The authors offer a framework rooted in behavioral decision research for the evaluation and regulation of communications. The approach considers consumer interpretations of product communications, the sensitivity of choice to such judgments, and the acceptability of misunderstanding to regulators.
BarryM.J., FowlerF.J.Jr., O'LearyM.P., BruskewitzR.C., HoltgreweH.L., MebustW.K., and CockettA.T. (1992), “The American Urological Association Symptom Index for Benign Prostatic Hyperplasia,”Journal of Urology, 148(5), 1549–57.
3.
BarryM.J., FowlerF.J.Jr., MulleyA.G.Jr., HendersonJ.V.Jr., and WennbergJ.E. (1995), “Patient Reactions to a Program Designed to Facilitate Patient Participation in Treatment Decisions for Benign Prostatic Hyperplasia,”Medical Care, 33(8), 771–82.
4.
CalfeeJohn E., and PappalardoJanis K. (1991), “Public-Policy Issues in Health Claims for Foods,”Journal of Public Policy & Marketing, 10(Spring), 33–53.
5.
CamererColin, IssacharoffSamuel, LoewensteinGeorge, O'DonoghueTed, and RabinMatthew (2003), “Regulation for Conservatives: Behavioral Economics and the Case for ‘Asymmetric Paternalism,’”University of Pennsylvania Law Review, 151(3), 1211–54.
6.
CasmanElizabeth, FischhoffBaruch, PalmgrenClaire, SmallMitchell, and WuFelicia (2000), “Integrated Risk Model of a Drinking Waterborne Cryptosporidiosis Outbreak,”Risk Analysis, 20(4), 493–509.
7.
CoxEli P.III, WogalterMichael S., StokesSara L., and Tipton MurffElizabeth J. (1997), “Do Product Warnings Increase Safe Behavior? A Meta-Analysis,”Journal of Public Policy & Marketing, 16(2), 195–204.
8.
DawesRobyn M. (1979), “Robust Beauty of Improper Linear Models in Decision Making,”American Psychologist, 34(7), 571–82.
9.
Dietary Supplement Health and Education Act (1994), Public Law Number 103-417, 108 Stat. 4325.
10.
EmordJonathan W. (2000), “Pearson v. Shalala: The Beginning of the End for FDA Speech Suppression,”Journal of Public Policy & Marketing, 19(Spring), 139–43.
11.
ErnstEdzard (2002), “The Risk-Benefit Profile of Commonly Used Herbal Therapies: Ginkgo, St. John's Wort, Ginseng, Echinacea, Saw Palmetto, and Kava,”Annals of Internal Medicine, 136(1), 42–53.
12.
FDA (1999a), “Food Labeling: Health Claims and Label Statements for Dietary Supplements; Strategy for Implementation of Pearson Court Decision,” Docket No. 91N-100H, Federal Register, 64(230), (December 1).
13.
FDA (1999b), “Guidance for Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements,” (December 22), (accessed December 2002), [available at http://www.cfsan.fda.gov/∼dms/ssaguide.html].
14.
FDA (2000a), “Dietary Supplement Claim for Saw Palmetto Extract and Benign Prostatic Hyperplasia: Denied,” (May 26), (accessed May 2002), [available at http://www.cfsan.fda.gov/∼dms/dspltr01.html].
15.
FDA (2000b), “Regulations on Statements Made for Dietary Supplements Concerning the Effect of the Product on the Structure or Function of the Body,” Docket No. 98N-0044, Federal Register, 65(4), (January 6).
16.
FDA (2002a), “Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach,” (accessed November 2003), [available at http://www.fda.gov/oc/guidance/gmp.html].
17.
FDA (2002b), “Guidance for Industry: Structure/Function Claims Small Entity Compliance Guide,” (accessed January 2003), [available at http://www.fda.gov].
18.
FDA (2002c), “Guidance for Industry: Qualified Health Claims in the Labeling of Conventional Foods and Dietary Supplements,” (December 18), (accessed January 2003), [available at http://vm.cfsan.fda.gov/∼dms/hclmgui2.html].
