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Endocrine, Metabolic & Immune Disorders - Drug Targets

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ISSN (Print): 1871-5303
ISSN (Online): 2212-3873

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Review Article

Nutraceuticals: A Comparative Analysis of Regulatory Framework in Different Countries of the World

Author(s): Rohit Bansal and Anju Dhiman*

Volume 20, Issue 10, 2020

Page: [1654 - 1663] Pages: 10

DOI: 10.2174/1871530320666200519084415

Price: $65

Abstract

Background: Nutraceutical is a term that is a combination of nutrition and pharmaceutical. They are believed to improve physical and mental health and provide therapeutic benefit in disease conditions. Nutraceuticals are claimed to be beneficial in several disease conditions which include cardiovascular disorder, neurodegenerative disorders, metabolic disorders and cancer prevention.

Objective: In the current review, we will study the current regulatory framework in some of the major countries of the world by comparing different parameters of these regulations.

Findings: Global nutraceutical market is currently expanding at a rapid pace but there are some restraints to the market growth which include poor quality manufacturing and unharmonized regulations leading to trade barriers across the globe. Although there are laws and regulations in place which govern nutraceutical products in different countries, these regulations lack harmonization and differ from country to country. Some of the countries follow stringent regulations, whereas, in some of the countries, well-structured and stern regulations for nutraceuticals are lacking.

Conclusion: The development of a well regulated, harmonized and research-driven approach can help boost the confidence of consumers in nutraceutical products in the world thereby driving the nutraceutical market.

Keywords: Nutraceuticals, FSS, DSHEA, EFSA, regulations, dietary supplements, functional food.

