Chapter 2. Regulation of Nutraceuticals in Canada and the United States

The purpose of this chapter is to provide an overview of the frameworks for the regulation of nutraceuticals in Canada and the United States. Although neither jurisdiction has a category for nutraceuticals, per se, there is a wide spectrum of products that can fall under the umbrella of nutraceuticals and no single pathway in either the Canadian or United States regulatory systems is capable of addressing every nutraceutical product. This chapter presents the regulatory requirements of several different defined products that a nutraceutical could fall into under the Canadian and United States regulatory frameworks. The chapter will provide an overview of each jurisdiction's requirements for products making health claims under food, drug and supplement laws. Additionally, the regulatory initiatives made by both jurisditions over the years to modernize their frameworks to better address and meet the issues and challenges faced in the evolving nutraceutical landscape will be discussed and presented.