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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Amsterdam Tobacco Co 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

Marvin Gutlove
Chief Executive Officer
Amsterdam Tobacco Co. Inc.
1614 Amsterdam Avenue
New York, NY 10031

WARNING LETTER

 

Re: Botshafter Blue (vanilla), Dhayan Bedi Vanilla, Dhayan Bedi Cherry, Dhayan Bedi Mint, Dhayan Bedi Grape, Dhayan Bedi Chocolate, Dhayan Bedi Strawberry, Djarum Gold (vanilla), Djarum Red (cherry), Dreams Belgian (chocolate), Dreams French (vanilla), Dreams Jubilee (cherry),Sherman Classic Mint, Sherman Hint of Mint, Sherman Touch of Clove, Springwater Vanilla, Springwater Cherry

Dear Mr. Gutlove:

The Food and Drug Administration (FDA) reviewed your website at the Internet address, http://www.amsterdamtobacco.com on September 24, 2009, and determined that your website has been offering for sale Botshafter Blue (vanilla), Dhayan Bedi Vanilla, Dhayan Bedi Cherry, Dhayan Bedi Mint, Dhayan Bedi Grape, Dhayan Bedi Chocolate, Dhayan Bedi Strawberry, Djarum Gold (vanilla), Djarum Red (cherry), Dreams Belgian (chocolate), Dreams French (vanilla), Dreams Jubilee (cherry), Sherman Classic Mint, Sherman Hint of Mint, Sherman Touch of Clove, Springwater Vanilla, and Springwater Cherry cigarettes (referred to hereafter as flavored cigarette products) 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 websites 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 products are cigarettes and contain vanilla, cherry, mint, grape, chocolate, strawberry, or clove that are characterizing flavors of the tobacco products. If your above-listed flavored cigarette products contain vanilla, cherry, mint, grape, chocolate, strawberry, or clove 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 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 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 the products contain vanilla, cherry, mint, grape, chocolate, strawberry, or clove 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 FDAFlavoredCigaretteTaskForce@FDA.HHS.GOV. We remind you that only written communications are considered official.

The violations discussed in this letter do 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