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[1]
Steffen, L.M.; Jacobs, D.R., Jr; Stevens, J.; Shahar, E.; Carithers, T.; Folsom, A.R. Associations of whole-grain, refined-grain, and fruit and vegetable consumption with risks of all-cause mortality and incident coronary artery disease and ischemic stroke: The Atherosclerosis Risk in Communities (ARIC) Study. Am. J. Clin. Nutr., 2003, 78(3), 383-390.
[http://dx.doi.org/10.1093/ajcn/78.3.383] [PMID: 12936919]
[2]
Whelton, S.P.; Hyre, A.D.; Pedersen, B.; Yi, Y.; Whelton, P.K.; He, J. Effect of dietary fiber intake on blood pressure: A meta-analysis of randomized, controlled clinical trials. J. Hypertens., 2005, 23(3), 475-481.
[http://dx.doi.org/10.1097/01.hjh.0000160199.51158.cf] [PMID: 15716684]
[3]
Petruzziello, L.; Iacopini, F.; Bulajic, M.; Shah, S.; Costamagna, G. Review article: Uncomplicated diverticular disease of the colon. Aliment. Pharmacol. Ther., 2006, 23(10), 1379-1391.
[http://dx.doi.org/10.1111/j.1365-2036.2006.02896.x] [PMID: 16669953]
[4]
Montonen, J.; Knekt, P.; Järvinen, R.; Aromaa, A.; Reunanen, A. Whole-grain and fiber intake and the incidence of type 2 diabetes. Am. J. Clin. Nutr., 2003, 77(3), 622-629.
[http://dx.doi.org/10.1093/ajcn/77.3.622] [PMID: 12600852]
[5]
Leray, C.; Wiesel, M.L.; Freund, M.; Cazenave, J.P.; Gachet, C. Long-chain n-3 fatty acids specifically affect rat coagulation factors dependent on vitamin K: relation to peroxidative stress. Arterioscler. Thromb. Vasc. Biol., 2001, 21(3), 459-465.
[http://dx.doi.org/10.1161/01.ATV.21.3.459] [PMID: 11231929]
[6]
Bucher, H.C.; Hengstler, P.; Schindler, C.; Meier, G. N-3 polyunsaturated fatty acids in coronary heart disease: A meta-analysis of randomized controlled trials. Am. J. Med., 2002, 112(4), 298-304.
[http://dx.doi.org/10.1016/S0002-9343(01)01114-7] [PMID: 11893369]
[7]
Albert, C.M.; Campos, H.; Stampfer, M.J.; Ridker, P.M.; Manson, J.E.; Willett, W.C.; Ma, J. Blood levels of long-chain n-3 fatty acids and the risk of sudden death. N. Engl. J. Med., 2002, 346(15), 1113-1118.
[http://dx.doi.org/10.1056/NEJMoa012918] [PMID: 11948270]
[8]
Iso, H.; Rexrode, K.M.; Stampfer, M.J.; Manson, J.E.; Colditz, G.A.; Speizer, F.E.; Hennekens, C.H.; Willett, W.C. Intake of fish and omega-3 fatty acids and risk of stroke in women. JAMA, 2001, 285(3), 304-312.
[http://dx.doi.org/10.1001/jama.285.3.304] [PMID: 11176840]
[9]
Nemets, B.; Stahl, Z.; Belmaker, R.H. Addition of omega-3 fatty acid to maintenance medication treatment for recurrent unipolar depressive disorder. Am. J. Psychiatry, 2002, 159(3), 477-479.
[http://dx.doi.org/10.1176/appi.ajp.159.3.477] [PMID: 11870016]
[10]
Solfrizzi, V.; Agosti, P.; Lozupone, M.; Custodero, C.; Schilardi, A.; Valiani, V.; Santamato, A.; Sardone, R.; Dibello, V.; Di Lena, L.; Stallone, R.; Ranieri, M.; Bellomo, A.; Greco, A.; Daniele, A.; Seripa, D.; Sabbà, C.; Logroscino, G.; Panza, F. Nutritional interventions and cognitive-related outcomes in patients with late-life cognitive disorders: A systematic review. Neurosci. Biobehav. Rev., 2018, 95, 480-498.
[http://dx.doi.org/10.1016/j.neubiorev.2018.10.022] [PMID: 30395922]
[11]
Mecocci, P.; Tinarelli, C.; Schulz, R.J.; Polidori, M.C. Nutraceuticals in cognitive impairment and Alzheimer’s disease. Front. Pharmacol., 2014, 5, 147.
[http://dx.doi.org/10.3389/fphar.2014.00147] [PMID: 25002849]
[12]
Miyanaga, N.; Akaza, H.; Hinotsu, S.; Fujioka, T.; Naito, S.; Namiki, M.; Takahashi, S.; Hirao, Y.; Horie, S.; Tsukamoto, T.; Mori, M.; Tsuji, H. Prostate cancer chemoprevention study: An investigative randomized control study using purified isoflavones in men with rising prostate-specific antigen. Cancer Sci., 2012, 103(1), 125-130.
