Toxicology Requirements

We have done a lot of testing. Do we need to include all of our results?

Mar 2001

Question: We have done a lot of testing. Do we need to include all of our results?

Answer: FDA's toxicity guidelines set forth the minimum toxicity requirements, and are available at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredientsandPackaging/ucm081825.htm. All relevant toxicity studies must be submitted, including genotoxicity testing and oral toxicity testing. Inhalation and dermal testing is generally not required to be submitted, since it is usually not relevant to oral exposure. However, if systemic effects (not associated with the site of the exposure) are found in such studies, then that data should be included as well.

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