Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jgt-tobacco-company-inc-cousins-distributing-inc-12092015
Timestamp: 2019-06-18 13:08:59
Document Index: 32810621

Matched Legal Cases: ['§ 321', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387']

JGT Tobacco Company, Inc. / Cousins Distributing, Inc. - 12/09/2015 | FDA
JGT Tobacco Company, Inc. / Cousins Distributing, Inc. - 12/09/2015
JGT Tobacco Company, Inc. / Cousins Distributing, Inc. 09/12/2015
d/b/a Just Good Tobacco
Attn: William Bernheim / Claire Vernasco
lotsaorders@gmail.com; justgoodtobacco@gmail.com
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.
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.”
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)).
Please note your reference number, RW1500435, in your response and direct your response to the following address:
JGT Tobacco Company, Inc.
255 Lincoln St.
Claire Vernasco / Marilyn Roscoe
Cousins Distributing, Inc.
765 Eubanks Drive, Suite D