The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed your website, http://www.wholesalecigarettetobacco.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. 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.wholesalecigarettetobacco.com, offers for sale 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 your website, you present loose tobacco products that are promoted and offered for sale as cigarette tobacco and/or roll-your-own tobacco, including Canadian Flue Cured and Smokers Choice Blend. Specifically, your website offers for sale these loose tobacco products listed under the heading, “Cigarette Tobacco Rolling Leaf.” In addition, these products are sold with cigarette tubes and personal tobacco shredders. Further, your website describes Smokers Choice Blend as “the best cigarettes on the market.” Thus, the overall presentation of theseloose tobacco products on your website strongly suggests that they are intended for use in a cigarette and/or appear to be suitable for use and likely to be offered to, or purchased by, consumers as tobacco for making cigarettes. Therefore, they meet the definitions of “cigarette tobacco” and/or “roll-your-own tobacco”in the FD&C Act.
FDA has determined that your Canadian Flue Cured and Smokers Choice Blend cigarette tobacco and/or roll-your-own tobaccoproducts 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. You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov.
Modified Risk Tobacco Product Violations
You sell or distribute products that you describe on your website, http://www.wholesalecigarettetobacco.com, as being mild or light by referring to them as such in product labeling or advertising. Specifically, our review of your website revealed that you sell or distribute cigarette tobacco and/or roll-your-own tobacco products listed as: Canadian Flue Cured (“mild tobacco leaves”) and Smokers Choice Blend (“light (Canadian) tobacco leaves”). You also describe a product you offer for sale on your website as containing a reduced level of a substance or presenting a reduced risk of exposure to a substance than one or more other commercially marketed products. Specifically, you offer for sale Canadian Flue Cured tobacco as being “lower in nicotine content.”
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)). A tobacco product is also considered a “modified risk tobacco product” under section 911(b)(2)(A)(i) of the FD&C Act (21 U.S.C. § 387k(b)(2)(A)(i)) if its label, labeling, or advertising explicitly or implicitly represents that:(1) the product presents a lower risk of tobacco-related disease or is less harmful than one or more other commercially marketed tobacco products; (2) the product or its smoke contains a reduced level of a substance or presents a reduced exposure to a substance; or (3) the product or its smoke does not contain or is free of a substance. 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 website uses the descriptor “light,” “mild,” or similar descriptors or claims that the above listed product contains a reduced level of a substance or presents a reduced risk of exposure to a substance, 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)).
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), 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.
Please note your reference number, RW1400213, in your response and direct your response to the following address:
DPAL-WL Response, Office of Compliance and Enforcement Food and Drug Administration 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.