The Regulatory Framework Across International Jurisdictions for Risks Associated with Consumption of Botanical Food Supplements

Comprehensive Reviews in Food Science and Food Safety

Volumn 16, Issue 5, 2017, Pages 821-834

  Low, Teng Yong ^a,b   Wong, Kwok Onn ^b   Yap, Adelene L L ^b   De Haan, Laura H J ^a   Rietjens, Ivonne M C M ^a  

^a WAGENINGEN UNIVERSITY   (Netherlands)

^b Regulatory Administration Group   (Singapore)

Author keywords

botanical food supplements; botanicals; regulatory challenges; regulatory framework; risk assessment

Indexed keywords

LAWS AND LEGISLATION; NETWORK FUNCTION VIRTUALIZATION; RISK ASSESSMENT;

BOTANICALS; FOOD SUPPLEMENTS; LEGISLATIVE FRAMEWORKS; PHARMACOLOGICALLY ACTIVE SUBSTANCES; REGULATORY CHALLENGES; REGULATORY FRAMEWORKS; REGULATORY OVERSIGHT; SAFETY ASSESSMENT CRITERION;

DIETARY SUPPLEMENTS;

EID: 85028954206     PISSN: None     EISSN: 15414337     Source Type: Journal    
DOI: 10.1111/1541-4337.12289     Document Type: Article

References (118)

1. Abdullah R, Diaz LN, Wesseling S, Rietjens IMCM. 2016. Risk assessment of plant food supplements and other herbal products containing aristolochic acids using the margin of exposure (MOE) approach. Food Addit Contam Part A Chem Anal Contr Expo Risk Assess 34:135–44. https://doi.org/10.1080/19440049.2016.1266098
2. Advisory Committee on Novel Foods and Processes (ACNFP). 2002. Guidelines on the use of human studies in the pre-market safety assessment of novel foods. Available from: https://acnfp.food.gov.uk/committee/acnfp/acnfppapers/inforelatass/guidetastehuman/guidlinespre-market. Accessed 10 Sep 2016.
3. Agence Française de Sécurité Sanitaire des Aliments (Afssa). 2003. Framework for the evaluation of the safety, the effect and the claims of foodstuff, made from plants, for the human diet. Available from: https://www.anses.fr/en/system/files/NUT-Ra-PlantesEN.pdf. Accessed 7 Sep 2016.
4. Alhusainy W, Paini A, Punt A, Louisse J, Spenkelink A, Vervoort J, Delatour T, Scholz G, Schilter B, Adams T, van Bladeren PJ, Rietjens IMCM. 2010. Identification of nevadensin as an important herb-based constituent inhibiting estragole bioactivation and physiology-based biokinetic modeling of its possible in vivo effect. Toxicol Appl Pharmacol 245:179–90. https://doi.org/10.1016/j.taap.2010.02.017.
5. Alhusainy W, van den Berg SJ, Paini A, Campana A, Asselman M, Spenkelink A, Punt A, Scholz G, Schilter B, Adams TB, van Bladeren PJ, Rietjens IMCM. 2012. Matrix modulation of the bioactivation of estragole by constituents of different alkenylbenzene-containing herbs and spices and physiologically based biokinetic modeling of possible in vivo effects. Toxicol Sci 129:174–87. https://doi.org/10.1093/toxsci/kfs196.
6. Alhusainy W, Williams GM, Jeffrey AM, Iatropoulos MJ, Taylor S, Adams TB, Rietjens IMCM. 2014. The natural basil flavonoid nevadensin protects against a methyleugenol-induced marker of hepatocarcinogenicity in male F344 rat. Food Chem Toxicol 74:28–34. https://doi.org/10.1016/j.fct.2014.08.016
7. Aschwanden C. 2001. Herbs for health, but how safe are they? Bull World Health Organ 79:691–2. https://doi.org/10.1590/S0042-96862001000700025.
8. Avigan M, Mozersky R, Seeff L. 2016. Scientific and regulatory perspectives in herbal and dietary supplement associated hepatotoxicity in the United States. Int J Mol Sci 17:331. https://doi.org/10.3390/ijms17030331.
