What is an FAP (Food Additive Petition) | FDA Approval Guide

 A Food Additive Petition (FAP) is a formal request sent to the U.S. Food and Drug Administration (FDA) asking for permission to use a new food additive that isn't Generally Recognized As Safe (GRAS). This process helps make sure any new substance added to food is checked for safety before it's used by consumers. FAPs are required by the Federal Food, Drug, and Cosmetic Act (FD&C Act), Section 409.What is included in a food additive petition?A standard Food Additive Petition sent to the FDA must include:Chemical Identity and Composition – A full description of the additive’s molecular structure and makeup.Manufacturing Process – A complete explanation of how the additive is made, to ensure it's consistent and pure.Proposed Uses and Levels of Use in Food – The specific foods the additive will be used in and the maximum amount allowed.Toxicological and Safety Data – Detailed safety evaluations, including toxicology reports and how much people might be exposed to.Environmental Assessment – An analysis of how the additive might affect the environment, or a statement that it doesn’t require a full environmental review.Labeling Information – Any proposed labeling requirements for the additive, if needed.FDA Review ProcessAfter receiving the petition, the FDA looks at all the scientific information to decide if the additive is safe for its intended use. If approved:The FDA creates a regulation in the Code of Federal Regulations (CFR) that officially allows the additive to be used.The FDA may also set specific limits on how much can be used, or set labeling rules.When does the FDA need a food additive petition?By law, a FAP must be submitted for additives like:Sweeteners  Preservatives  Emulsifiers  Other non-GRAS substances used in regular foods  Unlike GRAS substances, these additives can't be sold until they are officially approved by the FDA through the FAP process.Why is an FAP important?Filing a Food Additive Petition ensures that new food additives are thoroughly tested for safety, helping protect public health while allowing food companies to create new products. Once approved, the additive is officially listed in FDA regulations, giving clear guidelines for businesses to follow.If you need help preparing and submitting a Food Additive Petition to the FDA, reach out to regulatory experts like Freyr Solutions. They can help you navigate the process and get your product to market faster.