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View the official letter on FDA website.Click here !

Food and Drug Administration

Center for Tobacco Products

9200 Corporate Boulevard

Rockville MD 20850·3229

TO: limmalaysia@gmail.com

http://www.cigarettesdj.com

sales@cigarettesdj.com

FROM: Food and Drug Administration

RE: 0.1 Mix Ice Green Apple, OJ Mix Lemon Fresh, 0.1 Mix Strawberry, Peel Menthol Orange,

Peel menthol Sunny Peach, Peel Sweet Melon

DATE: November 2, 2009

WARNING LETTER

The Food and Drug Administration (FDA) reviewed your website at the Internet address

http://www.cigarettesdj.com on October 6, 2009 and determined that your website has been offering for

sale OJ Mix Ice Green Apple, OJ Mix Lemon Fresh, OJ Mix Strawberry, Peel Menthol Orange, Peel

menthol Sunny Peach, and Peel Sweet Melon 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 an artificial or natural flavor that is a characterizing flavor of the product 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 flavored cigarettes you offer for sale to U.S. consumers contain green

apple, lemon, strawberry, orange, peach and melon that are characterizing flavors of the tobacco

products.

If your flavored cigarettes contain green apple, lemon, strawberry, orange, peach and melon that are

characterizing flavors of the tobacco products, your flavored cigarettes 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, your flavored

cigarettes 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 makes the representation that the products contains green apple, lemon,

strawberry, orange, peach and melon that are characterizing flavors of the tobacco products.

Page 2 -Warning Letter

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.

If you are not located in the United States, please note that adulterated or misbranded tobacco products

offered for importation into the United States are subject to detention and refusal of admission. We will

advise the appropriate regulatory or law enforcement officials in the country from which you operate that

FDA considers your products listed above to be adulterated and/or misbranded products that cannot be

legally sold to consumers in the United States.

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 begin_of_the_skype_highlighting <span dir="ltr" title="Call this phone number in United States of America with Skype: +12402764017 begin_of_the_skype_highlighting              +12402764017      end_of_the_skype_highlighting begin_of_the_skype_highlighting              +12402764017 begin_of_the_skype_highlighting              +12402764017      end_of_the_skype_highlighting      end_of_the_skype_highlighting begin_of_the_skype_highlighting              +12402764017 begin_of_the_skype_highlighting              +12402764017      end_of_the_skype_highlighting      end_of_the_skype_highlighting” class=”skype_pnh_highlighting_inactive_common”>             (240) 276-4017      end_of_the_skype_highlighting begin_of_the_skype_highlighting              (240) 276-4017 begin_of_the_skype_highlighting              (240) 276-4017      end_of_the_skype_highlighting      end_of_the_skype_highlighting, or send via email to FDA Flavored Cigarette Task

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.

cigarettesdj.com WL pdf final

Visit www.cigarettesdj.com >> Go here!
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