1. FDA Regulation of Tobacco Washington, DC October 21, 2015 Packaging Issues for ENDS Products James D. Baumberger, MPP, Assistant Director, Department of Federal Affairs, American Academy of Pediatrics (AAP) Cynthia Cabrera, President and Executive Director, Smoke Free Alternatives Trade Association Moderated by Ilana M. Knopf, Esq, Director Public Health and Tobacco Policy Center, Northeastern University School of Law

2. Child Resistant Packaging: Efforts in the Vapor Space

3. 2 Things… 1. Vapor Products Are Adult Products & Should Be Treated As Such 2. 1300 Smokers Die Daily

4. Support For The Poison Prevention Packaging Act Of 1970 EDUCATE INFORM PROMOTE

5. EDUCATE Liquid Nicotine = (Incorrect) E-liquid Containing A % Of Nicotine = (Correct)

6. What is “Exposure”?

7. The term "exposure" means someone has had contact with the substance in some way; for example, ingested, inhaled, absorbed by the skin or eyes, etc. Not all exposures are poisonings or overdoses.

8. INFORM E-Liquid Exposure Cases (Children Under 6 Years of Age 2013) 111

9. Top 5 Exposure Substance Categories (Children < 6 Years of Age 2013*) Cosmetics and Personal Care 148,040 Household Cleaning Substances 109,548 Analgesics 97,388 Foreign Bodies, Toys & Misc. 73,366 Topical Preparations 65,756 *2013 Annual Report of the American Association of Poison Control Centers, National Poison Data System

10. PROMOTE None of these products has the harm reduction potential that could save a smokers life….

11. Cynthia Cabrera President & Executive Director Smoke-Free Alternative Trade Association www.sfata.org 202-559-8619

12. Protecting Children from Liquid Nicotine Poisoning James D. Baumberger, MPP Assistant Director, Department of Federal Affairs American Academy of Pediatrics FDLI Tobacco Conference October 21, 2015

13. Harm to Children Liquid nicotine is extremely toxic, especially to young children Liquid nicotine is attractive to young children Dramatic rise in calls to poison control centers One-year-old boy died last year No requirement for child- resistant packaging despite effectiveness E-cigarette Device and Liquid Nicotine Reported Exposures to Poison Centers Source: American Association of Poison Control Centers

14. Regulatory Action FDA published ANPRM in July 2015 Asked for comments on child-resistant packaging and nicotine exposure warnings AAP and 43 other groups urge quick FDA action: –FDA has clear authority –FDA should take urgent action on child- resistance and warnings –FDA should consider other issues including: flavors, colors, pictures, quantity/concentration, devices

15. Legislative Action Child Nicotine Poisoning Prevention Act of 2015 Designed to address urgent hazard Requires liquid nicotine containers to meet PPPA child-resistant packaging standard within 6 months Preserves all FDA authorities under Tobacco Control Act, deeming, ANPRM If passed, FDA and CPSC must work together