DOCSLIB.ORG

Reynolds American Inc. (Exact Name of Registrant As Specified in Its Charter)

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Reynolds American Inc. (Exact Name of Registrant As Specified in Its Charter) UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☑ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2016 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 1-32258 Reynolds American Inc. (Exact name of registrant as specified in its charter) North Carolina 20-0546644 (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification Number) 401 North Main Street Winston-Salem, NC 27101 (Address of principal executive offices) (Zip Code) (336) 741-2000 (Registrant’s telephone number, including area code) Securities registered pursuant to Section 12(b) of the Act: Title of each class Name of each exchange on which registered Common stock, par value $.0001 per share New York Securities registered pursuant to Section 12(g) of the Act: None Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☑ No ☐ Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. Yes ☐ No ☑ Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☑ No ☐ Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes ☑ No ☐ Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. ☑ Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one): Large accelerated filer ☑ Accelerated filer ☐ Non-accelerated filer ☐ (Do not check if a smaller reporting company) Smaller reporting company ☐ Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☑ The aggregate market value of common stock held by non-affiliates of Reynolds American Inc. on June 30, 2016, was approximately $44 billion, based on the closing price of $53.93. Directors, executive officers and a significant shareholder of Reynolds American Inc. are considered affiliates for purposes of this calculation, but should not necessarily be deemed affiliates for any other purpose. Indicate the number of shares outstanding of each of the registrant’s classes of common stock, as of the latest practicable date: January 23, 2017: 1,425,934,305 shares of common stock, par value $.0001 per share. Documents Incorporated by Reference: Portions of the Form 10-K/A of Reynolds American Inc. to be filed with the Securities and Exchange Commission on or before May 1, 2017, are incorporated by reference into Part III of this report. INDEX PART I Item 1. Business 2 Item 1A. Risk Factors 13 Item 1B. Unresolved Staff Comments 25 Item 2. Properties 25 Item 3. Legal Proceedings 25 Item 4. Mine Safety Disclosures 25 PART II Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 26 Item 6. Selected Financial Data 28 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 30 Item 7A. Quantitative and Qualitative Disclosures about Market Risk 62 Item 8. Financial Statements and Supplementary Data 65 Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure 177 Item 9A. Controls and Procedures 177 Item 9B. Other Information 177 PART III Item 10. Directors, Executive Officers and Corporate Governance 178 Item 11. Executive Compensation 178 Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 178 Item 13. Certain Relationships and Related Transactions, and Director Independence 178 Item 14. Principal Accounting Fees and Services 178 PART IV Item 15. Exhibits, Financial Statement Schedules 179 Signatures 186 1 Introduction On January 17, 2017, Reynolds American Inc., referred to as RAI, announced that it had entered into a Merger Agreement, as defined below, with British American Tobacco p.l.c., a public company incorporated under the laws of England and Wales, referred to as BAT, BATUS Holdings Inc., a Delaware corporation and a wholly owned subsidiary of BAT, and Flight Acquisition Corporation, a North Carolina corporation and a wholly owned subsidiary of BAT, referred to as Merger Sub. Unless stated otherwise, all forward-looking information contained in this report does not take into account or give any effect to the impact of the BAT Merger, as defined below. For additional details regarding the BAT Merger, see “Business” contained in Part I, Item 1, of this report, “Risk Factors” contained in Part I, Item 1A, of this report, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” contained in Part II, Item 7, of this report, and Note 22 to RAI’s consolidated financial statements, contained in Part II, Item 8, of this report. PART I Item 1. Business RAI is a holding company whose wholly owned operating subsidiaries include the second largest tobacco company in the United States, R. J. Reynolds Tobacco Company; the manufacturer and marketer of the leading super-premium cigarette brand, Santa Fe Natural Tobacco Company, Inc., referred to as SFNTC; the second largest smokeless tobacco products manufacturer in the United States, American Snuff Company, LLC, referred to as American Snuff Co.; R. J. Reynolds Vapor Company, referred to as RJR Vapor, a marketer of digital vapor cigarettes in the United States, manufactured on its behalf by R. J. Reynolds Tobacco Company; Niconovum USA, Inc. and Niconovum