9. BfR (German Federal Institute for Risk Assessment). 2008. Frequently Asked Questions on Food Supplements - BfR. Available from: http://www.bfr.bund.de/en/frequently_asked_questions_on_food_supplements-70347.html. Accessed 8 Nov 2016.
10. Chen LS, Lee MJ, Li H, Yang CS. 1997. Absorption, distribution, and elimination of tea polyphenols in rats. Drug Metab Dispos 25:1045–50.
11. Cheung TP, Xue C, Leung K, Chan K, Li CG. 2006. Aristolochic acids detected in some raw Chinese medicinal herbs and manufactured herbal products–a consequence of inappropriate nomenclature and imprecise labelling? Clin Toxicol (Phila) 44:371–8. https://doi.org/10.1080/15563650600671712.
12. China Food and Drug Administration (CFDA). 2016a. Detailed rules for the examination and approval of health food registration -Available from: http://www.sda.gov.cn/WS01/CL0847/166399.html. Accessed 2 Jan 2017.
13. China Food and Drug Administration (CFDA). 2016b. “Health food registration and record management approach” (State Food and Drug Administration Order No. 22). Available from: http://www.sfda.gov.cn/WS01/CL1197/145380.html. Accessed 7 Oct 2016.
14. Codex Alimentarius Commission. 1997. Report of the Twenty-Second Session of the Joint FAO/WHO Codex Alimentarius Commission. ALINORM 97/37. https://doi.org/10.1007/BF02582346.
15. Colombo ML. 2016. Botanicals authentication in food, food supplements and herbal medicinal products. Plant Biosyst 150:22–6. https://doi.org/10.1080/11263504.2014.984009.
16. Consumer Affairs Agency. 2015. Guidance for industry - The system of “Foods with Function Claims” has been launched! Available from: http://www.caa.go.jp/foods/pdf/151224_2.pdf. Accessed 12 Sep 2016.
17. Council of Europe. 2005. Guidelines on the quality, safety and marketing of plantbased food supplements - Public Health Committee, Committee of Experts on Nutrition, Food Safety and Consumer Health, Ad-hoc Group on Food Supplements.
18. Cousyn G, Dalfrà S, Scarpa B, Geelen J. 2013. Project BELFRIT: harmonizing the use of plants in food supplements in the European Union: Belgium, France and Italy - a first step. Eur Food Feed Law Rev 8:187–96.
19. Culley TM. 2013. Why vouchers matter in botanical research. Appl Plant Sci 1:1300076. https://doi.org/10.3732/apps.1300076.
20. Curry K, Schaffer SD, Yoon SJ. 2016. Laws and guidelines governing the use of herbal supplements. Nurse Pract 41:39–42. https://doi.org/10.1097/01.Npr.0000508171.52605.C5.
21. Debelle FD, Vanherweghem JL, Nortier JL. 2008. Aristolochic acid nephropathy: a worldwide problem. Kidney Int 74:158–69. https://doi.org/10.1038/ki.2008.129
22. Di Lorenzo C, Ceschi A, Kupferschmidt H, Lude S, De Souza Nascimento E, Dos Santos A, Colombo F, Frigerio G, Norby K, Plumb J, Finglas P, Restani P. 2015. Adverse effects of plant food supplements and botanical preparations: a systematic review with critical evaluation of causality. Br J Clin Pharmacol 79:578-92. https://doi.org/10.1111/bcp.12519
23. Edwards IR, Aronson JK. 2000. Adverse drug reactions: definitions, diagnosis, and management. Lancet 356:1255–9. https://doi.org/10.1016/S0140-6736(00)02799-9(00)02799-9
24. EFSA. 2005. Opinion of the Scientific Committee on a request from EFSA related to a harmonized approach for risk assessment of substances which are both genotoxic and carcinogenic. EFSA J 3:282. https://doi.org/10.2903/j.efsa.2005.282.
25. EFSA. 2009. Compendium of botanicals that have been reported to contain toxic, addictive, psychotropic, or other substances of concern. EFSA Supporting Publ 6. https://doi.org/10.2903/j.efsa.2009.281.
26. EFSA. 2016. Botanicals added to EFSA data warehouse. Available from: https://www.efsa.europa.eu/en/press/news/160705. Accessed 25 Jan 2017.
