This article outlines the importance of herbal dietary supplements regulation by providing a brief overview of history of supplement regulation in the US with emphasis placed on passage of the 1994 Dietary Supplement Health and Education Act (DSHEA) and post-DSHEA enforcement actions. This review also addresses international aspects of dietary supplement regulatory processes. The controversy surrounding the separation of structure/function claims from health claims is examined. Safety issues are summarized and the following proposals are offered to improve the herbal dietary supplements regulatory system. First, herbal dietary supplements should be subject to more strict regulation by the FDA, which means treating them more like pharmaceuticals and not like food. Only pre-market approval can guarantee consumer access to safe and effective product. Second, a suggested simplified procedure allows the registration of a traditional herbal dietary supplement. Third, due to the compositional diversity and complexity of botanical substances, every new submission of nontraditional herbal supplement must be processed on a case-by-case basis. Fourth, a mandatory post-marketing reporting system of all adverse events should be established rather than the current serious adverse event reporting scheme. And finally, legislative reform is needed to change the regulatory system of dietary supplements.
This is a preview of subscription content, access via your institution.
Buy single article
Instant access to the full article PDF.
Tax calculation will be finalised during checkout.
Subscribe to journal
Immediate online access to all issues from 2019. Subscription will auto renew annually.
Tax calculation will be finalised during checkout.
Dietary Supplement Health and Education Act of 1994. Public Law 103–417. 103rd Congress. Stat 4325 (codified at 21 USC 301. 9). http://69.20.211/opacom/laws/dshea.html. Accessed October 11, 2011.
Jiang T, Zhang S. Stringent laws and regulations for dietary supplement. Drug Information Journal. 2009;43:75–81.
Mason MJ. Drugs or dietary supplements: FDA’s enforcement of DSHEA. Journal of Public Policy & Marketing. 1998;17:296–301.
US Food and Drug Administration. Draft guidance for industry: dietary supplements: new dietary ingredient notifications and related issues. July 2011. https://doi.org/www.fda.gov/food/guidancecomplianceregulatoryinformation/guidancedocuments/dietarysupplements/ucm257563.htm. Accessed October 14, 2011.
Azizi R. Supplementing the DSHEA: Congress must invest the FDA with greater regulatory authority over nutraceutical manufacturers by amending the Dietary Supplements Education Act. https://doi.org/works.bepress.com/cgi/viewcontent.cgi?article=1005&context=rahi_azizi. Accessed September 22, 2011.
Lewis JD, Strom BL. Balancing safety of dietary supplements with the free market. Ann Intern Med. 2002;136:616–610.
United States Government Accountability Office (GAO) Report to Congressional Requesters. Dietary supplements. FDA Should take further actions to improve oversight and consumer understanding. GAO-09-250. January 2009. https://doi.org/www.gao.gov/new.items/d09250.pdf. Accessed September 23, 2011.
Dietary supplements: balancing consumer choice and safety. New York State Task Force on Life and the Law, 2005. https://doi.org/www.health.ny.gov/regulations/task_force/docs/dietary_supplement_safety.pdf. Accessed September 20, 2011.
Office of Inspector General. Adverse event reporting for dietary supplements: an inadequate safety valve. Department of Health and Human Services. April 2001. https://doi.org/oig.hhs.gov/oei/reports/oei-01-00-00180.pdf. Accessed October 6, 2011.
US Food and Drug Administration. Guidance for industry. Botanical drug products. U.S. Department of Health and Human Services. CDER. 2004. https://doi.org/www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070491.pdf. Accessed October 11, 2011.
US Food and Drug Administration. Claims that can be made for conventional foods and dietary supplements. September 2003. https://doi.org/www.fda.gov/Food/LabelingNutrition/LabelClaims/ucm111447.htm. Accessed November 3, 2009.
US Food and Drug Administration Guidance for industry: notification of a health claim or nutrient content claim based on authoritative statement of a scientific body. June 1998. https://doi.org/www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/ucm056975.htm. Accessed October 13, 2011.
