1. Update on the Family Smoking Prevention and Tobacco Control Act Mike Freiberg & Joelle Lester National Association of Chronic Disease Directors General Members Call May 24, 2012

2. Agenda 1.Introduction to the Consortium 2.Overview of the Tobacco Control Act 3.Role of Tobacco Control Advocates 4.Engaging with the FDA 5.Legal Challenges to the Law

3. The Tobacco Control Legal Consortium The legal network for tobacco control policy.

4. What the law does 1.Requires tobacco industry to disclose information to government

5. What the law does 1.Requires tobacco industry to disclose information to government 2.Restricts tobacco marketing

6. What the law does 1.Requires tobacco industry to disclose information to government 2.Restricts tobacco marketing 3.Strengthens restrictions on sales to youth

7. What the law does 1.Requires tobacco industry to disclose information to government 2.Restricts tobacco marketing 3.Strengthens restrictions on sales to youth 4.More accurately informs consumers

8. What the law does 1.Requires tobacco industry to disclose information to government 2.Restricts tobacco marketing 3.Strengthens restrictions on sales to youth 4.More accurately informs consumers 5.Regulates the contents of the products

9. What the law does 1.Requires tobacco industry to disclose information to government 2.Restricts tobacco marketing 3.Strengthens restrictions on sales to youth 4.More accurately informs consumers 5.Regulates the contents of the products 6.Articulates balance with state authority

10. Role of Tobacco Control Advocates 1.Report Violations

11. Role of Tobacco Control Advocates 1.Report Violations 1-877-CTP-1373 CTPCompliance@fda.hhs.gov For General Inquiries: AskCTP@fda.hhs.gov For flavored smokeless and cigars: Tobacco2@fda.hhs.gov Mail reports (photos accepted) to: FDA Center for Tobacco Products 9200 Corporate Boulevard Rockville, MD 20850-3229

12. Role of Tobacco Control Advocates 1.Report Violations 2.State and Local Ordinances

13. Role of Tobacco Control Advocates 1.Report Violations 2.State and Local Ordinances 3.Submit Comments to the FDA

14. What is Rulemaking? Method by which agencies create federal laws Many requirements to process, including public comment Mandated by Congress vs. Initiated by Agency Steps to Process: Notice -> Comments -> Final Rule

15. Guidance Documents Do not carry the weight of law. Represent FDA’s current thinking on a topic. Used by FDA as intermediary step before enacting certain regulations

16. Commenting ≠ Lobbying Commenting on proposed regulations is probably not lobbying under federal law. “The term ‘lobbying contact’ does not include a communication that is … made in response to a notice in the Federal Register … soliciting communications from the public and directed to the agency official specifically designated in the notice to receive such communications …” Lobbying Disclosure Act of 1995, 2 U.S.C. § 1602(8)(B)(x) Each organization must consider its own limitations based on its legal structure, funding sources and relevant law.

17. What kind of information will help the FDA?

18. How do I submit comments?

19. How detailed should my comments be?

23. How are my comments used? Agency addresses comments Substantially similar rule goes into effect Significantly changed rules require further comments.

24. Current Open Dockets 1.Draft guidance document on harmful and potentially harmful constituents (HPHC) 2.Draft guidance document on modified risk tobacco products (MRTP) Deadline for both: June 4, 2012

25. Legal Challenges to Rules Successful legal challenges must show that: –The rule is arbitrary and capricious or unsupported by the record –The rule exceeds statutory authority, or –The rule is a “bolt out of the blue”

26. Legal Challenges to the Law 1.Discount Tobacco City v. FDA

27. Legal Challenges to the Law 1.Discount Tobacco City v. FDA 2.R.J. Reynolds Tobacco Company v. FDA [graphic warning labels]

28. Legal Challenges to the Law 1.Discount Tobacco City v. FDA 2.R.J. Reynolds Tobacco Company v. FDA [graphic warning labels] 3.BBK Tobacco & Foods v. FDA [flavored rolling papers]

29. Legal Challenges to the Law 1.Discount Tobacco City v. FDA 2.R.J. Reynolds Tobacco Company v. FDA [graphic warning labels] 3.BBK Tobacco & Foods v. FDA [flavored rolling papers] 4.Lorillard v. FDA [TPSAC membership]

30. Consortium Resources on Tobacco Regulation Presentations  Conferences  Webinars Publications Website action center Email alerts

31. FDA Tobacco Action Center

32. Questions? Contact us: michael.freiberg@wmitchell.edu (651) 290-7517 joelle.lester@wmitchell.edu (651) 695-7603