 22, 2009 effective date for this provision, flavored cigarettes marketed and sold in the United States in violation of this provision are adulterated under section 902(5) of the FFDCA, 21 U.S.C. § 387b(5).

Your website represents that the above-listed tobacco products are cigarettes and contain clove, cherry,vanilla, chocolate mocha, chardonnay, cafe latte, or citrus flavors that are characterizing flavors of the tobacco product.

If your above-listed flavored cigarette products contain clove, cherry, vanilla, chocolate mocha, chardonnay, cafe latte or citrus flavors that are characterizing flavors of the tobacco products, your products are adulterated under section 902(5) of the FFDCA, 21 U.S.C. § 387b(5), because they are represented as cigarettes and fail to comply with the special rule for cigarettes detailed in section 907(a)(1)(A) of the FFDCA, 21 U.S.C. § 387g(a)(1)(A). If, however, your products do not contain a flavor,herb, or spice that is a characterizing flavor of the tobacco product, they are misbranded under section 903(a)(1) of the FFDCA, 21 U.S.C. § 387c(a)(1), as their labeling is false and misleading because it represents that the product contains clove, cherry, vanilla, chocolate, chardonnay, crossfire, cafe latte, or citrus that is a characterizing flavor of the tobacco product.

You should immediately correct this violation by ceasing the marketing and sale of your products or taking other appropriate action to bring your products into compliance with the requirements of the FFDCA. Failure to correct this violation may result in regulatory action being initiated by the FDA without further notice. These actions may include, but are not limited to, seizure and injunction.

Please note that adulterated or misbranded tobacco products offered for importation into the United States are subject to detention and refusal of admission.

Please submit a written response to this letter within 15 working days from the date you receive this letter, describing your intent to comply with this request and explaining your plan for discontinuing the marketing and sale, or relabeling, of these tobacco products. Please direct your response to Ann Simoneau, Regulatory Counsel, Center for Tobacco Products, Food and Drug Administration, 9200 Corporate Boulevard, Rockville, Maryland 20850, (240) 276-4017, or send via email to FDAFlavoredCigaretteTask Force@FDAHHS.GOV. We remind you that only written communications are considered official.

The violation discussed in this letter does not necessarily constitute an exhaustive list. It is your responsibility to ensure that your tobacco products comply with the applicable provisions of the FFDCA, as amended by the FSPTCA, that are currently in effect.

Sincerely,

/s/

Lawrence R. Deyton, M.S.P.H. M.D.
Director, Center for Tobacco Products

 

cc:
Mike Wazir
Owner
550A N. Beach Street
Fort Worth, TX 76111