Skip to main content
×
Home

A standardised approach towards PROving the efficacy of foods and food constituents for health CLAIMs (PROCLAIM): providing guidance

  • Alison M. Gallagher (a1), Gert W. Meijer (a2), David P. Richardson (a3), Virginie Rondeau (a4), Maria Skarp (a5), Marianne Stasse-Wolthuis (a6), Guy C. Tweedie (a7) and Renger Witkamp (a8) (a9)...
Abstract

Diet is well known to have beneficial health properties that extend beyond traditionally accepted nutritional effects. The approach involved in elucidating these beneficial physiological effects is becoming more important, as reflected by increasing research being undertaken. With growing consumer awareness of foods and food constituents and their relationship to health, the key questions for regulators, scientists and the food industry continue to relate to: (1) how consumers could be protected and have confidence that the health claims on foods are well supported by the evidence; (2) how research on physiological effects of food (constituents) and their health benefits could be stimulated and supported; (3) how research findings could be used in the development of innovative new food products. The objectives of this paper are to provide a set of recommendations on the substantiation of health claims for foods, to develop further guidance on the choice of validated markers (or marker patterns) and what effects are considered to be beneficial to the health of the general public (or specific target groups). Finally, the case for developing a standardised approach for assessing the totality of the available scientific data and weighing the evidence is proposed.

  • View HTML
    • Send article to Kindle

      To send this article to your Kindle, first ensure no-reply@cambridge.org is added to your Approved Personal Document E-mail List under your Personal Document Settings on the Manage Your Content and Devices page of your Amazon account. Then enter the ‘name’ part of your Kindle email address below. Find out more about sending to your Kindle.

      Note you can select to send to either the @free.kindle.com or @kindle.com variations. ‘@free.kindle.com’ emails are free but can only be sent to your device when it is connected to wi-fi. ‘@kindle.com’ emails can be delivered even when you are not connected to wi-fi, but note that service fees apply.

      Find out more about the Kindle Personal Document Service.

      A standardised approach towards PROving the efficacy of foods and food constituents for health CLAIMs (PROCLAIM): providing guidance
      Available formats
      ×
      Send article to Dropbox

      To send this article to your Dropbox account, please select one or more formats and confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your Dropbox account. Find out more about sending content to Dropbox.

      A standardised approach towards PROving the efficacy of foods and food constituents for health CLAIMs (PROCLAIM): providing guidance
      Available formats
      ×
      Send article to Google Drive

      To send this article to your Google Drive account, please select one or more formats and confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your Google Drive account. Find out more about sending content to Google Drive.

