Soniceast LLC

WARNING LETTER Soniceast LLC MARCS-CMS 596919 — January 14, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA UPS and Electronic Mail Product: Tobacco Recipient: Recipient Name Aysegul Bidav Soniceast LLC 38 Silleck St Clifton , NJ 07013 United States info@nicstopfilters.com info@tartrapfilters.com Issuing Office: Center for Tobacco Products 10903 New Hampshire Avenue Silver Spring , MD 20993 United States JAN 14, 2020 WARNING LETTER Dear Aysegul Bidav: The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the websites https://www.nicstopfilters.com and https://www.tartrapfilters.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 NicStop Cigarette Filter products and TarTrap Cigarette Filter 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. Modified Risk Tobacco Product Violations Our review of the websites https://www.nicstopfilters.com and https://www.tartrapfilters.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 websites https://www.nicstopfilters.com and https://www.tartrapfilters.com and/or product labels include the following claims: NicStop Cigarette Filters • "NICSTOP Cigarette Filters actively removes tar and nicotine without changing the taste of your cigarettes [sic]." • "NICSTOP® cigarette filters trap up to 90% of the tar and nicotine in cigarettes without changing it's taste [sic] ." • "Less Tar & Nicotine Same Taste" • "You don't have to inhale all the hazardous tar & nicotine any longer." • "Our filters will allow you to breath and taste better in little as an month of use [sic]." • "This small and simple life saving device, provides intensive cigarette smoke purification [sic]." • "Breathe easier. Help save your lungs and life." • "Helps to reduce your [m]orning coughs when used regularly." TarTrap Cigarette Filters • "TarTrap Cigarette Filters actively reduces tar and nicotine without changing the taste of your cigarette [sic]." • "TarTrap cigarette filters reduce the intake of TAR & NICOTINE." • "TarTrap cigarette filters reduce up to 90% of the tar and nicotine in cigarettes without changing it's taste [sic]." • "TarTrap reduces most of the tar and nicotine in the cigarette smoke while you can still enjoy the full, unchanged flavor of your favorite cigarettes!" • "TarTrap filters help reduce the tar by up to 90% and many smokers love it because the taste of the cigarette does not change! [emphasis in original]" • "This small and simple life saving device, provides intensive cigarette smoke purification [sic]." • "We use the most effective, multi stage, mechanical method cigarette smoke purification that drastically reduces tar, nicotine and other hazards from smoking cigarettes without altering the taste of your cigarette." • "Technologically advanced disposable cigarette filter that helps reduce smoking hazards!" • "Reduces up to 90% of tar from entering for lungs [sic]." • "Our filters will allow you to breath and taste better in little as an month of use [sic]." • "Regular use of TARTRAP Cigarette Filters reduce coughing, shortness of breath and relieves sore throa t [sic]. [emphasis in original]" • "Reduces coughing and shortness of breath" • "Breathe easier" 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 websites and/or product labels describe them as presenting a lower risk of tobacco-related disease, 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 these websites, 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, RW1901216, 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: Soniceast LLC 83 Knickerbocker Ave Paterson, NJ 07503 Soniceast Ltd 41 Watchung Plz, Ste 387 Montclair, NJ 07042 Tartrap filters 791 Paulison Ave unit 5 Clifton, NJ 07011 Domains By Proxy, LLC NICSTOPFILTERS.COM@domainsbyproxy.com Godaddy.com, LLC abuse@godaddy.com Cloudflare, Inc. noc@cloudflare.com WEBSITEWELCOME.COM ipadmin@websitewelcome.com Content current as of: 03/31/2020 Regulated Product(s) Tobacco