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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Han, Jeffrey

   

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

 

 

VIA FEDERAL EXPRESS

NOV 02 2009

 

WARNING LETTER  

 

Jeffrey Han
Owner
Tyger Imports
207 Anderson Rd.
Alameda, CA 94502

Re: DJ Mix Lights Strawberry Flavor, DJ Mix Lights Lemon Fresh Flavor, PEEL Sweet Melon Flavor Cigarettes, DJ Mix/Peel 6 Flavor Variety Pack of Cigarettes, Black Devil Brand Rose Flavor HOLLAND Cigarettes, Daybreak Peach Aroma Flavored Cigarettes, Black Devil Chocolate Flavor Cigs, DJ Mix/Peel/Black Devil SUPER VARIETY pack, and Ark Royal Sweet Chocolate Flavored Cigarettes

Dear Mr. Han:

This is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address http://www.tygerpipes.com on September 28, 2009, and determined that your website has been offering for sale DJ Mix Lights Strawberry Flavor, DJ Mix Lights Lemon Fresh Flavor, PEEL Sweet Melon Flavor Cigarettes, DJ Mix/Peel 6 Flavor Variety Pack of Cigarettes, Black Devil Brand Rose Flavor HOLLAND Cigarettes, Daybreak Peach Aroma Flavored Cigarettes, Black Devil Chocolate Flavor Cigs, DJ Mix/Peel/Black Devil SUPER VARIETY pack, and Ark Royal Sweet Chocolate Flavored Cigarettes 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 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 sells DJ Mix Lights Strawberry Flavor, DJ Mix Lights Lemon Fresh Flavor, PEEL Sweet Melon Flavor Cigarettes, DJ Mix/Peel 6 Flavor Variety Pack of Cigarettes, Black Devil Brand Rose Flavor HOLLAND Cigarettes, Daybreak Peach Aroma Flavored Cigarettes, Black Devil Chocolate Flavor Cigs, DJ Mix/Peel/Black Devil SUPER VARIETY pack, and Ark Royal Sweet Chocolate Flavored Cigarettes to consumers within the United States.

If DJ Mix Lights Strawberry Flavor, DJ Mix Lights Lemon Fresh Flavor, PEEL Sweet Melon Flavor Cigarettes, DJ Mix/Peel 6 Flavor Variety Pack of Cigarettes, Black Devil Brand Rose Flavor HOLLAND Cigarettes, Daybreak Peach Aroma Flavored Cigarettes, Black Devil Chocolate Flavor Cigs, DJ Mix/Peel/Black Devil SUPER VARIETY pack, and Ark Royal Sweet Chocolate Flavored Cigarettes contain strawberry, lemon, sweet melon, rose, peach aroma, chocolate, or sweet chocolate that are characterizing flavors of the tobacco products, then they are adulterated under section 902(5) of the FFDCA, 21 U.S.C. § 387b(5), because they 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, these tobacco products do not contain any flavor, herb, or spice that are characterizing flavors of the tobacco products, 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 makes the representation that they contain strawberry, lemon, sweet melon, rose, peach aroma, chocolate, or sweet chocolate that are characterizing flavors of the tobacco products.

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 FDAFlavoredCigaretteTaskForce@FDA.HHS.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:
Jeffrey Han
Owner
Tygerpipes.com
PO Box 607
San Mateo, CA 94401