Policy Styles and Epistemic Policies in the Regulation of Health Claims. A Comparison of Europe, the United States, and Japan

References

• Asp, N., and S. Bryngelsson. 2008. “Health Claims in Europe: New Legislation and PASSCLAIM for Substantiation.” Journal of Nutrition 138 (6): 1210S–1215S. doi:https://doi.org/10.1093/jn/138.6.1210S.
   PubMed Web of Science ®Google Scholar
• Aven, T. 2016. “Risk Assessment and Risk Management: Review of Recent Advances on Their Foundation.” European Journal of Operational Research 253 (1): 1–13. doi:https://doi.org/10.1016/j.ejor.2015.12.023.
   Web of Science ®Google Scholar
• Bagchi, D., Ed. 2014. Nutraceutical and Functional Food Regulations in the United States and around the World. Second ed. London: Elsevier .
   Google Scholar
• Biesalski, H, P. Aggett, R. Anton, P. Bernstein, J. Blumberg, R P. Heaney, J. Henry, et al. 2011. “26th Hohenheim Consensus Conference, (September 11, 2010)—Scientific Substantiation of Health Claims: Evidence-based Nutrition.” Nutrition 27 (10): S1–S20. doi:https://doi.org/10.1016/j.nut.2011.04.002.
   PubMed Web of Science ®Google Scholar
• Blumberg, J., R. Heaney, M. Huncharek, T. Scholl, M. Stampfer, R. Vieth, C M. Weaver, et al. 2010. “Evidence-based Criteria in the Nutritional Context.” Nutrition Reviews 68 (8): 478–484. doi:https://doi.org/10.1111/j.1753-4887.2010.00307.x.
   PubMed Web of Science ®Google Scholar
• Boobis, A., A. Chiodini, J. Hoekstra, P. Lagiou, H. Przyrembel, J. Schlatter, K. Schütte, et al. 2013. “Critical Appraisal of the Assessment of Benefits and Risks for foods—BRAFO Consensus Working Group.” Food and Chemical Toxicology 55: 659–675. doi:https://doi.org/10.1016/j.fct.2012.10.028.
   PubMed Web of Science ®Google Scholar
• CAA (Consumer Affairs Agency). 2015a. The System of “Foods with Function Claims” Has Been Launched! (Guidance for Industry). Government of Japan. Accessed June 2020. https://www.caa.go.jp/policies/policy/food_labeling/information/pamphlets/pdf/151224_2.pdf
   Google Scholar
• CAA. 2015b. What are “Foods with Function Claims”? (Guidance for Consumers). Government of Japan. Accessed June 2020. https://www.caa.go.jp/policies/policy/food_labeling/information/pamphlets/pdf/151224_1.pdf
   Google Scholar
• CAC (Codex Alimentarius Commission). 2001. “Guidelines for Use of Nutrition Claims”. In Codex Guidelines for the Use of Nutrition Claims (adopted at its 22nd Session, amended at its 24th Session). FAO/WHO. http://www.fao.org/3/y2770e/y2770e07.htm#fn22 (Accessed June 2020)
   Google Scholar
• Cox, L. 2015. Breakthroughs in Decision Science and Risk Analysis. Hoboken, NJ: John Wiley & Sons.
   Google Scholar
• Cranor, C. 1997. “The Normative Nature of Risk Assessment: Features and Possibilities.” Risk: Health, Safety and Environment 8 (2): 123–136.
   Google Scholar
• De Búrca, G., and J. Scott, Eds. 2006. Law and New Governance in the EU and the US. Oxford: Hart Publishing.
   Google Scholar
• Dehousse, R. 2016. “Has the European Union Moved Towards Soft Governance?” Comparative European Politics 14: 20–35. https://link.springer.com/article/10.1057/cep.2015.7
   Web of Science ®Google Scholar
• Douglas, H. 2009. Science, Policy, and the Value-Free Ideal. Pittsburgh: University of Pittsburgh Press.
