Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/leaf-only-llc-12162015
Timestamp: 2019-05-19 06:41:35
Document Index: 675775043

Matched Legal Cases: ['§ 321', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 4402']

Leaf Only LLC - 12/16/2015 | FDA
Leaf Only LLC - 12/16/2015
Leaf Only LLC 16/12/2015
Leaf Only LLC / John Wallace and Richard Stone
info@leafonly.com; john@leafonly.com; rich@leafonly.com
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.
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”).
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:
Please note your reference number, RW1500431, in your response and direct your response to the following address:
john@creativesunrise.com
69 Trolley Crossing Lane
support@websitewelcome.com