Abstract
Development and filing of a Food Additive Petition for a new food additive requires close liaison between the Food and Drug Administration (FDA) and the manufacturer, beginning with development of a protocol for data which will be required for the petition. Informal FDA guidelines for Food Additive Petitions require information on the identity of the additive, usage and labeling, efficacy or performance, method for determining the additive in food, proof of safety, and the proposed regulation. Pertinent literature, and biographical data on principal researchers also may be included. The clearance process, interaction of food additive regulations with food standards, time and cost for petition preparation, and possible use of the Food Additive Petition process in the future are discussed.
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