The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed your website, http://www.cvtobacco.com, and determined that cigarette tobacco products and roll-your-own tobacco products listed there are offered for sale to customers in the United States.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)).
FDA has determined that your website, http://www.cvtobacco.com, offers for sale cigarette tobacco and/or roll-your-own tobacco. 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 your website, http://www.cvtobacco.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 Criss Cross and Gambler Pipe Tobacco brand products. The overall presentation of these products on your 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, your website pages include statements describing the “pipe tobacco” products as “Dual Purpose Pipe Tobaccos” that “can be used either in a pipe or injected/rolled into a filtered cigarettes,” are “comparable in appearance, scent and it smokes like cigarette tobacco,” and “will work exactly in the same fashion as rolling tobacco.” Additionally, the same website has a page titled “Roll Your Own” that sells or promotes cigarette injectors, cigarette tubes and multiple brands of roll-your-own tobacco and pipe tobacco. Therefore, your products meet the definition of “cigarette tobacco” and/or “roll-your-own tobacco” in the FD&C Act.
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.
Flavored Cigarette Violations
Our review of your website, http://www.cvtobacco.com, revealed that you offer for sale the following cigarette tobacco and/or roll-your-own tobacco products: Criss Cross Vanilla and Gambler Mint, which are purported to contain an artificial or natural flavor that is a characterizing flavor of the products. Section 907(a)(1)(A) of the FD&C Act (21 U.S.C. § 387g(a)(1)(A)) provides:
[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 products are adulterated 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 their labeling or advertising is false or misleading because it makes the representation that the products contain, for example, vanilla or mint as a characterizing flavor of the tobacco products.
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 promotional materials 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 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 promotion, advertising, sale, and/or distribution of these tobacco products and your plan for maintaining compliance with the FD&C Act.
Please note your reference number, RW1400180, in your response and direct your response to the following address:
PAL-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.