ABSTRACT
In the early twentieth century, Harvey Wiley of the United States Department of Agriculture and others led an effort to put an end to food adulteration and to provide regulatory authority to the federal government. A food additive that is capable of and is intended to impart color when added or applied to a food is regulated separately as a color additive. The chapter discusses the implications for the safety evaluation and risk assessment process needed to ensure compliance with the applicable regulations for food and color additives, GRAS ingredients, and new dietary ingredients (NDIs)/dietary supplements. The safety of a genetically engineered food crop or a product made from that crop is evaluated by comparing the nutritional and toxicological equivalence of the product to its conventional counterpart. The Food Additive Amendments of 1958 stipulates that the manufacturers must satisfy the Food and Drug Administration's safety criteria prior to the marketing of a food additive.
