AD and AD International, Ltd. 10/31/11
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Silver Spring, MD 20993|
VIA Electronic Mail
OCT 31, 2011
The Center for Tobacco Products of the Food and Drug Administration (FDA) recently reviewed the website, http://www.bestcigarettesshop.com, and determined that your cigarette products listed are offered for sale to U.S. customers. Under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. § 321(rr)), as amended by the Family Smoking Prevention and Tobacco Control Act, these products are tobacco products because they are made or derived from tobacco and intended for human consumption. Certain tobacco products, including cigarettes, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)).
FDA has determined that several of your products are adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)) because you promote them as modified risk tobacco products without an FDA order in effect that permits such promotion. Additionally, FDA has determined that your Kiss Fresh Apple Superslims, Kiss Strawberry Superslims, Rich Aroma Apple, Rich Aroma Rum & Cherry, and Sobranie Slims Mints cigarettes are adulterated under section 902(5) of FD&C Act (21 U.S.C. § 387b(5)) or misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)). You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov.
You describe products that you offer for sale on your website as being “mild” by referring to them as such in product advertising. Specifically, our review of the website revealed that you offer for sale Chesterfield cigarettes with promotional material that reads, “The birthplace of these mild cigarettes is St. Louis, Missouri…” and “‘Chesterfield People: They like a mild smoke, but they don’t like filters’, says the slogan of this brand of cigarettes.”
In addition, your website contains the following statements for Epique, Karelia, and Kent cigarettes that you offer for sale on your website:
- Promotional material for Epique cigarettes claiming, “The producer cares a lot about cigarettes are being done only from natural components, without including any chemical elements.”
- Promotional material for Karelia cigarettes claiming, “This brand is clear of using chemical additives, but made of only natural components.”
- Promotional material for Kent cigarettes claiming, “It was a great boom, as Kent cigarettes were the first cigarettes, which had a filter to drastically reduce tar and nicotine,” and, “In 1954 Kent cigarettes got a new filter and a new slogan: ‘Kent takes out more nicotine and tars than any other leading cigarette – the difference in protection is priceless,’ since that time these cigarettes are popular all over the world.” (Emphasis in original).
A tobacco product with a label, labeling, or advertising that uses the descriptors “light,” “mild,” or “low,” or similar descriptors is a “modified risk tobacco product” under section 911(b)(2)(A)(ii) of the FD&C Act (21 U.S.C. § 387k(b)(2)). A tobacco product is also considered a “modified risk tobacco product” under section 911(b)(2)(A)(i) of the FD&C Act (21 U.S.C. § 387k(b)(2)) if its label, labeling, or advertising explicitly or implicitly represents such product as containing a reduced level of a substance, presenting a reduced exposure to a substance, or being less harmful than one or more other commercially marketed tobacco products. Under section 911(a) of the FD&C Act (21 U.S.C. § 387k(a)), no person may introduce or deliver for introduction into interstate commerce any modified risk tobacco product without an FDA order in effect under section 911(g) of the FD&C Act (21 U.S.C. § 387k(g)). A product that is in violation of section 911(a) of the FD&C Act (21 U.S.C. § 387k(a)) is adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)). Because your website uses the descriptor “mild” for the above-listed products and includes claims that the above-listed products contain a reduced level of a substance, present a reduced exposure to a substance, do not contain or are free of a substance, or are less harmful than other commercially marketed tobacco products, the products are modified risk tobacco products. Because these products are offered for sale to U.S. customers without an FDA order in effect under section 911(g) of the FD&C Act (21 U.S.C. § 387k(g)), these products are adulterated under 902(8) of the FD&C Act (21 U.S.C. § 387b(8)).
Additionally, our review of the website revealed that you offer for sale the following cigarettes: Kiss Fresh Apple Superslims, Kiss Strawberry Superslims, Rich Aroma Apple, Rich Aroma Rum & Cherry, and Sobranie Mints 100’s, which are purported to contain an artificial or natural flavor that is a characterizing flavor of the products. Section 907(a)(1)(A) of the FD&C Act (21 U.S.C. § 387g(a)(1)(A)) provides:
[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.
As of September 22, 2009, cigarettes marketed and sold in the United States in violation of this provision are adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)). Thus, your flavored cigarettes are adulterated.
If, however, these cigarettes do not contain a characterizing flavor, they are misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) as their labeling is false and misleading because it makes the representation that the products contain apple, strawberry, rum and cherry, and mint as characterizing flavors of the tobacco products.
You should immediately correct the violations stated above and take any necessary actions to bring your tobacco products into compliance with the FD&C Act. The violations discussed in this letter do not necessarily constitute an exhaustive list, and it is your responsibility to ensure that your tobacco products on this website, or any other websites you own, operate, and/or control, comply with the applicable provisions of the FD&C Act. Failure to ensure full compliance with the FD&C Act may result in FDA initiating further action without notice, including, but not limited to, civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. Please note that adulterated and 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 of receipt describing your corrective actions, including the dates on which you discontinued the violative promotion, advertising, sale, and/or distribution of these tobacco products.
Please direct your response to the following address:
PAL-WL Response, Office of Compliance and Enforcement
FDA Center for Tobacco Products
9200 Corporate Boulevard
c/o Document Control Center
Rockville, Maryland 20850.
If you have any questions about the content of this letter, please contact Ele Ibarra-Pratt at (301) 796-9235 or via email at Elenita.IbarraPratt@fda.hhs.gov.
Ann Simoneau, J.D.
Office of Compliance and Enforcement
Center for Tobacco Products
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