Vapor Galleria

WARNING LETTER Vapor Galleria MARCS-CMS 635809 — June 17, 2022 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA UPS and Electronic Mail Product: Tobacco Recipient: Recipient Name Gary McBurney Vapor Galleria 2724 East Carson Street Pittsburgh , PA 15203 United States Gmcburney@vaporgalleria.com Issuing Office: Center for Tobacco Products United States June 17, 2022 WARNING LETTER Dear Gary McBurney: The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https://www.vgvapor.com and determined that the e-liquid 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)), these products are tobacco products because they are made or derived from tobacco and intended for human consumption. Certain tobacco products, including e-liquid products, 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-liquid products 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 FD&C Act. These products include, but are not limited to, ENDS (including e-cigarettes and 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 . Generally, to be legally marketed in the United States, the FD&C Act requires “new tobacco products” to have a premarket authorization order in effect. 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://www.vgvapor.com revealed that you manufacture and offer for sale or distribution to customers in the United States an e-liquid product without a marketing authorization order including: Cotton Candy 60mL. 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 an FDA marketing authorization order 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, this product 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. Conclusion and Requested Actions All new tobacco products on the market without the statutorily required premarket authorization are marketed unlawfully and are subject to enforcement action at FDA’s discretion. Products for which no application is pending, including, for example, those with a Marketing Denial Order and those for which no application was submitted, are among our highest enforcement priorities. For information on how FDA intends to prioritize enforcement resources with regard to the marketing of certain adulterated and misbranded ENDS and other deemed new tobacco products, please refer to the FDA’s guidance titled Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Products on the Market Without Premarket Authorization, available at https://www.fda.gov/regulatory-information/search-fda-guidancedocuments/enforcement-priorities-electronic-nicotine-delivery-system-ends-and-other-deemed-products-market . It is your responsibility to ensure that all of 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), in any other media in which you advertise, and in any retail establishments comply with each applicable provision of the FD&C Act and FDA’s implementing regulations. Failure to address any violations of the FD&C 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 lead to regulatory 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 tobacco products offered for import into the United States that appear to be adulterated or misbranded may be detained or refused admission. The violations discussed in this letter do not necessarily constitute an exhaustive list. You should address any violations that are referenced above, as well as violations that are the same as or similar to those stated above, and promptly 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 actions to address any violations and bring your products into compliance, 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. This letter notifies you of our findings and provides you with an opportunity to address them. You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov. Please note your reference number, RW2201779, in your response and direct your response via email at CTPCompliance@fda.hhs.gov and 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 Bryan Hills at (301) 796-9367 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: Vapor Galleria Corporate Office 3901 Arlington Highlands Blvd STE 200 Arlington, TX 76018 Vapor Galleria - Tarrant 5636 N Tarrant Pkwy Fort Worth, TX 76244 Vapor Galleria - Euless 1301 W Glade Rd Euless, TX 76039 Vapor Galleria - South Loop 3256 South Loop W Houston, TX 77025 Vapor Galleria - Frankford 4727 Frankford Rd Dallas, TX 75287 Vapor Galleria – Camp Wisdom 3040 W Camp Wisdom Rd Grand Praire, TX 75052 Vapor Galleria - Allentown 4672 Broadway Allentown, PA 18104 Vapor Galleria - Tyler TX 1400 W Southwest Loop 323 Tyler, TX 75701 GoDaddy.com, LLC abuse@godaddy.com Amazon Technologies Inc. abuse@amazaonaws.com Content current as of: 06/28/2022 Regulated Product(s) Tobacco