FDA Regulation of Food and Drug Biotechnology
Thelen, A. J.
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CitationFDA Regulation of Food and Drug Biotechnology (1995 Third Year Paper)
AbstractIn its broadest sense, referring to the application of a biological process to provide a good or service, biotechnology has been affecting the human food supply for centuries In products such as beer and cheese. Similarly, since the shift from hunters and gatherers to farmers humans have been selecting and propagating certain varieties of organisms based on their genetic makeup. The discovery of DNA as the mediator of this heritable property forty years ago introduced a novel type of biotechnology based on the new science of molecular genetics. This biotechnological process of transferring DNA of one organism to another is commonly referred to as genetic engineering. Thus, genetic engineering can be seen as an extension of these age-old techniques to improve the food supply. However, it can also be seen as a completely novel technology with a great potential for abuse, therefore demanding a high level of regulatory supervision. The debate as to how the Food and Drug Administration should treat genetically engineered foods reflects these tensions precisely. This paper will consider the FDA. approach to regulating genetically engineered foods and drugs. A critique of this system will be presented centered around the issues of processed-based regulation, consumer labeling, and pre-market notification.
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