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WARNING LETTER

http://www.buydiscountcigars.com Sep 26, 2014

http://www.buydiscountcigars.com - 09/26/2014


Delivery Method:
USPS and Electronic Mail

Recipient:
http://www.buydiscountcigars.com


Newark, DE
United States

Issuing Office:
Center for Tobacco Products

United States


  

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

Public Health Service
Food and Drug Administration
 
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002 

SEPT 26, 2014 

VIA USPS and Electronic Mail
 
BuyDiscountCigars
P.O. Box 4673
Newark, DE 19715
 
WARNING LETTER
 
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website, http://www.buydiscountcigars.com, and determined that cigarette tobacco and/or roll-your-own 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 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 the website, http://www.buydiscountcigars.com, offers for sale cigarette tobacco and/or roll-your-own tobacco. 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 the website you present loose tobacco products containing the description “pipe tobacco” but are promoted and offered for sale as cigarette tobacco and/or roll-your-own tobacco, including 4 Aces, Carter Hall, Dark Hawk, Gambler, Kentucky Select, OHM, Captain Black, Criss Cross, Paladin, Prince Albert, Smoker’s Best, Smoker’s Pride, Southern Steel, and Super Value.  The overall presentation of these products on the 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 website’s “Pipe Tobacco/RYO” tab includes a list of loose tobacco products, along with cigarette “Tubes, Wraps, etc.” and “RYO Accessories.”  Additionally, the following loose tobacco product brands contain the following product descriptions:
 
  • The website’s “Frequently Asked Questions” page states “Q. How do I roll my own ‘cigarettes’?” and “A. Simply purchase a Gambler Cigarette Making Machine, some Gambler Cigarette Tubes, and some pipe tobacco. Although this will not make a true "cigarette," many customers find the flavor of the pipe tobacco acceptable and enjoy being able to make their own "cigarettes" at home for less than $20 a carton!” 
  • Gambler (“ . . . dual-purpose tobacco. It’s perfect for roll your own . . . ”)
  • Kentucky Select (“Many of my friends had told me that this tobacco was so good, that they were using it to roll cigarettes! I was in shock, rolling up pipe tobacco?!? Surely they are crazy. But, after such a great pipe smoking experience, I decided I would give it a go as well. I rolled up the Kentucky Select pipe tobacco in a typical cigarette paper, and much to my surprise, it was a great mellow smoke! With the fantastic flavors, Virginia tobacco, ability to smoke it like a cigarette, and the unbelievably low price, I would recommend Kentucky Select pipe tobacco to anyone.”)
  • OHM (“I HIGHLY recommend you to try OHM Pipe Tobacco who likes to roll their own cigarettes!”)
  • Captain Black (“Order for your pack of pipe tobacco and also search for filling machines and cigarette tubes at our one-stop online destination and save significant amount of money . . . The ribbon cut tobacco allows for easy rolling for both beginners and experience cigarette rollers.”)
  • 4 Aces (“ . . . tobacco ideal for rolling up. Some pipe tobacco is far too strong for smoking this way, but 4 Aces Pipe Tobacco is mild enough that you can smoke it like a cigarette.”).
 
Thus, the overall presentation of these loose tobacco products suggest that they appear to be suitable for use and likely to be offered to, or purchased by, consumers as tobacco for making cigarettes. Therefore, they 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. 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 products that you describe on the website, http://www.buydiscountcigars.com, as being “light,” “ultra light,” and “mild” by referring to them as such in product labeling or advertising and adding the qualifiers “light,” “ultra light,” and “mild” to the product names. Specifically, our review of the website revealed that you sell or distribute products listed as: 4 Aces Mellow, described as “mild”; 4 Aces Mint, described as “mild”; 4 Aces Regular, described as “mild”; Carter Hall, described as “mild”; Dark Hawk (Dark Hawk Light); Gambler Mellow, described as “mild”; Kentucky Select (Kentucky Select Ultra Light (Silver)); OHM Blue (OHM Mild (Blue)); and Captain Black Royal Blue, described as “light” and “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 the website uses the descriptors “light,” “Ultra 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 the website,http://www.buydiscountcigars.com, revealed that you offer for sale the following cigarette tobacco and/or roll-your-own tobacco products: 4 Aces Mint; Captain Black Gold, described as “vanilla”; Captain Black Regular, described as “vanilla”; Captain Black Royal Blue, described as “vanilla”; Criss Cross Mint; Criss Cross Black Cherry; Criss Cross Vanilla; Gambler Mint; Kentucky’s Best Mint; OHM Mint (Green), Paladin Black Cherry; Prince Albert Cherry Vanilla; Smoker’s Best Mint; Smoker’s Pride Cherry; Smoker’s Pride Vanilla; Smoker’s Pride Whiskey; Southern Steel Maxi Mint; Super Value Cherry; Super Value Vanilla; Super Value Whiskey, 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 cigarettes or as roll-your-own tobacco. 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 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 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, these cigarette tobacco and/or roll-your-own tobacco products 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)) or section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) as their labeling or advertising is false or misleading because it makes the representation that the products contain, for example, mint, vanilla, whiskey, cherry vanilla, or cherry as a characterizing flavor of the tobacco products.
 
We also note that your website, http://www.buydiscountcigars.com, lists the following cigarette tobacco and/or roll-your-own tobacco products as “out of stock” and “discontinued by manufacturer”: Middleton’s Cherry Blend; Southern Steel Vanilla; Southern Steel Wild Cherry; and Union Mint. Because these products purport to contain a characterizing flavor of mint, cherry or vanilla, we note that selling or offering these products for sale would violate sections 902(5), 903(a)(1), and/or 903(a)(7)(A) of the FD&C Act.
 
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 sell or 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, RW1400211, 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
 
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