27. EFSA NDA Panel (EFSA Panel on Dietetic Products‚ Nutrition and Allergies). 2016. Guidance on the preparation and presentation of an application for authorization of a novel food in the context of Regulation (EU) 2015/2283. EFSA J 14:4594. https://doi.org/10.2903/j.efsa.2016.4594.
28. EFSA Panel on Contaminants in the Food Chain (CONTAM). 2011. Scientific opinion on pyrrolizidine alkaloids in food and feed. EFSA J 9:2406. https://doi.org/10.2903/j.efsa.2011.2406.
29. EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS). 2012. Guidance for submission for food additive evaluations. EFSA J 10:2760. https://doi.org/10.2903/j.efsa.2012.2760.
30. EFSA Scientific Committee. 2004. Discussion paper on botanicals and botanical preparations widely used as food supplements and related products: coherent and comprehensive risk assessment and consumer information approaches. Available from: https://www.efsa.europa.eu/sites/default/files/assets/scdoc_advice03_botanicals_en.pdf. Accessed 12 Sep 2016.
31. EFSA Scientific Committee. 2009. Guidance on safety assessment of botanicals and botanical preparations intended for use as ingredients in food supplements, on request of EFSA. EFSA J 7:1–19. https://doi.org/10.2093/j.efsa.2009.1249.
32. EFSA Scientific Committee. 2014. Scientific opinion on a qualified presumption of safety (QPS) approach for the safety assessment of botanicals and botanical preparations. EFSA J 12:38. https://doi.org/10.2903/j.efsa.2014.3593.
33. EFSA Scientific Cooperation (ESCO) Working Group on Botanicals and Botanical Preparations. 2009. Advice on the EFSA guidance document for the safety assessment of botanicals and botanical preparations intended for use as food supplements, based on real case studies on request of EFSA. EFSA J 7:RN-280. https://doi.org/10.2903/j.efsa.2009.280.
34. Ernst E. 1998. Harmless herbs? A review of the recent literature. Am J Med 104:170–8. https://doi.org/10.1016/S0002-9343(97)00397-5.
35. European Advisory Services. 2007. The use of substances with nutritional or physiological effect other than vitamins and minerals in food supplements - Study undertaken for DG SANCO, European Commission. Available from: https://ec.europa.eu/food/sites/food/files/safety/docs/labelling_nutrition-supplements-2007_a540169_study_other_substances_en.pdf. Accessed 7 Sep 2016.
36. European Commission. 1997. Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients.
37. European Commission. 2002a. 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.
38. European Commission. 2002b. Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 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.
39. European Commission. 2004. Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use.
40. European Commission. 2008. Report from the Commission to the Council and the European Parliament on the use of substances other than vitamins and minerals in food supplements. Available from: https://ec.europa.eu/food/sites/food/files/safety/docs/labelling_nutrition-supplements-comm_2008_0824_en.pdf. Accessed 7 Oct 2016.
41. European Commission. 2015. Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001.
42. European Commission. 2016. Botanical food supplements: towards a workable regulatory framework – European Parliament, Brussels – 9 November 2016. Available from: https://ec.europa.eu/commission/commissioners/2014-2019/andriukaitis/announcements/botanical-food-supplements-towards-workable-regulatory-framework-european-parliament-brussels-9_en. Accessed 24 Nov 2016.
43. European Medicines Agency (EMA). 2007a. Committee on herbal medicinal products (HMPC) assessment report on Foeniculum vulgare Miller (Doc. Ref: EMEA/HMPC/137426/2006). Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Herbal_-_HMPC_assessment_report/2009/12/WC500018463.pdf. Accessed 6 Jan 2016.
44. European Medicines Agency (EMA). 2007b. Committee on herbal medicinal products (HMPC) community herbal monograph on Foeniculum vulgare miller subsp. vulgare var. vulgare, fructus. (Doc. Ref: EMEA/HMPC/137428/2006 Corr.). Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Herbal_-_Community_herbal_monograph/2009/12/WC500018464.pdf. Accessed 6 Jan 2017.
