| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Center for Tobacco Products|
9200 Corporate Boulevard
Rockville, MD 20850-3229
APR 07, 2014
Via Electronic Mail
To: Alexandru Slanovschi
Dear Mr. Slanovschi:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed your website, http://www.buyonline-cigarettes.com and determined that your cigarette products listed there are offered for sale to customers in the United States. 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 (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 cigarette products are adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)) because they are modified risk tobacco products sold or distributed without an FDA order in effect that permits such sale or distribution. You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov.
Modified Risk Tobacco Product Violations
You sell or distribute cigarette products that you describe on your website, http://www.buyonline-cigarettes.com, as being “Lights,” “Ultra lights,” “Extra Lights, ” or “Super Lights” by referring to them as such in product labeling or advertising and/or adding the qualifiers “Lights,” “Ultra lights,” “Extra Lights” or “Super Lights” to the product names. Our review of your website revealed that you sell or distribute cigarettes listed under the heading “Lights cigarettes” and/or described as “Lights cigarettes,” including but, not limited to: Bond Street described as “Bond Lights (Special Selection),” Camel Blue described as “Camel Lights (Blue),” Classic Blue, Davidoff Slims described as “Davidoff Slim Lights (Gold) 100’s,” Hilton Platinum, Kent HD described as “Kent Lights Nr. 1 (Infina),” L&M Blue Label described as “L&M Lights (Blue),” LD Blue, Lucky Strike Click and Roll, Marlboro Gold described as “Marlboro Lights (Gold),” Pall Mall described as “Pall Mall Lights (Blue),” Parliament Aqua Blue described as “Parliament Lights (Aqua Blue),” Prima Luxe described as “Prima Lux Blue,” Red&White International Fine described as “Red&White American Fine,” Rothmans described as “Rothmans Blue,” Vogue Bleue described as “Vogue Super Slims Bleue 100s,” Winston Blue described as “Winston Lights (Balanced Blue)” and Glamour Amber Super Slims described as “Glamour Super Slims Amber 100’s.”
In addition, you sell or distribute cigarettes listed under the heading “Ultra lights cigarettes” and/or described as “Ultra lights,” “Extra Lights,” or “Super Lights:” Prima Lux Gold, Prima Lux Silver, Parliament Silver Blue described as “Parliament Extra Lights,” Parliament One, and Winston Silver described as “Winston Super Lights (Subtle Silver).”
A tobacco product with a label, labeling, or advertising that uses the descriptor “light,” “mild,” or “low,” or a similar descriptor, 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)(ii)). 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 “Lights,” “Ultra lights,” “Extra Lights,” “Super Lights,” or similar descriptors for the above listed products, these products are modified risk tobacco products. Because these products are sold or distributed to customers in the United States without an appropriate FDA order in effect under section 911(g) of the FD&C Act (21 U.S.C. § 387k(g)), these products are adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)).
Conclusion and Requested Actions
The violations discussed in this letter do not necessarily constitute an exhaustive list. You should immediately correct the violations that are referenced above, as well as violations that are the same as or similar to those stated above, and take any necessary actions to bring your tobacco products into compliance with the FD&C Act.
It is your responsibility to ensure that your tobacco products and all related promotional materials on this website, on any other websites (including e-commerce, social networking, or search engine websites), and in any other media in which you advertise comply with each applicable provision of the FD&C Act and FDA’s implementing regulations. 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 import 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 and your plan for maintaining compliance with the FD&C Act.
Please note your reference number, RW1400159, in your response and 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 CTPCompliance@fda.hhs.gov.
Ann Simoneau, J.D.
Office of Compliance and Enforcement
Center for Tobacco Products
Via Electronic Mail