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WARNING LETTER

Leaf Only LLC


Delivery Method:
UPS and Electronic Mail

Recipient:
Leaf Only LLC

440 Middlefield Street

Middletown, CT 06457
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 16, 2015

VIA UPS and Electronic Mail
 
Leaf Only LLC / John Wallace and Richard Stone
440 Middlefield Street
Middletown, CT 06457
info@leafonly.com; john@leafonly.com; rich@leafonly.com
 
 
WARNING LETTER
 
Dear Mr. Wallace and Mr. Stone:
 
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website http://www.leafonly.com and determined that the cigarette tobacco and/or roll-your-own tobacco and smokeless tobacco products listed there are offered for sale or distributed 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, roll-your-own tobacco, and smokeless 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 website, http://www.leafonly.com, offers for sale or distributes 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 website you present loose tobacco products that are offered for sale or distributed as cigarette tobacco and/or roll-your-own tobacco, including 456 Semi-Oriental, Aged Burley, Brightleaf, Canadian Virginia Flue Cured, Turkish Combo, and Yenidje Oriental. The overall presentation of these products on the website 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 describes 456 Semi-Oriental as “commonly used . . . in cigarette tobacco blends” and “for cigarette tobacco leaf blends, MYO, and RYO”; Aged Burley Tobacco Leaf as “Mainly used to make cigarette tobacco leaf blends,” “cigarette tobacco leaves . . . meant to be converted into RYO or pipe tobacco,” and “Cigarette Blends, MYO Cigarettes”; Brightleaf Combo and Brightleaf Sweet Combo as “Raw Cigarette Tobacco Leaf, Tobacco Leaf Cigarette Blends, RYO Tobacco Leaf”; Canadian Virginia Flue Cured as “a major component in cigarette blends for almost every type of cigarette,” “commonly used in . . . cigarette tobacco blends,” able to be used as “RYO” with the use of your “new tobacco leaf cutter,” and “Cigarette Tobacco”; Turkish Combo as “Cigarette Tobacco Leaf, Tobacco Leaf Cigarette Blends, RYO Tobacco Leaf”; and Yenidje Oriental as “for . . . cigarette tobacco blends” and “Tobacco Leaves for cigarette tobacco leaf blends, MYO, and RYO.”  The products are also advertised under the heading “Cigarette Tobacco Leaves By the Pound.” Additionally, the “Frequently Asked Questions about Whole Leaf Tobacco” page has the question “How many packs of cigarettes can I make from 1 pound of tobacco?” with the response “Each pound of whole leaf tobacco will yield you approximately 1.5-2 cartons of cigarettes.” Finally, the home page of the website states “Leaf Only is your number one, online source for whole tobacco leaves, MYO tobacco, and tobacco leaf accessories. We've done our best to make our website an easy to use, online platform for purchasing a huge variety of tobacco leaf products including: cigar wrappers, binders, and fillers, myo cigarette tobacco leaves, hookah tobacco leaf, pipe tobacco leaf, maduro tobacco leaf, shade tobacco leaf, fronto leaf, grabba leaf, and much more!” (emphasis added). Therefore, the products meet the definition of “cigarette tobacco” and/or “roll-your-own tobacco” in the FD&C Act.
 
FDA has determined that several cigarette tobacco and/or roll-your-own tobacco 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 smokeless tobacco products are misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) and/or section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) because your webpages regarding smokeless tobacco products fail to include any health warning label statements.   
 
Modified Risk Tobacco Product Violations
 
Our review of the website, http://www.leafonly.com, revealed that you sell or distribute the following cigarette tobacco and/or roll-your-own tobacco products, which are listed as being light, mild, or using similar descriptors: 456 Semi-Oriental (described as “Light”), Aged Burley (described as “Mild” and “milder”), Brightleaf Combo (described as “ULTRA LIGHT”), Brightleaf Sweet Combo (described as “LIGHT”), Canadian Virginia Flue Cured (described as “lighter”), Turkish Combo (described as “ULTRA LIGHT”), and Yenidje Oriental (described as “light” and “lightest”).
 
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)). 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 products are modified risk tobacco products because the website uses the descriptors light, mild, or similar descriptors to describe these 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)).
 
Health Warning Statement Violations
 
Additionally, our review of the website, http://www.leafonly.com, revealed that the following smokeless tobacco products that you offer for sale or distribute in the United States do not include any health warning statements: Aged Burley (“used for . . . chewing tobacco leaf”), Dark Fire Cured (“this leaf is traditionally used to make chewing tobacco, snuf, snus”), Light Fire Cured (“this leaf is traditionally used to make chewing tobacco, snuf, snus”), Burley (“used for . . . chewing tobacco leaf”), Fronto / Dark Air Cured (“our most popular chewing tobacco types”), Aged Fronto / Dark Air Cured (“our most popular chewing tobacco types”), and CT 1DW (CT Broadleaf Chew) / CT 1DW Maduro (Aged).  Section 3(b) of the Comprehensive Smokeless Tobacco Health Education Act of 1986 (Smokeless Tobacco Act) (15 U.S.C. § 4402), as amended by section 204 of the Tobacco Control Act (P.L. 111-31, 123 Stat. 1846), requires that advertisements for smokeless tobacco products bear one of the following health warning label statements:
 
WARNING: This product can cause mouth cancer.
 
WARNING: This product can cause gum disease and tooth loss.
 
WARNING: This product is not a safe alternative to cigarettes.
 
WARNING: Smokeless tobacco is addictive.
 
A tobacco product is misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) if its labeling is false or misleading in any particular. In addition, a tobacco product is misbranded under section 903(a)(7)(A) of the FD&C Act, (21 U.S.C. § 387c(a)(7)(A)), if, in the case of any tobacco product distributed or offered for sale in any State, its advertising is false or misleading in any particular.  Under section 201(n) of the FD&C Act (21 U.S.C. § 321(n)), in determining whether labeling and/or advertising is misleading, the agency considers, among other things, the failure to reveal material facts concerning the consequences that may result from the customary or usual use of the product. 
 
Because your webpages regarding smokeless tobacco products do not include any health warnings, your smokeless tobacco products aremisbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) and/or section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)).   
 
In addition, we note that you are required to follow all other applicable federal laws and regulations.  For example, section 3(b)(3) of the Smokeless Tobacco Act (15 U.S.C. § 4402), requires the quarterly rotation of warning label statements on advertising for each brand of smokeless tobacco.  Quarterly rotation must be done in accordance with a plan submitted by the tobacco product manufacturer, importer, distributor, or retailer and approved by FDA. 
 
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 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 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, RW1500431, 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:
 
John Wallace
41 Ridge Road
Middletown, CT 06457
john@creativesunrise.com
 
Richard Stone
69 Trolley Crossing Lane
Middletown, CT 06457
 
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