No. 12-521: American Snuff Co. V. United States

Total Page:16

File Type:pdf, Size:1020Kb

No. 12-521: American Snuff Co. V. United States No. 12-521 In the Supreme Court of the United States AMERICAN SNUFF COMPANY, LLC, ET AL., PETITIONERS v. UNITED STATES OF AMERICA, ET AL. ON PETITION FOR A WRIT OF CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE SIXTH CIRCUIT BRIEF FOR THE RESPONDENTS IN OPPOSITION DONALD B. VERRILLI, JR. Solicitor General Counsel of Record STUART F. DELERY Principal Deputy Assistant Attorney General MARK B. STERN ALISA B. KLEIN Attorneys Department of Justice Washington, D.C. 20530-0001 [email protected] (202) 514-2217 QUESTIONS PRESENTED 1. Whether the court of appeals correctly upheld against a facial First Amendment challenge warning- label requirements in the Family Smoking Prevention and Tobacco Control Act (Act) for the packaging of and advertisements for cigarettes, 15 U.S.C. 1333 note (Supp. V 2011), and smokeless tobacco, 15 U.S.C. 4402 (Supp. V 2011). 2. Whether the court of appeals correctly upheld against a facial First Amendment challenge the Act’s requirement that a manufacturer establish the health benefits of a tobacco product before marketing it as a modified-risk tobacco product, 21 U.S.C. 387k (Supp. V 2011). 3. Whether the court of appeals correctly upheld against a facial First Amendment challenge regulations that— a. prohibit using the brand name of a cigarette or smokeless-tobacco brand on merchandise or to sponsor certain public events, 21 C.F.R. 1140.34(a) and (c), and b. generally prohibit the distribution of free samples of tobacco products, 21 C.F.R. 1140.16(d); see 21 U.S.C. 387a­1(a)(2)(G) (Supp. V 2011). (I) TABLE OF CONTENTS Page Opinions below ................................................................................ 1 Jurisdiction ...................................................................................... 1 Statement ......................................................................................... 2 Argument ....................................................................................... 13 A. Warning labels .............................................................. 13 B. Modified-risk tobacco products .................................. 20 C. Branded merchandise, event sponsorship, and free samples ................................................................... 30 Conclusion ...................................................................................... 36 TABLE OF AUTHORITIES Cases: Alexander v. Cahill, 598 F.3d 79 (2d Cir.), cert. denied, 131 S. Ct. 820 (2010) .............................................. 24 Central Hudson Gas & Elec. Corp. v. Public Serv. Comm’n, 447 U.S. 557 (1980) .................................. 12, 15, 26 Desert Outdoor Adver., Inc. v. City of Moreno Val- ley, 103 F.3d 814 (9th Cir. 1996), cert. denied, 522 U.S. 912 (1997) ............................................................... 27 FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000) ................................................. 2, 9, 10, 28 44 Liquormart, Inc. v. Rhode Island, 517 U.S. 484 (1996) ...................................................................................... 26 Freedman v. Maryland, 380 U.S. 51 (1965) ........................ 26 International Dairy Foods Ass’n v. Boggs, 622 F.3d 628 (6th Cir. 2010) ................................................ 18 Kordel v. United States, 335 U.S. 345 (1948)....................... 22 Lorillard Tobacco Co. v. Reilly, 533 U.S. 525 (2001) .................................................................... 30, 31, 34, 35 Nebraska Press Ass’n v. Stuart, 427 U.S. 539 (1976)......... 26 (III) IV Cases—Continued: Page New York Magazine v. Metropolitan Transp. Auth., 136 F.3d 123 (2d Cir.), cert. denied, 525 U.S. 824 (1998) ................................................................................ 26, 27 Nutritional Health Alliance v. Shalala, 144 F.3d 220 (2d Cir.), cert. denied, 525 U.S. 1040 (1998)...................... 27 Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999) ....... 23, 24 Public Citizen, Inc. v. Louisiana Attorney Discipli- nary Bd., 632 F.3d 212 (5th Cir. 2012)............................... 24 R.J. Reynolds Tobacco Co. v. FDA, 696 F.3d 1205 (D.C. Cir. 2012) ..................................................... 9, 13, 15, 16 Rubin v. Coors Brewing Co., 514 U.S. 476 (1995)............... 35 Sorrell v. IMS Health Inc., 131 S. Ct. 2653 (2011) ............. 26 Southeastern Promotions, Ltd. v. Conrad, 420 U.S. 546 (1975) ............................................................................... 26 Thompson v. Western States Med. Ctr., 535 U.S. 357 (2002) ...................................................................................... 