• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

EWSG, Inc. 8/12/14

  

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

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

AUG 12, 2014

VIA UPS and Electronic Mail
 
Richard Glaubinger
EWSG, Inc.
531 W. Hopkins St.
San Marcos, TX 78666                                                               
Ricg@brnews.com
 
 
WARNING LETTER
 
Dear Mr. Glaubinger:
 
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the websites, http://www.ryotobacco.com and http://www.pipetobacco.com and determined that the cigarette tobacco and/or roll-your-own tobacco products listed there are offered for sale to customers in the United States. FDA believes these websites are affiliated with one another because they share common contact information on the websites, registrant information, and the internal links from the website http://www.ryotobacco.com direct customers to http://www.pipetobacco.com. In addition, http://www.ryotobacco.com includes written directions to purchase tobacco products on http://www.pipetobacco.com.   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 websites, http://www.ryotobacco.com and http://www.pipetobacco.com, offer 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 your websites present loose tobacco products described as “pipe tobacco” but that are collectively promoted and offered for sale on your websites as cigarette tobacco and/or roll-your-own tobacco, including Gawith Hoggarth Smooth Tobacco-Gold, Kensington Pipe Tobacco- Old Virginia, Texas Tobacco- Mild Pipe tobacco, Gawith Hoggarth Top Black Cherry, Gawith Hoggarth Smooth Tobacco- Light Vanilla, and Kensington Pipe Tobacco- Old Kentucky. The overall presentation of these products on your websites 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 http://www.ryotobacco.com promotes and offers for sale their loose tobacco products labeled as “pipe tobacco” under a heading of “Roll Your Own.” In addition, the website offers for sale cigarette accessories, such as cigarette tubes, cigarette holders and filters, in close proximity to the “Roll Your Own” products. Although the website http://www.ryotobacco.com specifies that it will not ship pipe tobaccowith roll-your-own supplies, it directs consumers to buy their tobacco in “a separate order and separate shipment from our pipe tobacco site” and includes a link to “Pipetobacco.com.” Therefore, your products meet the definition of “cigarette tobacco” and/or “roll-your-own tobacco”in the FD&C Act.
                                                                                                                                    
FDA has also determined that several of your cigarette tobacco and/or roll-your-own tobacco products, areadulterated 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 productsare 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 websites, http://www.ryotobacco.com and http://www.pipetobacco.com, as being “light” and “mild” by referring to them as such in product labeling or advertising. Specifically, our review of the websites revealed that you sell or distribute the following cigarette tobacco and/or roll-your-own tobacco products:  Gawith Hoggarth Smooth Tobacco-Gold described as “a mild…tobacco,” Kensington Pipe Tobacco- Old Virginia described as “light,” and Texas Tobacco- Mild Pipe tobacco.
 
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 websites use the descriptors “Light” and “Mild” or similar descriptorsfor 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 websites revealed that you offer for sale the following cigarette tobacco and/or roll-your-own tobacco products: Gawith Hoggarth Top Black Cherry, Gawith Hoggarth Smooth Tobacco- Light Vanilla, and Kensington Pipe Tobacco- Old Kentucky (chocolate) 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 areadulterated 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 theirlabeling or advertising is false or misleading because it makes the representation that the products contain, for example, black cherry, vanilla, or chocolate 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 these websites, 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, RW1400186, in your response and direct your response to the following address:
 
PAL-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 
 
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:
 
sales@amazingcity.com
orderinfo@pipetobacco.com
abuse@web.com     
support@hostasaurus.com                                               
abuse@abuse.hostasaurus.com