Nixteria, Crafted by JuicyVapor, LLC

WARNING LETTER Nixteria, Crafted by JuicyVapor, LLC MARCS-CMS 609142 — August 10, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA UPS and Electronic Mail Product: Tobacco Recipient: Recipient Name Brad McNamara Nixteria, Crafted by JuicyVapor, LLC 2468 Niagara Falls Boulevard Suite 5 Tonawanda , NY 14150 United States brad@juicyvapor.com store@nixteria.com Issuing Office: Center for Tobacco Products United States August 10, 2020 WARNING LETTER Dear Brad McNamara: The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https://nixteria.com and determined that an e-liquid product listed there is 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)), this product is a tobacco products because it is made or derived from tobacco and intended for human consumption. Certain tobacco products, including e-liquids, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)) and 21 C.F.R. § 1100.1. Therefore, e-liquids are required to be in compliance with the requirements in the FD&C Act. Please be aware that, effective August 8, 2016, FDA deemed additional products meeting the definition of a tobacco product, except accessories to these newly deemed products, to be subject to regulation under the Act. These products include, but are not limited to, electronic nicotine delivery systems (ENDS) (including e-cigarettes), e-liquids, cigars, and pipe tobacco. See Final Rule, Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products, 81 Fed. Reg. 28,974 (May 10, 2016), available at https://federalregister.gov/a/2016-10685 . The FD&C Act requires “new tobacco products” to have premarket authorization. A “new tobacco product” is any tobacco product that was not commercially marketed in the United States as of February 15, 2007, or any modified tobacco product that was commercially marketed after February 15, 2007 (section 910(a) of the FD&C Act; 21 U.S.C. § 387j(a)). Generally, a marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act (21 U.S.C. § 387j(c)(1)(A)(i)) is required for a new tobacco product unless (1) the manufacturer of the product submitted a report under section 905(j) of the FD&C Act (21 U.S.C. § 387e(j)) and FDA issues an order finding the product substantially equivalent to a predicate tobacco product (section 910(a)(2)(A) of the FD&C Act) or (2) the manufacturer submitted a report under section 905(j)(1)(A)(ii) of the FD&C Act (21 U.S.C. § 387e(j)(1)(A)(ii)) and all modifications are covered by exemptions from the requirements of substantial equivalence granted by FDA under section 905(j)(3) of the FD&C Act (21 U.S.C. § 387e(j)(3)). New Tobacco Product Without Required Marketing Authorization is Adulterated and Misbranded Our review of the website https://nixteria.com revealed that you manufacture and offer for sale or distribution to customers in the United States the following e-liquid product without a marketing authorization order: Mocking Bird e-liquid. The e-liquid product listed above is a new tobacco product because it was not commercially marketed in the United States as of February 15, 2007. This product does not have FDA marketing authorization orders in effect under section 910(c)(1)(A)(i) of the FD&C Act and is not otherwise exempt from the marketing authorization requirement. Therefore, this product is adulterated under section 902(6)(A) of the FD&C Act. In addition, it is misbranded under section 903(a)(6) of the FD&C Act because a notice or other information respecting this product was not provided as required by section 905(j) of the FD&C Act. Additional Considerations FDA finds your product design for Mocking Bird e-liquid product particularly concerning because it appears to use a youth-appealing logo that is typically marketed toward and/or appealing to children. Specifically, the packaging for this e-liquid product features a graphic (see Exhibit A) that looks very similar to The Hunger Games Mockingjay logo (see Exhibit B), which is commonly marketed toward and/or appeals to children. FDA is concerned about the rising youth appeal and dramatic rise in youth use of ENDS products, including e-liquids. Any efforts to entice minors to use tobacco products are of concern to FDA. Sales of such products to minors are prohibited, and FDA is concerned that your actions likely encourage unlawful sales, maintain or increase youth use, and contribute to the public health and safety concerns associated with ENDS products. Conclusion and Requested Actions The violation discussed in this letter does not necessarily constitute an exhaustive list. You should promptly 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 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 initiating action, including, but not limited to, civil money penalties, seizure, and/or injunction. 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/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 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, RW2001382, 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, USPS, and UPS cc: Nixteria Corp. P.O. Box 1037 Buffalo, New York 14226 corporate@nixteria.com wholesale@nixteria.com Juicy Vapor, LLC Attn: Brad McNamara 37 John Glenn Drive, Amherst, New York 14228 Juicy Vapor, LLC d/b/a Nixteria 188 Creekside Dr, Amherst, NY 14228-2031 Corporation Service Company 80 State St. Albany, New York, 12207 Wild West Domains, LLC abuse@wildwestdomains.com Google LLC google-cloud-compliance@google.com Content current as of: 08/18/2020 Regulated Product(s) Tobacco