AB, marketers of nicotine replacement therapy products in the United States and Sweden, respectively; and until their sale on January 13, 2016, as described below, SFR Tobacco International GmbH, referred to as SFRTI, and various foreign subsidiaries affiliated with SFRTI. RAI was incorporated in the State of North Carolina on January 2, 2004, and its common stock is listed on the New York Stock Exchange, referred to as NYSE, under the symbol “RAI.” RAI’s headquarters are located in Winston-Salem, North Carolina. On July 30, 2004, the U.S. assets, liabilities and operations of Brown & Williamson Tobacco Corporation, now known as Brown & Williamson Holdings, Inc., referred to as B&W, an indirect, wholly owned subsidiary of BAT were combined with R. J. Reynolds Tobacco Company, a wholly owned operating subsidiary of R.J. Reynolds Tobacco Holdings, Inc., a wholly owned subsidiary of RAI, referred to as RJR. These transactions on July 30, 2004, generally are referred to as the B&W business combination. As a result of the B&W business combination and BAT Share Purchase, as defined below, BAT, through wholly owned subsidiaries, beneficially owns approximately 42% of RAI’s outstanding common stock. References to RJR Tobacco prior to July 30, 2004, relate to R. J. Reynolds Tobacco Company, a New Jersey corporation. References to RJR Tobacco on and subsequent to July 30, 2004 and until June 12, 2015, relate to the combined U.S. assets, liabilities and operations of B&W and R. J. Reynolds Tobacco Company. Concurrent with the completion of the B&W business combination, RJR Tobacco became a North Carolina corporation. References to RJR Tobacco on and subsequent to June 12, 2015, relate to R. J. Reynolds Tobacco Company, a North Carolina corporation, and reflect the effects of the Lorillard Merger and Divestiture, described below. Proposed Merger with BAT On January 16, 2017, RAI, BAT, a subsidiary of BAT, and Merger Sub entered into an Agreement and Plan of Merger, referred to as the Merger Agreement, pursuant to which, subject to the satisfaction or waiver of certain conditions, Merger Sub will merge with and into RAI, referred to as the BAT Merger, with RAI surviving as a wholly owned subsidiary of BAT. The BAT Merger has been approved by the independent directors of RAI who formed a committee to negotiate with BAT, referred to as the Transaction Committee, given BAT’s existing ownership stake in RAI and representation on RAI’s Board, and by the Boards of Directors of both companies. At the effective time of the BAT Merger, each share of RAI common stock (other than any shares of RAI common stock owned by BAT or any of its subsidiaries and by shareholders of RAI who have properly asserted and not lost or effectively withdrawn appraisal rights) will be converted into the right to receive 0.5260 of a BAT American Depositary Share, referred to as a BAT ADS, and $29.44 in cash, without interest, and subject to adjustment to prevent dilution. The BAT Merger is subject to customary closing conditions, including RAI and BAT shareholder approvals, including the approval of the BAT Merger by a majority of the shares of RAI common stock not owned, directly or indirectly, by BAT or its subsidiaries or any of RAI’s subsidiaries, and regulatory approvals.
Load more

Recommended publications
  • American Snuff Co., Memphis: the Business of Being Sustainable
    [ e American Snuff Co., Memphis: The Business of Being Sustainable American Snuff Company, an indirect subsidiary of Reynolds American Inc. (NYSE: RAI), is the nation’s second largest manufacturer of smokeless tobacco products, with Grizzly and • Established 1904 Kodiak leading the way. Closing in on a 90% diversion rate to the landfill, American Snuff Company of Memphis fully embraces the • Employs over 200 concept of a circula r economy; new ground for most industries in the United States. • Close to achieving “We realize the closer we come to being a zero-waste company, Zero Waste status the more effort and commitment it will take,” said Jaimie Bright, Lead Manager of the Environmental Health and Safety group with • Member since 2014 American Snuff. In recent years, American Snuff Company of Memphis has become one of the most sustainable industries in Tennessee. For American Snuff, this commitment to a sustainable business model presents a welcome challenge. Most companies accept that production waste is a part of business, and while most try to minimize the waste or find an outlet for it, not many will go the distance, literally, like American Snuff. “We had almost 20 tons of tobacco production waste a month that we had no real sustainable outlet for,” said Quincey Young, Senior Scientist at American Snuff, “but we were determined to find the most beneficial re-use we could.” TGSP Highlights- February 2017 Tobacco waste, as it turns out, is an excellent source of nitrogen which makes it a welcome addition to compost production. The nearest compost facility capable of using that much tobacco was The Compost Company LLC, in Ashland City, just over 200 miles away.
