Pretty Women UK LTD T/A Coil2oil and Mad Kingdom Liquids

WARNING LETTER Pretty Women UK LTD T/A Coil2oil and Mad Kingdom Liquids MARCS-CMS 610060 — September 09, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Product: Tobacco Recipient: Recipient Name Jagmeet Singh Pretty Women UK LTD T/A Coil2oil and Mad Kingdom Liquids United Kingdom vape247store@gmail.com coil2oil@outlook.com info@oil2coil.co.uk Issuing Office: Center for Tobacco Products United States WARNING LETTER Dear Jagmeet Singh: The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https://coil2oil.co.uk and the Instagram account https://www.instagram.com/mad.kingdom/ and determined that the electronic nicotine delivery system (ENDS) 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)), these products are tobacco products because they are made or derived from tobacco and intended for human consumption.  Certain tobacco products, including ENDS, 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, ENDS 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 . 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 und e r sec t ion 905(j ) ( 1 )(A )(i i ) 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://coil2oil.co.uk revealed that you offer for sale or distribution to customers in the United States the following ENDS product without a marketing authorization order, for example: Ice Menthol 50ml Shortfill by Mad King. The ENDS 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, 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. Modified Risk Tobacco Product Violations FDA has determined that your ENDS 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://coil2oil.co.uk and the Instagram account https://www.instagram.com/mad.kingdom/ revealed that you sell or distribute ENDS products, the label, labeling, or advertising of which represents explicitly or implicitly that: (1) the products present a lower risk of tobacco-related disease or is 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. For example, the website https://coil2oil.co.uk and Instagram Account https://www.instagram.com/mad.kingdom/ include the following claims regarding your ENDS products: “Mad Kingdom Smoking Kills Vaping Can Save Your Life . . .  Shop At > > > Coil2Oil.Co.Uk” “The vape device works by heating a liquid which is made of nicotine, propylene glycol, or vegetable glycerine and different flavourings. . . . This vapour is safer than the smoke because smoke is made by burning tobacco but vapor is made by heating E-liquid. . . . Premium E-liquids from Uk, USA, and Malaysian top Brands are available at Coil2Oil with so many flavors to choose from . . . .” ( emphasis in the original ) “Vaping devices have been designed by keeping in mind the normal tobacco smokers, so that it would be easy for you to trick the brain. It is used in a similar way as the normal cigarettes but is free of the majority toxic chemicals found in normal cigarettes. Vaping is safer than normal tobacco smoking. It is a great alternative to tobacco. If you want to get rid of the bad habit of smoking tobacco then you should choose a vaping device without any doubt and Coil2Oil is helping millions to achieve this goal.” (emphasis in the original) “Premium e-liquids are a little expensive than the regular ones but all the ingredients used in the premium e-liquids are safe for consumption.  Regular e-liquids may be bit (s ic) harmful as compared to the premium e-liquids but they are still safer to consume as compared to the traditional cigarettes. . . . Explore and buy your favourite eliquids: https://coil2oil.co.uk/collections/eliquids” 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)). Additional Considerations FDA finds the Ice Menthol 50ml Shortfill by Mad King e-liquid particularly concerning because the product features graphic images of cartoon kings (see Exhibit A).  Such cartoon images are commonly marketed toward and/or appealing to children. FDA is concerned about the rising youth appeal and dramatic rise in youth use of ENDS products.  Sales of such products to individuals under the age of 21 are prohibited and any efforts to entice youth to use tobacco products, including marketing products with youth-appealing cartoons or animated characters, including kings, are of concern to FDA.   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 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 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 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 promptly 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. 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, RW2001418, 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 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: GoDaddy Legal Department legal@godaddy.com GoDaddy.com, LLC abuse@godaddy.com Shopify abuse@shopify.com Content current as of: 09/09/2020 Regulated Product(s) Tobacco