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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Tobacco Outlet Express LLC 7/30/13

  

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

Public Health Service
Food and Drug Administration
 Center for Tobacco Products
9200 Corporate Boulevard
Rockville, MD 20850-3229

JUL 30, 2013

VIA UPS
 
Armand F. Nannicola
Tobacco Outlet Express, LLC
1100 Corby Drive
Youngstown, OH 44509
 
Donald Fleck
Tobacco Outlet Express, LLC
29072 Cedar Drive
Big Pine Key, FL 33043
 
 
WARNING LETTER
 
Dear Mr. Nannicola and Mr. Fleck:
 
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed your website, http://www.smokin-g.com, and determined that your products listed there are manufactured and promoted 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, these products are tobacco products because they are made or derived from tobacco and intended for human consumption. Certain tobacco products, including cigarette 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.smokin-g.com, promotes for sale cigarette tobacco, defined by the FD&C Act as consisting of loose tobacco intended for use by consumers in a cigarette.  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.” We note that under the “Products” section of your website, you present graphic images of your product brand Smokin’G, which are labeled as “pipe tobacco”; however, the overall presentation of your product on your website strongly suggests that it is intended for use in a cigarette.  Specifically, in your “Find My Blend” section of the website, you make no reference to pipe tobacco blends but provide an extensive table of cigarette brands and the Smokin’ G blends and tubes that can be used to mimic those cigarettes.[1] For example, the table suggests that the use of your “Smokin’G…MRD Blend…Paired with [the] Hot Rod Green (menthol) Tube” will produce a cigarette comparable to “Marlboro Menthol.” By suggesting that consumers pair your loose tobacco blends with certain cigarette tubes to produce comparable cigarette brands, sub-brands, or brand-styles, you indicate an intent for these products to be used by consumers in cigarettes. Therefore, these products, although labeled as “pipe tobacco,” nonetheless meet the definition of “cigarette tobacco” under the FD&C Act.
 
FDA has also 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 several of your 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)). You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov.
 
Modified Risk Tobacco Product Violations
 
You manufacture and promote for sale “cigarette tobacco” products on your website, http://www.smokin-g.com, as being light by referring to them as such in product labeling or advertising and adding the qualifier “Light.” Specifically, our review of your website revealed that you manufacture and promote for sale products listed as: Smokin’G “MINT Blend” described as comparable to “Newport Light” cigarettes; and Smokin’G “CLT Blend” described as comparable to “Newport Light ALT” cigarettes.
 
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 describes the above listed tobacco products as comparable to products described as “Light,” these products are modified risk tobacco products. Because these products are promoted 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)).
 
Flavored Cigarette Violations
 
Additionally, our review of yourwebsite, http://www.smokin-g.com, revealed that you manufacture and promote for sale the following cigarette tobacco: Smokin’G “MINT Blend,” which is purported to contain an artificial or natural flavor that is a characterizing flavor of the product. 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.
 
As of September 22, 2009, cigarettes marketed and sold in the United States in violation of section 907(a)(1)(A) of the FD&C Act (21 U.S.C. § 387g(a)(1)(A)) are adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)). Section 900(3) of the FD&C Act (21 U.S.C. § 387(3)) defines “cigarette” as including “tobacco, in any form…that is likely to be offered to, or purchased by, consumers as a cigarette or as roll-your-own tobacco.” Loose tobacco intended to be used in cigarettes or as roll-your-own tobacco meets the definition of “cigarette” and, therefore, is subject to section 907(a)(1)(A) of the FD&C Act (21 U.S.C. § 387g(a)(1)(A)). Additionally, section 900(4) of the FD&C Act (21 U.S.C. 387(4)) states that, “[u]nless otherwise stated, the requirements applicable to cigarettes . . . shall apply to cigarette tobacco.” Thus, your flavored cigarette tobacco is adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)).
 
If, however, your cigarette tobacco does not contain a characterizing flavor, it is 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 its labeling or advertising is false or misleading because it makes the representation that the product contains, for example, mint as a characterizing flavor of the tobacco product.
 
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, or any other websites or 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 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, RW1300094, 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.   
 
 
Sincerely,
 
/S/
Ann Simoneau, J.D.
Director
Office of Compliance and Enforcement
Center for Tobacco Products
 
VIA UPS and Electronic Mail
 
cc:
 
info@Smokin-G.com
 
Lisa Jackson
Registrant
http://www.smokin-g.com
1415 Fourth Avenue
New Brighton, PA 15066
info@tightwadtobacco.com  
 


[1] Your website states: “Our Blends have been tested for years by smokers of various brands…although we cannot MATCH a brand (brand names are trademarked), we have found that our blends satisfy a certain number of smokers of particular name brands.” This statement is followed by a table that lists various cigarette brands and suggestions to pair certain of your Smokin’G blends with a particular tube to produce cigarettes that are comparable to the specific sub-brands and brand-styles of cigarette brands listed in the table, such as Marlboro, Pall Mall, Camel, Winston, American Spirit, and Newport.