1. Consumer Behavior and FDA Regulation of Food, Drugs and Tobacco Saul Shiffman, Ph.D. Senior Scientific Advisor Pinney Associates & Professor of Psychology and Pharmaceutical Sciences University of Pittsburgh

2. Regulatory Objectives Food: safety Drugs: safety, efficacy Tobacco: protection of public health

3. FOOD OTC DRUG TOBACCO

4. Food Informational Technical Quantitative Non-evaluative Non-directive

5. OTC Drug Evaluative Highly directive

6. Tobacco Informational Technical Mildly evaluative Non-directive Informational Provocative Motivational Directive

7. Tobacco Location, location, location Size matters

8. Comparison

9. Labeling Tobacco Like OTCs Do not use

10. Labeling Tobacco Like Food Some Ingredients in Cigarettes

11. Compounds Identified by FDA as Potentially Harmful Acetaldehyde Acetamide Acetone Acrolein Acrylamide Acrylonitrile Aflatoxin B1 4-Aminobiphenyl 1-Aminonaphthalene 2-Aminonaphthalene Ammonia Anabasine o-Anisidine Arsenic A-α-C (2-Amino-9H- pyrido[2,3-b]indole) Benz[a]anthracene Benz[j]aceanthrylene Benzene Benzo[b]fluoranthene Benzo[k]fluoranthene Benzo[b]furan Benzo[a]pyrene Benzo[c]phenanthrene Beryllium 1,3-Butadiene Cadmium Caffeic acid Carbon monoxide Catechol Chlorinated dioxins/furans Chromium Chrysene Cobalt Coumarin Cresols (o-, m-, and p- cresol) Crotonaldehyde Cyclopenta[c,d]pyrene Dibenz[a,h]anthracene Dibenzo[a,e]pyrene Dibenzo[a,h]pyrene Dibenzo[a,i]pyrene Dibenzo[a,l]pyrene 2,6-Dimethylaniline Ethyl carbamate (urethane) Ethylbenzene Ethylene oxide Formaldehyde Furan Glu-P-1 (2-Amino-6- methyldipyrido[1,2-a:3',2'- d]imidazole) Glu-P-2 (2- Aminodipyrido[1,2-a:3',2'- d]imidazole) Hydrazine Hydrogen cyanide Indeno[1,2,3-cd]pyrene IQ (2-Amino-3- methylimidazo[4,5- f]quinoline) Isoprene Lead MeA-α-C (2-Amino-3- methyl)-9H-pyrido[2,3- b]indole) Mercury Methyl ethyl ketone 5-Methylchrysene 4-(Methylnitrosamino)-1-(3- pyridyl)-1-butanone (NNK) Naphthalene Nickel Nicotine Nitrobenzene Nitromethane 2-Nitropropane N-Nitrosodiethanolamine (NDELA) N-Nitrosodiethylamine N-Nitrosodimethylamine (NDMA) N-Nitrosomethylethylamine N-Nitrosomorpholine (NMOR) N-Nitrosonornicotine (NNN) N-Nitrosopiperidine (NPIP) N-Nitrosopyrrolidine (NPYR) N-Nitrososarcosine (NSAR) Nornicotine Phenol PhIP (2-Amino-1-methyl-6- phenylimidazo[4,5- b]pyridine) Polonium-210 Propionaldehyde Propylene oxide Quinoline Selenium….. Styrene o-Toluidine Toluene Trp-P-1 (3-Amino-1,4- dimethyl-5H-pyrido[4,3- b]indole) Trp-P-2 (1-Methyl-3-amino- 5H-pyrido[4,3-b]indole ) Uranium-235 Uranium-238 Vinyl acetate Vinyl chloride

12. Modified Risk Tobacco Products Reduction in exposure Reduction in risk 20% believe completely safe

13. Rx Drugs Still Administered by Consumer Standards for Rx Patient Information

15. Evaluating OTC Labeling Show consumers the label Test their understanding Include people with limited literacy skills

16. Tested Consumer Information + Med Guide + Prescribing Information in adults without college Used Label Comprehension Methods (per Guidance) Result: Symptoms of possibly fatal syndrome: 13% understood Performance of Rx Patient Information Materials

17. Beyond “Labeling”

18. Labeling, Regulation, and Individual Choice

20. Known Human Carcinogens in Cigarette Smoke (Among 4,000+ chemical constituents) ChemicalAmount (per cigarette) Acetaldehyde 980 micrograms to 1.37 milligrams 4-Aminobiphenyl0.2 to 23 nanograms o-Anisidineo-Anisidine hydrochloridehydrochlorideunknown Arsenicunknown Benzene5.9 to 75 micrograms Beryllium0.5 nanograms 1,3-Butadiene152 to 400 micrograms Cadmium1.7 micrograms 1,1-Dimethylhydrazineunknown Ethylene oxideunknown Formaldehydeunknown Furanunknown Heterocyclic aminesunknown Hydrazine32 micrograms Isoprene3.1 milligrams ChemicalAmount (per cigarette) Leadunknown 2-Naphthylamine1.5 to 35 nanograms Nitromethaneunknown N-Nitrosodi-n-butylamine 3 nanograms N-Nitrosodiethanolamine24 to 36 nanograms N-Nitrosodiethylamineup to 8.3 nanograms N-Nitrosodimethylamine5.7 to 43 nanograms N-Nitrosodi-n-propylamine1 nanogram 4-(N-Nitrosomethylamino)-1-(3- pyridyl)-1-butanone up to 4.2 micrograms N-Nitrosonornicotine14 micrograms N-Nitrosopiperidineunknown N-Nitrosopyrrolidine113 nanograms N-Nitrososarcosine22 to 460 nanograms Polonium-210variable, Polycyclic aromatic hydrocarbons28 to 100 milligrams o-Toluidine32 nanograms Vinyl chloride5.6 to 27 nanograms