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  5. www.eacarey.com - 05/01/2015
  1. Compliance Actions and Activities

WARNING LETTER

www.eacarey.com May 01, 2015

www.eacarey.com - 05/01/2015


Delivery Method:
UPS andElectronic Mail

Recipient:
www.eacarey.com

7090 Whipple Ave NW

North Canton, OH 44720
United States

Issuing Office:
Center for Tobacco Products

United States


  

Department of Health and Human Services logoDepartment of Health and Human Services

Food and Drug Administration
 
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring, MD 20993 

 

 

MAY 1, 2015
VIA UPS andElectronic Mail
 
           
E. A. Carey’s Smokeshop
Attn: William L. Miller
7090 Whipple Ave NW
North Canton, OH 44720
custserv@eacarey.net 
 
 
WARNING LETTER
 
Dear Mr. Miller:
 
The Center for Tobacco Products ofthe U.S. Food and Drug Administration (FDA) recently reviewed your website, http://www.eacarey.com, and determined that your cigarette tobacco and/or roll-your-own tobacco products listed there are offered for sale or distributed to customers in the United States. Under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (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 cigarette tobacco and roll-your-own 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 your website, http://www.eacarey.com, offers for sale cigarette tobacco and/or roll-your-own tobacco products. Section 900(4) of the FD&C Act (21 U.S.C. § 387(4)) defines “cigarette tobacco” as “any product that consists of loose tobacco that is intended for use by consumers in a cigarette.” Section 900(15) of the FD&C Act (21 U.S.C. § 387(15)) defines “roll-your-own tobacco” as “any tobacco product which, because of its appearance, type, packaging, or labeling, is suitable for use and likely to be offered to, or purchased by, consumers as tobacco for making cigarettes.” 
 
We note that on your website, you present loose tobacco products containing the package description “pipe tobacco”but that are offered for sale or distributed as cigarette tobacco and/or roll-your-own tobacco, including E.A. Carey, Captain Black, Mac Baren, Smoker’s Pride, Peterson, Dunhill, and Erik Stokkebye. The overall presentation of these products on your website strongly suggests that they are intended for use in a cigarette, likely to be offered to consumers for making cigarettes, and/or likely to be purchased by consumers for making cigarettes. Specifically, the websitesells these loose tobacco products in conjunction with roll-your-own/make-your own equipment, including cigarette rolling machines, cigarette tubes, and roll-your-own cigarette papers, tips, and filter plugs, and states, “Care to make your own cigarettes?... We carry a large selection of RYO pipe tobaccos, rolling machines and accessories, along with complete RYO cigarette kits.” Therefore, your products meet the definition of “cigarette tobacco” and/or “roll-your-own tobacco” in the FD&C Act.
 
FDA has determined that several of your cigarette tobacco and/or roll-your-own tobacco 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. Additionally, FDA has determined that several of your cigarette tobacco and/or roll-your-own tobacco products are adulterated under section 902(5) of the 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)) or section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) because they purport to contain a natural or artificial characterizing flavor.  
 
Modified Risk Tobacco Product Violations
 
You sell or distribute products that you describe on the website, http://www.eacarey.com, as being light or mild by referring to them as such in product labeling or advertising. Specifically, our review of your website revealed that you sell or distribute cigarette tobacco and/or roll-your-own tobacco products, including, but not limited to: Vintage Estate Pipe Tobacco (described as “light”), Traditional Virginia Pipe Tobacco (described as “mild”), Europa Pipe Tobacco (described as “mild”), Captain Black Pipe Tobacco Gold (described as “mild”), Mac Baren Golden Extra Pipe Tobacco (described as “mild”), 4th Generation 1897 Erik Paul Stokkebye Blend Pipe Tobacco (described as “light” and “milder”), Skandinavik Regular Cavendish Tobacco (described as “mild”), and Bella Vanilla Flavours Pipe Tobacco by CAO (described as “mild”).
 
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,” “Mild,” 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)).
 
Flavored Cigarette Violations
 
Additionally,our review of your website, http://www.eacarey.com, revealed that you offer for sale the following flavored cigarette tobacco and/or roll-your-own tobacco products, including, but not limited to: 50th Anniversary Pipe Tobacco (chocolate and vanilla), Cream Cherry Pipe Tobacco (cherry, vanilla), Black Currant Pipe Tobacco (black currant, apple), Berries & Crème Pipe Tobacco (raspberry), Cinnamon Pipe Tobacco (cinnamon, vanilla, spices), Europa Pipe Tobacco (wild berry), Irish Cream Pipe Tobacco (mocha and vanilla), Smoker’s Pride Vanilla Cavendish Loose Pipe Tobacco, Captain Black Pipe Tobacco Cherry, Mac Baren Vanilla Flake Pipe Tobacco, Peterson Sweet Killarney Pipe Tobacco Tin (caramel), Dunhill My Mixture 965 Pipe Tobacco (Chocolate), Erik Stokkebye 4th Generation Aromatic Holiday 2 Pack Pipe Tobacco Tins (vanilla, honey), Stanwell Vanilla Pipe Tobacco 50g Tin (vanilla), Cherry Bomb Flavours Pipe Tobacco by CAO (cherry, vanilla, black currant), Eileen’s Dream Flavours Pipe Tobacco by CAO (white chocolate, cocoa, peaches, vanilla, coconut, hazelnut, almond, cream), and Pipa Vanilla Cavendish Smoking Pipe Tobacco and Corncob Pipe Kit, 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 . . . that is a characterizing flavor of the tobacco product or tobacco smoke.
 
These requirements apply to cigarettes and cigarette tobacco, which includes roll-your-own tobacco and any other loose tobacco intended to be used in making cigarettes. See sections 900(3), 900(4), 907(a)(1)(A) of the FD&C Act; (21 U.S.C. § 387(3); 21 U.S.C. § 387(4); 21 U.S.C. § 387g(a)(1)(A)). As of September 22, 2009, cigarettes, cigarette tobacco, and roll-your-own tobacco sold or distributed 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 cigarette tobacco and/or roll-your-own tobacco products are adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)).
 
If, however, thecigarette tobacco and/or roll-your-own tobacco products do not contain a characterizing flavor, they aremisbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) or section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) as labeling or advertising is false or misleading because it makes the representation that the products contain, for example, vanilla, chocolate, cherry, black currant, apple, raspberry, cinnamon, spices, wild berry, black cherry, mocha, peach, berry, caramel, honey, blackberry, white chocolate, cocoa, coconut, hazelnut, almond, or cream as a characterizing flavor of the tobacco products.
 
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 and all related labeling and/or advertising 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, and in retail establishments 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, RW1500278, in your response and direct your response to the following address:
 
DPAL-WL Response, Office of Compliance and Enforcement
FDA Center for Tobacco Products
c/o Document Control Center
Building 71, Room G335
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
 
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.   
 
 
Sincerely,
/S/ 
Ann Simoneau, J.D.
Director
Office of Compliance and Enforcement
Center for Tobacco Products
 
VIA Electronic Mail
 
cc:
 
Jen Thames
Zenvesco, Inc.
jthames@neo.rr.com
 
Melbourne IT Ltd.
abuse@melbourneit.com.au
 
Yahoo Inc.
abuse@yahoo-inc.com