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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Tobacco Source Three LLC 2/1/12

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 

Silver Spring MD 20993 


VIA UPS


To: Michael K. McBride
4542 N. University Dr.
Lauderhill, FL 33351


FEB 1 2012


WARNING LETTER


Dear Mr. McBride:


The Center for Tobacco Products (CTP) at the Food and Drug Administration (FDA) reviewed your advertisement displayed on the website http://www.valpak.com promoting cigarettes for sale to U.S. customers at your Tobacco Source retail establishments. 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 cigarettes, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387(b)).


FDA has determined that your cigarettes 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. Additionally, FDA has determined that your cigarettes are misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)), in that they are sold or distributed in violation of 21 C.F.R. Part 1140. You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov.


Your advertisement on the website http://www.valpak.com for cigarettes, which offered for sale to U.S. customers cigarettes at two of your Tobacco Source retail locations, contains the statements, "LOW PRICE AND CHEMICAL FREE ... JUST LIKE THE GOOD OL’ DAYS," "We are a chemical free tobacco store," and "CHEMICAL FREE TOBACCO." A tobacco product with a label, labeling, or advertising that explicitly or implicitly represents such product as not containing or being free of a substance is a "modified risk tobacco product" under section 911(b)(2)(A)(i) of the FD&C Act (21 U.S.C. § 387k(b)(2)). 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 advertisement includes claims that your cigarettes do not contain or are free of a substance, your products are modified risk tobacco products. Because your products are offered for sale to U.S. customers without an FDA order in effect under section 911(g) of the FD&C Act (21 U.S.C. § 387k(g)), these products as advertised are adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)).


Additionally, our review of your advertisement revealed that you offer "FREE CIGARETTE CASE AND LIGHTER WITH THE PURCHASE OF 2 BOXES (200 COUNT) HOUSE BLEND EXCLUDED." Your offer for a free cigarette case and lighter with the purchase of cigarettes is a violation of 21 C.F.R. § 1140.34(b). Offering or causing to be offered a gift or item other than cigarettes or smokeless tobacco to any person purchasing cigarettes or smokeless tobacco products in consideration of such purchase, or in consideration of furnishing evidence such as credits, proofs-of-purchase, or coupons of such a purchase is a violation of 21 C.F.R. § 1140.34(b). Therefore, your tobacco products are misbranded within the meaning of section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)).


You should immediately correct the violations stated above and take any necessary actions to bring your tobacco products into compliance with the FD&C Act. We have noticed that the advertisement no longer appears on the website http://www.valpak.com. If this change is permanent, then it would correct the violations discussed above. The violations discussed in this letter, however, do not necessarily constitute an exhaustive list, and it is your responsibility to ensure that all of your tobacco products, promotional materials, and marketing activities comply with the applicable provisions of the FD&C Act and its 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, seizure, injunction, and/or criminal prosecution.


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.


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 Ibarra-Pratt at (301) 796-9235 or via email at Elenita.IbarraPratt@fda.hhs.gov.


Sincerely,

/S/
Ann Simoneau, J.D.
Director
Office of compliance and Enforcement
Center for Tobacco Products