03 Issues & Trends
Cereal Foods World, Vol. 65, No. 3
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Health Claims for Food—The Need for More Harmonization
Frank Thielecke1,2 and Wai Mun Poon3

1 Swiss Distance University of Applied Sciences, 8105 Regensdorf-Zurich, Switzerland, and T2 Bene Ltd., Bettenstrasse 60a, CH-4123 Allschwil, Switzerland. LinkedIn: www.linkedin.com/in/frank-thielecke-phd-69401932, #nutrition, #regulatory, #foodscience; Twitter: #nutrition, #science, #healthregulation; ORCID: https://orcid.org/0000-0003-4975-5327; ResearcherID: https://publons.com/researcher/3508419/frank-thielecke (AAJ-3422-2020)

2 Corresponding author. Tel: +41 (0)79 536 06 31; E-mail: frank.b.thielecke@gmail.com

3 #19-61, Tower 2, 1 Raffles Place, Singapore 048616, Singapore. LinkedIn: www.linkedin.com/in/wai-mun-poon-61aa72b

© 2020 Cereals & Grains Association


A health claim is a strong marketing tool for food manufacturers. Countries put legislation regulating health claims in place with the aim of ensuring consumer protection as well as fair trade. The underlying principles for establishing health claims are laid out in the Codex Alimentarius. However, significant diversity in health claim regulations still exists internationally and presents challenges in terms of resources for health claim applications, as well as trade risk for manufacturers and organizations that are active in a global market. Using European and Asian legislation as examples, the existing diversity in health claim regulations is highlighted. The resulting challenges warrant further harmonization between countries that have health claim regulations.