US Food and Drug Administration. Guidance for industry: structure/function claims, small entity compliance guide. January 9, 2002. https://doi.org/www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/DietarySupplements/ucm103340.htm. Accessed October 13, 2011.
Harris IM. Regulatory and ethical issues with dietary supplements. Pharmacotherapy. 2000;20:1295–1302.
Sanders ME, Levy DD. The science and regulations of probiotic food and supplement product labeling. Ann N Y Acad Sci. 2011;1219(suppl 1):1–23. https://doi.org/onlinelibrary.wiley.com/doi/10.1111/j.1749-6632.2010.05956.x/pdf. Accessed October 17, 2011.
Kurtzweil P. An FDA guide to dietary supplements. Center for Food and Applied Nutrition. FDA Consumer. January 1999. https://doi.org/vm.cfsan.fda.gov/—dms/fdsupp.html. Accessed October 11, 2011.
Dier JK. S.O.S. from the FDA: a cry for help in the world of unregulated dietary supplements. Albany Law Review. 2011;74:385–419. https://doi.org/www.albanylawreview.org/article.php?id=360. Accessed September 19, 2011.
US Food and Drug Administration. Department of Health and Human Services Administrative Proceeding, Docket No. 97P-0441 Final Decision. May 20, 1996. https://doi.org/www.fda.gov/ohrms/dockets/dockets/97p0441/ans0002.pdf. Accessed November 7, 2011.
Ram YG, Becker DJ. The role of red yeast rice for the physician. Current Atherosclerosis Reports. 2011;13:73–80. https://doi.org/www.springerlink.com/content/2307wu6657465528/. Accessed November 20, 2011.
Kimpel PA. The cholestin case: drugs vs. supplements. Cholestin natural or not? 2000. https://doi.org/iml.jou.ufl.edu/projects/spring2000/kimpel/cholestin.html. Accessed October 13, 2011.
Harrison T. Narrowing the field: FDA’s recent decision to deny OVOS’ NDI request may be a sign of things to come. Nutraceutical World. April 2011. https://doi.org/www.nutraceuticalsworld.com/issues/2011-04/view_columns/capitol-comments-narrowing-the-field/. Accessed September 5, 2011.
Bachrach EE. OTCs, switch, and the impact of dietary supplements. Drug Information Journal. 1999;33:805–810.
Bowen D. Nonprescription drug regulation in the United States. Drug Information Journal. 2000;34:323–327.
Center for Science in the Public Interest (CSPI) Reports: Functional foods. United States—a good system gone bad. 1998. https://doi.org/www.cspinet.org/reports/functional_foods/usa_regltry.html. Accessed October 3, 2011.
Fontanarosa PB, Rennie D, DeAngelis CD. The need for regulation dietary supplements lesson from Ephedra. JAMA. 2003;289:1568–1570.
Harmon S. Melatonin mania: can the FDA regulate hormonal dietary supplements to protect consumer interests in light of the Dietary Supplements Health and Education Act of 1994? Dayton Law Review. 1996;22:77–99.
Federal Trade Commission (FTC) dietary supplements: an advertising guide for industry. 2001. https://doi.org/business.ftc.gov/sites/default/files/pdf/bus09-dietary-supplements-advertising-guide-industry.pdf. Accessed October 28, 2011.
Peeler CL. The regulation of dietary supplements: a review of consumer safeguards. Prepared statement of the Federal Trade Commission. Committee on Government Reform. United States House of Representatives. March 9, 2006. https://doi.org/www.ftc.gov/os/2006/03/P064502.pdf. Accessed October 11, 2011.
Dietary supplements: A historical examination of its regulation. April 2002. https://doi.org/leda.law.harvard.edu/leda/data/526/Wang.pdf. Accessed January 16, 2012.
DeAngelis CD, Fontanarosa PB. Drugs alias dietary supplements. JAMA. 2003;290:1519–1521.
Scarbrough B. Dietary supplements: a review of United States regulation with emphasis on the dietary supplement health and education act of 1994 and subsequent activity. 2004 https://doi.org/leda.law.harvard.edu/leda/data/663/Scarbrough.html. Accessed September 22, 2011.