[http://dx.doi.org/10.1111/j.1349-7006.2011.02120.x] [PMID: 21988617]
[13]
Bettuzzi, S.; Brausi, M.; Rizzi, F.; Castagnetti, G.; Peracchia, G.; Corti, A. Chemoprevention of human prostate cancer by oral administration of green tea catechins in volunteers with high-grade prostate intraepithelial neoplasia: a preliminary report from a one-year proof-of-principle study. Cancer Res., 2006, 66(2), 1234-1240.
[http://dx.doi.org/10.1158/0008-5472.CAN-05-1145] [PMID: 16424063]
[14]
Patel, K.R.; Brown, V.A.; Jones, D.J.; Britton, R.G.; Hemingway, D.; Miller, A.S.; West, K.P.; Booth, T.D.; Perloff, M.; Crowell, J.A.; Brenner, D.E.; Steward, W.P.; Gescher, A.J.; Brown, K. Clinical pharmacology of resveratrol and its metabolites in colorectal cancer patients. Cancer Res., 2010, 70(19), 7392-7399.
[http://dx.doi.org/10.1158/0008-5472.CAN-10-2027] [PMID: 20841478]
[15]
Duthie, G.G.; Gardner, P.T.; Kyle, J.A.M. Plant polyphenols: are they the new magic bullet? Proc. Nutr. Soc., 2003, 62(3), 599-603.
[http://dx.doi.org/10.1079/PNS2003275] [PMID: 14692595]
[16]
Scalbert, A.; Johnson, I.T.; Saltmarsh, M. Polyphenols: Antioxidants and beyond. Am. J. Clin. Nutr., 2005, 81(Suppl. 1), 215S-217S.
[http://dx.doi.org/10.1093/ajcn/81.1.215S] [PMID: 15640483]
[17]
Santini, A.; Cammarata, S.M.; Capone, G.; Ianaro, A.; Tenore, G.C.; Pani, L.; Novellino, E. Nutraceuticals: opening the debate for a regulatory framework. Br. J. Clin. Pharmacol., 2018, 84(4), 659-672.
[http://dx.doi.org/10.1111/bcp.13496] [PMID: 29433155]
[18]
Ministry of health and family welfare (FSSAI): No. 1-4/Nutraceutical/FSSAI-2013. Gazette of India, extraordinary, part III, Section 4:, 2016. Available at: https://archive.fssai.gov.in/dam/jcr:c0b36c0c-ccc9-446d-ada6-5b164de27460/Gazette_Notification_Functional_Foods_06_01_2017.pdf (Accessed on August 16, 2019)
[19]
Ministry of Health and Family Welfare. FSSAI. Gazette notification (extraordinary) on organic food. (Part III, Section 4), 2017 December;
[20]
Dalmia, V.P. Law of Nutritional and Supplemental Food Products in India - The Conflict: Food or Drug?, Available at: http://www.mondaq.com/india/x/221116/food+drugs (Accessed on August 18, 2019)
[21]
Jain, P.; Rathod, M.; Jain, V.; Vijayendraswamy, S. Current regulatory requirements for registration of nutraceuticals in India and USA. Int. J. Drug Reg Affairs, 2018, 6(2), 22-29.
[http://dx.doi.org/10.22270/ijdra.v6i2.232]
[22]
United States Food and Drug Administration (FDA). Dietary Supplement Health and Education Act (DSHEA). U.S. Department of Health and Human Services. 1994. United States. Amended through P.L. 116-8, Enacted., Available at: http://www.fda.gov (Accessed on August 18, 2019)
[23]
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., Available at: https://dash.harvard.edu/bitstream/handle/1/8852160/scarbrough.pdf?sequence=1 (Accessed on August 18, 2019)
[24]
Electronic Code of Federal Regulations (e-CFR). Title 21, Chapter 1 (Part 190). Subpart B- New Dietary Ingredient Notification., Available at: https://www.ecfr.gov/cgi-bin/text-idx?SID=5c99c81e8c2aa803c370d8930bcb9708&mc=true&node=sp21.3.190.b&rgn=div6 (Accessed on August 18, 2019)
[25]
Kessler, R.C.; Davis, R.B.; Foster, D.F.; Van Rompay, M.I.; Walters, E.E.; Wilkey, S.A.; Kaptchuk, T.J.; Eisenberg, D.M. Long-term trends in the use of complementary and alternative medical therapies in the United States. Ann. Intern. Med., 2001, 135(4), 262-268.
[http://dx.doi.org/10.7326/0003-4819-135-4-200108210-00011] [PMID: 11511141]
[26]