FischhoffBaruch (1977), “Cognitive Liabilities and Product Liability,”Journal of Products Liability, 1(3), 207–219.
21.
FischhoffBaruch (1984), “Setting Standards—A Systematic Approach to Managing Public Health and Safety Risks,”Management Science, 30(7), 823–43.
22.
FischhoffBaruch (1992), “Giving Advice: Decision Theory Perspectives on Sexual Assault,”American Psychologist, 47(4), 577–88.
23.
FischhoffBaruch (1999), “Why (Cancer) Risk Communication Can Be Hard,”Journal of the National Cancer Institute Monographs, 25, 7–13.
24.
FischhoffBaruch (2000), “Scientific Management of Science?”Policy Sciences, 33(1), 73–87.
25.
FischhoffBaruch (in press), “Cognitive Issues in Stated Preference Methods,” inHandbook of Environmental Economics, MälerK.-G., and VincentJ., eds. Amsterdam: Elsevier.
26.
FischhoffBaruch, BostromAnn, and QuadrelMarilyn J. (2002), “Risk Perception and Communication,” in Oxford Textbook of Public Health, DetelsR., McEwenJ., BeagleholeR., and TanakaH., eds. London: Oxford University Press.
27.
FischhoffBaruch, RileyDonna, KovackDan C., and SmallMitchell (1998), “What Information Belongs in a Warning?”Psychology and Marketing, 15(October), 663–86.
28.
FurnhamAdrian (1988), Lay Theories: Everyday Understanding of Problems in the Social Sciences.New York: Pergamon Press.
29.
General Accounting Office (2000), “Food Safety: Improvements Needed in Overseeing the Safety of Dietary Supplements and ‘Functional Foods,’” Research Report RCED-00-156, General Accounting Office, (July 11).
30.
GentnerDedre, and StevensAlbert (1983), Mental Models.Hills-dale, NJ: Lawrence Erlbaum Associates.
31.
GilovichThomas, GriffinDale, and KahnemanDaniel, eds. (2002), Heuristics and Biases: The Psychology of Intuitive Judgment.New York: Cambridge University Press.
32.
GlickmanTheodore S., and GoughMichael, eds. (1990), Readings in Risk.Washington, DC: Resources for the Future.
GreigerConstance (1998), “Health Claims: History, Current Regulatory Status, and Consumer Research,”Journal of the American Dietetic Association, 98(11), 1312–22.
35.
HansonJon, and KeysarDouglas (1999), “Taking Behavioralism Seriously: The Problem of Market Manipulation,”New York University Law Review, 4(3), 630–749.
36.
HastieReid, and DawesRobyn M. (2001), Rational Choice in an Uncertain World.Thousand Oaks, CA: Sage Publications.
37.
JollsChristine, SunsteinCass R., and ThalerRichard (1998), “A Behavioral Approach to Law and Economics,”Stanford Law Review, 50(5), 1471–1550.
38.
KahnemanDaniel, SlovicPaul, and TverskyAmos, eds. (1982), Judgment Under Uncertainty: Heuristics and Biases.New York: Cambridge University Press.
39.
LoewensteinGeorge, and LernerJennifer S. (2003), “The Role of Affect in Decision Making,” in Handbook of Affective Science, DavidsonR., SchererK., and GoldsmithH., eds. New York: Oxford University Press, 619–42.
40.
MarksLeonard S., PartinAlan W., EpsteinJonathan I., TylerVarro E., SimonInpakala, MacairanMaria L., ChanTheresa C., DoreyFrederick J., GarrisJoel B., VeltriRobert W., BryanPaul, SantosC., StonebrookKerry A., and deKernionJean B. (2000), “Effects of a Saw Palmetto Herbal Blend in Men with Symptomatic Benign Prostatic Hyperplasia,”Journal of Urology, 163(May), 1451–56.
41.