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  1. Atkins, D., Best, D., Briss, P. A., Eccles, M., Falck-Ytter, Y., et al. Grading quality of evidence and strength of recommendations. BMJ 328:1490, 2004.
  2. Ball, D. With food sales flat, Nestlé stakes future on healthier fare. Wall Street J. March 18, p. A1, 2004.
  3. Brookes, G. Economic impact assessment of the European Union (EU)’s Nutrition & Health Claims Regulation on the EU food supplement sector and market. Available online at www.pgeconomics.co.uk/pdf/Impact-Assessment-health-claims.pdf. European Health Claims Alliance, 2010.
  4. Consumer Affairs Agency Japan. Foods with functional claims. Guidance for industry. Published online at www.caa.go.jp/policies/policy/food_labeling/information/pamphlets/pdf/151224_2.pdf. CAA, Tokyo, Japan, 2015.
  5. Consumer Affairs Agency Japan. Outline of food labelling systems for health and nutrition. Published online at www.caa.go.jp/en/policy/food_labeling/pdf/food_labeling_191001_0001.pdf. CAA, Tokyo, Japan, 2019.
  6. Emanuel, E. J., Schnipper, L. E., Kamin, D. Y., Levinson, J., and Lichter, A. S. The costs of conducting clinical research. J. Clin. Oncol. 21:4145, 2003.
  7. European Commission. Health claims. Published online at https://ec.europa.eu/food/safety/labelling_nutrition/claims/health_claims_en. EC, Brussels, Belgium, 2012.
  8. European Federation of Associations of Health Product Manufacturers. What is a health claim? Available online at https://ehpm.org/regulatory-issues/h-claims.html. EHPM, Brussels, Belgium, 2017.
  9. European Food Safety Authority. Regulation (EC) No. 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods. Off. J. Eur. Union, L 404/9, 2006.
  10. European Food Safety Authority. General scientific guidance for stakeholders on health claim applications. EFSA J. 14:4367, 2016.
  11. Ferguson, D. Researchers show how to navigate complex EU health claim regulations for food and drinks. University of Surrey, Guildford, U.K., 2017.
  12. Food and Agriculture Organization of the United Nations. Guidelines for use of nutrition and health claims. CAC/GL 23-1997. Published online at www.fao.org/input/download/standards/351/CXG_023e.pdf. FAO, Rome, Italy, 2013.
  13. Food and Drug Administration Thailand. Announcement of the Food and Drug Administration. Re: Declaration of Nutrient Function Claim. Published online at http://food.fda.moph.go.th/law/data/announ_fda/English/1%20Declaration%20of%20Nutrient%20Function%20Claim.pdf. Food and Drug Administration, Nonthaburi, Thailand, 2008.
  14. Grossklaus, R. Codex recommendations on the scientific basis of health claims. Eur. J. Nutr. 48(Suppl. 1):S15, 2009.
  15. Harmayani, E., Anal, A. K., Wichienchot, S., Bhat, R., Gardjito, M., Santoso, U., Siripongvutikorn, S., Puripaatanavong, J., and Payyappallimana, U. Healthy food traditions of Asia: Exploratory case studies from Indonesia, Thailand, Malaysia, and Nepal. J. Ethn. Foods. DOI: https://doi.org/10.1186/s42779-019-0002-x. 2019.
  16. Hawkes, C., and World Health Organization, Noncommunicable Diseases and Mental Health Cluster. Nutrition Labels and Health Claims: The Global Regulatory Environment. WHO, Geneva, Switzerland, 2004.
  17. Kwak, N. S., and Jakes, D. Issues in the substantiation process of health claims. Crit. Rev. Food Sci. Nutr. 41:465, 2001.
  18. Lalor, F., and Wall, P. G. Health claims regulations: Comparison between USA, Japan and European Union. Br. Food J. 113:298, 2011.
  19. Lawrence, M., and Rayner, M. Functional foods and health claims: A public health policy perspective. Public Health Nutr. 1:75, 1998.
  20. Lenssen, K. G. M., Bast, A., and de Boer, A. Clarifying the health claim assessment procedure of EFSA will benefit functional food innovation. J. Funct. Foods 47:386, 2018.
  21. Mariotti, F., Kalonji, E., Huneau, J. F., and Margaritis, I. Potential pitfalls of health claims from a public health nutrition perspective. Nutr. Rev. 68:624, 2010.
  22. Merten-Lenz, K. Impact of health claims regulations on the food industry and future innovation potential. Page 13 in: Health Claims and Food Labelling. S. Astley, ed. Royal Society of Chemistry, Croydon, U.K., 2020.
  23. Ministry of Food and Drug Safety Republic of Korea. Health functional food code. Available online at www.mfds.go.kr/eng/brd/m_15/view.do?seq=70011&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=2. Cheongju-si, Republic of Korea, 2016.
  24. Ministry of Health Malaysia. Guide to nutrition labelling and claims. Available online at https://extranet.who.int/nutrition/gina/sites/default/files/MYS%202010%20Guide%20to%20Nutrition%20Labelling%20and%20Claims.pdf. MOH, Federal Territory of Putrajaya, Malaysia, 2010.
  25. Ministry of Health People’s Republic of China. National Food Safety Standard: General Rules for Nutrition Labeling of Prepackaged Foods. GB 28050-2011. MOH, Beijing, China, 2011.
  26. Richardson, D. P. Scientific substantiation of health claims: A global analysis. International Alliance of Dietary/Food Supplement Associations, Brussels, Belgium, 2010.
  27. Shi, H., Zhu, W.-L., Yuan, Y.-M., and Tao, Q. Introducing Chinese food therapy: A review of origin, developing course and modern application. TMR Integr. Nursing 2:42, 2018.
  28. Singapore Food Agency. A Guide to Food Labelling and Advertisements. Published online at www.sfa.gov.sg/docs/default-source/tools-and-resources/resources-for-businesses/aguidetofoodlabellingandadvertisements.pdf. SFA, Singapore, 2019.
  29. Speich, B., Schur, N., Gryaznov, D., von Niederhäusern, B., Hemkens, L. G., et al. Resource use, costs, and approval times for planning and preparing a randomized clinical trial before and after the implementation of the new Swiss human research legislation. PLoS One. DOI: https://doi.org/10.1371/journal.pone.0210669. 2019.
  30. State Food and Drug Administration, State Health and Family Planning Commission, and State Administration of Traditional Chinese Medicine People’s Republic of China. Announcement on issuing the catalogue of raw materials for health food (1) and the catalogue of health care functions allowed be claims of health food (1) (2016 No. 205). Available online at www.samr.gov.cn/tssps/tzgg/zjwh/201903/t20190313_291950.html. State Administration of Market Supervision and Administration, Beijing, China, 2016.
  31. Tee, E. Nutrition labelling and claims: Concerns and challenges; experiences from the Asia Pacific Region. Asia Pac. J. Clin. Nutr. 11(Suppl. 6):S215, 2002.
  32. Tillotson, J. E. Does nutrition sell? Do health claims work? Part 1. Nutr. Today 37:233, 2002.
  33. Tillotson, J. E. Does nutrition sell? Do health claims work? Part 2. Nutr. Today 38:6, 2003.
  34. U.S. Food and Drug Administration. Label claims for conventional foods and dietary supplements. Published online at www.fda.gov/food/food-labeling-nutrition/label-claims-conventional-foods-and-dietary-supplements. FDA, Silver Spring, MD, 2018.
  35. U.S. Food and Drug Administration. Qualified health claims. Published online at www.fda.gov/food/food-labeling-nutrition/qualified-health-claims. FDA, Silver Spring, MD, 2019.
  36. Vergari, F., Tibuzzi, A., and Basile, G. An overview of the functional food market: From marketing issues and commercial players to future demand from life in space. Adv. Exp. Med. Biol. 698:308, 2010.
  37. Wahlqvist, M., and Wattanapenpaiboon, N. Can functional foods make a difference to disease prevention and control. In: Globalization, Diets and Noncommunicable Diseases. Available online at https://apps.who.int/iris/bitstream/handle/10665/42609/9241590416.pdf;sequence=1. World Health Organization, Geneva, Switzerland, 2002.
  38. Weaver, C. M., and Miller, J. W. Challenges in conducting clinical nutrition research. Nutr. Rev. 75:491, 2017.