"FDA has a long history of interpreting the definition of a “new drug” broadly, basing it on the functional claim intended from a new technology. Under the FFDCA, new drugs include “articles (other than food) intended to affect the structure or any function of the body of man or other animals.”220 Thus, for example, FDA is currently reviewing genetically engineered (GE) “fast growing” salmon under its “new animal drug” authority, because the GE fish is structurally and functionally affected by the technology. Similarly, cloning companies claim that their technology will affect both the structure and function of the cloned animal, by producing animals with improved meat qualities or high-yielding dairy animals. Furthermore, cloning experts say that the cloning technology is the same in animals as it would be in humans, and FDA has already stated that any human cloning research would be regulated as a new drug by the agency under FFDCA, and would require submission of an “investigational new drug application.”221 FDA offers no explanation as to why animal cloning should be exempted from the rigorous new drug review procedures that it requires for human cloning research."
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Center for Food Safety, "Not Ready for Prime Time: FDA's Flawed Approach to Assessing the Safety of Food from Animal Clones", March 2007, p. 19
https://en.wikiquote.org/wiki/Cloning
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Cloning
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