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WARNING LETTER

Nova Distributors, LLC MARCS-CMS 539670 —

Delivery Method:
VIA UPS and Electronic Mail
Recipient:
Recipient Name
Donald E. Bruch
Nova Distributors, LLC

One Nova Way
R.R. 1 Box 52
Golden Eagle, IL 62036
United States

Issuing Office:
Center for Tobacco Products

United States

  

Department of Health and Human Services logo

 
 
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring, MD 20993 

 

NOV 17, 2017
VIA UPS and Electronic Mail
 
Donald E. Bruch
Nova Distributors
One Nova Way
R.R. 1 Box 52
Golden Eagle, IL 62036
info@tarbarfilter.com
 
 
WARNING LETTER
 
Dear Mr. Bruch:
 
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website http://www.tarbarfilter.com and determined that the disposable cigarette filters listed there are offered for sale or distribution to customers in the United States. 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 components or parts of products made or derived from tobacco and intended for human consumption. Certain tobacco products, including disposable cigarette filters, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)). 
 
FDA has determined that several disposable cigarette filter products areadulterated 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.
 
Modified Risk Tobacco Product Violations
 
Our review of the website http://www.tarbarfilter.com revealed that you sell or distribute disposable cigarette filter products that aredescribed as presenting a lower risk of tobacco-related disease, being less harmful than one or more other commercially marketed tobacco products, or having a reduced level of/exposure to a substance.  Specifically, the website http://www.tarbarfilter.com includes the following claims:
 
TarBar
  • "The objective of TARBAR is to provide a product to the smoker that removes, tar, nicotine, ect. [sic],"
  • "TARBAR removes a significant amount of damaging impurities,"
  • “Scientific research performed in the United States indicates an average tar removal of 33 percent and nicotine removal of 19 percent,”
  • “The new TARBAR with 6 ports almost doubles the tar removal,”
  • "The visual stimulation along with the mental awareness that the filter is a roughly two-thirds barrier, meaning that one-third of the same materials are still entering the body, is a powerful deterrent,"
  • “TARBAR filters are small clear disposable filters that utilize the Venturi principle of drawing the smoke through pinpoint openings at high velocity. This process causes the heavy particles, tar and nicotine, to be separated and adhere to the inside filter wall. The percentage of tar removed varies, but is clearly visible to the user by simply looking at the filter,”
  • “The smoker will normally breathe better in 7-14 days,”
  • “Reduces Tar-Nicotine and other harmful chemicals,”
  • “Reduces the yellow staining of teeth and lessons [sic] damage to the gums, providing whiter teeth,”
  • “Reduces tar, nicotine and other harmful chemicals from entering your lungs,”
  • “Lessens damage to gums,” 
TarBar II
  • “Reduces Tar and other harmful substances,”
  • “After one week you will feel the benefit of easier breathing.”
A tobacco product is considered a “modified risk tobacco product” under section 911(b)(2)(A)(i) of the FD&C Act (21 U.S.C. § 387k(b)(2)(A)(i)) if its label, labeling, or advertising explicitly or implicitly represents that:(1) the product presents a lower risk of tobacco-related disease or is less harmful than one or more other commercially marketed tobacco products; (2) the product or its smoke contains a reduced level of a substance or presents a reduced exposure to a substance; or (3) the product or its smoke does not contain or is free of a substance. 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)). 
 
The above listed products are modified risk tobacco products because the website describes them as presenting a lower risk of tobacco-related disease or being less harmful than one or more other commercially marketed tobacco products and containing a reduced level of a substance or presenting a reduced exposure to a substance. Because these products aresold 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)).
 
Conclusion and Requested Actions
 
The violation discussed in this letter does not necessarily constitute an exhaustive list. You should immediately correct the violation that is referenced above, as well as violations that are the same as or similar to the one 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 labeling and/or advertising on this website, on any other websites (including e-commerce, social networking, or search engine websites), and in any other 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 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 labeling, advertising, sale, and/or distribution of these tobacco products and your plan for maintaining compliance with the FD&C Act. You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov.
 
Please note your reference number, RW1700807, in your response and direct your response to the following address:
 
DPAL-WL Response, Office of Compliance and Enforcement
FDA Center for Tobacco Products
c/o 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
 
 
VIA UPS and Electronic Mail
 
cc:
 
Susan Bruch
Tom Bruch
Nova Distributors
One Nova Way
R.R. 1 Box 52
Golden Eagle, IL 62036
info@tarbarfilter.com
 
Privacy Protect, LLC
d/b/a PrivacyProtect.org
contact@privacyprotect.org
 
WebsiteWelcome.com
abuse@websitewelcome.com
 
Hostgator.com
abuse@hostgator.com
 
 

 

 
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