Ravenstorm AUA-father Christmas Group

WARNING LETTER Ravenstorm AUA-father Christmas Group MARCS-CMS 546471 — February 09, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Ravenstorm AUA-father Christmas Group United States Issuing Office: Center for Tobacco Products United States Center for Tobacco Products 10903 New Hampshire Avenue Silver Spring, MD 20993 FEB 9, 2018 VIA USPS and Electronic Mail Ravenstorm AUA-father Christmas Group Attn:Abdul Wakeel P.O. Box 4418 Jersey City, NJ 07304 medici-arm@ravenstormaua.org syroscropolizia@yahoo.com WARNING LETTER Dear Abdul Wakeel: The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website http://www.ravenstormaua.org and determined that the pipe tobacco 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 (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 pipe tobacco, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)). FDA has determined thatyour Tobak Spice Oriental Sampler pipe tobacco is misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)) because you sold this product to a person younger than 18 years of age. Sales to Minors Violation FDA’s investigation of the website http://www.ravenstormaua.org revealed that you sold a pipe tobacco productto a minor. Specifically, during our investigation of http://www.ravenstormaua.org , a person younger than 18 years of age purchased Tobak Spice Oriental Sampler pipe tobacco from your website. Additionally, you sent a complimentary Q. Victoriapipe tobacco product from the website.  No retailer may sell covered tobacco products, including e-liquid, cigar, pipe tobacco, waterpipe tobacco, and dissolvable tobacco products, as well as electronic nicotine delivery system (ENDS) products that contain any tobacco derivative, to a person younger than 18 years of age under 21 C.F.R. § 1140.14(b). Under 21 C.F.R. § 1140.3, a “covered tobacco product” is defined as any tobacco product deemed to be subject to chapter IX of the FD&C Act by 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 1140. Because this product is sold or distributed to consumers in the United States younger than 18 years of age, in violation of 21 C.F.R. § 1140.14(b), this 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 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), 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 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 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. You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov . Please note your reference number, RW1800829, 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 cc: Contact Privacy Inc. ravenstormaua.org@contactprivacy.com Tucows Inc. domainabuse@tucows.com Yahoo! Inc. abuse@yahoo-inc.com Content current as of: 04/24/2018