FDA’s Center for Tobacco Products

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/GuidanceComplianceRegulatoryInformation/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/GuidanceComplianceRegulatoryInformation/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 • Internal FDA review process underway – no date set for response • Dissolvable Products • TPSAC Report: 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

11. Additional Resources • Want to know which Michigan retailers have been inspected under FDA? • http://www.accessdata.fda.gov/scripts/oce/inspections/oce_insp_searching.cfm • Retailers with RYO machines must be licensed as Manufacturer (Federal and State) • http://www.ttb.gov/announcements/ttb_announcement_ryo_tobacco_notice.pdf (Federal) • http://www.michigan.gov/documents/taxes/Public_Act_188_of_2012_Notice_391321_7.pdf (State)