45. European Medicines Agency (EMA). 2010. Questions and answers on the guideline on the limits of genotoxic impurities. (EMA/CHMP/SWP/431994/2007 Rev. 3). Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002907.pdf. Accessed 6 Jan 2016.
46. European Medicines Agency (EMA). n.d. European Medicines Agency - Human regulatory - Herbal medicinal products. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000208.jsp&mid=WC0b01ac05800240cf. Accessed 25 Jan 2017.
47. Felter SP, Conolly RB, Bercu JP, Bolger PM, Boobis AR, Bos PMJ, Carthew P, Doerrer NG, Goodman JI, Harrouk WA, Kirkland DJ, Lau SS, Llewellyn GC, Preston RJ, Schoeny R, Schnatter AR, Tritscher A, van Velsen F, Williams GM. 2011. A proposed framework for assessing risk from less-than-lifetime exposures to carcinogens. Crit Rev Toxicol 41:507–44. https://doi.org/10.3109/10408444.2011.552063.
48. Food and Drug Administration (FDA). 2008. Guidance for Industry: genotoxic and carcinogenic impurities in drug substances and products: recommended approaches (Draft guidance). Available from: http://www.fda.gov/ohrms/dockets/98fr/fda-2008-d-0629-gdl.pdf. Accessed 1 Feb 2017.
49. Food Safety and Standards Authority of India (FSSAI). 2016. Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016.
50. Food Standards Australia New Zealand (FSANZ). 2016. Food Standards Code. Available from: http://www.foodstandards.gov.au/code/Pages/default.aspx. Accessed 26 Jan 2017.
51. Fujita Y, Terui K, Fujita M, Kakizaki A, Sato N, Oikawa K, Aoki H, Takahashi K, Endo S. 2007. Five cases of aconite poisoning: Toxicokinetics of aconitines. J Anal Toxicol 31:132–7. https://doi.org/10.1093/jat/31.3.132.
52. Garcia-Alvarez A, Egan B, de Klein S, Dima L, Maggi FM, Isoniemi M, Ribas-Barba L, Raats MM, Meissner EM, Badea M, Bruno F, Salmenhaara M, Mila-Villarroel R, Knaze V, Hodgkins C, Marculescu A, Uusitalo L, Restani P, Serra-Majem L. 2014. Usage of plant food supplements across six European countries: findings from the PlantLIBRA consumer survey. PLoS One 9:e92265. https://doi.org/10.1371/journal.pone.0092265.
53. Health Canada. 2013. The approach to natural health products - Health Canada. Available from: http://www.hc-sc.gc.ca/dhp-mps/prodnatur/nhp-new-nouvelle-psn-eng.php. Accessed 26 Jan 2017.
54. Health Canada. 2016. About natural health product regulations in Canada - Health Canada. Available from: http://www.hc-sc.gc.ca/dhp-mps/prodnatur/about-apropos/index-eng.php. Accessed 26 Jan 2017.
55. Hepburn P, Howlett J, Boeing H, Cockburn A, Constable A, Davi A, de Jong N, Moseley B, Oberdorfer R, Robertson C, Wal JM, Samuels F. 2008. The application of post-market monitoring to novel foods. Food Chem Toxicol 46:9–33. https://doi.org/10.1016/j.fct.2007.09.008.
56. Herrmann K, Schumacher F, Engst W, Appel KE, Klein K, Zanger UM, Glatt H. 2013. Abundance of DNA adducts of methyleugenol, a rodent hepatocarcinogen, in human liver samples. Carcinogenesis 34:1025–30. https://doi.org/10.1093/carcin/bgt013.
57. Howlett J, Edwards DG, Cockburn A, Hepburn P, Kleiner J, Knorr D, Kozianowski G, Müller D, Peijnenburg A, Perrin I, Poulsen M, Walker R. 2009. The safety assessment of novel foods and concepts to determine their safety in use. Int J Food Sci Nutr 54:1–32. https://doi.org/10.1080/09637480310001610308.
58. Intertek Cantox. 2012. Critical review of the Results rof the National Toxicology Program (NTP) Rodent carcinogenicity studies conducted with a specific Ginkgo biloba leaf extract. Available from: https://ntp.niehs.nih.gov/ntp/about_ntp/trpanel/2012/february/publiccomm/cantoxreview.pdf. Accessed 16 Jan 2017.
