Data Requirements

What is the impact of a positive (adverse) genotoxicity result where there are other studies and data available to support safety?

Mar 2001

Question: What is the impact of a positive (adverse) genotoxicity result where there are other studies and data available to support safety?

Answer: There have been circumstances where FDA has allowed an FCN to become effective on a substance with a positive genotox result, but, before doing so, FDA will closely examine the weight of the evidence. A "positive" mutagenicity study may or may not trigger FDA's rejection of the submission, depending on the answers to a number of questions, such as: Are there countervailing genotoxicity studies with negative results? Are chronic studies available that clearly conclude the substance is not a carcinogen? What is the strength of the positive result? What does a structure activity analysis indicate? What is the exposure to the compound of interest? Is it the food-contact substance or merely a constituent of the FCS?

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