Policy Challenges and Consumer Conundrums
Chapter 4: Health claim regulations in developed markets
This chapter reviews the regulatory environment for the health foods sector in major developed markets, including the USA, Canada, the UK (prior to regulatory harmonization within the EU), the EU, Japan, Australia and New Zealand. A primary focus of the discussion is the regulations surrounding allowable health claims and product approval processes. Nutrient content labelling regulations, nutritional labelling and novel foods regulations pertaining to novel functional foods are also discussed. Tables offering country-by-country comparisons of structure/function claims, disease risk reduction claims and nutrient content claims can be found in Appendix 1. The US FDA has regulatory authority over the food sector in the USA and has established three categories of permitted claims: (1) health claims (disease risk reduction) describe the relationship between a food and a disease or health-related conditions; (2) nutrient content claims indicate the level of a nutrient in a food; (3) structure/function claims describe how a nutrient or dietary supplement affects the normal growth, development or functioning of the human body (Subirade, 2007). According to the FDA, the regulatory status of a food product is determined primarily by its intended use, its label and accompanying labelling information, which include nutrient information, nutrient content claims and health claims. Manufacturers must therefore make a definitive choice in marketing their product as either a food or a drug, thereby choosing their regulatory classification. The FDA does not provide a legal definition for functional food and no formal regulatory category exists for such foods.
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