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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Smokers Outlet Online 4/23/14

  

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 

APR 23, 2014

VIA UPS
 
Frederick Fogelman
Smokers Outlet Online, Inc.
75 Acco Drive
Suite A-12
York, PA 17402
 
 
WARNING LETTER
 
Dear Mr. Fogelman:
 
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed your website, http://www.smokersoutlet.com, and determined that your products listed there are manufactured and 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 your website, http://www.smokersoutlet.com, offers for sale cigarette tobacco and 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” (RYO) 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.” 
 
Specifically, your website header states “Smokers Outlet Online - Your source for make your own (roll your own or stuff your own) cigarette supplies: pipe tobacco, tubes, papers, machines, and accessories” and promotes your loose tobacco products, which are labeled as “pipe tobacco,” for “multi-use” or “RYO/MYO” (roll-your-own/make-your-own). You promote: Criss Cross Smooth (described as “a multi-use tobacco and would be perfect for use in a pipe or for our MYO/RYO smokers”), Direct Buy Blue (as “a multi-use tobacco and would be perfect for pipe or MYO/RYO smokers”), Direct Buy Silver (described as “a multi-use tobacco and would be perfect for pipe or MYO/RYO smokers”), and Golden Harvest Silver (described as “a multi-use tobacco and would be perfect for use in a pipe or MYO/RYO smokers”). In addition, your website promotes Criss Cross Mint (described as “a multi-use tobacco and would be perfect for use in a pipe or for our MYO/RYO smokers”), Golden Harvest Mint (described as “a multi-use tobacco and would be perfect for use in a pipe or for our MYO/RYO smokers”), and Smokers Outlet Mint (described as “a multi-use tobacco and would be perfect for use in a pipe or for our MYO/RYO smokers”). Thus, the overall presentation of your loose tobacco products suggests that they are intended for use in a cigarette or 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 “roll-your-own tobacco” in the FD&C Act.
 
FDA has determined that several of these 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 these 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 cigarette tobacco and RYO tobacco products that you describe on your website as being “light,” “ultra light,” and “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 RYO tobacco products listed as: Criss Cross Smooth (“light/mild tobacco”), Direct Buy Blue (“light”), Direct Buy Silver (“ultra light”), and Golden Harvest Silver (“ultra light”).
 
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 your website, http://www.smokersoutlet.com, revealed that you manufacture and/or offer for sale the following cigarette and RYO tobacco products: Criss Cross Mint, Golden Harvest Mint, and Smokers Outlet Mint, 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 roll-your-own tobacco productsareadulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)).
 
If, however, these cigarette tobacco and 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 theirlabeling or advertising is false or misleading because it makes the representation that the products contain, for example, mint 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 promotional materials on this website, on any other websites (including e-commerce, social networking, or search engine websites), 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, RW1400158, 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:
 
Smokers Outlet, Inc.
Frederick Fogelman
1100 Mount Rose Avenue
York, PA 17403
it-vendors@smokersoutletonline.com
 
Smokers Outlet, Inc.
Frederick Fogelman
1636 Market Street
York, PA 17404
 
GoDaddy.com, LLC
abuse@godaddy.com
 
Hosting Service, Inc.
Attn: Matt McBride
mmcbride@westhost.com
abuse@uk2group.com