Dodge T, Litt D, Kaufman DA. Influence of the Dietary Supplement Health and Education Act on consumer beliefs about the safety and effectiveness of dietary supplements. J Health Communication. 2011:1–15.
Ernst E, Cohen MH, Stone J. Ethical problems arising in evidence based complementary and alternative medicine. J Med Ethics. 2004;30:156–159.
United States Government Accountability Office (GAO) teport to Congressional requesters. Food labeling. FDA needs to reassess its approach to protecting consumers from false or misleading claims. GAO-11-102.2011, 60. https://doi.org/www.gao.gov/new.items/d11102.pdf. Accessed October 8, 2011.
United States Government Accountability Office (GAO) report to congressional requesters. Herbal dietary supplements. Examples of deceptive or questionable marketing practices and potentially dangerous advice and consumer understanding. GAO-10-662 T. 2010. https://doi.org/www.gao.gov/new.items/d10662t.pdf. Accessed October 2, 2011.
Mason MJ, Scammon DL. Health claims and disclaimers: extended boundaries and research opportunities in consumer interpretation. Journal of Public Policy & Marketing. 2000;19:144–150.
Office of Inspector General. Dietary supplement labels: An assessment. Department of Health and Human Services. April 2003. OEI-01-01-00121.101. https://doi.org/oig.hhs.gov/oei/reports/oei-01-01-00120.pdf. Accessed October 13, 2011.
American Dietetic Association (ADA) reports. Practice paper of the American Dietetic Association: dietary supplements. J Am Diet Assoc. 2005;105:460–470.
Timbo B, Ross PM, McCarthy PV, Chung-tung JL. Dietary supplements in a national survey prevalence of use and repots of adverse events. J Am Diet Assoc. 2006;106:1966–1974.
Van Ornum M, Webe C. Dietary supplements: applying the knowledge. Life and Health Library. Journal of Neuroscience Nursing. 2002. https://doi.org/findarticles.com/p/articles/mi_hb6374/is_3_34/ai_n28923232/pg_5/?tag=content;col1. Accessed February 14, 2012.
Nowak RE. DSHEA’s failure: why a proactive approach to dietary supplement regulation is needed to effectively protect consumers. University of Illinois Law Review. 2010. https://doi.org/illinoislawreview.org/wp-content/ilr-content/articles/2010/3/Nowak.pdf. Accessed September 22, 2011.
Hegefeld HA. Overview of federal regulation of dietary supplements: past, present, and future trends. 2000. https://doi.org/leda.law.harvard.edu/leda/data/242/Hegefeld,_Heather.pdf. Accessed March 15, 2012.
US Food and Drug Administration. Significant dates in U.S. food and drug law history. https://doi.org/www.fda.gov/aboutfda/whatwedo/history/milestones/ucm128305.htm. Accessed March 13, 2012.
Mason SA. Dietary supplement regulation: a comparative study. Journal of Transnational Law & Policy. 2011:20;103–127. https://doi.org/www.law.fsu.edu/journals/transnational/vol20/mason.pdf. Accessed March 2, 2012.
Gardiner P, Sarma DN, Dog TL, et al. The state of dietary supplement adverse event reporting in the United States. Pharmacoepidemiology and Drug Safety. 2008;17:962–970.
Palmer EM, Haller C, McKinney PE, et al. Adverse events associated with dietary supplements: an observation study. Lancet. 2003;361:101–106.
Noah L, Noah BA. A drug by any other name? Paradoxes in dietary supplement risk regulation. Digital Commons@ Western New England University School of Law. 2006. https://doi.org/digitalcommons.law.wne.edu/facschol/42/. Accessed February 18, 2012.
Dinh C. Dietary supplement industry and lack of regulation. Rice Digital Scholarship Archive. Published May 22, 2009. https://doi.org/hdl.handle.net/1911/21952. Accessed November 2, 2009.
Slifman NR, Obermeyer WR, Aloi BK, et al. Contamination of botanical dietary supplements by Digitalis lanata. New Engl J Med. 1998;339:806–811.
