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Update on the Family Smoking Prevention and Tobacco Control Act
Mike Freiberg & Joelle LesterNational Association of Chronic Disease Directors General Members CallMay 24, 2012
Agenda1.Introduction to the Consortium2.Overview of the Tobacco Control Act3.Role of Tobacco Control Advocates4.Engaging with the FDA 5.Legal Challenges to the Law
The Tobacco Control Legal Consortium
The legal network for tobacco control policy.
What the law does1.Requires tobacco industry to disclose information to government
What the law does1.Requires tobacco industry to disclose information to government
2.Restricts tobacco marketing
What the law does1.Requires tobacco industry to disclose information to government
2.Restricts tobacco marketing3.Strengthens restrictions on sales to youth
What the law does1.Requires tobacco industry to disclose information to government
2.Restricts tobacco marketing3.Strengthens restrictions on sales to youth4.More accurately informs consumers
What the law does1.Requires tobacco industry to disclose information to government
2.Restricts tobacco marketing3.Strengthens restrictions on sales to youth4.More accurately informs consumers5.Regulates the contents of the products
What the law does1.Requires tobacco industry to disclose information to government
2.Restricts tobacco marketing3.Strengthens restrictions on sales to youth4.More accurately informs consumers5.Regulates the contents of the products6.Articulates balance with state authority
Role of Tobacco Control Advocates
1.Report Violations
Role of Tobacco Control Advocates
1.Report Violations1-877-CTP-1373 CTPCompliance@fda.hhs.govFor General Inquiries:
AskCTP@fda.hhs.govFor flavored smokeless and cigars:
Tobacco2@fda.hhs.gov Mail reports (photos accepted) to:
FDA Center for Tobacco Products 9200 Corporate BoulevardRockville, MD 20850-3229
Role of Tobacco Control Advocates
1.Report Violations2.State and Local Ordinances
Role of Tobacco Control Advocates
1.Report Violations2.State and Local Ordinances3.Submit Comments to the FDA
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
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
Commenting ≠ LobbyingCommenting 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.
What kind of information will help the FDA?
How do I submit comments?
How detailed should my comments be?
How detailed should my comments be?
How detailed should my comments be?
How detailed should my comments be?
How are my comments used?
• Agency addresses comments
• Substantially similar rule goes into effect
• Significantly changed rules require further comments.
Current Open Dockets1. 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
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”
Legal Challenges to the Law1.Discount Tobacco City v. FDA
Legal Challenges to the Law1.Discount Tobacco City v. FDA2.R.J. Reynolds Tobacco Company v. FDA [graphic warning
labels]
Legal Challenges to the Law1.Discount Tobacco City v. FDA2.R.J. Reynolds Tobacco Company v. FDA [graphic warning
labels]3.BBK Tobacco & Foods v. FDA [flavored rolling papers]
Legal Challenges to the Law1.Discount Tobacco City v. FDA2.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]
Consortium Resources on Tobacco Regulation
• PresentationsConferencesWebinars
• Publications• Website action center• Email alerts
FDA Tobacco Action Center
Questions?
Contact us:
michael.freiberg@wmitchell.edu
(651) 290-7517
joelle.lester@wmitchell.edu
(651) 695-7603