ABSTRACT
Science and technology are modernizing the face of consumable products, such as conventional foods and dietary supplements, and constantly changing our perceptions of “healthy.” Two main scientiœc areas-safety and efœcacy-that fall under the purview of regulatory authorities, such as Health Canada and the United States Food and Drug Administration (the U.S. FDA), are key determinants of
10.1 Introduction .......................................................................................................................... 141 10.2 Canada .................................................................................................................................. 142
10.2.1 Classiœcation of Foods, Natural Health Products (NHPs), and Drugs and Related Legislation and Regulatory Authorities ................................................ 142
10.2.2 Safety Considerations for Foods and NHPs ............................................................. 144 10.2.2.1 Food Ingredients and Novel Foods ............................................................ 144 10.2.2.2 Food Additives and Food-Processing Aids ............................................... 145 10.2.2.3 Flavoring Agents in Foods ......................................................................... 145 10.2.2.4 NHPs .......................................................................................................... 146
10.2.3 Health Claim Categories Applicable to Foods and NHPs ........................................ 146 10.2.4 Health Claim Substantiation Standards Applicable to Foods and NHPs ................. 148
10.3 The United States.................................................................................................................. 150 10.3.1 Classiœcation of Foods, Dietary Supplements and Drugs, and Related
Legislation and Regulatory Authorities ............................................................... 150 10.3.2 Safety Considerations for Foods and Dietary Supplements ..................................... 152
10.3.2.1 Food Additives and Generally Recognized as Safe (GRAS) Substances ... 152 10.3.2.2 Dietary Ingredients .................................................................................... 153
10.3.3 Health Claim Categories Applicable to Foods and Dietary Supplements ................ 155 10.3.4 Health Claim Substantiation Standards Applicable to Foods
and Dietary Supplements ......................................................................................... 157 10.4 Conclusions ........................................................................................................................... 159 References ...................................................................................................................................... 159
how quickly and effectively marketing and commercialization initiatives can be pursued in Canada and the United States, respectively.
