A Food Additive Petition is a formal submission to the FDA requesting the approval of a new food additive or a new use of an existing one. It involves providing comprehensive data that demonstrates the safety of the substance under its intended conditions of use. Once approved, the additive and its specifications are listed in Title 21 of the Code of Federal Regulations (21 CFR).

1. Regulatory Feasibility Assessment
   • Determine if your substance requires an FAP or qualifies under GRAS
   • Identify data gaps and outline strategy options
2. Literature Review and Data Compilation
   • Comprehensive review of safety data, toxicology studies, and historical use
   • Collection of relevant analytical, manufacturing, and exposure data
3. Petition Preparation and Submission
   • Authoring of the complete FAP dossier in line with FDA requirements
   • Inclusion of safety narrative, technical data, and environmental assessment (EA)
4. FDA Liaison and Response Management
   • Ongoing communication with FDA officials
   • Preparation of responses to information requests or objections
5. Post-Approval Compliance Support
   • Labeling and marketing reviews to ensure proper compliance
   • Monitoring for regulatory changes or amendments to approved uses