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: Second Edition

Volumn , Issue , 2014, Pages 41-51

  Shao, Andrew ^a  

^a Herbalife International America Inc   (United States)

Author keywords

Negative list; Notification; Positive list; Registration

Indexed keywords

EID: 84902231896     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1016/B978-0-12-405870-5.00003-7     Document Type: Chapter

References (38)

1. FDA. (2012). Food additives. Retrieved January 15, 2013, from http://www.fda.gov/Food/FoodIngredientsPackaging/FoodAdditives/default.htm.
2. FDA. (2012). Generally Recognized as Safe (GRAS). Retrieved January 15, 2013, from http://www.fda.gov/Food/FoodIngredientsPackaging/GenerallyRecognizedasSafeGRAS/default.htm.
3. European Commission. Food additives and flavourings. Retrieved January 15, 2013, from http://ec.europa.eu/food/fs/sfp/flav_index_en.html.
4. JECFA. About Codex. Codex Alimentarius Retrieved January 15, 2013, from 2013. http://www.codexalimentarius.org/scientific-basis-for-codex/jecfa/en/.
5. Therapeutic Goods Administration. (2007). Substances that may be used in Listed medicines in Australia. Retrieved January 15, 2013, from http://www.tga.gov.au/pdf/cm-listed-substances.pdf.
6. SFDA. Regulations on Supervision of Functional Foods (Draft for Approval). Retrieved January 15, 2013; 2009.
7. Natural Health Products Directorate. Compendium of Monographs. Drugs and Health Products Retrieved January 15, 2013, from 2009. http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-prod/monograph/index-eng.php.
8. European Commission. Commission Regulation (EC) No 1170/2009 of 30 November 2009 amending Directive 2002/46/EC of the European Parliament and of Council and Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards the lists of vitamin and minerals and their forms that can be added to foods, including food supplements. Official Journal of the European Union L314/36, 2009.
9. European Commission. Novel foods and novel food ingredients. Food and Feed Safety Retrieved January 15, 2013, from 2012. http://ec.europa.eu/food/food/biotechnology/novelfood/index_en.htm.
10. European Commission. Novel Food catalogue-Search. Food and Feed Safety Retrieved January 15, 2013, from http://ec.europa.eu/food/food/biotechnology/novelfood/nfnetweb/mod_search/index.cfm.
11. Ministero della Salute. Altri Nutrienti E Altre Sostanze Ad Effetto Nutritivo O Fisiologico. Retrieved January 15, 2013, from http://www.salute.gov.it/imgs/C_17_pagineAree_1268_listaFile_itemName_4_file.pdf.
12. Ministerialtidende. Bekendtgørelse om tilsætning af visse andre stoffer end vitaminer og mineraler til fødevarer. Retrieved January 15, 2013, from 2012. https://www.retsinformation.dk/Forms/R0710.aspx?id=137299.
13. SBÍRKA ZÁKONǔ. Kterou se stanoví požadavky na doplňky stravy a na obohacování potravin, 2008.
14. Customs Union Commission. Uniform sanitary and epidemiological and hygienic requirements for products subject to sanitary and epidemiological supervision (control), 2010.
15. FDA. Final rule declaring dietary supplements containing ephedrine alkaloids adulterated because they present an unreasonable risk. 2004;69:6788-6854.
16. CFSAN, C. f. F. S. a. N., Office of Food Additive Safety. FDA Response to OVOS Natural Health Homotaurine Petition. Department of Health and Human Services, Food and Drug Administration, Washington, DC; 2011.
17. FDA. FDA Advises Dietary Supplement Manufacturers to Remove Comfrey Products From the Market 2001.
18. FDA. February 28, 2003 Warning Letter to Powerhouse Supplements 2003.
19. FDA. Letter to Health Professionals regarding safety concerns related to the use of botanical products containing aristolochic acid, 2001.
20. FDA. Consumer Advisory: Kava-Containing Dietary Supplements May be Associated With Severe Liver Injury, 2002.
21. ASEAN. Guiding Principles for Inclusion of Active Substances into the Restricted List for Traditional Medicines and Health Supplements (TMHS), 2010.
22. ANVISA. Novos Ingredientes Aprovados. Retrieved January 15, 2013, from 2009. http://portal.anvisa.gov.br/wps/content/Anvisa+Portal/Anvisa/Inicio/Alimentos/Assuntos+de+Interesse/Novos+Alimentos+e+Novos+Ingredientes/29bd7700401adec6b403b654e035b7cb.
23. COFEPRIS. What is the COFEPRIS? Retrieved January 15, 2013, from 2011. http://www.cofepris.gob.mx/Paginas/Idiomas/Ingles.aspx.
24. Asociacion Nacional de la Industria de los Suplementos Alimenticios. ANAISA Noticias. Retrieved January 15, 2013, from 2013. http://www.anaisa.mx/.
25. European Food Safety Authority, E Compendium of botanicals reported to contain naturally occuring substances of possible concern for human health when used in food and food supplements. EFSA J 2012, 2012:10.
26. Ministero della Salute. Disciplina dell'impiego negli integratori alimentari di sostanze e preparati vegetali (G.U. 21-7-2012 serie generale n. 169), 2012.
27. Belgian Health, F. C. S. a. E. Food supplements - Enriched foodstuffs. Retrieved January 15, 2013, from 2012. http://www.health.belgium.be/eportal/foodsafety/foodstuffs/foodsupplements/index.htm?fodnlang=en#Plants.
28. The Federal Office of Consumer Protection and Food Safety (BVL). Entwurf einer Liste für die Kategorie "Pflanzen und Pflanzenteile". Retrieved January 15, 2013, from 2010. http://www.bvl.bund.de/SharedDocs/Downloads/01_Lebensmittel/stoffliste/stoffliste_pflanzen_pflanzenteile.html?nn=1406620.
29. European Commission. Directive 2002/46/EC Of The European Parliament And Of The Council, 2002.
30. ASEAN. Harmonization of Standards and Technical Requirements in ASEAN. Retrieved January 15, 2013, from 2012. http://www.asean.org/news/item/harmonization-of-standards-and-technical-requirements-in-asean.
31. ASEAN. Profile of Definition, Terminology, and Technical Requirement of Traditional Medicines and Health Supplements among ASEAN Member Countries 2006.
32. FDA. Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues. Retrieved January 15, 2013, from 2011. http://www.fda.gov/food/guidancecomplianceregulatoryinformation/guidancedocuments/dietarysupplements/ucm257563.htm.
33. FDA. New Dietary Ingredients in Dietary Supplements-Background for Industry. Retrieved January 15, 2013, from 2012. http://www.fda.gov/Food/DietarySupplements/ucm109764.htm.
34. ANVISA. Registration of Products: Manual covering procedures for registration and exemption from registration of imported products. Retrieved January 15, 2013, from 2000. http://www.anvisa.gov.br/eng/food/registration.htm.
35. TFDA. Food and Drug Administration, Department of Health. Retrieved January 15, 2013, from 2012. http://www.taiwan.gov.tw/ct.asp?xItem=25613&ctNode=1957&mp=999.
36. TGA. The regulation of complementary medicines in Australia-an overview: Pre-market assessment. Retrieved January 15, 2013, from 2012. http://www.tga.gov.au/industry/cm-basics-regulation-overview.htm#pre.
37. TGA. Australian Guidelines for Complementary Medicines (ARGCM) Part II: Listed Complementary Medicines, 2011.
38. Health Canada. Natural Health Products. Retrieved January 15, 2013, from 2012. http://www.hc-sc.gc.ca/dhp-mps/prodnatur/index-eng.php.