25 United States v. Article … Consisting of 216 Cartoned Bottles, More or Less, Sudden Change, 409 F.2d 734 (2d Cir. 1969).................................................. 22 United States v. Caronia, 703 F.3d 149 (2d Cir. 2012)....... 23 United States v. Philip Morris USA Inc.: 449 F. Supp. 2d 1 (D.D.C. 2006), aff’d in part and vacated in part on other grounds, 566 F.3d 1095 (D.C. Cir. 2009), cert. denied, 130 S. Ct. 3501 (2010)......................................... passim 556 F.3d 1095 (D.C. Cir. 2009), cert. denied, 130 S. Ct. 3501 (2010)...................................... 4, 5, 6, 11 686 F.3d 832 (D.C. Cir. 2012)....................................... 7, 25 Washington State Grange v. Washington State Republican Party, 552 U.S. 442 (2008) ................. 16, 17, 33 Whitaker v. Thompson, 353 F.3d 947 (D.C. Cir.), cert. denied, 543 U.S. 925 (2004)......................................... 23 V Case—Continued: Page Zauderer v. Office of Disciplinary Counsel, 471 U.S. 626 (1985) ................................................... 11, 14, 18 Constitution, statutes, regulations and rule: U.S. Const. Amend. I ..................................................... passim Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111­31, Div. A, 123 Stat. 1776 ....................................................................... 2, 8, 9, 13, 23 § 2, 123 Stat. 1777-1781 (21 U.S.C. 387 note (Supp. V 2011)).................................................... passim 15 U.S.C. 1333 note (Supp. V 2011) ...................... 8, 11, 13 15 U.S.C. 1333(a)(1) note (Supp. V 2011) .........................8 15 U.S.C. 1333(a)(2) note (Supp. V 2011) .........................8 15 U.S.C. 1333(b)(1) note (Supp. V 2011) .........................8 15 U.S.C. 1333(b)(2) note (Supp. V 2011) .........................8 15 U.S.C. 1333(d) note (Supp. V 2011) ........... 8, 11, 16, 20 15 U.S.C. 4402 (Supp. V 2011) ............................... 8, 11, 13 15 U.S.C. 4402 note (Supp. V 2011) ................................19 15 U.S.C. 4402(a)(1) (Supp. V 2011) ..................................8 15 U.S.C. 4402(a)(2) (Supp. V 2011) ..................................8 15 U.S.C. 4402(b)(1) (Supp. V 2011) .................................8 15 U.S.C. 4402(b)(2) (Supp. V 2011) .................................8 15 U.S.C. 4402(d) (Supp. V 2011) ......................................8 21 U.S.C. 321(g)(1)(B) .......................................................22 21 U.S.C. 321(m) ................................................................22 21 U.S.C. 321(p) .................................................................22 21 U.S.C. 355(a) .................................................................22 21 U.S.C. 355(d) .................................................................22 21 U.S.C. 387 note (Supp. V 2011) ....................................2 21 U.S.C. 387a (Supp. V 2011) .........................................10 21 U.S.C. 387a-1(a) (Supp. V 2011) .................................10 VI Statutes, regulations and rule—Continued: Page 21 U.S.C. 387a­1(a)(2)(G) (Supp. V 2011) .......................10 21 U.S.C. 387k (Supp. V 2011) ....................... 12, 20, 21, 28 21 U.S.C. 387k(a) (Supp. V 2011) ......................................9 21 U.S.C. 387k(b) (Supp. V 2011) ....................................23 21 U.S.C. 387k(b)(1) (Supp. V 2011) .................................9 21 U.S.C. 387k(b)(2)(A) (Supp. V 2011) ............................9 21 U.S.C. 387k(d) (Supp. V 2011) ......................................9 21 U.S.C. 387k(g) (Supp. V 2011) ......................................9 21 U.S.C. 387k(g)(1)(B) (Supp. V 2011) ..........................27 21 U.S.C. 387k(g)(4) (Supp. V 2011) ...............................27 21 C.F.R.: Pt. 897 (1997) .......................................................................9 Pt. 1140 ...............................................................................10 Section 1140.16(d)............................................ 10, 13, 30 Section 1140.16(d)(1) ...................................................10 Section 1140.16(d)(2) ...................................................10 Section 1140.34 ............................................................10 Section 1140.34(a) ............................................ 10, 13, 30 Section 1140.34(c) ............................................ 10, 13, 30 Sup. Ct. R. 10 ...........................................................................31 Miscellaneous: 146 Cong. Rec. 4571 (2000) .......................................................4 150 Cong. Rec. 10,527 (2004) ....................................................6 155 Cong. Rec. (2009): p. 13,654 ..............................................................................29 p. 13,655 ............................................................................ 2, 6 pp.
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]