   Google Scholar
• EC (European Commission). 2001. European Governance, a White Paper (COM 428). Brussels: European Commission. https://eur-lex.europa.eu/legal-content/ES/TXT/?uri=LEGISSUM%3Al10109
   Google Scholar
• EC. 2006. From Science and Society to Science in Society. Towards a Framework for Cooperative Research. Brussels: European Commission. https://op.europa.eu/en/publication-detail/-/publication/4bd7721c-677f-457d-8ba3-9186f64c1823
   Google Scholar
• EC. 2007. Taking European Knowledge Society Seriously. Report of the Expert Group on Science and Governance to the Science, Economy and Society Directorate. Brussels: European Commission. https://op.europa.eu/en/publication-detail/-/publication/5d0e77c7-2948-4ef5-aec7-bd18efe3c442
   Google Scholar
• EC. 2008. Public Engagement in Science: Report of the Science in Society Session. Brussels: European Commission. https://op.europa.eu/en/publication-detail/-/publication/2d7d42ad-d69e-46ab-94bd-035b068ae676/language-en
   Google Scholar
• Edinger, W.H. 2016. “Promoting Educated Consumer Choices. Has EU Food Information Legislation Finally Matured?” Journal of Consumer Policy 39: 9–22. doi:https://doi.org/10.1007/s10603-015-9307-3.
   Google Scholar
• EFSA-NDA (European Food Safety Authority-Panel on Dietetic Products, Nutrition and Allergies). 2011. “General Guidance for Stakeholders on the Evaluation of Article 13.1, 13.5 And 14 Health Claims.” EFSA Journal 9 (4): 2135. doi:https://doi.org/10.2903/j.efsa.2011.2135.
   Google Scholar
• EFSA-NDA. 2016. “General Scientific Guidance for Stakeholders on Health Claim Applications.” EFSA Journal 24 (1): 4367. doi:https://doi.org/10.2903/j.efsa.2016.4367.
   Google Scholar
• Elzinga, A., and A. Jamison . 1995. “Changing Policy Agendas in Science and Technology.” In Handbook of Science and Technology Studies, edited by S. Jasanoff, G. Markle, J. Peterson and T. Pinch, 572–597. Thousand Oaks, California: Sage Publications.
   Google Scholar
• European Parliament and Council. 2006. Regulation No. 1924/of the European Parliament and of the Council on Nutrition and Health Claims Made on Foods. Vol. OJ L 404. 12 (30 December). Accessed June 2020. https://eur-lex.europa.eu/legal-content/en/ALL/?uri=CELEX%3A32006R1924
   Google Scholar
• FDA (Food and Drug Administration). 1990. Nutrition Labelling and Education Act (NLEA-1990) Public Law 101-553, 104 Sat. 2353 Codified at 21 USC 343 (1993). Accessed September 2019.
   Google Scholar
• FDA. 2003. Consumer Health Information for Better Nutrition Initiative: Task Force Final Report. Office of Nutrition and Food Labelling. Accessed June 2020. https://www.fda.gov/food/food-labeling-nutrition/consumer-health-information-better-nutrition-initiative-task-force-final-report
   Google Scholar
• FDA. 2009 January. Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims. Office of Nutrition and Food Labelling. Accessed September 2019. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-evidence-based-review-system-scientific-evaluation-health-claims
   Google Scholar
• Gilsenan, M.B. 2011. “Nutrition & Health Claims in the EU: A Regulatory Overview.” Trends in Food Science & Technology 22 (10): 536–542. doi:https://doi.org/10.1016/j.tifs.2011.03.004.
   Web of Science ®Google Scholar
• González‐Díaz, C., D. Gil‐González, and C. Álvarez‐Dardet. 2018. “Scientific Evidence on Functional Food and Its Commercial Communication: A Review of Legislation in Europe and the USA.” Journal of Food Science 83 (11): 2710–2717. doi:https://doi.org/10.1111/1750-3841.14359.
   PubMed Web of Science ®Google Scholar
• Greer, S., and B. Vanhercke. 2010. “The Hard Politics of Soft Law: The Case of Health.” In Health Systems Governance in Europe: The Role of European Union Law and Policy, edited by E. Mossialos, G. Permanand, R. Baeten, and T. Hervey, 186–230. Cambridge: Cambridge University Press. doi:https://doi.org/10.1017/CBO9780511750496.005.
   Google Scholar
• Gregori, D., and C. Gafare. 2012. “Multifunctional Food: Medical Evidence and Methodological Notes on Substantiating Health Claims.” International Journal of Food Sciences and Nutrition 63 (sup.1): 29–36. doi:https://doi.org/10.3109/09637486.2011.653553.