    [Show full text]
  • Batus Holdings Inc, Организовано У Складу Са Правом Сједињених Америчких Држава , Са Седиштем На Адреси 2711 Centerville Rd
    Република Србија КОМИСИЈА ЗА ЗАШТИТУ КОНКУРЕНЦИЈЕ Број : 6/0-02-180/2017-8 Датум : 03. март 2017. године Б е о г р а д Председник Комисије за заштиту конкуренције , на основу члана 37. став 2. Закона о заштити конкуренције („ Службени гласник РС “, број 51/09 и 95/13), члана 192. став 1. Закона о општем управном поступку („ Службени лист СРЈ ", бр . 33/97, 31/01 и „ Службени гласник РС “, бр . 30/10) и члана 2. став 1. тачка 6. Тарифника о висини накнада за послове из надлежности Комисије за заштиту конкуренције („ Службени гласник РС “, број 49/11), одлучујући по пријави концентрације број 6/0- 02-180/2017-8, коју је дана 31. јануара 2017. године поднело привредно друштво Batus Holdings Inc, организовано у складу са правом Сједињених Америчких Држава , са седиштем на адреси 2711 Centerville Rd. Suite 400, Vilmington, Delaver, SAD, 19808, регистровано при Заводу за корпорације Delaver State Department под бројем 0851178, преко пуномоћника адвокат a Тијане Којовић из Адвокатског ортачког друштва БДК Адвокати , Београд , Мајке Јевросиме бр . 23, дана 03. марта 2017. године , доноси следеће Р Е Ш Е Њ Е 1 I ОДОБРАВА СЕ у скраћеном поступку концентрација учесника на тржишту која настаје стицањем непосредне појединачне контроле од стране друштва , Batus Holdings Inc, организовано у складу са правом Сједињених Америчких Држава , са седиштем на адреси 2711 Centerville Rd. Suite 400, Vilmington, Delaver, SAD, 19808, регистровано при Заводу за корпорације Delaver State Department под бројем 0851178, над друштвом Reynolds American Inc, организованим у складу са правом Сједињених Америчких Држава , са седиштем на адреси 327 Hillsborough Street, Raleigh, Severna Karolina 27603- 1725, регистрованим код Државног Секретара Северне Каролине под регистарским бројем 0705047, до које долази на основу уговорног преузимања већинског удела у капиталу Reynolds American Inc, као Циљном друштву .
