Chapter 5 - The Food Safety Modernization Act (FSMA)’s role in the safety of functional foods and their ingredients

Abstract

The Food Safety Modernization Act (FSMA), signed into law in 2011, provided a major overhaul of the US food safety system. The FSMA requires a paradigm shift in prevention and shared responsibility across the supply chain for all foods consumed in the United States irrespective of where they are produced. FSMA's broad scope has made it challenging for the food industry to assess responsibilities, particularly for the functional food industry, because there is no regulatory definition for this category in the United States. The regulatory burden varies greatly based on the product or ingredient. Functional foods classified as conventional foods (i.e., nutritionally fortified foods, probiotics, fruits and vegetables, etc.) by the US Food and Drug Administration (FDA) are required to comply with most FSMA provisions. Functional foods classified as dietary supplements by the FDA have a more complicated road to navigate that is littered with exemptions and overlapping or competing regulations (e.g., 21 CFR Part 111 versus 21 CFR Part 117). This chapter discusses the FSMA regulations that have the greatest impact on the functional food industry and outlines requirements that apply to functional food ingredients and their manufacturers and importers that are regulated as conventional foods or dietary supplements.