Ministry of Health. Labour and Welfare (MHLW). Food for Specified Health Uses (FOSHU)., Available at: https://www.mhlw.go.jp/english/topics/foodsafety/fhc/02.html (Accessed on August 18, 2019)
[27]
Bailey, R. International Nutraceutical and Functional Food Updates: Japan In: Nutraceuticals and Functional Foods Division; November ed.;;, 2005; pp. 3-4.
[28]
Ohama, H.; Ikeda, H.; Moriyama, H. Health foods and foods with health claims in Japan. Toxicology, 2006, 221(1), 95-111.
[http://dx.doi.org/10.1016/j.tox.2006.01.015] [PMID: 16488527]
[29]
Ohama, H.; Ikeda, H.; Moriyama, H. Health Foods and Foods with Health Claims in Japan. Nutraceutical and Functional Food Regulations in the United States and Around the World, 2nd ed; Bagchi, D., Ed.; Elsevier Inc., 2014, pp. 265-300.
[http://dx.doi.org/10.1016/B978-0-12-405870-5.00016-5]
[30]
Patel, D.; Dufour, Y.; Domigan, N. Functional food and nutraceutical registration process in Japan and China: Similarities and differences. Pharm Pharmaceut Sci., 2008, 11(4), 1-11.
[http://dx.doi.org/10.18433/J32S3N] [PMID: 19183509]
[31]
Shimizu, T. Health claims on functional foods: The Japanese regulations and an international comparison. Nutr. Res. Rev., 2003, 16(2), 241-252.
[http://dx.doi.org/10.1079/NRR200363] [PMID: 19087392]
[32]
SFDA. Interim Administrative Measures of Health Food RegistrationDecree No.19, 2005, issued April 30, 2005. Available at: http://www.sfda.gov.cn/WS01/CL1131/24516.html (Accessed on August 18, 2019)
[33]
Hu, C. Historical Change of Raw Materials and Claims of Health Food Regulations in China.Nutraceutical and Functional Food Regulations in the United States and Around the World, 2nd ed; Bagchi, D., Ed.; Elsevier Inc., 2014, pp. 363-389.
[http://dx.doi.org/10.1016/B978-0-12-405870-5.00021-9]
[34]
SFDA. Letter to seek public comments again on the provisions of new function application and evaluation of health food (consulting version) (SFDA Health Food and Cosmetic Division letter No 490, 2012, issued November 5, 2012. Available at: http://www.sfda.gov.cn/WS01/CL0780/75896.html (Accessed on August 18, 2019)
[35]
Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements. Off J Eur Communities 2002; L183/51- 7., 2002. Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32002L0046&from=EN (Accessed on August 18, 2019)
[36]
Regulation (EC) No 178/2002 of The European Parliament and of the council. Laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety, Available at: https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2002:031:0001:0024:EN:PDF (Accessed on August 18, 2019)
[37]
Gulati, O.P.; Ottaway, P.B.; Coppens, P. Botanical Nutraceuticals, (Food Supplements, Fortified and Functional Foods) in the European Union with Main Focus on Nutrition and Health Claims Regulation.Nutraceutical and Functional Food Regulations in the United States and Around the World, 2nd ed; Bagchi, D., Ed.; Elsevier Inc., 2014, pp. 221-257.
[http://dx.doi.org/10.1016/B978-0-12-405870-5.00014-1]
[38]
EU Regulations on Food Supplements, Health Foods, Herbal Medicines. Internet., https://www.export.gov/article?id=EU-Regulations-on-Food-Supplements-Health-Foods-Herbal-Medicines1#content (Accessed on August 17, 2019)
[39]
Scientific Committee on Food of the EU. SCF/CS/ADD/GEN/26 final of July 12, 2001.
[40]
Directive 2004/24/EC of the European Parliament and of the Council of 31st March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/ EC on the Community code relating to medicinal products for human use Official Journal L 136, 30/04/2004,; 0085-0907.
[41]