59. Jadot I, Decleves AE, Nortier J, Caron N. 2017. An integrated view of aristolochic acid nephropathy: update of the literature. Int J Mol Sci 18:297. https://doi.org/10.3390/ijms18020297.
60. Japan External Trade Organization (JETRO). 2011. Guidebook for export to Japan (Food Articles) 2011 March, 2011. Available from: https://www.jetro.go.jp/ext_images/en/reports/market/pdf/guidebook_food_health_foods_dietary_supplem.pdf. Accessed 12 Sep 2016.
61. Lord GM, Tagore R, Cook T, Gower P, Pusey CD. 1999. Nephropathy caused by Chinese herbs in the UK. Lancet 354:481–2. https://doi.org/10.1016/S0140-6736(99)03380-2.
62. Mahady GB. 2001. Global harmonization of herbal health claims. J Nutr 131:1120S–3S.
63. Mangino E, Hayashi Y. 2015. GAIN Report - Japan: Japan's new health claims labeling system creates opportunities. Available from: https://www.xfas.usda.gov/data/japan-japan-s-new-health-claims-labeling-system-creates-opportunities. Accessed 26 Jan 2017.
64. Merz KH, Schrenk D. 2016. Interim relative potency factors for the toxicological risk assessment of pyrrolizidine alkaloids in food and herbal medicines. Toxicol Lett 263:44–57. https://doi.org/10.1016/j.toxlet.2016.05.002.
65. Muller L, Mauthe RJ, Riley CM, Andino MM, Antonis DD, Beels C, DeGeorge J, De Knaep AG, Ellison D, Fagerland JA, Frank R, Fritschel B, Galloway S, Harpur E, Humfrey CD, Jacks AS, Jagota N, Mackinnon J, Mohan G, Ness DK, O'Donovan MR, Smith MD, Vudathala G, Yotti L. 2006. A rationale for determining, testing, and controlling specific impurities in pharmaceuticals that possess potential for genotoxicity. Regul Toxicol Pharmacol 44:198–211. https://doi.org/10.1016/j.yrtph.2005.12.001.
66. National Health and Family Planning Commission of the People's Republic of China. 2014. Notice on the Issuance of 37 National Standards for Food Safety, such as GB2760-2014, the National Standard for the Use of Food Additives in Food Safety- . Available from: http://www.nhfpc.gov.cn/zwgkzt/cybz/201412/d9a9f04bc35f42ecac0600e0360f8c89.shtml. Accessed 30 Jan 2017.
67. National Toxicology Program (NTP). 2013. NTP Technical report on the toxicology and carcinogenesis studies of Ginko biloba extract (CAS No. 90045-36-6) in F344/N rats and B6C3F1/N mice. Available from: https://ntp.niehs.nih.gov/ntp/htdocs/lt_rpts/tr578_508.pdf. Accessed 16 Jan 2017.
68. National Toxicology Program (NTP). 2016. NTP Botanical Dietary Supplements Program. Available from: https://www.niehs.nih.gov/health/materials/ntp_botanical_fact_new_508.pdf. Accessed 16 Jan 2017.
69. New York State Office of the Attorney General. 2015. A.G. Schneiderman asks major retailers to halt sales of certain herbal supplements as DNA tests fail to detect plant materials listed on majority of products tested. Available from: https://ag.ny.gov/press-release/ag-schneiderman-asks-major-retailers-halt-sales-certain-herbal-supplements-dna-tests. Accessed 9 Jan 2017.
70. New Zealand Medicines and Medical Devices Safety Authority. n.d. Regulation of dietary supplements. Available from: http://www.medsafe.govt.nz/regulatory/DietarySupplements/Regulation.asp. Accessed 26 Jan 2017.