    [Show full text]
  • Warnings for Chewing Tobacco Products
    COMMENTS ON PETITION OF R.J. REYNOLDS TOBACCO COMPANY AND AMERICAN SNUFF COMPANY FOR RULEMAKING TO ADJUST STATUTORY SMOKELESS TOBACCO WARNING DOCKET NO. FDA-2011-P-0573 November 9, 2012 The undersigned organizations submit these comments on the Petition of R.J. Reynolds Tobacco Company (“RJR”) and the American Snuff Company (“ASC”), Reynolds American, Inc.’s smokeless tobacco subsidiary, requesting the Commissioner of Food and Drugs to initiate a rulemaking proceeding to alter the text of the statutorily-required smokeless tobacco (“ST”) product warning statement. The undersigned urge that the Petition be denied by the Food and Drug Administration (“FDA”). Though presented as merely a request to FDA to modify one of the statutory product warnings on smokeless tobacco, in reality the RJR Petition is a transparent attempt to secure FDA’s support for their marketing of ST as a safer product than cigarettes, while evading the evidentiary requirements that Congress carefully constructed to ensure that such claims of reduced harm do not serve to increase tobacco use, cause more people to become addicted to tobacco, and die from tobacco-related disease. The Petition thus represents an attack on the integrity of the Family Smoking Prevention and Tobacco Control Act (“Tobacco Control Act”), the statute FDA is charged with enforcing, and should be treated as such. The Petition is part and parcel of a broader industry campaign to circumvent the requirements of Section 911 of the Tobacco Control Act in order to promote ST as a “harm reducing” product, led by the 1 two largest cigarette manufacturers – RJR and Philip Morris USA – who have entered the ST market and have every incentive to both expand the use of ST and to ensure that ST functions to protect and expand the market for cigarettes.
    [Show full text]
  • RAI Board Member Daly Resigns; Jerome Abelman Designated to Succeed Him
    Reynolds American Inc. P.O. Box 2990 Winston-Salem, NC 27102-2990 Contact: Investor Relations: Media: RAI 2016-03 Morris Moore Jane Seccombe (336) 741-3116 (336) 741-5068 RAI board member Daly resigns; Jerome Abelman designated to succeed him WINSTON-SALEM, N.C. – Jan. 15, 2016 – Reynolds American Inc. (NYSE: RAI) announced today that John P. Daly has resigned as a member of RAI’s board of directors, effective Feb. 4. Daly has served on RAI’s board since December 2010, one of five board members designated by Brown & Williamson Holdings, Inc. (B&W), a subsidiary of British American Tobacco p.l.c. (BAT), under the terms of the 2004 governance agreement, as amended, between RAI, B&W and BAT. His three-year term as a Class II director was scheduled to expire in 2018. Daly, former chief operating officer at BAT, retired from BAT in 2014. Jerome Abelman, director of legal and external affairs, and general counsel at BAT, has been designated by BAT for nomination to RAI’s board to succeed Daly, effective Feb. 4. RAI’s board will vote on Abelman’s formal nomination at its regularly scheduled Feb. 4 meeting. “John has given us outstanding business advice and counsel to the benefit of RAI and its shareholders, and we wish him the very best in retirement,” said Thomas C. Wajnert, chairman of RAI’s board. Abelman has been with the BAT Group for 13 years and has held a number of legal, corporate and regulatory roles. He joined BAT’s management board as director, corporate and regulatory affairs, in January 2015, and was appointed director, legal and external affairs, and general counsel in May 2015.
    [Show full text]
  • Case M1287J Proposed Acquisition of Reynolds American Inc by British
    Case M1287J Proposed Acquisition of Reynolds American Inc by British American Tobacco Plc, Batus Holdings Inc, and Flight Acquisition Corporation ______________ _____________ Decision Document No: CICRA 17/07 Date: 10 April 2017 Jersey Competition Regulatory Authority 2nd Floor Salisbury House, 1-9 Union Street, St Helier, Jersey, JE2 3RF Tel 01534 514990, Fax 01534 514991 Web: www.cicra.je Summary 1. This Decision concerns the proposed acquisition by British American Tobacco PLC (BAT), Batus Holdings Inc (BATUS) and Flight Acquisition Corporation (FAC) of Reynolds American Inc (RAI). The transaction has been notified to the Jersey Competition Regulatory Authority (JCRA) for approval pursuant to Article 21 of the Competition (Jersey) Law 2005 (the Law). 2. The JCRA has determined that the proposed acquisition will not lead to a substantial lessening of competition in any relevant market in Jersey and hereby approves the acquisition. The Notified Transaction 3. On 15 March 2017 the JCRA received an application for approval from BAT, BATUS and FAC (the Purchasers) for their proposed acquisition of RAI (the Target). 4. As a result of the transaction, BATUS will acquire 58% of the share capital in RAI, and therefore acquire direct sole control. [] Accordingly, after the merger, BATUS will own 100% of RAI’s share capital, either directly or through wholly owned subsidiaries. 5. The JCRA registered the application on its website on 15 March, with a deadline for comments of 29 March. No submissions were received. The Parties 6. The Target is
    [Show full text]
  • First-Of-Its-Kind Filing for VUSE Products
