Policy Styles and Epistemic Policies in the Regulation of Health Claims. A Comparison of Europe, the United States, and Japan

ABSTRACT

I analyse epistemic and non-epistemic factors involved in expert advisory practices and decision-making relating to the regulation of health claims in the US, EU, and Japan. I consider the changes that have taken place, historically, in regulatory policies in all three cases in order to confirm the hypothesis that not only epistemic, but also non-epistemic factors and values determine the methodological decisions on which expert assessments are based for the authorization of health claims. I found that the current European, US, and Japanese assessment systems are based on different kinds of what have been termed ‘epistemic policies’ and that these policies and other characteristics shape what might be identified as differing ‘policy styles’ in the regulation of health claims.

KEYWORDS:

• Benefits assessment
• standards of evidence
• regulatory science
• governance of science and technology

Acknowledgments

I would like to thank Oliver Todt for his suggestions on how to improve the first version of this study and to Rachel Waters for the supervision of the English.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Notes

1. From Richardson’s 1982 proposal of this concept to increasing more recent studies of governance modes and on new governance (see below), although mostly available case studies refer, originally as well as currently, to European countries or the EU jurisdiction.

2. EU Register of Nutrition and Health Claims: http://ec.europa.eu/food/safety/labelling_nutrition/claims/register/public/?event=register.home (Last access: May 2021)

3. For more general information on this scientific controversy, see Hoffmann, Fraser, Palumbo, Ravel et al. (2012, 16).

4. The appeal by Durk Pearson and Sandy Shaw against the Department of Health and Human Services also included as appellants the American Preventive Medical Association and Citizens for Health (consumer organizations working specializing in dietary supplements and health care).

5. However, European and American assessments of the same evidence might not concur due to the accepted highest standard of evidence. In this sense, compare the health claims shown in Tables 1 and 3 regarding the benefits of dietary fibres. No health claim that relates fibre, grains or similar foods to coronary health conditions has been approved in the EU (see the EU Register of Nutrition and Health Claims).

6. Source: https://www.fda.gov/food/food-labeling-nutrition/questions-and-answers-health-claims-food-labeling (last access: May 2021)

7. ‘Disease risk reduction FOSHU’ assessments must take into account some required extra information (see Yamada et al. 2008).

8. For more detailed information in English on the required criteria and procedure, see Guidance for industry on the CAA website: https://www.caa.go.jp/en/policy/food_labeling/ (Last access: June 2020).

9. In 2001, the Japanese government changed the FOSHU system for the ‘Food with Health claims’ (FHC) system (to which the aforementioned FOSHU reclassification was later introduced). This change was primarily made to adapt Japanese categories to the Codex Alimentarius Guidelines of the FAO-WHO (United Nations) (Shimizu 2015). The ‘Foods with Nutrient Function Claims’ (FNFC) category is equivalent to the UN ‘Nutrient function claim’ (Shimizu 2014).

10. Since March 2021, the following health claim can be included on food product labels in Japan: ‘This product contains lactic acid bacteria GR-1® (Lactobacillus rhamnosus) and RC-14® (Lactobacillus reuteri). It has been reported that lactic acid bacteria GR-1® and RC-14® have the functions of improving the vaginal environment and regulating the condition in the vagina’ (see: https://www.chr-hansen.com/en/media/news/2021/03/chr-hansen-probiotic-strains-receive-landmark-health-claim-in-Japan (last access: May 2021)). However, this has not been approved in the EU (see Table 1) or the US, (as a HC or QHC).

11. For a more general analysis of recent European policies in terms of hard and soft governance, see Dehousse (2016).

12. There are, however, a few influential associations and groups that emphasize this topic. See, e.g., the American Association for the Advancement of Science’s Why Public Engagement Matters, available at www.aaas.org/pes/what-public-engagement (accessed 9 October 2020); and the more recent request from ‘Day One Project’ at https://www.dayoneproject.org/post/a-federal-strategy-for-science-engagement (accessed 1 September 2021).

13. A relevant comparison of national EU and US, styles can be found in De Búrca and Scott (2006).

Additional information

Funding

This work was supported by the MCIN/AEI/10.13039/501100011033 under Grant PID2020-113449GB-I00; and the Spanish Ministry for Science and Innovation under Grant Cas18/00126.

Notes on contributors

Noemí Sanz Merino

Noemí Sanz Merino, PhD, is Associate Professor in Logic and Philosophy of Science. She also holds an MA in Social Studies of Science and her works’ fields are Philosophy of Regulatory Science, Public Policy and Science Communication.