| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Center for Tobacco Products|
9200 Corporate Boulevard
Rockville, MD 20850-3229
OCT 9, 2013
VIA UPS and Facsimile
Rafiq P. Khoja
3840 Eisenhower Parkway
Macon, GA 31206
108 North Haven Drive
Macon, GA 31210
Dear Mr. Khoja:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed your website, http://www.serenawholesaler.com, and determined that your cigarettes and smokeless tobacco 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 and smokeless tobacco, 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 smokeless tobacco products are misbranded under section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)). You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov.
Modified Risk Tobacco Product Violations
You describe cigarette products that you offer for sale on your website as being light by referring to them as such in product labeling or advertising and adding the qualifier “Light” to the product names. Specifically, our review of your website revealed that you offer for sale cigarettes listed as: “Rave Menthol Light 100’s,” “Rave Menthol Light King,” and “Silver Menthol Light King.”
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 “Light” for the above listed products, these products are modified risk tobacco products. Because these products are offered for sale 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)).
Health Warning Statement Violation
FDA has determined that your smokeless tobacco products are misbranded under section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) because you failed to include in your smokeless tobacco product advertisements any warning label statements. Such statements are required under section 3 of the Comprehensive Smokeless Tobacco Health Education Act of 1986 (Smokeless Tobacco Act) (15 U.S.C. § 4402), as amended by section 204 of the Tobacco Control Act (P.L. 111-31, 123 Stat. 1846). Under section 903(a)(7)(A) of the FD&C Act, (21 U.S.C. 387c(a)(7)(A)), a tobacco product is misbranded if, in the case of any tobacco product distributed or offered for sale in any State, its advertising is false or misleading in any particular. Under section 201(n) of the FD&C Act (21 U.S.C. 321(n)), in determining whether labeling or advertising is misleading, the agency considers, among other things, the failure to reveal material facts concerning the consequences that may result from the customary or usual use of the product.
Our review of your website, http://www.serenawholesaler.com, revealed that you advertise and promote for sale several smokeless tobacco products without warnings, including, but not limited to the following products: “Bloodhound Thick Cut 15ct,” “Chattanooga Tobacco B1G1F,” “Grizzly L/C Mint 5ct,” “JD’s Blend Chew Tobaco 12ct,” “Longhorn F/C Natural 5ct,” “Railroad Maccoboy Pocket 12ct,” “Redman Green Chew Tob 12ct,” “Skoal L/C Spearmint 5ct,” “Timber Wolf F/C Natural $0.50,” and “Tuberose Swt Scotch Snuff 12ct.” Section 3(b) of the Smokeless Tobacco Act, as amended, requires that advertisements for smokeless tobacco products bear one of the following warning label statements:
WARNING: This product can cause mouth cancer.
WARNING: This product can cause gum disease and tooth loss.
WARNING: This product is not a safe alternative to cigarettes.
WARNING: Smokeless tobacco is addictive.
Because your smokeless tobacco product advertisements do not include any warnings, your smokeless tobacco products are misbranded under section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)).
In addition, we note that you are required to follow all other applicable federal laws and regulations. For example, section 3(b)(3) of the Smokeless Tobacco Act requires the quarterly rotation of warning label statements on advertising for each brand of smokeless tobacco. Quarterly rotation must be done “in accordance with a plan submitted by the tobacco product manufacturer, importer, distributor, or retailer” and approved by FDA.
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 or media in which you advertise, and in your retail establishment(s) 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 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 and your plan for maintaining compliance with the FD&C Act.
Please note your reference number, RW130112, 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