Ozone Smoke, Inc

WARNING LETTER Ozone Smoke, Inc MARCS-CMS 564745 — October 11, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA UPS and Electronic Mail Product: Tobacco Recipient: Recipient Name Dimitry Bekkerman Ozone Smoke, Inc 2038 Cass Lake Rd #7 Keego Harbor , MI 48320 United States sales@ozonesmoke.com customerservice@ozonesmoke.com Issuing Office: Center for Tobacco Products United States OCT 11, 2018 WARNING LETTER Dear Dimitry Bekkerman: This is to advise you that the Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https://www.ozonesmoke.com and determined that thee-liquid 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)), 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 your Pink Sticks e-liquid is misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1 )) and/or section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) because its labeling and/or advertising is false or misleading. Misbranding Violation FDA's investigation of the website https://www.ozonesmoke.com revealed that it sells or distributes Pink Sticks e-liquid with labeling and/or advertising that causes it to imitate food products, particularly ones that are marketed toward, and/or appealing to, children (see Exhibit A). Specifically, the labeling and/or advertising of the product looks very similar to Pocky Strawberry biscuit sticks (see Exhibit B), a product that is marketed toward, and/or appealing to, children. For example, the labeling and/or advertising for Pink Sticks e-liquid includes the appearance of a box of biscuit sticks that is substantially similar to the packages in which biscuit sticks are sold, an image of arrayed biscuit sticks, and a color scheme that is substantially similar to the biscuit stick package in Exhibit B. Further, Pink Sticks e-liquid has a strong scent like Pocky Strawberry biscuit sticks that is easily detected without opening the package. This labeling and/or advertising causes the product to imitate food products, particularly ones that are marketed toward, and/or appealing to, children and is therefore misleading. Children are at particular risk for ingesting e-liquid products with labeling and/or advertising that causes the product to imitate a food or beverage, particularly a food or beverage that is typically marketed toward, and/or appealing to, children. Moreover, children are at particular risk because exposure to the nicotine in thee-liquid product, even in relatively small amounts, could result in acute toxicity. Child poisonings due to the ingestion of liquid nicotine have recently increased substantially. Severe harms can occur in small children from ingestion of liquid nicotine, including death from cardiac arrest, as well as seizure, coma, and respiratory arrest. Given that the labeling and/or advertising of Pink Sticks e-liquid describes its nicotine content as 6mg/ml, with a total volume of 60ml, an accidental ingestion of approximately half a teaspoon would reach the lower end of the fatal dose range for an average two-year-old. Additionally, an accidental ingestion of approximately 2% of a teaspoon would reach the lower end of the non-fatal acute toxicity range for an average two-year-old. The FD&C Act provides, in part, that a tobacco product shall be deemed to be misbranded (1) if its labeling is false or misleading in any particular (section 903(a)(1 )), or (2) if the tobacco product is distributed or offered for sale in any State and its advertising is false or misleading in any particular (section 903(a)(7)(A)). The labeling and/or advertising for Pink Sticks e-liquid is misleading because it causes the product to imitate food products, particularly ones that are marketed toward, and/or appealing to, children. Therefore, the product is misbranded under section 903(a)(1) and/or 903(a)(7)(A) of the FD&C Act. Conclusion and Requested Actions The violation discussed in this letter does not necessarily constitute an exhaustive list. You should immediately 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), 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 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 any 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, RW1800977, 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, 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: Dimitry Tolkachier Ozone Smoke, Inc 3150 Livernois Rd Suite 235 Troy, Michigan 48083 ozonesmoke@gmail.com GoDaddy.com, LLC abuse@godaddy.com MageMojo, LLC support@magemojo.com Content current as of: 10/30/2018 Regulated Product(s) Tobacco