1. FDA’s Center for Tobacco Products Overview of FDA’s Authority and Current Enforcement Activities July 25, 2012

2. The Center for Tobacco Products www.fda.gov/tobacco Overview of the Family Smoking Prevention and Tobacco Control Act or “TCA” http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegu latoryInformation/UCM246207.pdf TCA Timeline http://www.tobaccofreekids.org/content/what_we_do/federal_issues/fda/fda _effective_dates.pdf

3. Center for Tobacco Products (CTP) Regulatory Authority Includes products made or derived from tobacco intended for human consumption Current statutory jurisdiction limited to cigarettes, roll-your-own, & smokeless tobacco Intends to assert jurisdiction over all tobacco products—e-cigs and Other Tobacco Products (OTPs) in the future

4. Current Enforcement of TCA Includes Ban on: Artificial or natural flavors Light/Low/Mild descriptors Vending machine or self-service displays of cigarettes or smokeless tobacco except in adult-only facilities Single cigarette sales

5. Current Enforcement of TCA includes Ban on: Sales of tobacco to minors No free samples with tobacco purchase Rebates or coupon redemption by mail Non-tobacco items bearing tobacco brand name Tobacco brand sponsorship of events

6. Future CTP Enforcement Smokeless Tobacco Packaging and Advertising Restrictions Status: New, larger format for warning labels on packages are in effect but not currently enforced by FDA Commissioned Inspectors – can be reported independently by the public New Cigarette Graphic Health Warnings Status: Case of R.J. Reynolds Tobacco Co. vs. U.S. Food and Drug Administration is on appeal http://www.fda.gov/downloads/TobaccoProducts/GuidanceCompli anceRegulatoryInformation/UCM293291.pdf

7. Future CTP Enforcement – (via rule-making process) Cigars Dissolvable Tobacco – Strips, Orbs and NicoSpan Pipe Tobacco Electronic Cigarettes Hookah Pipe Flavored RYO papers

8. But what about… Menthol FDA Tobacco Products Scientific Advisory Committee (TPSAC) report Report FAQ: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials /TobaccoProductsScientificAdvisoryCommittee/UCM247652.pdf http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials /TobaccoProductsScientificAdvisoryCommittee/UCM247652.pdf Internal FDA review process underway – no date set for response Dissolvable Products TPSAC Report: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials /TobaccoProductsScientificAdvisoryCommittee/UCM295994.pdf http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials /TobaccoProductsScientificAdvisoryCommittee/UCM295994.pdf Committee acknowledges need for continued information gathering, surveillance and research

9. Electronic Cigarettes Falls under FDA jurisdiction and it intends to propose legislation to extend the Agency’s “tobacco product” authorities in Chapter IX of the FD&C Act. http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm252360.htm Internet tobacco sales to youth Monitored by FDA Center for Tobacco Products Tobacco advertising within 1,000 feet of schools/playgrounds March 2010, FDA requested comments on outdoor advertising restrictions as included in 1996 rule FDA will use this info to inform its future regulation of outdoor advertising of cigarettes and smokeless tobacco

10. Questions? Contact: Linda Nordeen at (517) 335-8386 or nordeenl@michigan.gov nordeenl@michigan.gov

11. Additional Resources Want to know which Michigan retailers have been inspected under FDA? http://www.accessdata.fda.gov/scripts/oce/inspections/oc e_insp_searching.cfm http://www.accessdata.fda.gov/scripts/oce/inspections/oc e_insp_searching.cfm Retailers with RYO machines must be licensed as Manufacturer (Federal and State) http://www.ttb.gov/announcements/ttb_announcement_ryo_tobacco_noti ce.pdf (Federal) http://www.ttb.gov/announcements/ttb_announcement_ryo_tobacco_noti ce.pdf http://www.michigan.gov/documents/taxes/Public_Act_188_of_2012_Not ice_391321_7.pdf (State) http://www.michigan.gov/documents/taxes/Public_Act_188_of_2012_Not ice_391321_7.pdf