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WARNING LETTER

www.primewholesale.com


Recipient:
www.primewholesale.com


United States

Issuing Office:
Center for Tobacco Products

United States


  

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

Food and Drug Administration
 
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring, MD 20993 

 

AUG 13, 2014 

VIA UPS and Electronic Mail
 
Eugene Braverman
PrimeWholesale.com
502 Kellywood Manor
New Kensington, PA  15068
sales@primewholesale.com
admin@primewholesale.com
                                   
 
 
WARNING LETTER
 
Dear Mr. Braverman,
 
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed your website, http://www.primewholesale.com, and determined that your cigarette tobacco and roll-your-own tobacco products listed there are distributed 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 your website, http://www.primewholesale.com, offers for sale cigarette tobacco and 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” (RYO) 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, http://www.primewholesale.com, you present loose tobacco products containing the package description “pipe tobacco” but that are promoted and offered for sale as cigarette tobacco and/or roll-your-own tobacco, including Golden Harvest and OHM. The overall presentation of these products on your website strongly suggests that they are intended for use in a cigarette, likely to be offered to consumers for making cigarettes, and/or likely to be purchased by consumers for making cigarettes. Specifically, you sell and promote loose tobacco products, which appear under the “Pipe Tobacco > Light/Mild” section heading of your website, as “multi-use tobacco” or “dual purpose tobacco.” For example, the following loose tobacco product brands are sold and promoted for multi-use or dual purpose: Golden Harvest (described as “This multi-use genesis ingredient of both cigars and cigarettes is a less expensive solution to your smoking needs” and a “New multi-use tobacco line”) and OHM (described as “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”). Therefore, your products meet the definition of “cigarette tobacco” and/or “roll-your-own tobacco” in the FD&C Act.
 
FDA has determined  that several of your cigarette tobacco and/or RYO tobacco products 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. Additionally, FDA has determined that several of your cigarette tobacco and/or RYO tobacco 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)) because they purport to contain a natural or artificial characterizing flavor. 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 cigarette tobacco and/or RYO tobacco products that you describe on your website, http://www.primewholesale.com, as being light or mild by referring to them as such in product labeling or advertising and adding the qualifiers “Light” or “Mild” to the product names. Specifically, our review of your website revealed that you sell or distribute cigarette tobacco and RYO tobacco products listed as: OHM Mild.  Additionally, your website sells the following cigarette tobacco and RYO tobacco products under a filter labeled “Light/Mild”: Golden Harvest Silver, OHM Blue, OHM Blue (OHM Mild), OHM Gold Mint, and OHM Silver.
 
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 “Mild,” or similar descriptors for the above listed products, 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)).
 
Flavored Cigarette Violations
 
Additionally,our review of your website, http://www.primewholesale.com, revealed that you offer for sale the following cigarette tobacco and/or RYO products: OHM Mint, OHM Mild Mint, Golden Harvest Mint, and OHM Gold Mint, which are purported to contain an artificial or natural flavor that is a characterizing flavor of the products. 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.
 
These requirements apply to cigarettes and cigarette tobacco, which includes roll-your-own tobacco and any other loose tobacco intended to be used in cigarettes or as roll-your-own tobacco. See sections 900(3), 900(4), 907(a)(1)(A) of the FD&C Act; (21 U.S.C. § 387(3); 21 U.S.C. § 387(4); 21 U.S.C. § 387g(a)(1)(A)). As of September 22, 2009, cigarettes, cigarette tobacco, and roll-your-own tobacco marketed and sold in the United States in violation of this provision are adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)). Thus, your flavored cigarette tobacco and/or roll-your-own tobacco products are adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)).
 
If, however, these cigarette tobacco and/or RYO tobacco products do not contain a characterizing flavor, they are 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 their 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, on any other websites (including e-commerce, social networking, or search engine websites), and in any other media, 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, RW1400187, 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
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.   
 
 
Sincerely,
/S/
 
Ann Simoneau, J.D.
Director
Office of Compliance and Enforcement
Center for Tobacco Products
 
VIAUPS and Electronic Mail
 
cc:
 
Eugene Braverman
primewholesale@atrubka.com
 
GoDaddy.com, LLC
abuse@godaddy.com
 
CariNet Networking
complaints@cari.net