1. Consumer Demand Conference Potential FDA Regulation Mitch Zeller PinneyAssociates May 4, 2007

2. Past Legislative/Regulatory Efforts 1996: FDA assertion of jurisdiction –Overturned by U.S. Supreme Court in 2000 1997/1998: Provisions in proposed settlement of state lawsuits requiring legislative codification –Resulted in McCain bill –A divided public health community –Collapsed under its own weight on Senate floor 2004/2005: Kennedy/DeWine and farmer buy- out “marriage of convenience” –Buy-out passed; FDA failed

3. Current Legislative Effort Essentially same bill as Kennedy/DeWine Vastly different political environment –Democratic control of House and Senate –Supported by broad coalition of public health groups (and Philip Morris) –Views of Bush Administration not known

4. Key Provision Related to Treatment Non-binding language that urges FDA to take a more flexible approach to the review of NRT, including: –Fast track evaluation and approval –Extended duration of use –Additional indications, including craving relief and relapse prevention Will serve as platform to call attention over time to Congress' intent Can be used as reason for ongoing Congressional scrutiny of FDA behavior if agency continues “business as usual” approach Does not guarantee a change in agency behavior, but has worked in the past with FDA

5. Key Provisions on Tobacco Pre-market evaluation of any express or implied health claim for tobacco products under rigorous scientific standards Ban the use of “light” and similar descriptors Authorization for warning labels on up to 50% of the front and back package panels

6. Prospects for Passage Conventional wisdom puts it as high as 50/50 No target date for passage Senate mark-up scheduled for April 25 postponed until late May/early June House action not yet underway

7. Implications Passage of the bill will “level the playing field,” especially if FDA honors the language regarding treatment Rigorous pre-market evaluation of tobacco health claims minimizes chances of a repeat of the “lights” public health disaster –Two generations of would-be quitters were lost to the false promise of “lights”