Inspections, Compliance, Enforcement, and Criminal Investigations
FairPrice Tobacco, Inc d/b/a www. RYOCigarette.com 5/24/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Center for Tobacco Products|
9200 Corporate Boulevard
Rockville, MD 20850-3229
MAY 24, 2012
FairPrice Tobacco, Inc
724 W. Algonquin Road
Arlington Heights, IL 60008
Dear Mr. Patel:
The Center for Tobacco Products (CTP) at the Food and Drug Administration (FDA) recently reviewed the websites www. RYOCigarette.com and www.QWAAQ.com- which are both owned by FairPrice Tobacco, Inc, and are identical in their content- and determined that cigarette tobacco listed there is being offered for sale to U.S. consumers. Under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (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. § 387(b)). You can find the FD&C Act and Tobacco Control Act through links on FDA's homepage at http://www.fda.gov.
FDA has determined that both of your websites, www.RYOCigarette.com and www.QWAAQ.com, offer for sale cigarette tobacco, which consists of loose tobacco intended for use by consumers in a cigarette. The "Rolling Tobacco" sections of these websites contain the following statement, among others:
Due to Federal Regulation, cigarette tobacco & rolling tobacco can no longer be purchased or sold online. What is now being offered is a multi-purpose pipe tobacco. This dual purpose tobacco is a highly recommended low-cost alternative to the standard cigarette tobacco. "Dual Purpose Tobacco" is also called "Alternative Tobacco" and "Pipe Cut Tobacco." "Pipe-cut" pipe tobacco is the same as cigarette tobacco, with exception to the leaf being cut a little wider. Dual purpose pipe-cut tobacco is a dry tobacco works well with all of our cigarette machines and cigarette tubes.
Please visit our TOBACCO section to order quality Dual-Purpose 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" and also states that, "[u]nless otherwise stated, the requirements applicable to cigarettes ... shall apply to cigarette tobacco." The "Dual Purpose Tobacco" products observed within your sites' "Tobacco" section are collectively described as, among other things, an " ... alternative to the standard cigarette tobacco" and "the same as cigarette tobacco" except for a change in leaf size. They are also advertised to work well with cigarette machines and cigarette tubes. Therefore, these products meet the FD&C Act's definition of "cigarette tobacco."
FDA has also determined that your "Dual Purpose Tobacco" products "OHM"; "Kentucky Select"; "Criss Cross"; and "4 Aces" 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.
Within the "Tobacco" section of your sites, you describe several products that you offer for sale on both www.RYOCigarette.com and www.QWAAQ.com as being "light" or "mild" by adding the qualifiers "Light", "Mild", or "Extra Mild" to the product names. Specifically, our review of your websites revealed that you offer for sale products listed as "OHM Tobacco 1 lb Bag (Silver/Extra Mild)"; "OHM Tobacco 1 lb Bag (Blue/Mild)"; "OHM Tobacco 1 lb Bag (Gold Mint/Mild Mint)", which are further described as "Ultra Light", "Light", and "Menthol Light", respectively. The sites also offer "Kentucky Select Tobacco 11b.- Mild (Gold)", which is further described as "Light". In addition, the description of "Criss Cross Tobacco Bags" includes the statement: "Criss Cross Tobacco is available in three blends: Original, Smooth, Mint- Full Flavor, Light, and Menthol."; and the description of "4 Aces Gambler Tobacco Bags" includes the statement: "4-Aces Gambler Tobacco is available in three blends: Regular, Mellow and Mint- Full Flavor, Mild, and Menthol."
Cigarettes, cigarette tobacco, and/or smokeless tobacco with labels, labeling, or advertising that uses the descriptor "light," "mild," or "low," or a similar descriptor, are "modified risk tobacco products" under section 911(b)(2)(A)(ii) of the FD&C Act (21 U.S.C. § 387k(b)(2)(A)(ii)). A retailer must NOT sell a modified risk tobacco product unless there is an FDA order permitting that product to be sold. Doing so violates section 911(a) of the FD&C Act (21 U.S.C. § 387k(a)). There is no FDA order permitting the sale of the above-listed products offered for sale on your websites. Therefore, the products are adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)).
You should immediately correct the violation[s] listed above. Failure to correct the violation[s] may result in FDA taking regulatory action without further notice. These actions may include, but are 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.
The violation[s] indicated in this letter may not be a complete list of violations on your websites. It is your responsibility to ensure that your tobacco products on this website, any other websites you own, or any of your retail establishment(s) that sell FDA regulated tobacco products comply with all the applicable laws and regulations. For more information on these requirements, helpful resources for retailers, a database of inspections, and free Break the Chain of Tobacco Addiction materials, visit our website at http://www.fda.gov/TobaccoProducts.
You have 15 working days from the date you receive this letter to respond. In your response, explain your plan for correcting the listed violation[s] and preventing future violations. Include a telephone number and address.
Please 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 lbarra-Pratt at (301) 796-9235.
Ann Simoneau, J.D.
Office of Compliance and Enforcement
Center for Tobacco Products
VIA UPS, Fax, and Electronic Mail
1643 Algonquin Road
Rolling Meadows, IL 60008
3315 Algonquin Road Suite 202
Rolling Meadows, IL 60008
701 First Avenue
Sunnyvale, CA 94089