Gilmour J, Harrison C, Asadi L, Cohen MH, Vohra S. Natural health product-drug interactions: evolving responsibilities to take complementary and alternative medicine into account. Pediatrics. 2011;128(suppl 4):155–160.
Mannel M. Drug interaction with St. John’s wort: mechanisms and clinical implications. Drug Safety. 2004;7:773–797.
Wang Z, Gorski JC, Hamman MA, Huang SM, Lesko LJ, Hall DD. The effect of St. John’s wort (Hypericum perforatum) on human cytochrome P450 activity. Clinical Pharmacology and Therapeutics. 2001;70:317–326.
Markowitz JS, Donovan JL, DeVane CL, et al. Effect of St John’s wort on drug metabolism by induction of cytochrome P450 3A4 enzyme. JAMA. 2003;290:1500–1504.
Rosenblatt M, Mindel J. Spontaneous hyphema associated with ingestion of Ginkgo biloba extract. N Engl J Med. 1997;36:1108.
Chavez ML, Melane AJ, Chavez PI. Evidence-based drug—herbal interactions. Life Science. 2006;78:2146–2157.
Guideline on fixed combination medicinal products. European Medicines Agency, London, February 21 2008; Doc. Ref. CPMP/EWP/240/95 Rev. 1. https://doi.org/www.ema.europa.eu/docs/en_GB/document/WC500003689.pdf. Accessed January 25, 2012.
Gabrielyan E, Amroyan E, Zakaryan AA, Grigoryan G. The regulatory of herbal medicinal products in Armenia. Drug Information Journal. 2004;38:273–281.
Smet PAGM. Overview of herbal quality control. Drug Information Journal. 1999;33:717–724.
Sovak M, Seligso AL, Konas M, Hajduch M, Dolezal M, Machala M. Herbal composition PC-SPES for management of prostate cancer: identification of active principles. J Natl Cancer Inst. 2002;94:1275–1280.
Sabucedo AJ, Gutierrez MA, Mueller KC, et al. Sex, lies, and Niagra. JAMA. 2004;291:560–562.
Cohen PA. American roulette—contaminated dietary supplements. N Engl J Med. 2009;361:1523–1525.
Wasserman I, Sutton LT. 2011 FDA Warning Letters review: the rise of GMPs. NutraIngredients. February 10, 2012. https://doi.org/www.nutraingredients-usa.com/Regulation/2011-FDA-Warning-Letter-Review-The-Rise-of-GMPs. Accessed February 5, 2012.
US Food and Drug Administration. Consumers update: beware of fraudulent dietary supplements. March 15, 2011. https://doi.org/www.fda.gov/ForConsumers/ConsumerUpdates/ucm246744.htm. Accessed January 7, 2012.
WebMed: Find a vitamin or supplement magnesium. November 24, 2011. https://doi.org/www.webmd.com/vitamins-supplements/ingredientmono-998-Magnesium.aspx?activeIngredientId=998&activeIngredientName=Magnesium. Accessed October 28, 2011.
Busse W. The significance of quality for efficacy and safety of herbal medicinal products. Drug Information Journal. 2000;34:15–23.
Abdel-Rahman A, Anyangwe N, Carlacci L, et al. The safety and regulation of natural products used as foods and food ingredients. Toxicol Sci. 2011;123:333–348.
National Consumers League (NCL). A consumer guide to dietary supplements. 2011. https://doi.org/nclnet.org/health/129-dietary-supplements/231-a-consumer-guide-to-dietary-supplements. Accessed October 21, 2011.
Nutrition Business Journal. Supplement Business Report 2010: An Analysis of Markets, Trends, Competition and Strategy in the U.S. Dietary Supplement Industry. Boulder, CO: Penton Media Inc.; 2010.
Gahche J, Bailey R, Burt V, et al. Dietary supplement use among U.S. adults has increased since NHANES III (1988–1994). NCHS Data Brief. 2010;61:1–8.
Ervin RB, Wright RD, Kennedy-Stephenson J. Use of dietary supplements in United States, 1988–1994. US Department of Health and Human Services, Centers for Disease Control and Prevention. June1999; Series11:244.16.