   PubMed Web of Science ®Google Scholar
• Hart, A., J. Hoekstra, H. Owen, M. Kennedy, M J. Zeilmaker, N. de Jong, and H. Gunnlaugsdottir. 2013. “Qalibra: A General Model for Food Risk-benefit Assessment that Quantifies Variability and Uncertainty.” Food and Chemical Toxicology 54:4–17. doi:https://doi.org/10.1016/j.fct.2012.11.056.
   PubMed Web of Science ®Google Scholar
• Heaney, R.P. 2008. “Nutrients, Endpoints, and the Problem of Proof.” Journal of Nutrition 138 (9): 1591–1595. doi:https://doi.org/10.1093/jn/138.9.1591.
   PubMed Web of Science ®Google Scholar
• Herrera, A. 1971. Ciencia Y Política En América Latina [Science and Policy in Latin-America]. Mexico: Siglo XXI.
   Google Scholar
• Hoffmann, D.E., C.M. Fraser, F. Palumbo, J. Ravel, et al. 2012. Federal Regulation of Probiotics: An Analysis of the Existing Regulatory Framework and Recommendations for Alternative Frameworks. Final report (rev’d January 2016). Francis King Carey School of Law, University of Maryland https://www.law.umaryland.edu/media/SOL/pdfs/Programs/Health-Law/FinalWhitePaper.pdf.
   Google Scholar
• Iwatani, S., and N. Yamamoto. 2019. “Functional Food Products in Japan: A Review.” Food Science and Human Wellness 8 (2): 96–101. doi:https://doi.org/10.1016/j.fshw.2019.03.011.
   Google Scholar
• Jasanoff, Sh. 2005. Designs on Nature: Science and Democracy in Europe and the United States. Princeton, NJ: Princeton University Press.
   Google Scholar
• Kamioka, H., K. Tsutani, H. Origasa, T. Yoshizaki, et al. 2019. “Quality of Systematic Reviews of the Foods with Function Claims in Japan: Comparative Before- and After-Evaluation of Verification Reports by the Consumer Affairs Agency.” Nutrients 11 (7): 1583. doi:https://doi.org/10.3390/nu11071583.
   Web of Science ®Google Scholar
• Knudsen, J.S. 2018. “Government Regulation of Corporate Social Responsibility: The Implications for Corporate Governance.” In Corporate Governance in Contention, edited by C. Driver and G. Thomson, 280–300. Oxford: Oxford University Press.
   Google Scholar
• Lalor, F., and G. Wall. 2011. “Health Claims Regulations. Comparison between USA, Japan and European Union.” British Food Journal 113 (2): 298–313. doi:https://doi.org/10.1108/00070701111105358.
   Web of Science ®Google Scholar
• Laudan, L. 2004. “The Epistemic, the Cognitive and the Social.” In Science, Values and Objectivity, edited by P. Machamer, and G. Wolters, 14–23. Pittsburgh: University of Pittsburgh Press.
   Google Scholar
• Luján, J.L., and O. Todt. 2020. “Standards of Evidence and Causality in Regulatory Science: Risk and Benefit Assessment.” Studies in History and Philosophy of Science Part A 80: 82–89. doi:https://doi.org/10.1016/j.shpsa.2019.05.005.
   PubMed Web of Science ®Google Scholar
• Luján, J.L., and O. Todt. 2018. “Regulatory Science: Between Technology and Society.” In Spanish Philosophy of Technology, edited by B. Laspra and J.A. López Cerezo, 59–72. Cham: Springer. doi:https://doi.org/10.1007/978-3-319-71958-0_5.
   Google Scholar
• Maeda-Yamamoto, M. 2017. “Development of Functional Agricultural Products and Use of a New Health Claim System in Japan.” Trends in Food Science & Technology 69 (Part B): 324–332. doi:https://doi.org/10.1016/j.tifs.2017.08.011.
   Web of Science ®Google Scholar
• Maggetti, M. 2015. “Hard and Soft Governance.” In Research Methods in European Union Studies, edited by K. Lynggaard, I. Manners, and K. Löfgren, 252–265. Palgrave Studies in European Union Politics. London: Palgrave Macmillan. doi:https://doi.org/10.1057/9781137316967_16.
   Google Scholar
• Magnússon, S.H., H. Gunnlaugsdottir, H. van Loveren, F. Holm, N. Kalogeras, O. Leino, J.M. Luteijn, et al. 2012. “State of the Art in Benefit-risk Analysis: Food Microbiology”. Food and Chemical Toxicology 50 (1): 33–39. doi:https://doi.org/10.1016/j.fct.2011.06.005.
