Ashlynn Marketing Group, Inc

WARNING LETTER Ashlynn Marketing Group, Inc MARCS-CMS 557715 — July 26, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Recipient Name Wasem Saliman Ashlynn Marketing Group, Inc 10870 Hartley Road, Ste. B Santee , CA 92071 United States Issuing Office: Center for Tobacco Products United States Center for Tobacco Products 10903 New Hampshire Avenue Silver Spring, MD 20993 VIA UPS and Electronic Mail JUL 26, 2018 Wasem Saliman Ashlynn Marketing Group, Inc. d/b/a Imperial Smoke 10870 Hartley Road, Ste. B Santee, CA 92071 wes@imperialcigs.com saliman@cox.net WARNING LETTER Dear Wasem Saliman: The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website FD&C Act http://imperialcigs.com and determined that the disposable hookah 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 ( ) (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 hookah 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 the Imperial Hookah Filter product isadulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)) because it is a modified risk tobacco product 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://imperialcigs.com revealed that you sell or distribute a disposable hookah filter product (to be used with combustible hookah tobacco) that isdescribed 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://imperialcigs.com includes the following claim: Imperial Hookah Filter “Reduces Tar and Nicotine” 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 product is a modified risk tobacco product because the website describes it 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 this product issold 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)), this product is 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. 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, RW1800911, 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: Ashlynn Marketing Group, Inc/Poway Distribution 124 W Main Street, Suite 210 El Cajon, CA 92020 GoDaddy.com, LLC abuse@godaddy.com Unified Layer abuse@unifiedlayer.com Content current as of: 08/21/2018