Joseph Anderson d/b/a Smokin Joes

WARNING LETTER Joseph Anderson d/b/a Smokin Joes MARCS-CMS 577579 — April 30, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Tobacco Recipient: Recipient Name Joseph M. Anderson Recipient Title Owner Joseph Anderson d/b/a Smokin Joes 4900 Indian Hill Road Lewiston , NY 14092 United States Issuing Office: Center for Tobacco Products United States VIA UPS and Electronic Mail APR 30, 2019 Joseph M. Anderson Owner Joseph Anderson, d/b/a Smokin Joes 4900 Indian Hill Road Lewiston, NY  14092 blacey@smokinjoe.com WARNING LETTER Dear Mr. Anderson: The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) has reviewed your submissions to the FDA and our inspection records, and determined that Joseph Anderson d/b/a Smokin Joes manufactures and distributes cigarette products for commercial distribution in the United States, and that the cigarette products 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)), 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.  Cigarette products are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)). New Tobacco Products Without Required Marketing Authorization Are Adulterated and/or Misbranded FDA has determined that you have manufactured, sold, and/or distributed to customers in the United States the cigarette products listed in the table below without a marketing authorization order. Product Name Date of NSE Order STN Smokin Joes Blue 100 Size Box Fire Safe 10/12/2018 SE0002985 Smokin Joes Blue 100 Size Soft Pack Fire Safe 10/12/2018 SE0002986 Smokin Joes Blue King Size Box Fire Safe 10/12/2018 SE0002987 Smokin Joes Blue King Size Soft Pack Fire Safe 10/12/2018 SE0002988 Smokin Joes Gold 100 Size Box Fire Safe 10/12/2018 SE0002990 Smokin Joes Gold 100 Size Soft Pack Fire Safe 10/12/2018 SE0002991 Smokin Joes Gold King Size Box Fire Safe 9/6/2017 SE0004632 Smokin Joes Gold King Size Soft Pack Fire Safe 9/6/2017 SE0004629 Smokin Joes Menthol 100 Size Box Fire Safe 10/12/2018 SE0002993 Smokin Joes Menthol 100 Size Soft Pack Fire Safe 10/12/2018 SE0002994 Smokin Joes Menthol Gold 100 Size Box Fire Safe 10/12/2018 SE0002995 Smokin Joes Menthol Gold 100 Size Soft Pack Fire Safe 10/12/2018 SE0002996 Smokin Joes Menthol Gold King Size Box Fire Safe 10/12/2018 SE0002997 Smokin Joes Menthol Gold King Size Soft Pack Fire Safe 8/23/2018 SE0002998 Smokin Joes Menthol King Size Box Fire Safe 8/23/2018 SE0003001 Smokin Joes Menthol King Size Soft Pack Fire Safe 8/23/2018 SE0003000 Smokin Joes Natural Menthol 100 Size Box Fire Safe 11/30/2017 SE0004989 Smokin Joes Natural Menthol 100 Size Soft Pack Fire Safe 8/23/2018 SE0003012 Smokin Joes Natural Menthol Gold 100 Size Soft Pack Fire Safe 8/23/2018 SE0003015 Smokin Joes Natural Menthol King Size Box Fire Safe 8/23/2018 SE0003014 Smokin Joes Natural Purple 100 Size Box Fire Safe 8/23/2018 SE0003020 Smokin Joes Natural Purple 100 Size Soft Pack Fire Safe 8/23/2018 SE0003021 Smokin Joes Natural Purple King Size Box Fire Safe 8/23/2018 SE0003022 Smokin Joes Natural Purple King Size Soft Pack Fire Safe 8/23/2018 SE0003023 Smokin Joes Natural Silver 100 Size Box Fire Safe 7/5/2018 SE0003026 Smokin Joes Natural Silver 100 Size Soft Pack Fire Safe 7/5/2018 SE0003027 Smokin Joes Natural Silver King Size Box Fire Safe 7/5/2018 SE0003028 Smokin Joes Natural Silver King Size Soft Pack Fire Safe 7/5/2018 SE0003029 Smokin Joes Natural White 100 Size Box Fire Safe 7/5/2018 SE0003030 Smokin Joes Natural White 100 Size Soft Pack Fire Safe 7/5/2018 SE0003031 Smokin Joes Natural White King Size Soft Pack Fire Safe 7/5/2018 SE0003032 Smokin Joes Red 100 Size Box Fire Safe 8/23/2018 SE0003005 Smokin Joes Red 100 Size Soft Pack Fire Safe 8/23/2018 SE0003006 Smokin Joes Red King Size Soft Pack Fire Safe 9/6/2017 SE0004615 The FD&C Act generally requires premarket review for any “new tobacco product,” which means any tobacco product that was not commercially marketed in the United States as of February 15, 2007, or any modification of a tobacco product where the modified product was commercially marketed in the United States after February 15, 2007 (section 910(a) of the FD&C Act; 21 U.S.C. § 387j(a)). [1] 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) 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) FDA issues an order fi n ding the product to be exempt f r o m the requ i rements o f substantial equivalence (SE Exemption Order), and you submit a report und e r sec t ion 905(j ) ( 1 ) of the FD&C Act (21 U.S.C. § 387e(j)(1)) (Abbreviated Report) that includes the information required in sections 905(j)(1)(A)(ii) and 905(j)(1)(B) of the FD&C Act, and ninety days have passed since FDA receipt of your Abbreviated Report. During FDA’s December 18–20, 2018 inspection of your manufacturing establishment, FDA determined that the cigarette products listed above were new tobacco products that had been commercially marketed in the United States after receiving NSE orders.  