ABSTRACT

Nearly 25 years ago, the United States Food and Drug Administration (FDA) started the approach of using umbrella regulations to help the food industries to produce wholesome food as required by the Federal Food, Drug, and Cosmetic Act (the Act). In 1986, the FDA promulgated the first umbrella regulations under the title of Good Manufacturing Practice Regulations (GMPR). Since then, many aspects of the regulations have been revised [1].