Proportionality in Public Health Regulation: The Case of Dietary Supplements
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The idea that the degree of infringement public health interventions have on individual rights should be proportional to the degree of expected benefits has emerged as an influential principle in public health ethics and policy. While proportionality makes sense in theory, it may be difficult to implement in practice, due to the inherent conflict between individual rights and the common good underlying the principle. To apply the proportionality principle to a decision of policy, one must still find a reasonable way of balancing these competing values in light of the available options and empirical evidence. In this article, I consider how the proportionality principle applies to the regulation of dietary supplements and examine some critiques of the current oversight system. I argue that it may be difficult maintain proportional oversight because the risks of dietary supplements vary considerably. Strengthening the regulations may therefore promote an appropriate level of regulation in some cases but lead to overregulation in others.
KeywordsDietary supplements Public health Safety Regulation Proportionality Ethics Consumer choice
This research was supported by the Intramural Program of the National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH). It does not represent the views of the NIEHS, NIH, or US government. I am grateful to Bruce Androphy, Mark Miller, Shepherd Schurman and Mary Wolfe for helpful comments.
Compliance with Ethical Standards
Conflict of Interest
The author has no conflicts of interest to disclose.
- Abdel-Rahman, A., N. Anyangwe, L. Carlacci, S. Casper, R.P. Danam, E. Enongene, G. Erives, D. Fabricant, R. Gudi, C.J. Hilmas, F. Hines, P. Howard, D. Levy, Y. Lin, R.J. Moore, E. Pfeiler, T.S. Thurmond, S. Turujman, and N.J. Walker. 2011. The safety and regulation of natural products used as foods and food ingredients. Toxicological Sciences 123 (2): 333–348.CrossRefGoogle Scholar
- Bradley J. 2015. NBJ: ‘The US supplement industry is $37 billion, not 12 billion’. Nutrition Business Journal, June 1, 2015. Available at: http://www.nutraingredients-usa.com/Markets/NBJ-The-US-supplement-industry-is-37-billion-not-12-billion. Accessed 23 Dec 2016.
- Council for Responsible Nutrition. 2016a. Economic impact of the dietary supplement industry. Available at: https://www.crnusa.org/resources/economic-impact-dietary-supplement-industry. Accessed 30 Dec 2016.
- Council for Responsible Nutrition. 2016b. Voluntary guidelines/best practices. Available at: https://www.crnusa.org/self-regulation/voluntary-guidelines-best-practices. Accessed 30 Dec 2016.
- Daemmrich, A.A. 2004. Pharmacopolitics: drug regulation in the United States and Germany. Chapel Hill: University of North Carolina Press.Google Scholar
- Dawson, A., ed. 2011. Public health ethics. Cambridge: Cambridge University Press.Google Scholar
- Dietary Supplement Health and Education Act. 1994. Public Law 103–417.Google Scholar
- Faden R, Shebeya S. 2015. Public health ethics. Stanford encyclopedia of philosophy. Available at: https://plato.stanford.edu/entries/publichealth-ethics/. Accessed 1 Sept 2017.
- Food and Drug Administration. 2017. Glossary of terms. Available at: https://www.fda.gov/drugs/informationondrugs/ucm079436.htm. Accessed 1 Sept 2017.
- Hawthorne, F. 2005. Inside the FDA: the business and politics behind the drugs we take and the food we eat. New York: Wiley.Google Scholar
- Holland, S. 2015. Public health ethics. 2nd ed. Cambridge: Polity Press.Google Scholar
- Institute for Safe Medication Practices. 2015. Special report: A critique of FDA’s key drug safety reporting system. QuarterWatch, January 29, 2015. Available at: https://www.ismp.org/newsletters/acutecare/showarticle.aspx?id=100. Accessed 28 Dec 2016.
- Institute of Medicine. 2012. Ethical and scientific issues in studying the safety of approved drugs. Washington, DC: National Academies Press.Google Scholar
- Mayo Clinic. 2016. Statin side effects: weight the benefits and risks. Available at: http://www.mayoclinic.org/diseases-conditions/high-blood-cholesterol/in-depth/statin-side-effects/art-20046013. Accessed 29 Dec 2016.