71. Newmaster SG, Grguric M, Shanmughanandhan D, Ramalingam S, Ragupathy S. 2013. DNA barcoding detects contamination and substitution in North American herbal products. BMC Med 11:222. https://doi.org/10.1186/1741-7015-11-222
72. Nortier JL, Martinez M-CM, Schmeiser HH, Arlt VM, Bieler CA, Petein M, Depierreux MF, De Pauw L, Abramowicz D, Vereerstraeten P, Vanherweghem J-L. 2009. Urothelial carcinoma associated with the use of a Chinese herb (Aristolochia fangchi). N Engl J Med 342:1686–92. https://doi.org/NJ200006083422301
73. Persistence Market Research. 2015a. Dietary supplements market - Global study on dietary supplements: Botanical supplements to be the largest market by 2020. Available from: http://www.persistencemarketresearch.com/market-research/dietary-supplements-market.asp. Accessed 18 Oct 2016.
74. Persistence Market Research. 2015b. Dietary supplements market will reach US 179.8 Billion globally in 2020. Available from: http://www.persistencemarketresearch.com/mediarelease/dietary-supplements-market.asp. Accessed 18 Oct 2016.
75. Prinsloo G, Papadi G, Hiben MG, de Haan L, Louisse J, Beekmann K, Vervoort J, Rietjens IMCM. 2017. In vitro bioassays to evaluate beneficial and adverse health effects of botanicals: promises and pitfalls. Drug Discov Today 22:1187–1200. https://doi.org/10.1016/j.drudis.2017.05.002.
76. Reeuwijk NM, Venhuis BJ, de Kaste D, Hoogenboom LA, Rietjens IMCM, Martena MJ. 2013. Sildenafil and analogous phosphodiesterase type 5 (PDE-5) inhibitors in herbal food supplements sampled on the Dutch market. Food Addit Contam Part A Chem Anal Control Expo Risk Assess 30:2027–34. https://doi.org/10.1080/19440049.2013.848294.
77. Reeuwijk NM, Venhuis BJ, de Kaste D, Hoogenboom RLAP, Rietjens IMCM, Martena MJ. 2014. Active pharmaceutical ingredients detected in herbal food supplements for weight loss sampled on the Dutch market. Food Addit Contam Part A Chem Anal Control Expo Risk Assess 31:1783–93. https://doi.org/10.1080/19440049.2014.958574.
78. Rider CV. 2016. Report on workshop: addressing challenges in the assessment of botanical dietary supplement safety workshop. Available from: https://ntp.niehs.nih.gov/ntp/about_ntp/bsc/2016/june/presentations/botanicals_508.pdf. Accessed 11 Jan 2017.
79. Rietjens IMCM, Tyrakowska B, van den Berg SJPL, Soffers AEMF, Punt A. 2015. Matrix-derived combination effects influencing absorption, distribution, metabolism and excretion (ADME) of food-borne toxic compounds: implications for risk assessment. Toxicol Res 4:23–35. https://doi.org/10.1039/C4TX00081A.
80. Rocha T, Amaral JS, Oliveira MBPP. 2016. Adulteration of dietary supplements by the illegal addition of synthetic drugs: a review. Compr Rev Food Sci Food Saf 15:43–62. https://doi.org/10.1111/1541-4337.12173.
81. Rozman KK, Doull J, Hayes Jr WJ. 2010. Dose and time determining, and other factors influencing, toxicity. In: R. Krieger editor. Hayes' handbook of pesticide toxicology. 3rd ed. London: Academic Press. p 3–101.
82. SCF EC. 2001a. Opinion of the Scientific Committee on Food on estragole (1-Allyl-4-methoxybenzene). Available from: https://ec.europa.eu/food/sites/food/files/safety/docs/sci-com_scf_out104_en.pdf. Accessed 12 Sep 2016.
83. SCF EC. 2001b. Opinion of the Scientific Committee on Food on methyleugenol (4-Allyl-1,2-dimethoxybenzene). Available from: https://ec.europa.eu/food/sites/food/files/safety/docs/sci-com_scf_out102_en.pdf. Accessed 29 May 2017.
84. Schilter B, Andersson C, Anton R, Constable A, Kleiner J, O'Brien J, Renwick AG, Korver O, Smit F, Walker R. 2003. Guidance for the safety assessment of botanicals and botanical preparations for use in food and food supplements. Food Chem Toxicol 41:1625–49. https://doi.org/10.1016/S0278-6915(03)00221-7.
