East Coast Vapors, LLC d/b/a VapeScorpion.com

WARNING LETTER East Coast Vapors, LLC d/b/a VapeScorpion.com MARCS-CMS 609573 — July 24, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA UPS and Electronic Mail Product: Tobacco Recipient: Recipient Name Michael Piker East Coast Vapors, LLC d/b/a VapeScorpion.com 10859 Bustleton Avenue Philadelphia , PA 19116 United States jenshimberg@gmail.com vapescorpion@gmail.com Issuing Office: Center for Tobacco Products United States July 24, 2020 WARNING LETTER Dear Michael Piker: The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https://vapescorpion.com and determined that the e-liquid products listed there are advertised 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 e-liquids, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)). FDA has determined that an e-liquid 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 advertising an e-liquid product fails to include the required nicotine warning statement. E-Liquid Product with Advertising that Fails to Include the Required Nicotine Warning Statement is Misbranded Our review of the website https://vapescorpion.com revealed that the advertising for an e-liquid product that you sell, offer for sale or distribute in the United States does not include the required nicotine warning statement in the manner required by 21 CFR 1143.3(b), for example: Heisenberg (THEBERG). 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 e-liquid 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). 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 an e-liquid product does not include the required nicotine warning statement for this product, in violation of 21 C.F.R. § 1143.3(b), your e-liquid 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), 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 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. Please note that adulterated and misbranded tobacco products offered for import into the United States are subject to detention and refusal of admission. The violation discussed in this letter does not necessarily constitute an exhaustive list. You should promptly correct any violations that are 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. 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, RW2001384, 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: VapeScorpion.com Attn: Michael Piker 6557 Senator Lane Bensalem, PA 19020 GoDaddy.com, LLC abuse@godaddy.com Google, LLC google-cloud-compliance@google.com Content current as of: 08/18/2020 Regulated Product(s) Tobacco