Smokers Unit

WARNING LETTER Smokers Unit MARCS-CMS 609386 — July 17, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA UPS and Electronic Mail Product: Tobacco Recipient: Smokers Unit 550 Montgomery Street San Francisco , CA 94111 United States sales@smokersunit.com smokersunitsales@gmail.com Issuing Office: Center for Tobacco Products United States July 17, 2020 WARNING LETTER The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed https://smokersunit.com and determined that the cigarette and waterpipe tobacco products 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 made or derived from tobacco and intended for human consumption. Certain tobacco products, including cigarettes and waterpipe tobacco, 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 cigarette 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 an artificial or natural flavor that is a characterizing flavor of the product. Additionally, FDA has determined that several cigarette 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. Finally, FDA has determined that a waterpipe tobacco product is misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)) because your website’s advertising regarding waterpipe products fails to include the required nicotine warning statement as required under 21 CFR 1143.3(b). Flavored Cigarette Violations Our review of the website https://smokersunit.com revealed that you offer for sale or distribute the following cigarette products: Bentoel Biru (clove), Djarum Black (clove), Djarum Black Cappucino [sic] (cappuccino, clove), Extreme Mild (clove), Gudang Garam Neslite Black Edition (clove), Sampoerna Avolution (clove), Winston Classic (clove), and Wismilak Diplomat (clove). These products 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. Cigarettes that are distributed or offered for sale 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 products are adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)). If, however, these cigarette 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, clove or cappuccino as a characterizing flavor of the tobacco products. Modified Risk Tobacco Product Violations FDA has determined that your cigarette 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. Our review of the website https://smokersunit.com revealed that you sell or distribute cigarette products while explicitly or implicitly representing that: (1) the products present a lower risk of tobacco-related disease or are less harmful than one or more other commercially marketed tobacco products; (2) the products or their smoke contain a reduced level of a substance or present a reduced exposure to a substance; or (3) the products or their smoke do not contain or are free of a substance. Additionally, the labeling or advertising of these cigarette products uses the descriptors “light,” or “mild.” For example, the website https://smokersunit.com includes the following claims regarding your cigarette products, such as, Bentoel Biru, Djarum Black, Gudang Garam Neslite Black Edition, Sampoerna Avolution, and Wismilak Diplomat: • “less harmful compared to other clove cigarettes” • “contain low tar” • “mild, light, and with less nicotine” • “lighter and mild on the throat” 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 modified risk tobacco product application under section 911(d) of the FD&C Act (21 U.S.C. § 387k(d)) is required to provide scientific evidence and other information to support issuance of an order 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)). A Waterpipe Tobacco Product with Advertising that Fails to Include the Required Nicotine Warning Statement is Misbranded Our review of the website https://smokersunit.com revealed that the advertising for the following waterpipe tobacco product that you sell or distribute within the United States does not include the required nicotine warning statement in the manner required by 21 C.F.R. § 1143.3(b): Afzal Apple Flavored Hookah Tobacco. Under 21 C.F.R. § 1143.3(b), advertising for cigarette tobacco, roll-your-own tobacco, and covered tobacco products (other than cigars), such as waterpipe tobacco products, must bear the following warning statement: WARNING: This product contains nicotine. Nicotine is an addictive chemical. For cigarette tobacco, roll-your-own tobacco, and covered tobacco products other than cigars, it is unlawful for any such tobacco product manufacturer, packager, importer, distributor, or retailer of the tobacco product to advertise or cause to be advertised within the United States any tobacco product unless each advertisement bears the required warning statement (21 C.F.R. § 1143.3(b)(1)). Further, the required warning statement must meet the requirements of 21 C.F.R. § 1143.3(b)(2). Under 21 C.F.R. § 1143.1, a “covered tobacco product” is defined as any tobacco product deemed to be subject to the FD&C Act under 21 C.F.R. § 1100.2, excluding components or parts not made or derived from tobacco. Before 21 C.F.R. § 1100.2 became effective, only cigarettes, smokeless tobacco, roll-your-own tobacco, and cigarette tobacco were subject to chapter IX of the FD&C Act. 21 C.F.R. § 1100.2 deems all other tobacco products, except accessories of such tobacco products, subject to chapter IX and its implementing regulations. The product cited in this violation is a “covered tobacco product.” Under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)), tobacco products are misbranded if sold or distributed in violation of regulations prescribed under section 906(d) of the FD&C Act, including those within 21 C.F.R. Part 1143. Because your website regarding waterpipe tobacco products does not include the required nicotine warning statement, in violation of 21 C.F.R. § 1143.3(b), your waterpipe tobacco product is misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C.§ 387c(a)(7)(B)). Conclusion and Requested Actions 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 address any violations of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., Chapter IX, relating to tobacco products including the tobacco regulations in 21 C.F.R. Parts 1140, 1141, and 1143, may result in FDA taking regulatory action. However, this Warning Letter does not constitute “written notice” for purposes of section 303(f)(9)(B)(i)(II) of the FD&C Act. Please note that adulterated and misbranded tobacco products offered for import into the United States are subject to detention and refusal of admission. The violations discussed in this letter do not necessarily constitute an exhaustive list. You should immediately correct any 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. 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 do not believe that your products are 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, RW2001383, 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 Electronic Mail cc: WhoisGuard, Inc. 9c9ef0ecbd18439fb1e3e72eb5c4ad70.protect@whoisguard.com NameCheap, Inc. abuse@namecheap.com Content current as of: 09/08/2020 Regulated Product(s) Tobacco