   PubMed Web of Science ®Google Scholar
• Oberthür, S. 2019. “Hard or Soft Governance? The EU’s Climate and Energy Policy Framework for 2030.” Politics and Governance 7 (1): 17–27. doi:https://doi.org/10.17645/pag.v7i1.1796.
   Web of Science ®Google Scholar
• Osimani, B. 2020. “Epistemic Gains and Epistemic Games: Reliability and Higher Order Evidence in Medicine and Pharmacology.” In Uncertainty in Pharmacology. Epistemology, Methods, and Decisions, edited by A. LaCaze and B. Osimani, 345–372. Cham: Springer.
   Google Scholar
• Parker, B.J. 2003. “Food for Health - the Use of Nutrient Content, Health, and Structure/Function Claims in Food Advertisements.” Journal of Advertising 32 (3): 47–55. doi:https://doi.org/10.1080/00913367.2003.10639135.
   Web of Science ®Google Scholar
• Radaelli, C., and A. Meuwese. 2010. “Hard Questions, Hard Solutions: Proceduralisation through Impact Assessment in the EU.” West European Politics 33 (1): 136–153. doi:https://doi.org/10.1080/01402380903354189.
   Web of Science ®Google Scholar
• Rapp, M.S., T. Schmid, and M. Wolff. 2011. “Hard or Soft Regulation of Corporate Governance?” HHL Research Paper Series in Corporate Governance 6: 1–38. doi:https://doi.org/10.2139/ssrn.1930847.
   Google Scholar
• Richardson, J., Ed. 1982. Policy Styles in Western Europe. London: George Allen and Unwin.
   Google Scholar
• Senden, L. 2005. “Soft Law, Self-regulation and Co-regulation in European Law: Where Do They Meet?” Electronic Journal of Comparative Law 9 (1): 1–27.
   Google Scholar
• Shimizu, T. 2014. History and Current Status of Functional Food Regulations in Japan Ed. D. Bagchi, 257–299.
   Google Scholar
• Shimizu, T. 2015. “Health Claims Regulation and Scientific Substantiation of Functional Foods and the International Comparison.” In Clinical Aspects of Functional Foods and Nutraceuticals, edited by D. Ghosh, D. Bagchi, and T. Konishi, 217–226. Boca Ratón: CRC Press.
   Google Scholar
• Shrader-Frechette, K. 2010. “Conceptual Analysis and Special-interest Science.” Synthese 177: 449–469. doi:https://doi.org/10.1007/s11229-010-9792-5.
   Web of Science ®Google Scholar
• Tijhuis, M.J., M. Pohjola, H. Gunnlaugsdóttir, N. Kalogeras, O. Leino, J.M. Luteijn, S.H. Magnússon, et al. 2012. “Looking beyond Borders: Integrating Best Practices in Benefit-risk Analysis into the Field of Food and Nutrition.” Food and Chemical Toxicology 50 (1): 77–93. doi:https://doi.org/10.1016/j.fct.2011.11.044.
   PubMed Web of Science ®Google Scholar
• Todt, O., and J.L. Luján. 2017. “Health Claims and Methodological Controversy in Nutrition Science.” Risk Analysis 37 (5): 958–968. doi:https://doi.org/10.1111/risa.12665.
   PubMed Web of Science ®Google Scholar
• US DC Circuit (United States Court of Appeals, District of Columbia Circuit). 1999. Durk PEARSON and Sandy Shaw, American Preventive Medical Association and Citizens for Health, Appellants, Vs. Donna E. SHALALA, Secretary, United States Department of Health and Human Services, Et Al., Appellees. No. 98 No. 98-5043, 98-5084. Decided: 15 January 1999. Accessed January 2019 15. https://law.justia.com/cases/federal/appellate-courts/F3/172/72/599421/
   Google Scholar
• Weingart P., M. Joubert, and K. Connoway. 2021. ”Public engagement with science—Origins, motives and impact in academic literature and science policy.” PLoS ONE 16 (7): e0254201 https://doi.org/https://doi.org/10.1371/journal.pone.0254201.
   PubMed Web of Science ®Google Scholar
• Yamada, K., N. Sato-Mito, J. Nagata, and K. Umegaki. 2008. “Health Claim Evidence Requirements in Japan”. Journal of Nutrition 138 (6): 1192S–19. doi:https://doi.org/10.1093/jn/138.6.1192S.
   PubMed Web of Science ®Google Scholar