Factors influencing the development and commercialization of functional food and nutraceutical (FFN) products are explored. Count data models are developed to relate firm, market, and regulatory covariates to the number of FFN product lines firms have under development, on the market, and in total. Canadian firm-level innovation data were taken from Statistics Canada (2003) Functional Food and Nutraceutical Survey. Firms involved in product development/scale-up had more product lines in total and on the market. Firms with a strong and positive perception of the impact of regulatory reform related to generic health claims and harmonization of Canadian regulations with U.S. regulations had fewer product lines in total and on the market. Firms with more positive perceptions of the business impact of structure and function health claims had more product lines on the market. One implication of the study is the importance of developing policies and reforming regulations which better enable use of generic health claims on FFN products. Further, policies which better enable or foster development/scale-up of product lines would increase the Canadian FFN sector's ability to develop new products. [EconLit: O130, L500, Q180]. © 2008 Wiley Periodicals, Inc.