      A standardised approach towards PROving the efficacy of foods and food constituents for health CLAIMs (PROCLAIM): providing guidance
      Available formats
      ×
Copyright
Corresponding author
Correspondence: ILSI Europe a.i.s.b.l., Avenue E. Mounier 83, Box 6, 1200 Brussels, Belgium, fax +32 2 762 00 44, email: publications@ilsieurope.be
References
Hide All
1Aggett PJ, Antoine J-M, Asp N-G, et al. (2005) Process for the assessment of scientific support for claims on foods (PASSCLAIM). Eur J Nutr 44, Suppl. 1, 130.
2Aggett PJ, Antoine J-M, de Vries J, et al. (2010) Beyond PASSCLAIM – guidance to substantiate health claims on foods. Summary report of workshop held in December 2009 in Nice, France. Organised by the ILSI Europe Functional Foods Task Group. http://www.ilsi.org/Europe/Publications/Beyond%20PASSCLAIM%20Report%202010.pdf (accessed October 2010).
3European Parliament and Council (2007) Corrigendum to Regulation (EC) no. 1924/2006 of the European Parliament and of the Council of 20th December 2006 on nutrition and health claims made on foods. OJ L12, 318. http://eur-lex.europa.eu/LexUriServ/site/en/oj/2007/l_012/l_01220070118en00030018.pdf (accessed October 2010).
4US FDA (2003) Claims that can be made for conventional foods and dietary supplements. http://www.fda.gov/Food/LabelingNutrition/LabelClaims/ucm111447.htm . (accessed October 2010).
5Codex Alimentarius (1997/amended 2009) Nutrition and health claims (CAC/GL 23-1997). http://www.codexalimentarius.net/web/more_info.jsp?id_sta = 351 (accessed October 2010).
6EFSA Panel on Dietetic Products, Nutrition and Allergies (2010) Scientific Opinions on the substantiation of health claims. http://www.efsa.europa.eu/en/nda/ndaclaims.htm (accessed October 2010).
7US FDA/CFSAN (1998) Guidance for industry: notification of a health claim or nutrient content claim based on an authoritative statement of a scientific body. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/ucm056975.htm.
8US FDA/CFSAN (2007) Qualified health claims subject to enforcement discretion. http://www.fda.gov/Food/LabelingNutrition/LabelClaims/QualifiedHealthClaims/ucm073992.htm (accessed October 2010).
9US FDA (2009) Guidance for industry: evidence-based review system for the scientific evaluation of health claims. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/ucm073332.htm (accessed October 2010).
10US FDA (2009) Health claims meeting significant scientific agreement (SSA). http://www.fda.gov/Food/LabelingNutrition/LabelClaims/HealthClaimsMeetingSignificantScientificAgreementSSA/default.htm (accessed October 2010).
11US FDA (2009) Qualified health claims: letters of enforcement discretion. http://www.fda.gov/Food/LabelingNutrition/LabelClaims/QualifiedHealthClaims/ucm072756.htm (accessed October 2010).
12US FDA (2009) Letters of denial. http://www.fda.gov/Food/LabelingNutrition/LabelClaims/QualifiedHealthClaims/ucm072751.htm (accessed October 2010).
14Welch RW, Woodside JV, Antoine J-M, et al. Guidelines for the design, conduct and reporting of human intervention studies to evaluate the health benefits of foods. Br J Nutr (accepted).
15World Health Organisation (1946) Preamble to the Constitution of the World Health Organization as Adopted by the International Health Conference, New York, 19–22 June, 1946.
16EFSA (2010) Guidance on human health risk-benefit assessment of food. EFSA J 8, 1673. http://www.efsa.europa.eu/en/scdocs/doc/1673.pdf (accessed October 2010).
17EFSA Panel on Dietetic Products, Nutrition and Allergies (2011) General guidance for stakeholders on the evaluation of Article 13.1, 13.5 and 14 health claims. EFSA J 9, 2135. Published online:http://www.efsa.europa.eu/en/efsajournal/doc/2135.pdf (accessed June 2011).
18Blumberg J, Heaney RP, Huncharek M, et al. (2010) Evidence-based criteria in the nutritional context. Nutr Rev 68, 478484.
19Wiseman M (2008) The second World Cancer Research Fund/American Institute for Cancer Research expert report. Food, nutrition, physical activity, and the prevention of cancer: a global perspective. Proc Nutr Soc 67, 253256.
20Code of Federal Regulations (2003) Title 21 – Food and Drugs, Volume 2, Chapter I – Food and Drug Administration, Department of Health and Human Services, Part 101 – Food Labeling, Sec. 101.78 Health Claims: Fruits and Vegetables and Cancer, pp. 134–136.
21Heaney RP (2008) Nutrients, endpoints and the problem of proof. J Nutr 138, 15911595.
22NIH Definition Working Group (2001) Biomarkers and surrogate endpoints: preferred definitions and conceptual framework. Clin Pharmacol Ther 69, 8995.
23EFSA Panel on Dietetic Products, Nutrition and Allergies (2011) Guidance on the scientific requirements for health claims related to gut and immune function. EFSA J 9, 1984. Published online:http://www.efsa.europa.eu/en/efsajournal/doc/1984.pdf (accessed June 2011).
24Irvine EJ, Whitehead WE, Chey WD, et al. (2006) Design of treatment trials for functional gastrointestinal disorders. Gastroenterol 130, 15381551.
25Van Ommen B, Fairweather-Tait S, Freidig A, et al. (2008) A network biology model of micronutrient related health. Br J Nutr 99, Suppl. 3, S72S80.
26EFSA Panel on Dietetic Products, Nutrition and Allergies (2009) Frequently Asked Questions (FAQ) related to the assessment of Article 14 and 13.5 health claims applications on request of EFSA. EFSA J 7, 1339(8 pp.).
27Bureau of Nutritional Sciences (2009) Food Directorate, Health Products and Food Branch. Guidance document for preparing a submission for food health claims. Health Canada. http://www.hc-sc.gc.ca/fn-an/alt_formats/hpfb-dgpsa/pdf/legislation/health-claims_guidance-orientation_allegations-sante-eng.pdf (accessed October 2010).
28Asp NG & Bryngelsson S (2008) Health claims in Europe: new legislation and PASSCLAIM for substantiation. J Nutr 138, 1210S1215S.
29World Health Organisation (2003) Diet, Nutrition and the Prevention of Chronic Diseases: Report of a Joint FAO/WHO Expert Consultation. WHO Technical Report Series 916. World Health Organisation Geneva.
30World Cancer Research Fund International/American Institute for Cancer Research Expert Report (2007) Food, nutrition, physical activity and the prevention of cancer: a global perspective. http://www.dietandcancerreport.org/ (accessed October 2010).
31EFSA (2010) Scientific opinion on establishing food-based dietary guidelines. EFSA J 8, 1460. http://www.efsa.europa.eu/en/scdocs/doc/1460.pdf (accessed October 2010).
32Mente A, de Koning L, Shannon H, et al. (2009) A systematic review of the evidence supporting a causal link between dietary factors and coronary heart disease. Arch Intern Med 169, 659669.
33Richardson DP, Affertsholt T, Asp N-G, et al. (2003) PASSCLAIM – synthesis and review of existing processes. Eur J Nutr 42, 96111.
Recommend this journal

Email your librarian or administrator to recommend adding this journal to your organisation's collection.

British Journal of Nutrition
  • ISSN: 0007-1145
  • EISSN: 1475-2662
  • URL: /core/journals/british-journal-of-nutrition
Please enter your name
Please enter a valid email address
Who would you like to send this to? *
×

Keywords:

Metrics

Full text views

Total number of HTML views: 5
Total number of PDF views: 78 *
Loading metrics...

Abstract views

Total abstract views: 287 *
Loading metrics...

* Views captured on Cambridge Core between September 2016 - 17th November 2017. This data will be updated every 24 hours.