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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Trademark Co., Inc., d/b/a Golden Valley Tobacco 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 and Electronic Mail
 
 
Trademark Company, Inc.
d/b/a Golden Valley Tobacco
10234 Erskine St. NE
Blaine, MN 55449
 
info@goldenvalleytobacco.com
 
WARNING LETTER
 
To: info@goldenvalleytobacco.com 
 
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed your website, http://www.goldenvalleytobacco.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.goldenvalleytobacco.com, promotes for sale cigarette 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.”  We note that under the “Products” section of your website, you present graphic images of your product brand, Golden Valley, which are labeled as “pipe tobacco;” however, the overall presentation of your product strongly suggests that it is intended for use in a cigarette.  Specifically, in your “Products” section of the website, you describe your Golden Valley Mint Blend as being made to “provide a different way of smoking a cigarette,” and your Golden Valley Mild Blend as being made to “produce a lighter cigarette.” The UPC product-list on your website provides that your primary products are loose tobacco and cigarette components, parts, and accessories.  On your website’s product-page for Golden Valley Cigarette Papers, you state that the product is, “For use with Golden Valley Roll Your Own Tobacco.” These statements appear to suggest that your Golden Valley blends are intended to be used as cigarette tobacco with your cigarette components, parts, and accessories. Thus, the overall presentation of your Golden Valley Blend products, which consist of loose tobacco, suggests that they are intended for use in a cigarette, and therefore, meet the FD&C Act’s definition of “cigarette tobacco.”
 
FDA also has determined that one of your products is adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)) because you promote this product as a modified risk tobacco product without an FDA order in effect that permits such promotion. Additionally, FDA has determined that one of your products is 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 a “cigarette tobacco” product on your website, http://www.goldenvalleytobacco.com, as being mild and lighter by referring to it as such in product labeling or advertising and adding the qualifier “Mild,” and “Lighter.” Specifically, our review of your website revealed that you manufacture and promote a product listed as: Golden Valley “Mild Blend,” described as “mild,” and as made to “produce a lighter cigarette.” 
 
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 descriptors “Mild,” “Lighter,” or similar descriptors for the above listed product, this product is a modified risk tobacco product. Because this product is 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)), this product is 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.goldenvalleytobacco.com, revealed that you manufacture and promote for sale the following cigarette tobacco: Golden Valley “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 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 or 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, RW1300103, 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 Electronic Mail
 
cc:
 
goldenvalleytobacco@domainsbyproxy.com
 
abuse@godaddy.com
 
noc@godaddy.com
 
legal@godaddy.com
 
Golden Valley Tobacco
P.O. Box 32834
Fridley, MN 55432
 
Golden Valley Tobacco
7880 Beech St. NE
Fridley, MN 55432