Tutelyan, V.A.; Sukhanov, B.P.; Kochetkova, A.A.; Sheveleva, S.A.; Smirnova, E.A. Russian Regulations on Nutraceuticals and Functional Foods. In: Nutraceutical and Functional Food Regulations in the United States and Around the World, 2nd ed; Bagchi, D., Ed.; Elsevier Inc., 2014; pp. 309-327.
[http://dx.doi.org/10.1016/B978-0-12-405870-5.00018-9]
[42]
Russia: Technical Regulations on the custom union “About Safety of foods” (Article 24, TP TC 021/2011) Biologically Active Supplements to food (BASs), 2011. Available at: http://www.eurasiancommission.org/ru/act/texnreg/deptexreg/tr/Documents/TR%20TS%20PishevayaProd.pdf (Accessed on August 18, 2019)
[43]
Tutelyan, V.A.; Sukhanov, B.P. Food supplements: Modern approaches to quality and safety. Vopr. Pitan., 2008, 77(4), 4-15.
[PMID: 18839802]
[44]
Sukhanov, B.; Kerimova, M.; Elizarova, E.; Chigireva, E. Sanitary and epidemiological examination of foods in the frame of state sanitary and epidemiological surveillance on the customs border and customs territory of the customs union. Vopr. Pitan., 2011, 80(4), 25-31.
[PMID: 22232879]
[45]
Health Canada. Health products and food branch. Natural and Nonprescription Health Products Directorate (NNHPD), Available at: https://www.canada.ca/en.html (Accessed on August 18, 2019)
[46]
Harrison, J.R.; Nestmann, E.R. Current Canadian Regulatory Initiatives and Policies for Natural Health Products (Dietary Supplements). Nutraceutical and Functional Food Regulations in the United States and Around the World, 2nd ed; Bagchi, D., Ed.; Elsevier Inc., 2014, pp. 183-200.
[http://dx.doi.org/10.1016/B978-0-12-405870-5.00012-8]
[47]
Health Canada. Overview of the Reporting Adverse Reactions to Marketed Health Products - Guidance Document for Industry., Available at: https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/reporting-adverse-reactions-marketed-health-products-guidance-industry.html (Accessed on August 18, 2019)
[48]
Health Canada. Adverse Reaction Reporting for Natural Health Products., Available at: http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/pubs/medeff/fs-if/2011-reporting-declaration_nhp-psn/2011_reporting-declaration_nhp-psn-eng.pdf (Accessed on August 18, 2019)
[49]
Therapeutic Goods Administration (TGA) under the Therapeutic Goods Act 1989 (the Act). Therapeutic Goods Regulations 1990, part 1 (2)., 1989. Available at: https://www.tga.gov.au (Accessed on August 18, 2019)
[50]
Ghosh, D. Complementary Medicine Regulation in Australia.Nutraceutical and Functional Food Regulations in the United States and Around the World, 2nd ed; Bagchi, D., Ed.; Elsevier Inc., 2014, pp. 301-308.
[http://dx.doi.org/10.1016/B978-0-12-405870-5.00017-7]
[51]
Australian regulatory guidelines for complementary medicines (ARGCM) Part A: General guidance on complementary medicine regulation in Australia. Types of ingredients in listed and registered complementary medicines, Available at: https://www.tga.gov.au/node/759303 (Accessed on August 18, 2019)
[52]
Therapeutic Goods Administration. Reporting adverse events., Available at: https://www.tga.gov.au/reporting-adverse-events (Accessed on August 18, 2019)
[53]
Australian regulatory guidelines for complementary medicines (ARGCM) Part A: General guidance on complementary medicine regulation in Australia Literature-based submissions for complementary medicines, https://www.tga.gov.au/node/759312 (Accessed on August 18, 2019)
[54]
Australian regulatory guidelines for complementary medicines (ARGCM) Part A: General guidance on complementary medicine regulation in Australia Complementary medicines exempt/excluded from certain regulatory requirements., Available at: https://www.tga.gov.au/node/759299 (Accessed on August 18, 2019)
