Regulating Genetically Altered Animals

The futuristic vision of genetically altered animals has been slowly creeping up on us for years, a fact the FDA recently acknowledged by issuing a new approval process aimed specifically at genetically altered animals. The new regulatory and approval process is a huge step forward for the growing market of genetically altered animals, and not just those used for research. The regulations will cover all types of genetically modified animals including livestock and those headed for your dinner table, and will provide a clearer route for approving the use of the genetically modified animals, many of which had been stuck in limbo seeking approval, making it very difficult to make the products feasible. This means that several new genetically altered products may be available in the next few years pending FDA approval, but the manner in which these new products are approved has raised some questions. Under the new guidelines each genetically altered product will be considered a drug, and thus will have to be approved via the drug approval process typical of prescription drugs, not food products. This type of approval is mostly a closed-door process that will leave many people in the dark about the circumstances of the product's approval. This, and the fact that food produced from genetically altered will not carry special labels unless the alterations change the nutritional values of the food. Overall the new approval process seems like a step in the right direction: cautiously embracing genetic modification.


http://www.nature.com/news/2009/090116/full/news.2009.36.html
http://www.fda.gov/cvm/Guidance/guide187.pdf