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WARNING LETTER

JGT Tobacco Company, Inc. / Cousins Distributing, Inc. Dec 09, 2015

JGT Tobacco Company, Inc. / Cousins Distributing, Inc. - 12/09/2015


Delivery Method:
UPS and Electronic Mail

Recipient:
JGT Tobacco Company, Inc. / Cousins Distributing, Inc.

1891 Woolner Avenue
Suite I
Fairfield, CA 95433
United States

Issuing Office:
Center for Tobacco Products

United States


  

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

Food and Drug Administration
 
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring, MD 20993 

 

DEC 9, 2015

VIA UPS and Electronic Mail
 
JGT Tobacco Company, Inc. / Cousins Distributing, Inc.
d/b/a Just Good Tobacco
Attn: William Bernheim / Claire Vernasco
1891 Woolner Avenue
Suite I
Fairfield, CA 95433
lotsaorders@gmail.com; justgoodtobacco@gmail.com

 
WARNING LETTER
 
Dear Mr. Bernheim and Ms. Vernasco:
 
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the websites http://www.justgoodtobacco.com, http://yhst-140088619863136.stores.yahoo.net, http://www.freshchoicetobacco.com, http://www.craftblendedtobacco.com, http://www.howtogrowyourowntobacco.com, http://www.justnaturaltobacco.com, http://www.mentholtobacco.com, http://www.natural-tobacco.net, http://www.thejustgoodtobaccompany.com, and http://www.tobaccoseedlings.com and determined that the cigarette tobacco and/or roll-your-own tobacco products listed there are offered for sale or distribution to customers in the United States. Under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (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.justgoodtobacco.com and http://yhst-140088619863136.stores.yahoo.net offer for sale or distribute cigarette tobacco and/or roll-your-own tobacco products. 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 websites, http://www.justgoodtobacco.com and http://yhst-140088619863136.stores.yahoo.net, you present loose tobacco productsthat are offered for sale or distributed as cigarette tobacco and/or roll-your-own tobacco, including Natural Blue American Blend / Just Good Tobacco Unmanufactured American Blue. The overall presentation of these products on the websites strongly suggests that they areintended 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 websites sell loose tobacco in conjunction with “Machines,” “Shredder,” “Tubes,” and “Accessories,” to “improve your smoking experience” and “for your RYO [roll-your-own] and MYO [make-your-own] needs.” Additionally, the website http://www.justgoodtobacco.com states: “We invented, produce, and sell the Just Good Tobacco System because we believe smokers should be able to smoke just good tobacco at a reasonable cost[, and] that our system provides you with the best cigarette machine, the best shredder and the best tobacco.”  “We recognized that if people wanted to smoke just good tobacco, they needed to make their own cigarettes. We began work on our electric cigarette machine in 1998 and perfected it in 2006. Since that time we’ve sold thousands of our machines in the United States and in forty two other countries . . . We were fortunate to find a Master Tobacco Blender during our years in the manufactured cigarette business. Today we sell a system where smokers can smoke all premium natural tobacco for just sixty seven cents a pack . . . We work . . . to bring the best tobacco system and the best tobacco to folks who enjoy smoking.”  Finally, during checkout, a customer is presented with “Related items,” such as cigarette tubes. Therefore, the products meet the definition of “cigarette tobacco” and/or “roll-your-own tobacco” in the FD&C Act.
 
FDA has determined that Natural Blue American Blend / Just Good Tobacco Unmanufactured American Blue 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.
 
Modified Risk Tobacco Product Violations
 
Our review of the websites, http://www.justgoodtobacco.com and http://yhst-140088619863136.stores.yahoo.net, revealed that you sell or distribute cigarette tobacco and/or roll-your-own tobacco products that are described as having a reduced level of/exposure to a substance.  Specifically, the websites include the following claim: Natural Blue American Blend / Just Good Tobacco Unmanufactured American Blue, described as being “lower in nicotine content.”
 
A tobacco product with a label, labeling, or advertising that uses the descriptor “light,” “mild,” “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)). A tobacco product is also considered a “modified risk tobacco product” under section 911(b)(2)(A)(i) of the FD&C Act (21 U.S.C. § 387k(b)(2)(A)(i)) if its label, labeling, or advertising explicitly or implicitly represents that: (1) the product presents a lower risk of tobacco-related disease or is less harmful than one or more other commercially marketed tobacco products; (2) the product or its smoke contains a reduced level of a substance or presents a reduced exposure to a substance; or (3) the product or its smoke does not contain or is free of a substance. 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)). 
 
The above listed product is a modified risk tobacco product because its labeling and/or advertising explicitly or implicitly represents that the product or its smoke contains a reduced level of nicotine. Because this product is 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)), this product is adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)).
 
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 labeling and/or advertising on these websites, on any other websites (including e-commerce, social networking, or search engine websites), in any other media in which you advertise, and in any 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 labeling, advertising, sale, and/or distribution of these tobacco products and your plan for maintaining compliance with the FD&C Act. You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov.
 
Please note your reference number, RW1500435, 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
 
VIA UPS and Electronic Mail
 
cc:
 
William Bernheim
JGT Tobacco Company, Inc.
255 Lincoln St.
Dixon, CA 95620
 
Claire Vernasco / Marilyn Roscoe
Cousins Distributing, Inc.
765 Eubanks Drive, Suite D
Vacaville, California 95688
 
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