- Delivery Method:
- VIA UPS and Electronic Mail
Recipient NameCem Cigir
- Turkish Trade LLC d/b/a Tarblock, Inc.
2036 Forest Dr
Clearwater, FL 33763
- Issuing Office:
- Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring, MD 20993
JAN 14, 2020
Dear Cem Cigir:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https://www.tarblockshop.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, 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 your Tarblock Cigarette Filters 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.
Modified Risk Tobacco Product Violations
Our review of the website https://www.tarblockshop.com revealed that you sell or distribute disposable cigarette filter products (to be used with combustible tobacco products) that are described 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 https://www.tarblockshop.com includes the following claims:
Tarblock Cigarette Filters
• "Tarblock Cigarette Filters reduce Tar & Chemicals without changing your cigarette taste."
• "Tarblock minimizes the bad effects of smoking."
• "Get rid of morning cough with Tarblock."
• "Easier breathing after a short time."
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 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)).
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/or 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. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. You can find the FD&C Act through links on FDA's homepage at http://www.fda.gov.
Please note your reference number, RW1901219, 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.
Ann Simoneau, J.D.
Office of Compliance and Enforcement
Center for Tobacco Products
VIA USPS, UPS, and Electronic Mail
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St. Petersburg, FL 33736
Attn: Filiz Angin and Zeynep Koller
9525 Blind Pass Rd. #403
Saint Petersburg, FL 33706