- Mendeloff, J. 1981. Does overregulation cause underregulation? Regulation 5 (September–October): 47–52.Google Scholar
- Miller, H.I. 2000. To America’s health: a proposal to reform the food and drug administration. Stanford: Hoover Institution Press.Google Scholar
- National Center for Complementary and Integrative Medicine. 2016. Red yeast rice. Available at: https://nccih.nih.gov/health/redyeastrice. Accessed 29 Dec 2016.
- National Institutes of Health. 2016. Office of Dietary Supplements. ODS Research Portfolio. Available at: https://ods.od.nih.gov/Funding/Grants__Contracts.aspx. Accessed 26 Dec 2016.
- National Safety Foundation. 2017. Dietary supplements. Available at: https://www.nsf.org/services/by-industry/dietary-supplements. Accessed 4 Jan 2017.
- National Toxicology Program. 2016. NTP Botanical Dietary Supplements Program. Available at: https://www.niehs.nih.gov/health/materials/ntp_botanical_fact_new_508.pdf. Accessed 26 Dec 2016.
- Natural Products Insider. 2016. FDA data: supplement cGMP compliance rates show modest improvement. Available at: https://www.naturalproductsinsider.com/news/2014/02/fda-data-supplement-cgmp-compliance-rates-show-mo.aspx. Accessed 27 Dec 2016.
- New York Task Force on Life and Law. 2005. Dietary supplements: balancing consumer choice and safety. Available at: https://www.health.ny.gov/regulations/task_force/docs/dietary_supplement_safety.pdf. Accessed 22 Dec 2016.
- Nuffield Council on Bioethics. 2007. Public health: ethical issues. London: Nuffield Council.Google Scholar
- Office of Dietary Supplements. 2016a. Vitamin D. Available at: https://ods.od.nih.gov/factsheets/VitaminD-Consumer/. Accessed 29 Dec 2016.
- Office of Dietary Supplements. 2016b. Folate. Available at: https://ods.od.nih.gov/factsheets/Folate-HealthProfessional/. Accessed 29 Dec 2016.
- Office of Inspector General. 2003. Dietary supplement labels: an assessment. Washington, DC: US Department of Health and Human Services, Office of Inspector General.Google Scholar
- Schüklenk, U. 2000. Access to experimental drugs in terminal illness: ethics issues. Binghamton: Haworth Press.Google Scholar
- Shanahan C, de Lorimier R. 2013. Smart prevention: health care cost savings associated with targeted use of dietary supplements. Report prepared by Frost & Sullivan for the Council for Responsible Nutrition. Available at: https://www.crnusa.org/sites/default/files/pdfs-hccs/SmartPrevention-fullreport0913.pdf. Accessed 29 Dec 2016.
- Tufts Center for the Study of Drug Development. 2016. Press release, March 10, 2016: Tufts CSDD assessment of cost to develop and win marketing approval for a new drug now published. Available at: http://csdd.tufts.edu/news/complete_story/tufts_csdd_rd_cost_study_now_published. Accessed 28 Dec 2016.
- US Government Accountability Office. 2010. Herbal dietary supplements: examples of deceptive or questionable marketing practices and potentially dangerous advice. Washington, DC: US Government Accountability Office.Google Scholar
- US Government Accountability Office. 2013. Dietary supplements—FDA may have opportunities to expand its use of reported health problems to oversee products. Washington, DC: US Government Accountability Office.Google Scholar
- World Health Organization. 2007. Ethical considerations in developing a public health response to pandemic influenza. Available at: http://apps.who.int/iris/bitstream/10665/70006/1/WHO_CDS_EPR_GIP_2007.2_eng.pdf. Accessed 5 Sept 2017.
- Young, K.A. 2014. Of poops and parasites: unethical FDA overregulation. Food and Drug Law Journal 69 (4): 555–574.Google Scholar