    Reynolds American Inc. P.O. Box 2990 Winston-Salem, NC 27102-2990 Media Contact: Kaelan Hollon [email protected] 202-421-4921 VUSE Premarket Tobacco Product Application Filed for Substantive Review by the FDA First-of-its-Kind Filing for VUSE Products WINSTON-SALEM, N.C. – Nov. 27, 2019 – Today, Reynolds American Inc. (“RAI”) announced that the recently-submitted Premarket Tobacco Product Application (“PMTA”) for VUSE vapor products has been filed by the Food and Drug Administration (“FDA”) for substantive scientific review, moving the application one step further through the review process. “This is a first-of-its-kind application for VUSE products, and it puts VUSE one step closer to gaining a marketing order from the FDA. FDA will now review our scientific justification and determine the appropriateness of VUSE e-cigarette products against the public health standard,” notes RAI CEO Ricardo Oberlander. “For adult tobacco consumers seeking an alternative source of nicotine, having FDA oversight of e-cigarette products is an important step to ensure those alternatives meet strict regulatory scrutiny.” The FDA’s scientific review of the VUSE application – which totals more than 150,000 pages of research and data – comes just over six weeks after its initial submission to the FDA. The FDA, per its earlier-issued guidance, considers the following issues, among others: • Risks and benefits to the population as a whole, including both users and nonusers of tobacco products; • Whether people who currently use any tobacco product would be more or less likely to stop using such products if the proposed new tobacco product were available; • Whether people who currently do not use any tobacco products would be more or less likely to begin using tobacco products if the new product were available; and • The methods, facilities, and controls used to manufacture, process, and pack the new tobacco product.
    [Show full text]
  • Reynolds American Inc
    REYNOLDS AMERICAN INC. Consolidated Financial Statements December 31, 2020 and 2019 (With Independent Auditors’ Report Thereon) Proprietary and Confidential - For Intended Use Only REYNOLDS AMERICAN INC. Consolidated Financial Statements Index Independent Auditors’ Report ................................................................................................................................................. 1 Consolidated Statements of Income – For the Years Ended December 31, 2020 and 2019 ................................................... 2 Consolidated Statements of Comprehensive Income – For the Years Ended December 31, 2020 and 2019 ......................... 3 Consolidated Statements of Cash Flows – For the Years Ended December 31, 2020 and 2019 ............................................ 4 Consolidated Balance Sheets – As of December 31, 2020 and 2019 ...................................................................................... 5 Consolidated Statements of Shareholders’ Equity – For the Years Ended December 31, 2020 and 2019 ............................. 6 Notes to Consolidated Financial Statements ........................................................................................................................... 7 KPMG LLP Suite 1000 620 S. Tryon Street Charlotte, North Carolina 28202-1842 Independent Auditors’ Report The Board of Directors Reynolds American Inc.: We have audited the accompanying consolidated financial statements of Reynolds American Inc. and its subsidiaries, which comprise the consolidated
    [Show full text]
  • R.J. Reynolds Tobacco Company Submits Modified Risk Tobacco Product Applications for Camel Snus
    Reynolds American Inc. P.O. Box 2990 Winston-Salem, NC 27102-2990 Contact: Media: David Howard RAI 2017-06 (336) 741-3489 R.J. Reynolds Tobacco Company Submits Modified Risk Tobacco Product Applications For Camel Snus WINSTON-SALEM, N.C. – April 3, 2017 – Reynolds American Inc. (NYSE: RAI) today announced that its R.J. Reynolds Tobacco Company (RJRT) subsidiary has submitted Modified Risk Tobacco Product (MRTP) applications to the U.S. Food and Drug Administration (FDA) covering six styles of Camel Snus, its premium pouched, smokeless tobacco product introduced in 2006 and marketed nationwide. To support the applications, R.J. Reynolds has provided the FDA more than 450,000 pages of documentation. As the submission guidelines advise, the documentation covers results and discussion from an extensive suite of scientific studies, including: Chemistry, pre-clinical and clinical toxicology, as well as epidemiology; Consumer perception and understanding studies of the proposed MRTP; Likelihoods of use studies based on the proposed MRTP claims; and Population-level modeling under a scenario in which the MRTP claims are authorized for dissemination to adult smokers. R.J. Reynolds now awaits FDA’s review of the applications to determine whether they are accepted for substantive review, and the company looks forward to working with the agency as the process moves forward. Web and Social Media Disclosure RAI’s website, www.reynoldsamerican.com, is the primary source of publicly disclosed news, including our quarterly earnings, about RAI and its operating companies. RAI also uses Twitter to publicly disseminate company news via @RAI News. It is possible that the information we post could be deemed to be material information.
