RSB Tobacco Inc 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 and Electronic Mail
Rose S. Bowen
RSB Tobacco, Inc.
217 Elliott Dixon Road
Ayden, NC 28513
Dear Ms. Bowen:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed your website, http://www.rsbtobacco.com, and determined that your products listed there are manufactured and 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, 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 also determined that your website, http://www.rsbtobacco.com, offers for sale cigarette tobacco and 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.” You refer to your The Good Stuff brand, which is labeled as “pipe tobacco,” as “The Good StuffTM Cigarette Tobaccos.” You also state that “In 2008, the name of [‘Blackjack’] RYO blends…changed to ‘The Good StuffTM’ to reflect the quality of the blends,” implying that the change was in name only, and, therefore, “The Good Stuff” brand is roll-your-own (aka RYO) tobacco. Additionally, you state that your Red blend tobacco is “much like the tobaccos and casings used in traditional full flavor or king style cigarettes.” Thus, the overall presentation of your The Good Stuff products, which consist of loose tobacco, suggests that they are intended for use in a cigarette or appear to be suitable for use and likely to be offered to, or purchased by, consumers as tobacco for making cigarettes and, therefore, meet the definition of “cigarette tobacco” and “roll-your-own tobacco” in the FD&C Act.
FDA has also 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 them as modified risk tobacco products without an FDA order in effect that permits such promotion. 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 products that you manufacture and promote for sale on your website, http://www.rsbtobacco.com, as being light, ultra light, and mild by referring to them as such in product labeling or advertising and adding the qualifiers “Light,” “Ultra Light,” and “Milder.” Specifically, our review of your website revealed that you manufacture and offer for sale products listed as: The Good Stuff Gold described as “Light”; The Good Stuff Silver described as “Ultra Light”; and The Good Stuff Menthol Gold described as “Light” and “Our Milder Blend.”
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,” “Ultra Light,” or “Milder” or similar descriptors for the above listed products, these products are modified risk tobacco products. Because these products are offered 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)), 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, 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, RW1300095, 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
P.O. Box 70
Ayden, NC 28513
P.O. Box 73
Farmville, NC 27828