85. Schilter B, Benigni R, Boobis A, Chiodini A, Cockburn A, Cronin MTD, Lo Piparo E, Modi S, Thiel A, Worth A. 2014. Establishing the level of safety concern for chemicals in food without the need for toxicity testing. Regulatory Toxicol Pharmacol 68:275–96. https://doi.org/10.1016/j.yrtph.2013.08.018.
86. Shao A. 2017. Chapter 15 – Global market entry regulations for nutraceuticals, functional foods, dietary/food/health supplements. In: Debasis Bagchi, Sreejayan Nair editors. Developing new functional food and nutraceutical products. Amsterdam: Academic Press. p 279–90.
87. Shaw D, Leon C, Kolev S, Murray V. 1997. Traditional remedies and food supplements. Drug Safety 17:342–56. https://doi.org/10.2165/00002018-199717050-00006.
88. Shen C, Pang SM, Kwong EW, Cheng Z. 2010. The effect of Chinese food therapy on community dwelling Chinese hypertensive patients with Yin-deficiency. J Clin Nurs 19:1008–20. https://doi.org/10.1111/j.1365-2702.2009.02937.x.
89. Silano V, Coppens P, Larranaga-Guetaria A, Minghetti P, Roth-Ehrang R. 2011. Regulations applicable to plant food supplements and related products in the European Union. Food Funct 2:710–9. https://doi.org/10.1039/c1fo10105f.
90. Stegelmeier BL, Brown AW, Welch KD. 2015. Safety concerns of herbal products and traditional Chinese herbal medicines: dehydropyrrolizidine alkaloids and aristolochic acid. J Appl Toxicol 35:1433–7. https://doi.org/10.1002/jat.3192.
91. SUKL (Czech State Institute for Drug Control). 2010. Distinction between dietary supplements and medicinal products, State Institute for Drug Control. Available from: http://www.sukl.eu/medicines/distinction-between-dietary-supplements-and-medicinal. Accessed 8 Nov 2016.
92. Sun J, Chen P. 2011. Differentiation of Panax quinquefolius grown in the USA and China using LC/MS-based chromatographic fingerprinting and chemometric approaches. Anal Bioanal Chem 399:1877–89. https://doi.org/10.1007/s00216-010-4586-7.
93. Swann JP. 2016. The history of efforts to regulate dietary supplements in the USA. Drug Test Anal 8:271–82. https://doi.org/10.1002/dta.1919.
94. Therapeutic Goods Administration (TGA). 2006. European Union guidelines used by the Office of Complementary Medicines. Available from: https://www.tga.gov.au/european-union-guidelines-used-office-complementary-medicines. Accessed 03 Nov 2016.
95. Therapeutic Goods Administration (TGA). 2013a. Listed complementary medicines | Therapeutic Goods Administration (TGA). Available from: https://www.tga.gov.au/listed-complementary-medicines. Accessed 27 Jan 2017.
96. Therapeutic Goods Administration (TGA). 2013b. An overview of the regulation of complementary medicines in Australia | Therapeutic Goods Administration (TGA). Available from: https://www.tga.gov.au/overview-regulation-complementary-medicines-australia. Accessed 26 Jan 2017.
97. Therapeutic Goods Administration (TGA). 2013c. Registered complementary medicines | Therapeutic Goods Administration (TGA). Available from: https://www.tga.gov.au/registered-complementary-medicines. Accessed 26 Jan 2017.
98. Therapeutic Goods Administration (TGA). 2016a. Australian regulatory guidelines for complementary medicines (ARGCM) V6.0. Available from: https://www.tga.gov.au/publication/australian-regulatory-guidelines-complementary-medicines-argcm. Accessed 10 Sep 2016.
99. Therapeutic Goods Administration (TGA). 2016b. Herbal materials & extracts. Available from: https://www.tga.gov.au/herbal-materials-extracts. Accessed 03 Nov 2016.
100. Therapeutic Goods Administration (TGA). 2016c. List of evaluated registered complementary medicines. Available from: https://www.tga.gov.au/list-evaluated-registered-complementary-medicines. Accessed 08 Nov 2016.
101. Tims M. 2016. Putting the cart before the horse: Toward the appropriate use of DNA methods for quality assurance in the herbal supplement industry. J Altern Complement Med 22:588–90. https://doi.org/10.1089/acm.2016.29007.mjt.
