ABSTRACT
Products of biotechnology intended for use as functional foods or nutraceuticals are subject to regulations that have evolved in various jurisdictions around the world. The focus of this chapter is regulation, in the United States, of these products of biotechnology that are intended for use as foods or additives or ingredients in foods. For safety considerations, regulation is guided by provisions
28.1 Introduction ..........................................................................................................................507 28.2 Regulation of Biotechnology-Derived Food Products ..........................................................508 28.3 Role of GRAS in the Regulation of Food Products of Biotechnology ................................. 510
28.3.1 Chemistry and Manufacturing ................................................................................. 510 28.3.2 Intended Uses ............................................................................................................ 511 28.3.3 Safety ........................................................................................................................ 511
28.3.3.1 Substantial Equivalence ............................................................................. 512 28.3.3.2 History of Safe Use .................................................................................... 513 28.3.3.3 Safety of Novel Proteins ............................................................................ 514
28.3.4 General Recognition of Safety ................................................................................. 517 28.4 Foods Derived from Biotechnology and Health Claims in the United States ...................... 518
28.4.1 Permissible Food Claims in the United States ......................................................... 518 28.4.2 Nutrient Content Claims ........................................................................................... 521
28.4.2.1 De nition and Scope .................................................................................. 521 28.4.2.2 Applicable Regulations, Scienti c Requirements, and Guidance
Documents ................................................................................................. 523 28.4.3 Structure/Function Claims ....................................................................................... 523
28.4.3.1 De nition and Scope .................................................................................. 523 28.4.3.2 Applicable Regulations, Scienti c Requirements, and Guidance
Documents ................................................................................................. 523 28.4.4 Health Claims ........................................................................................................... 524
28.4.4.1 De nition and Scope .................................................................................. 524 28.4.4.2 Applicable Regulations, Scienti c Requirements, and Guidance
Documents ................................................................................................. 524 28.4.5 Claims as They Relate to Crops Genetically Modi ed for Output Traits ................ 527
References ...................................................................................................................................... 527
in the Federal Food Drug and Cosmetic Act (FFDCA) concerning “generally recognized as safe, under the conditions of intended use,” or GRAS for short. Much has been written on the legal de nition and applications of the GRAS concept (Kessler et al., 1992; Vetter, 1996), and this chapter is not intended to address such legal issues. Rather, the focus of this chapter deals, in two separate parts, (1) with the scienti c basis for achieving GRAS status for speci ed uses of biotechnology-derived food products and (2) with the standards of evidence to obtain regulatory approval of claims related to nutrient composition/health bene ts. As the name GRAS implies, this aspect of regulation concerns safety of the public who would be consumers of the product under the intended conditions of use, whether or not health bene ts are claimed for such uses. Health claims are not subject to the well-established GRAS safety standard, but are considered separately.
