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Health claims regulations: Comparison between USA, Japan and European Union

Lalor, Fiona, Wall, Patrick G.
British food journal 2011 v.113 no.2-3 pp. 298-313
European Union, business enterprises, food industry, foods, health claims, laws and regulations, nutrition, product development, trade liberalization, Japan, United States
Purpose – The purpose of this paper is to review and compare the scientific and regulatory environments for nutrition and health claims on foodstuffs in the USA, Japan and the European Union. Design/methodology/approach – A review of the literature and the relevant legislation in the three different countries is conducted. Regulations are reviewed and scientific evidence requirements are outlined in each country. Findings – Full regulatory approval for claims across all three countries requires the support of robust scientific evidence. To obtain this, companies must submit comprehensive dossiers and detailed applications to the regulators with full descriptions of the tests and studies completed during product development. However in the USA and Japan, an alternative process exists. A health claim that is suggested but not supported by scientific evidence is known as a qualified health claim and is permitted in the USA and Japan, but not in the EU. Practical implications – The paper demonstrates the difference in regulatory requirements in different countries which leads to different claims being permitted in different countries. It also leads to different levels of scientific support for similar claims which causes consumer confusion and develops an uneven playing pitch for the industry. Given that the industry operates in a global market place, it is imperative that a consensus is reached as to the level of scientific evidence required to approve a health claim. In that way, consumers can be safeguarded from being misled, consumer confusion will not be a concern and products can be globally distributed in line with the increasing liberalisation of trade. Originality/value – This paper is of value to regulators and the food industry.