Consumer Behavior and FDA Regulation of Food,

Drugs and TobaccoSaul Shiffman, Ph.D.Senior Scientific Advisor

Pinney Associates&

Professor of Psychology and Pharmaceutical SciencesUniversity of Pittsburgh

Regulatory Objectives

• Food: safety• Drugs: safety, efficacy• Tobacco: protection of public health

FOODOTC DRUG

TOBACCO

Food

• Informational• Technical• Quantitative• Non-evaluative• Non-directive

OTC Drug

• Evaluative• Highly directive

Tobacco• Informational• Technical • Mildly evaluative• Non-directive

• Informational• Provocative • Motivational• Directive

Tobacco

• Location, location, location

• Size matters

Comparison

Labeling Tobacco Like OTCs

Do not use

Labeling Tobacco Like FoodSome Ingredients in Cigarettes

Compounds Identified by FDA as Potentially HarmfulAcetaldehydeAcetamideAcetoneAcroleinAcrylamideAcrylonitrileAflatoxin B14-Aminobiphenyl1-Aminonaphthalene2-AminonaphthaleneAmmoniaAnabasineo-AnisidineArsenicA-α-C (2-Amino-9H-pyrido[2,3-b]indole)Benz[a]anthraceneBenz[j]aceanthryleneBenzeneBenzo[b]fluorantheneBenzo[k]fluorantheneBenzo[b]furanBenzo[a]pyreneBenzo[c]phenanthreneBeryllium

1,3-ButadieneCadmiumCaffeic acidCarbon monoxideCatecholChlorinated dioxins/furansChromiumChryseneCobaltCoumarinCresols (o-, m-, and p-cresol)CrotonaldehydeCyclopenta[c,d]pyreneDibenz[a,h]anthraceneDibenzo[a,e]pyreneDibenzo[a,h]pyreneDibenzo[a,i]pyreneDibenzo[a,l]pyrene2,6-DimethylanilineEthyl carbamate (urethane)EthylbenzeneEthylene oxideFormaldehydeFuran

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)HydrazineHydrogen cyanideIndeno[1,2,3-cd]pyreneIQ (2-Amino-3-methylimidazo[4,5-f]quinoline)IsopreneLeadMeA-α-C (2-Amino-3-methyl)-9H-pyrido[2,3-b]indole)MercuryMethyl ethyl ketone5-Methylchrysene4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK)NaphthaleneNickelNicotine

NitrobenzeneNitromethane2-NitropropaneN-Nitrosodiethanolamine (NDELA)N-NitrosodiethylamineN-Nitrosodimethylamine (NDMA)N-NitrosomethylethylamineN-Nitrosomorpholine (NMOR)N-Nitrosonornicotine (NNN)N-Nitrosopiperidine (NPIP)N-Nitrosopyrrolidine (NPYR)N-Nitrososarcosine (NSAR)NornicotinePhenolPhIP (2-Amino-1-methyl-6-phenylimidazo[4,5-b]pyridine)Polonium-210 PropionaldehydePropylene oxideQuinolineSelenium…..Styreneo-ToluidineTolueneTrp-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-235Uranium-238Vinyl acetateVinyl chloride

Modified Risk Tobacco Products

• Reduction in exposure• Reduction in risk

20%

believe

completely

safe

Rx Drugs Still Administered by ConsumerStandards for Rx Patient Information

Evaluating OTC Labeling

• Show consumers the label• Test their understanding• Include people with limited literacy skills

• 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

Beyond “Labeling”

Labeling, Regulation, and Individual Choice

Known Human Carcinogens in Cigarette Smoke(Among 4,000+ chemical constituents)

Chemical Amount (per cigarette)

Acetaldehyde 980 micrograms to 1.37 milligrams

4-Aminobiphenyl 0.2 to 23 nanogramso-Anisidine hydrochloride unknownArsenic unknownBenzene 5.9 to 75 microgramsBeryllium 0.5 nanograms1,3-Butadiene 152 to 400 microgramsCadmium 1.7 micrograms1,1-Dimethylhydrazine unknownEthylene oxide unknownFormaldehyde unknownFuran unknownHeterocyclic amines unknownHydrazine 32 microgramsIsoprene 3.1 milligrams

Chemical Amount (per cigarette)Lead unknown2-Naphthylamine 1.5 to 35 nanogramsNitromethane unknownN-Nitrosodi-n-butylamine 3 nanogramsN-Nitrosodiethanolamine 24 to 36 nanogramsN-Nitrosodiethylamine up to 8.3 nanogramsN-Nitrosodimethylamine 5.7 to 43 nanogramsN-Nitrosodi-n-propylamine 1 nanogram4-(N-Nitrosomethylamino)-1-(3-pyridyl)-1-butanone

up to 4.2 micrograms

N-Nitrosonornicotine 14 microgramsN-Nitrosopiperidine unknownN-Nitrosopyrrolidine 113 nanogramsN-Nitrososarcosine 22 to 460 nanograms

Polonium-210 variable,

Polycyclic aromatic hydrocarbons 28 to 100 milligramso-Toluidine 32 nanogramsVinyl chloride 5.6 to 27 nanograms