ABSTRACT
This chapter addresses the definition of a food additive. It examines the regulatory consequences if a substance is deemed to be a food additive. The chapter explores possible options for a company that is considering the addition of a chemical substance to depuration water. Substances that are intentionally added to food or that are used in such a way that they may reasonably be expected to become a component of food are subject to regulation by Food and Drug Administration (FDA) pursuant to various provisions of the FDC Act. If a substance is "generally recognized as safe", a food manufacturer is free to use it without ever obtaining FDA approval or even notifying the agency of its use. Accordingly, companies should be certain to evaluate carefully the status of any substance intended to be added to shellfish depuration water, to assure that the substance complies with any applicable FDA-enforced requirements prior to use.