    [Show full text]
  • Conwood Company to Change Name to American Snuff Company
    Conwood Company to change name to American Snuff Company MEMPHIS, Tenn. – Nov. 24, 2009 – Conwood Company, LLC, is changing its name to American Snuff Company, LLC, effective Jan. 1, 2010. Conwood, the nation’s second largest manufacturer of smokeless tobacco products, is an operating company of Reynolds American Inc. (NYSE: RAI). The company name change will not affect any of the company’s operations, products or staffing levels. “Reassuming our historical company name emphasizes our commitment to the core values on which our company was founded,” said Bryan K. Stockdale, Conwood’s president and chief executive officer. “We are focused on delivering the highest quality smokeless tobacco products to our customers and adult tobacco consumers, and returning to our historical company name drives that home.” American Snuff Company was founded before 1900. In 1912, American Snuff Company’s headquarters moved from New York to Memphis, and for 40 years, the company manufactured dry snuff. In the 1950s and 1960s, the company began diversifying, acquiring manufacturers of chewing tobaccos, as well as companies that manufactured shoe polish, popcorn, theater supplies and yogurt. In 1966, to reflect its diversified operations, the company changed its name to Conwood Company. Since the 1980s, Conwood has divested all its non-tobacco lines of business and focused solely on smokeless tobacco products. Its Grizzly brand is the best-selling brand of moist snuff in the U.S. ABOUT US Conwood Company, LLC is the nation’s second-largest manufacturer of smokeless tobacco products. Its leading brands are Grizzly, Kodiak and Levi Garrett. Conwood also sells and distributes a variety of tobacco products manufactured by Lane, Limited, including Winchester and Captain Black little cigars, and Bugler roll-your-own tobacco.
    [Show full text]
  • Not Substantially Equivalent Letter from FDA CTP to R.J. Reynolds
    ~ i,,.... Jf( .....U.S. FOOD& DRUG U.S. Food & Drug Administration i1 10903 New Hampshire Avenue \,::::::z.f- ADMINISTRATION Silver Spring, MD 20993 www.fda.gov May 12, 2020 NOT SUBSTANTIALLY EQUIVALENT R.J. Reynolds Tobacco Company Attention: Michael W. Ogden, Ph.D. Senior Vice President, Scientific & Regulatory Affairs RAI Services Company 401 North Main Street Winston-Salem, NC 27101 FDA Submission Tracking Number (STN): SE0000280, see Appendix A Dear Dr. Ogden: We completed our review of your SE Report1 and determined that the new tobacco product is not substantially equivalent to the predicate tobacco products listed in Appendix A. Refer to Appendix B for a list of amendments received in support of your application. Your SE Report includes information for an additional predicate tobacco product (Camel Snus Frost) that you identified in your April 3, 2015, amendment as a predicate tobacco product. Information for this additional predicate tobacco product is provided alongside information for the new and predicate tobacco products identified in the SE Report at the time scientific review commenced. Because the comparison between the new tobacco product and the identified predicate tobacco product is a fundamental aspect of an SE Report, changing the predicate tobacco product changes the basis of the substantial equivalence evaluation. An applicant may change its predicate tobacco product if scientific review of the application has not yet started. However, once FDA commences scientific review, an applicant should not change its predicate tobacco product(s); the application review will be based on the comparison between the predicate tobacco product(s) in place at the start of scientific review and the new tobacco product.
