Foods and natural health products: Gaps and ambiguities in the Canadian regulatory regime

Canadian regulations have different rules for foods and natural health products (NHPs) regarding allowable health claims, requirements for use in clinical trials and good manufacturing standards and labeling requirements. How these rules apply to products at the food-NHP interface is often unclear. This paper describes the regulatory environment and explores two product examples - probiotic yogurt and green tea - to illustrate the issue. In addition, results from a qualitative study of NHP/food researchers highlights the confusion and frustration of those working in the field. Interim agreements between the NHP and Foods Directorate of Health Canada regarding products reviews provide a temporary response but regulatory amendments, accompanied by clear guidance to stakeholders, are needed.