Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm405483.htm
Timestamp: 2019-04-20 14:57:09+00:00

Document:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed your websites, http://www.snappycigars.com, http://www.best-price-wholesale.com, and http://www.eztobacco.com, and determined that your cigarette tobacco and roll-your-own tobacco products listed there are offered for sale to customers in the United States. FDA believes these websites are affiliated with one another because the websites share the same contact information for Trivett Sales. Additionally, the websites http://www.snappycigars.com and http://www.eztobacco.com each refer to a “sister site,” http://www.best-price-wholesale.com. 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 (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)).
We note that on your websites,http://www.snappycigars.com, http://www.best-price-wholesale.com, and http://www.eztobacco.com, you present loose tobacco products containing the package description “pipe tobacco” but that are promoted and offered for sale as cigarette tobacco and/or roll-your-own tobacco, including 4 Aces, Bacco, Borkum Riff, Gambler, Kentucky’s Best, Largo, OHM, Red Buck, Sparrow, and Smokers Pride brand products. The overall presentation of these products on your websites 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 above listed products are featured under the “Roll Your Own Tobacco” category of your websites. Therefore your products meet the definition of “cigarette tobacco” or “roll-your-own tobacco” in the FD&C Act.
FDA has determined that several of your 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 of your products are 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)) because they purport to contain a natural or artificial characterizing flavor. You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov.
You sell or distribute cigarette tobacco and/or roll-your-own tobacco products that you describe on your websites, http://www.snappycigars.com, http://www.best-price-wholesale.com, and http://www.eztobacco.com, as being “mild” by referring to them as such in product labeling or advertising and including the qualifier “Mild” in the product names. Specifically, our review of your websites revealed that you sell or distribute cigarette tobacco and/or roll-your-own tobacco products listed as: Bacco Mild Pipe Tobacco, Kentucky’s Best Mild Pipe Tobacco, OHM Blue Mild Pipe Tobacco, OHM Silver Extra Mild Pipe Tobacco, Red Buck Mild Pipe Tobacco, and Sparrow Mild Pipe Tobacco Pouch.
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 websitesuse the descriptors “mild,” “extra mild,” or similar descriptors for the above listed products, these products are modified risk tobacco 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)).
[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.
These requirements apply to cigarettes and cigarette tobacco, which includes roll-your-own tobacco and any other loose tobacco intended to be used in cigarettes or as roll-your-own tobacco. See sections 900(3), 900(4), 907(a)(1)(A) of the FD&C Act; (21 U.S.C. § 387(3); 21 U.S.C. § 387(4); 21 U.S.C. § 387g(a)(1)(A)). As of September 22, 2009, cigarettes, cigarette tobacco, and roll-your-own tobacco marketed and sold in the United States in violation of this provision are adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)). Thus, your flavored cigarette tobacco and/or roll-your-own tobacco productsareadulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)).
If, however, these cigarette tobacco and/or roll-your-own tobacco products do not contain a characterizing flavor, they are 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 theirlabeling or advertising is false or misleading because it makes the representation that the products contain, for example, mint, cherry, whiskey, vanilla, or rum as a characterizing flavor of the tobacco products.
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 these websites, on any other websites (including e-commerce, social networking, or search engine websites), and in any other 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 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 promotion, advertising, sale, and/or distribution of these tobacco products and your plan for maintaining compliance with the FD&C Act.
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.

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