[55]
Grand view research, Inc. Nutraceutical market size by 2025. 2017. Available at: https://www.grandviewresearch.com/press-release/global-nutraceuticals-market (Accessed on August 19, 2019)
[56]
BCC research. Nutraceuticals: Global Markets to 2023, 2018. Available at: https://www.bccresearch.com/market-research/food-and-beverage/nutraceuticals-global-markets.html (Accessed on August 19, 2019)
[57]
Allied market research. Nutraceuticals Market Overview, 2016 December; https://www.alliedmarketresearch.com/nutraceuticals-market[August 19, 2019]
[58]
Shao, A. Global Market Entry Regulations for Nutraceuticals, Functional Foods, Dietary/Food/Health Supplements.Nutraceutical and Functional Food Regulations in the United States and Around the World, 2nd ed; Bagchi, D., Ed.; Elsevier Inc., 2014, p. 42.
[http://dx.doi.org/10.1016/B978-0-12-405870-5.00003-7]
[59]
Codex Alimentarius. General standard for food additives., Available at: http://www.fao.org/gsfaonline/docs/CXS_192e.pdf (Accessed on August 18, 2019)
[60]
Commission Regulation (EU) No 231/2012 of 9 March 2012. Laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council Text with EEA relevance. Last consolidated version, 2018. http://data.europa.eu/eli/reg/2012/231/oj (Accessed on August 18, 2019)
[61]
European Food Safety Authority (EFSA). Dietary Reference Values for nutrients (Summary report), 2017. Available at: https://efsa.onlinelibrary.wiley.com/doi/abs/10.2903/sp.efsa.2017.e15121 (Accessed on August 18, 2019)
[62]
Park, J.H.; Choi, S.M.; Moon, S.; Kim, S.; Kim, B.; Kim, M.K.; Lee, S. Development of an adverse events reporting form for Korean folk medicine. Pharmacoepidemiol. Drug Saf., 2017, 26(5), 498-508.
[http://dx.doi.org/10.1002/pds.4077] [PMID: 27501410]
[63]
Shao, A. Global adverse event reporting regulations for nutraceuticals, functional foods, and Dietary/Food/Health Supplements. Nutraceutical and Functional Food Regulations in the United States and Around the World, 2nd ed; Bagchi, D., Ed.; Elsevier Inc., 2014, pp. 519-528.
[http://dx.doi.org/10.1016/B978-0-12-405870-5.00029-3]
[64]
Health Canada. Guidance Document for Industry - Reporting Adverse Reactions to Marketed Health Products: Adverse Reaction Reporting by Market Authorization Holders, http://hc-sc.gc.ca/dhp-mps/pubs/medeff/_guide/2011-guidance-directrice_reporting-notification/index-eng.php#a13 (Accessed on August 18, 2019)
[65]
Therapeutic Goods Administration. Australian Adverse Drug Reactions Bulletin., 2011. Available at: http://www.tga.gov.au/hp/aadrb.htm (Accessed on August 18, 2019)
[66]
South Korean Ministry of Health and Welfare. Ministry of Health and Welfare Decree No. 142, 2012.8.1: Enforcement Regulations of the Functional Health Foods Act; Ministry of Legislation, National Law Information Center: Seoul, Korea, 2012.
[67]
The Peruvian National Authority for Pharmaceuticals. Medical Devices and Health Products. Title V of the pharmacovigilance and technovigilance system; Peruvian Government: Lima, Peru, 2011.
[68]
ANSES. Dispositif national de vigilance sur les comple’ments alimentaires: Bilan de la phase pilote et propositions pour la mise en place du dispositif national de nutrivigilance; ANSES, Maisons-Alfort Cedex: France, 2010.
[69]
Borchers, A.T.; Keen, C.L.; Gershwin, M.E. The Basis of Structure/Function Claims of Nutraceuticals. Clin. Rev. Allergy Immunol., 2016, 51(3), 370-382.
[http://dx.doi.org/10.1007/s12016-016-8536-9] [PMID: 27122022]
[70]
Harrison, J.R. International Regulation of Natural Health Products; Universal Publishers: Boca Raton, 2008.

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