    [Show full text]
  • Oregon's Directory of Smokeless Tobacco Brands Approved for Stamping and Sale
    ALPHABETICAL BRAND LIST The following is Oregon’s Directory of Smokeless Tobacco Brands Approved for Stamping and Sale in alphabetical order. The List is divided into three Sections: First Section – Deletions to the List in the Last 30 Days Second Section – Additions to the List in the Last 30 Days Third Section – Main List That Reflects Current Status UPDATED September 16, 2021 DM #7268435 BRAND - Deletions to the List Manufacturer NPM Product Initial in the Last 30 Days /PM Certified Date BRAND - Additions to the List Manufacturer NPM Product Initial in the Last 30 Days /PM Certified Date Cougar - Fine Cut Natural 1.2 oz. American Snuff Company, LLC Moist 8/18/2021 Puck Snuff Cougar - Long Cut Straight 1.2 oz. American Snuff Company, LLC Moist 8/18/2021 Puck Snuff Cougar - Long Cut Wintergreen 1.2 American Snuff Company, LLC Moist 8/18/2021 oz. Puck Snuff Grizzly - Snus Artic Blue .53 oz. Tin American Snuff Company, LLC Moist 9/16/2021 Snuff Grizzly - Snus Natural .53 oz. Tin American Snuff Company, LLC Moist 9/16/2021 Snuff Grizzly - Snus Wintergreen .53 oz. American Snuff Company, LLC Moist 9/16/2021 Tin Snuff Kodiak - Premium Natural 1.2 oz. American Snuff Company, LLC Moist 8/18/2021 Puck Snuff Kodiak - Premium Natural Extra American Snuff Company, LLC Moist 8/18/2021 Long Cut 1.2 oz. Puck Snuff Kodiak - Premium Natural Fine Cut American Snuff Company, LLC Moist 8/18/2021 1.2 oz. Puck Snuff Kodiak - Premium Natural Long Cut American Snuff Company, LLC Moist 8/18/2021 1.2 oz.
    [Show full text]
  • Durante Resigns from Reynolds American Board, Daly Nominated to Succeed Him
    Reynolds American Inc. P.O. Box 2990 Winston-Salem, NC 27102-2990 Contact: Media: Jane Seccombe RAI 2010-14 (336) 741-5068 Durante resigns from Reynolds American board, Daly nominated to succeed him WINSTON-SALEM, N.C. – Aug. 18, 2010 – Reynolds American Inc. (NYSE: RAI) announced that Nicandro Durante, the chief operating officer of British American Tobacco p.l.c. (BAT), has resigned as a member of RAI’s board of directors, effective Dec. 1. John Daly, BAT’s regional director for Asia- Pacific, has been nominated to RAI’s board to succeed Durante, effective Dec. 1. The changes stem from a planned executive realignment at BAT, which was announced earlier this year. Durante has been a member of RAI’s board since December 2008, as one of the five board members designated by Brown & Williamson Holdings, Inc. (B&W), a subsidiary of BAT, under the terms of the 2004 governance agreement between RAI, B&W and BAT. Durante’s three-year term as a Class II director was due to expire in 2012. Durante is scheduled to become BAT’s chief executive designate on Sept. 1, 2010, and will become the company’s chief executive at the end of February 2011. Susan M. Ivey, the chairman, president and chief executive officer of Reynolds American, thanked Durante for his contributions to the company and its shareholders. “Nicandro has provided outstanding advice and counsel during his years of service on the board,” Ivey said. Daly, who joined the management board of BAT as regional director for Asia-Pacific in October 2004, will succeed Durante as chief operating officer of BAT on Sept.1.
    [Show full text]