These products did not have required FDA marketing authorization orders in effect under section 910(c)(1)(A)(i) of the FD&C Act.  Therefore, they were adulterated under section 902(6)(A) of the FD&C Act and/or misbranded under section 903(a)(6) of the FD&C Act because a notice or other information respecting these products was not provided as required by section 905(j) of the FD&C Act (21 U.S.C. § 387e(j)).  The introduction into interstate commerce of any tobacco product that is adulterated or misbranded is a prohibited act under section 301(a) of the FD&C Act (21 U.S.C. § 331(a)). Additionally, to the extent that a report was required under section 905(j) of the FD&C Act, the failure to provide such report is a prohibited act under section 301(p) of the FD&C Act (21 U.S.C. § 331(p)). In the time since FDA’s December 18–20, 2018 inspection, some of the cigarette products listed above have received SE Exemption Orders.  To legally market these products, however, you must submit an Abbreviated Report and ninety days must have passed since FDA receipt of your Abbreviated Report.  As of the date of this letter, neither of these requirements have been met for these products and, as such, these products cannot be legally marketed.  Commercial marketing of these products prior to satisfying these requirements would render your products misbranded under section 903(a)(6) of the FD&C Act.  The introduction into interstate commerce of any tobacco product that is misbranded is a prohibited act under section 301(a) of the FD&C Act (21 U.S.C. § 331(a)). In the time since FDA’s December 18–20, 2018 inspection, you have indicated that some of the cigarette products listed above have been “reformulated” to be identical to other cigarette products that are lawfully marketed pursuant to section 905(j) of the FD&C Act.  Please provide further evidence—such as production records and master manufacturing records—that these products have been reformulated to lawfully marketed products. Conclusion and Requested Actions The violations discussed in this letter do not necessarily constitute an exhaustive list.  You should immediately correct the violations that are referenced above, as well as violations that are the same as or similar to the ones 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 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, criminal prosecution, seizure, and/or injunction.  Please note that any adulterated and/or 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 and preventative actions, including the dates on which you discontinued the violative sales, and/or distribution of these tobacco products, confirmation that you are not introducing any products without required marketing authorization into interstate commerce, further evidence on reformulated products, and your plan for maintaining and ensuring future compliance with the premarket authorization requirements of 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, ER1900018, in your response and direct your response to the following address: DEM-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 Lillian Ortega at (240) 402-9041 or Lillian.Ortega@fda.hhs.gov . Sincerely, /S/ Ann Simoneau, J.D. Director Office of Compliance and Enforcement Center for Tobacco Products [1] A “provisional” tobacco product—i.e., a new tobacco product first introduced or delivered for introduction into interstate commerce for commercial distribution after February 15, 2007, and prior to March 22, 2011, and for which a section 905(j) report (substantial equivalence report) was submitted no later than March 22, 2011—can be legally marketed unless FDA issues a not substantially equivalent (NSE) order for the product. Content current as of: 05/07/2019 Regulated Product(s) Tobacco