Answer: The only reason FDA might require the filing of a Food Additive Petition is in a situation where the 120-day period might not provide enough time to review the supporting toxicology data.
FDA?s proposed regulations thus call for a petition where:
(1) the new use increases the cumulative dietary intake for the substance to 1 part per million (ppm) or greater in the daily diet, thus triggering the need for two-year studies (unless the substance is a biocide, where the trigger is 200 ppb), or (2) a bioassay exists on the FCS that has not been reviewed by FDA and the bioassay is not clearly negative for carcinogenic effects.
FDA has, though, expressly stated that the agency might agree that an FCN is more appropriate, for example, where the CEDI is greater than 1 ppm but where the agency has established an acceptable daily intake (ADI) for the substance that is greater than the CEDI.
One possible alternative to the filing of a petition is to prepare an FCN on the compound of interest. If FDA refuses to accept the FCN for further processing because of a lack of two-year data, the notifier could talk with FDA?s Division of Health Effects Evaluation to obtain guidance on the conduct of the two-year study, which could then be submitted to FDA?s toxicologists for their review.
It is conceivable that FDA might be willing to develop an ADI based on this submission and, once developed, the FCN could be resubmitted. While we have not yet encountered this situation, it seems a reasonable way to avoid the years-long delays encountered under the petition route.
Back to FAQs