MasonMarlys J., and ScammonDebra L. (2000), “Health Claims and Disclaimers: Extended Boundaries and Research Opportunities in Consumer Interpretation,”Journal of Public Policy & Marketing, 19(Spring), 144–50.
42.
MellersBarbara, SchwartzAlan, and RitovIlana (1999), “Emotion-Based Choice,”Journal of Experimental Psychology: General, 128(3), 332–45.
43.
MerzJon F., and FischhoffBaruch (1990), “Informed Consent Does Not Mean Rational Consent: Cognitive Limitations on Decision Making,”Journal of Legal Medicine, 11(3), 321–50.
44.
MerzJon F., FischhoffBaruch, MazurDennis J., and FischbeckPaul (1993), “Decision-Analytic Approach to Developing Standards of Disclosure for Medical Informed Consent,”Journal of Toxics and Liability, 15, 191–215.
45.
MoormanChristine (1996), “A Quasi Experiment to Assess the Consumer and Informational Determinants of Nutrition Information Processing Activities: The Case of the Nutrition Labeling and Education Act,”Journal of Public Policy & Marketing, 15(Spring), 28–44.
46.
MorganM. Granger, FischhoffBaruch, BostromAnn, and AtmanCynthia (2001), Risk Communication: A Mental Models Approach.New York: Cambridge University Press.
47.
National Academy of Sciences (1994), Science and Judgment in Risk Analysis.Washington, DC: National Academies Press.
48.
Nutrition Labeling and Education Act (1990), Public Law Number 101-535, 104 Stat. 2353.
49.
PayneJohn W., BertmanJames R., and JohnsonEric J. (1993), The Adaptive Decision Maker.Cambridge, UK: Cambridge University Press.
50.
Pearson v. Shalala (1999), 164 F.3d 650 (D.C. Cir.).
51.
RileyDonna M., FischhoffBaruch, SmallMitchell, and FischbeckPaul (2001), “Evaluating the Effectiveness of Risk-Reduction Strategies for Consumer Chemical Products,”Risk Analysis, 21(2), 357–69.
52.
SchulzM.W., ChenJ., WooH.H., KeechM., WatsonM.E., and DaveyP.J. (2002), “A Comparison of Techniques in Patients with Benign Prostatic Hyperplasia,”Journal of Urology, 168(July), 155–59.
53.
SimonHerbert A. (1957), Models of Man.New York: John Wiley & Sons.
54.
SlovicPaul (1987), “Perception of Risk,”Science, 236(4799), 280–85.
55.
TengsTammy O., and WallaceAmy (2000), “One Thousand Health-Related Quality-of-Life Estimates,”Medical Care, 38(6), 583–637.
56.
VladeckDavid C. (2000), “Truth and Consequences: The Perils of Half-Truths and Unsubstantiated Health Claims for Dietary Supplements,”Journal of Public Policy & Marketing, 19(Spring), 132–38.
57.
von WinterfeldtDetlof, and EdwardsWard (1986), Decision Analysis and Behavioral Research.New York: Cambridge University Press.
58.
WiltTimothy J., IshaniAreef, StarkGerold, MacDonaldRoderick, LauJoseph, and MulrowCynthia (1998), “Saw Palmetto Extracts for Treatment of Benign Prostatic Hyperplasia,”Journal of the American Medical Association, 280(18), 1604–1609.
59.
WimisbergJacob, DownsJulie S., CookRobert L., and DawesRobyn M. (2002), “Which Disease Do You Prefer? Measuring Individual Differences in Preferences for Health States,” paper presented at the annual conference of the Society for Judgment and Decision Making, Kansas City, Missouri (November 24–25).
60.
WogalterMichael S., YoungSteven, and LaugheryKenneth R., eds. (2001), Human Perspectives on Warnings, Vol. 2. Santa Monica, CA: Human Factors and Ergonomics Society.
61.
StevenWoloshin, and SchwartzLisa M. (1999), “How Can We Help Patients Make Sense of Medical Data?”Effective Clinical Practice, 2, 176–83.