Challenges and Opportunities for Health Claims on Products at the Food/Drug Interface

In both the U.S. and Canada there are regulatory distinctions between the nature of health claims that can be made for foods versus drugs. For marketing in the U.S., the Food and Drug Administration provides guidance on food and dietary supplement claims in contrast to botanical (and other) drug claims. For marketing in Canada, Health Canada is developing a series of guidance documents on product classification, evidence requirements and procedures for regulatory compliance based on those classification decisions, including labeling of products at the food/natural health product interface. However, the range of currently marketed products' ingredients, formats and representations for use form a continuum rather than discrete product categories. This creates challenges for the interpretation and application of the regulators' written guidance on claim labeling and advertising when companies try to navigate the regulations in the two jurisdictions. Health Canada's guidance and requirements will be summarized and contrasted with the U.S. FDA's guidance and requirements in order to facilitate international regulatory cooperation and trade. The need for such international regulatory perspectives increases as experimental and clinical research provide a rapidly growing evidence base to support specific health benefits of products in this expanding category.