1. Latham & Watkins operates as a limited liability partnership worldwide with affiliated limited liability partnerships conducting the practice in the United Kingdom, France and Italy. ©Copyright 2008 Latham & Watkins. All Rights Reserved. FDA’s Regulation of The Tobacco Industry TMA’s 94 th Annual Meeting Kingsmill Resort Williamsburg, VA John R. Manthei May 18, 2009

2. 2 Family Smoking Prevention and Tobacco Control Act of 2009 The U.S. Food and Drug Administration -Office of the Commissioner -Office of the Chief Counsel -Associate Commissioner for Regulatory Affairs -Deputy Commissioner -Associate Commissioner for Policy/Legislative Affairs -District Offices (“The Field”) Center for Tobacco Control -The Center Director -“Offices” -Divisions -Branches

3. 3 The Department of Health and Human Services The Office of Management and Budget (OMB) The White House Congress -House Energy and Commerce Committee -House Government Reform and Oversight Committee -Senate Health Education, Labor, and Pensions Committee (HELP)

4. 4 The Federal Food, Drug, and Cosmetic Act -Legislative Intent – House and Senate Report Language -The Administrative Procedures Act (APA) -Rulemakings (Notice and Comment) -Implementing Guidance Documents -“Statements from the Podium” -Enforcement Actions Entitled Letters Warning Letters The Department of Justice

5. 5 Similar to the Drug and Medical Device Industries, the scope of FDA's new authority will be a complete "umbrella." Product Development, Premarket Approval, and Standards Manufacturing, Registration, and Listing Product Labels, "Labeling" and Advertising Records and Reporting Violations, and Civil and Criminal Penalties

6. 6 Premarket Development, Approvals and Standards Investigational Tobacco Product Exemptions Premarket Notification ("substantially equivalent") Premarket Review Application (“PMA”) Modified Risk Tobacco Product Tobacco Product Standards Nicotine Replacement Products

7. 7 Manufacturing/Registration/Listing Good Manufacturing Practices Facility Registration, Product Listing, and Inspections

8. 8 Labeling and Advertising Cigarette and Smokeless Tobacco Warning Labels General Labeling Requirements Labeling and Advertising of Modified Risk Tobacco Products Product Names General Advertising Requirements Free Samples Nontobacco Items and Event Sponsorship Matchbooks Retail Establishments Accessible to Children State Preemption Federal Trade Commission (FTC) Jurisdiction

9. 9 Records and Reporting Submission of Data Ingredient and Smoke Constituent Testing and Reporting Reporting of Illegal Transactions Adverse Event and Removal/Correction Reporting Tobacco Product Constituent Disclosure Confidentiality of Reported Information User Fees

10. 10 Violations and Penalties Misbranding Adulteration FDA Form 483 Facility Inspections Competitor Complaints Untitled Letters Warning Letters Recalls, Seizures, Consent Agreements (including 3 rd Party) Civil and Criminal Penalties

11. 11 Now What? Next 12 Months are Critical Actively Engage the Regulators, and Policy Makers Advocate During Each Step of the Policy Making Process