Kumar MK, Jethwani H. Developing traditional Chinese medicines as botanical drugs for the US market. Regulatory Focus, 2009; 6. https://doi.org/www.amarexcro.com/articles/docs/RAPS_Focus_ChineseMeds_BotDrugs_Aug2. Accessed October 12, 2011.
World Health Organization. Traditional medicine strategy 2002–2005. Geneva. 2002. https://doi.org/whqlibdoc.who.int/hq/2002/who_edm_trm_2002.1.pdf. Accessed December 19, 2011.
World Health Organization. National policy on traditional medicine and regulation of herbal medicines. Report of a WHO global survey. Geneva, May 2005. https://doi.org/apps.who.int/medicinedocs/pdf/s7916e/s7916e.pdf. Accessed October 19, 2011.
National Consumers League (NCL). Naturally misleading: consumers’ understanding of “natural” and “plant-derived” labeling claims. 2011. https://doi.org/www.nclnet.org/images/PDF/naturalsreport.pdf. Accessed October 21, 2011.
McNamara S. Food and Drug Administration regulation of dietary supplements. In: Regulation of Functional Foods and Nutraceuticals: A Global Perspective. New York: Blackwell Publishing; 2005, 89–101.
Russian Federation Ministry of Health Guidance. Assessment of Certification of Biologically Active Supplements (BADS). 1997; Moscow, Russia.
Gabrielyan E, Amroyan E, Zakaryan A, Grigoryan G. The regulation of dietary supplements in the Republic of Armenia. Drug Information Journal. 2002;36:889–897.
EC: European Commission. Directive 2002/46/EC of the European Parliament and of the Council. Official Journal of the European Communities. 2002; 51–57. https://doi.org/eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2002:183:0051:0057:EN:PDF. Accessed October 11, 2011.
Shimizu T. Newly established regulation in Japan: foods with health claims. Asia Pacific J Clin Nutr. 2002;11:S94–S96.
Wojewnik P. The Canadian marketplace and regulations for dietary supplements. Natural Product Insider. 2010. https://doi.org/www.naturalproductsinsider.com/articles/2010/01/canadian-supplement-market-and-regs.aspx. Accessed February 3, 2012.
US Food and Drug Administration. Guidance for industry: fda’s implementation of “qualified health claims”: questions and answers; final guidance. May 12, 2006. https://doi.org/www.fda.gov/food/guidancecomplianceregulatoryinformation/guidancedocuments/foodlabelingnutrition/ucm053843.htm. Accessed September 30, 2011.
How to register your product under the Traditional Herbal Medicines Registration Scheme: overview and scope of the EU Directive 2004 2004/24/EC on Traditional Herbal Medicinal Products. The Medicines and Healthcare Products Regulatory Agency (MHRA). 2004. https://doi.org/www.mhra.gov.uk/Howweregulate/Medicines/Herbalmedicinesregulation/RegisteredTraditionalHerbalMedicines/HowtoregisteryourproductundertheTraditionalHerbalMedicinesRegistrationScheme/OverviewandscopeoftheEUDirective2004200424EConTraditionalHerbalMedicinalProducts/index.htm. Accessed January 7, 2012.
US Food and Drug Administration. Guidance for industry: frequently asked questions about GRAS. December 2004s. https://doi.org/www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredientsandPackaging/ucm061846.htm. Accessed November 13, 2011.
US Food and Drug Administration. New dietary ingredients in dietary supplements—background for industry. September 10, 2001. https://doi.org/www.fda.gov/Food/DietarySupplements/ucm109764.htm. Accessed November 13, 2011.
World Health Organization. General guidelines for methodologies on research and evaluation of traditional medicine. 2000. https://doi.org/whqlibdoc.who.int/hq/2000/WHO_EDM_TRM_2000.1.pdf. Accessed October 2011.
About this article
Cite this article
Zakaryan, A., Martin, I.G. Regulation of Herbal Dietary Supplements: Is There a Better Way?. Ther Innov Regul Sci 46, 532–544 (2012). https://doi.org/10.1177/0092861512452121
- dietary supplements