102. Tremmel R, Herrmann K, Engst W, Meinl W, Klein K, Glatt H, Zanger UM. 2017. Methyleugenol DNA adducts in human liver are associated with SULT1A1 copy number variations and expression levels. Arch Toxicol. https://doi.org/10.1007/s00204-017-1955-4.
103. U. S. Food and Drug Administration (FDA). 2011. Safety Alerts & Advisories - Aristolochic Acid: FDA Warns Consumers to Discontinue Use of Botanical Products that Contain Aristolochic Acid. Available from: https://www.fda.gov/Food/RecallsOutbreaksEmergencies/SafetyAlertsAdvisories/ucm096388.htm. Accessed 12 May 2017.
104. U. S. Food and Drug Administration (FDA). 2016a. Dietary supplements. Available from: http://www.fda.gov/Food/DietarySupplements/. Accessed 26 Jan 2017.
105. U. S. Food and Drug Administration (FDA). 2016b. Draft guidance for industry: dietary Supplements: new dietary ingredient notifications and related issues. Available from: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm257563.htm. Accessed 7 Sep 2016.
106. U. S. Food and Drug Administration (FDA). 2016c. Information for consumers - questions and answers on dietary supplements. Available from: https://www.fda.gov/Food/DietarySupplements/UsingDietarySupplements/ucm480069.htm#FDA_role. Accessed 12 May 2017.
107. U.S. Food and Drug Administration (FDA). 2008. Consumer updates - Is it really ‘FDA approved?’ Available from: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm047470.htm. Accessed 26 Jan 2017.
108. United States Pharmacopeial Convention (USP). 2015. USP urges validation of DNA test methods for herbal supplements | U.S. Pharmacopeial Convention. Available from: http://www.usp.org/news/united-states-pharmacopeial-convention-urges-scientific-validation-dna-test-methods-regulating-quality-herbal-supplements. Accessed 9 Jan 2017.
109. van den Berg SJPL, Alhusainy W, Restani P, Rietjens IMCM. 2014. Chemical analysis of estragole in fennel based teas and associated safety assessment using the margin of exposure (MOE) approach. Food Chem Toxicol 65:147–54. https://doi.org/10.1016/j.fct.2013.12.035.
110. van der Meulen BMJ, Szajkowska A. 2014. The General Food Law: general provisions of food law. In: B. M. J. van der Meulen editor. EU Food Law Handbook. Wageningen: Wageningen Academic Publishers. p 229–59.
111. Vanherweghem J-L. 1998. Misuse of herbal remedies: the case of an outbreak of terminal renal failure in Belgium (Chinese herbs nephropathy). J Altern Complement Med 4:9–13. https://doi.org/10.1089/acm.1998.4.1-9.
112. Wohlmuth H, Leach D, McGrath K, Gordon L, Mouatt P, Voss JD. 2016. Is DNA barcoding using universal barcodes a useful test for botanical raw materials, extracts and products? Presented at the Joint Meeting of 16th Annual International Conference on the Science of Botanicals (ICSB) with 5th Interim American Society of Pharmacognosy (ASP); Oxford, Mississippi, 11–14 April 2016. Planta Med 82:OA43. https://doi.org/10.1055/s-0036-1578613
113. World Health Organization. 1999. WHO Monographs on selected medicinal plants - Volume 1 Geneva: World Health Organization (WHO).
114. World Health Organization. 2004. WHO Monographs on selected medicinal plants - Volume 2 Geneva: World Health Organization (WHO).
115. World Health Organization. 2007. WHO Monographs on selected medicinal plants - Volume 3 Geneva: World Health Organization (WHO).
116. World Health Organization. 2009. WHO Monographs on selected medicinal plants - Volume 4 Geneva: World Health Organization (WHO).
117. World Health Organization. 2010. WHO Monographs on medicinal plants commonly used in the Newly Independent States (NIS). World Health Organization (WHO).
118. Zakaryan A, Martin IG. 2012. Regulation of herbal dietary supplements: Is there a better way? Drug Inform J 46:532–44. https://doi.org/10.1177/0092861512452121.