Smart Toothpicks, LLC

WARNING LETTER Smart Toothpicks, LLC MARCS-CMS 597094 — January 31, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA UPS and Electronic Mail Product: Tobacco Recipient: Recipient Name Kirk R. Hansen Smart Toothpicks, LLC 500 S. 52nd St Suite 308 Tempe , AZ 85281 United States info@smarttoothpicks.com kirkh@smarttoothpicks.com Issuing Office: Center for Tobacco Products 10903 New Hampshire Avenue Silver Spring , MD 20993 United States VIA UPS and Electronic Mail Smart Toothpicks, LLC Attn: Kirk R. Hansen 500 S. 52nd St Suite 308 Tempe, AZ 85281 info@smarttoothpicks.com kirkh@smarttoothpicks.com WARNING LETTER Dear Kirk R. Hansen: The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https://www.smarttoothpicks.com and determined that the dissolvable tobacco products listed there are manufactured and 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 made or derived from tobacco and intended for human consumption.  Certain tobacco products, including dissolvable tobacco products such as nicotine infused toothpicks, 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 dissolvable tobacco products, Peppermint Ice Nicotine Toothpicks, are misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)) because you sold this product to a person younger than 18 years of age. FDA has also determined that several nicotine infused toothpicks 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. Additionally, FDA has determined that several dissolvable tobacco products manufactured, advertised, and offered for sale or distribution on your website are misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)) because both (1) the product package for the Peppermint Ice Nicotine Toothpicks and (2) your website advertising several dissolvable tobacco products fails to include the required nicotine warning statement. Sales to Minors Violation FDA’s investigation of the website https://www.smarttoothpicks.com revealed that you sold dissolvable tobacco products to a minor. Specifically, during our investigation of https://www.smarttoothpicks.com , a person younger than 18 years of age purchased Peppermint Ice Nicotine Toothpicks from your website. No retailer may sell covered tobacco products, including e-liquid, cigar, pipe tobacco, waterpipe tobacco, and electronic nicotine delivery system (ENDS) products, as well as dissolvable tobacco products, including nicotine infused toothpicks, that contain any tobacco derivative, to a person younger than 18 years of age under 21 C.F.R. § 1140.14(b). Under 21 C.F.R. § 1140.3, a “covered tobacco product” is defined as any tobacco product deemed to be subject to chapter IX of the FD&C Act by 21 C.F.R. § 1100.2, excluding components or parts not made or derived from tobacco. 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 1140. Because this product is sold or distributed to persons younger than 18 years of age in violation of 21 C.F.R. § 1140.14(b), this product is misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)). Modified Risk Tobacco Product Violations Additionally, our review of your website https://www.smarttoothpicks.com revealed that you sell or distribute dissolvable tobacco products the labeling and/or advertising of which represents explicitly and/or implicitly that the products present a lower risk of tobacco-related disease or are less harmful than one or more other commercially marketed tobacco products and/or does not contain or is free of a substance.  For example, your website https://www.smarttoothpicks.com revealed that you sell or distribute dissolvable tobacco products with the following claim: “Nicotine Satisfaction without smoke damage to your lungs” 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 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)). The labeling and/or advertising for your dissolvable tobacco products, which uses the claim above, represents explicitly and/or implicitly that these products present a lower risk of tobacco-related disease or are less harmful than one or more other commercially marketed tobacco products and/or does not contain or is free of a substance. As such, these products are modified risk tobacco products. 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)). Dissolvable Tobacco Product with Packaging that Fails to Include the Required Nicotine Warning Statement is Misbranded FDA’s investigation of the website https://www.smarttoothpicks.com r evealed that the package for a dissolvable tobacco product that you manufacture, package, sell, offer to sell, distribute, and/or import for sale or distribution into the United States does not include the nicotine warning statement required by 21 C.F.R. § 1143.3(a), specifically Peppermint Ice Nicotine Toothpicks. Under 21 C.F.R. § 1143.3(a), packages for cigarette tobacco, roll-your-own tobacco, and covered tobacco products (other than cigars), such as dissolvable 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 person to manufacture, package, sell, offer to sell, distribute, or import for sale or distribution in the United States such product unless such tobacco product package bears the required warning statement on the package label (21 C.F.R. § 1143.3(a)(1)). Further, the required warning statement must meet the requirements of 21 C.F.R. § 1143.3(a)(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. 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 dissolvable tobacco product does not include the required nicotine warning statement on the package, in violation of 21 C.F.R. § 1143.3(a), your dissolvable tobacco product is misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)). Dissolvable Tobacco Products with Advertising that Fails to Include the Required Nicotine Warning Statement are Misbranded Additionally, our review of the website https://www.smarttoothpicks.com revealed that the advertising for several dissolvable tobacco products that you manufacture, package, import, distribute or retail in the United States does not include the nicotine warning statement required by 21 C.F.R. § 1143.3(b), for example: Peppermint Ice Nicotine Toothpicks, Cinnamon Nicotine Toothpicks, and Wintergreen Nicotine Toothpicks. 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 dissolvable 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 a 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). As described above, the products cited in this violation are “covered tobacco products.” 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 dissolvable tobacco products does not include the required nicotine warning statement for these products, in violation of 21 C.F.R. § 1143.3(b), your dissolvable tobacco products are misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)). Conclusion and Requested Actions The violations discussed in this letter do not necessarily constitute an exhaustive list.  You should immediately correct the 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. 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 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, RW1901220 , 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: Smart Toothpicks, LLC Attn: Kirk R. Hansen 1111 E. Redmon Dr. Tempe, AZ 85283 Smart Toothpicks, LLC Attn: Greg Johnson gregj@smarttoothpicks.com GoDaddy.com, LLC abuse@godaddy.com Domains By Proxy, LLC Smarttoothpicks.com@domainsbyproxy.com Content current as of: 01/31/2020 Regulated Product(s) Tobacco