BnB Enterprise LLC 7/30/13
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Center for Tobacco Products|
9200 Corporate Boulevard
Rockville, MD 20850-3229
JUL 30, 2013
VIA UPS, Electronic Mail, and Fax
BnB Enterprise LLC
344 Maple Ave., West #110
Vienna, Virginia 22180
Dear Mr. Pyatt:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed your website, http://www.bnbtobacco.com, and determined that your products listed there are promoted for sale to customers in the United States. Under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act and intended for human consumption. Certain tobacco products, including cigarette tobacco, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)).) (21 U.S.C. § 321(rr)), as amended by the Family Smoking Prevention and Tobacco Control Act, these products are tobacco products because they are made or derived from tobacco
FDA has determined that your website, http://www.bnbtobacco.com, offers for sale cigarette 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.” We note that under the “Pipe Tobacco” section of your website, you present graphic images of the product brands 4 Aces, The Good Stuff, Kentucky Select, and Red River, which are promoted or labeled as “pipe tobacco;” however, the overall presentation of these products strongly suggests that they are intended for use in a cigarette. Specifically, in your “Pipe Tobacco” section of the website, you promote these product brands for sale with cigarette-injector machines or as part of roll-your-own starter packages or starter kits, which include tobacco, cigarette tubes, and a cigarette machine. This presentation suggests that your products are intended to be used to make cigarettes with the cigarette machines and cigarette tubes with which you promote them. Because the overall presentation of your products, which consist of loose tobacco, suggests that they are intended for use in cigarettes, they meet the FD&C Act’s definition of “cigarette tobacco.”
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 you promote these products as modified risk tobacco products without an FDA order in effect that permits such promotion. 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)). You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov.
Modified Risk Tobacco Product Violations
You describe a product that you offer for sale on your website, http://www.bnbtobacco.com, as being light by referring to it as such in product labeling or advertising and adding the qualifier “light.” Specifically, our review of your website revealed that you offer for sale a product listed as: Good Stuff Gold (described as “Good Stuff Light…”).
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 website uses the descriptor “light,” or similar descriptors for the above listed product, this product is a modified risk tobacco product. Because this product is promoted for sale 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)), this product is adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)).
Flavored Cigarette Violations
Additionally, our review of yourwebsite, http://www.bnbtobacco.com, revealed that you offer for sale the following cigarette tobacco: “4 Aces Mint,” “Kentucky Select Mint,” and “Red River Mint,” which are purported to contain an artificial or natural flavor that is a characterizing flavor of the product. 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.
As of September 22, 2009, cigarettes marketed and sold in the United States in violation of section 907(a)(1)(A) of the FD&C Act (21 U.S.C. § 387g(a)(1)(A)) are adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)). Section 900(3) of the FD&C Act (21 U.S.C. 387(3)) defines “cigarette” as including “tobacco, in any form…that is likely to be offered to, or purchased by, consumers as a cigarette or as roll-your-own tobacco.” Loose tobacco intended to be used in cigarettes meets the definition of “cigarette” and, therefore, is subject to section 907(a)(1)(A) of the FD&C Act (21 U.S.C. § 387g(a)(1)(A)). Additionally, section 900(4) of the FD&C Act (21 U.S.C. 387(4)) states that, “[u]nless otherwise stated, the requirements applicable to cigarettes . . . shall apply to cigarette tobacco.” Thus, your flavored cigarette tobacco is adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)).
If, however, your cigarette tobacco does not contain a characterizing flavor, it is 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 its or labeling or advertising is false or misleading because it makes the representation that the products contain, for example, 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, or any other websites or 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 importation 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, RW1300104, in your response and direct your response to the following address:
PAL-WL Response, Office of Compliance and Enforcement
FDA Center for Tobacco Products
9200 Corporate Boulevard
c/o Document Control Center
Rockville, Maryland 20850
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.
Ann Simoneau, J.D.
Office of Compliance and Enforcement
Center for Tobacco Products
VIA UPS and Electronic Mail
BnB Enterprise LLC
1928 Labrador Lane
Vienna, Virginia 22182
BnB Enterprise LLC
44621 Guilford Drive, Suite 130
Ashburn, Virginia 20147