| || |
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 23, 2013
VIA UPS and Electronic Mail
Leonard Stebbins, Jr.
Dewey Avenue Smoke Shop
1405 Dewey Avenue
Rochester, NY 14613
Dear Mr. Stebbins,
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed your website http://www.deweyavesmokeshop.com, and determined that your 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 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 smokeless tobacco products aremisbranded under section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) because you fail to include in your smokeless tobacco product advertisements any health warning label statements. You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov.
Health Warning Statement Violation
As stated above, 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.deweyavesmokeshop.com, revealed that you advertise and promote for sale several smokeless tobacco products without any warning statements, including, but not limited to: Gawith Apricot, Gawith Cola, Gletscher Prise, Ozona Cherry, Ozona Raspberry, Ozona Spearmint, Ozona President, Wilsons of Sharrow Rum+Blackberry, Wilsons of Sharrow Strawberry, Bruton, C+C (Carhart’s), Dixie, Honey Bee, Tops Sweet, Tube Rose, W E Garrett + Sons (scotch or sweet), Copenhagen Regular, Copenhagen Black, Copenhagen Long Cut, Copenhagen Straight Long Cut, Copenhagen Pouch, Grizzly Natural Fine Cut, Grizzly Wintergreen Fine Cut, Grizzly Wintergreen Long Cut, Grizzly Straight Long Cut 5, Grizzly Mint Long Cut 5, Hawken Wintergreen, Husky Fine Cut Natural, Husky Long Cut Straight, Husky Long Cut Mint, Husky Long Cut Wintergreen, Kayak Fine Cut Wintergreen, Kayak Long Cut Wintergreen, Kayak Long cut Straight, Kayak Long Cut Apple, Kayak Long Cut Peach, Kodiak Ice, Kodiak Straight, Kodiak Wintergreen, Longhorn Fine Cut Natural, Longhorn Long Cut Straight, Longhorn Long Cut Mint, Longhorn Long Cut Wintergreen, Red Seal Fine Cut Natural, Red Seal Wintergreen L/C, Red Seal Long Cut Straight, Red Seal Long Cut Black Cherry, Red Seal Fine Cut Wintergreen, Red Seal Mint, Redwood Fine Cut Natural, Redwood Snuff, Redwood Coffee, Rooster Long Cut Mint 5's, Rooster Long Cut Wintergreen, Silver Creek Fine Cut Wintergreen, Silver Creek Cherry, Silver Creek Long Cut Straight, Silver Creek Long Cut Wintergreen, Skoal Bandit Straight, Skoal Bandit Wintergreen, Skoal Bandit Mint, Skoal Fine Cut Wintergreen, Skoal Long Straight, Skoal Long Cut Classic, Skoal Long Cut Berry, Skoal Long Cut Cherry, Skoal Long Cut Apple, Skoal Long Cut Spearmint, Skoal Long Cut Peach, Skoal Long Cut Mint, Skoal Long Cut Wintergreen, Skoal Mint Pouch, Skoal Berry Pouch, Skoal Apple Pouch, Skoal Peach Pouch, Skoal Vanilla, Timber Wolf Cool Wintergreen, Timber Wolf Fine Cut Wintergreen, Timber Wolf Fine Cut Natural, Timber Wolf Cool Mint, Timber Wolf Long Cut Natural, Timber Wolf Long Cut Straight, Timber Wolf Long Cut Apple, Timber Wolf Long Cut Peach, Timber Wolf Wintergreen Long, Oliver Twist Citrus, Oliver Twist Mint, Oliver Twist Original, Oliver Twist Sun Berry, Oliver Twist Tropical, Oliver Twist Winter Green, Beechnut, Bowie, Stoker’s Fred’s Choice, Havana Blossom, Lancaster, Redman - Regular, Redman - Golden, Stoker -Tennessee Chew, Trophy Bonus, Amish Plain, Amish Sweet, Amish Super Sweet, Good Bite, Reach In, Apple Thick Cut, Bloodhound, Brown's Mule, Bull of The Woods, Cannon Ball, and Day's Work.
Section 3(b) of the Smokeless Tobacco Act, as amended, requires that advertisements for smokeless tobacco products bear one of the following warning labels:
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, RW1300133, 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
Tucows Domains Inc.