This session will serve as a primer for food industry professionals on the pre-market review programs for food and color additives at the US Food and Drug Administration (FDA), as well as the notification program for generally recognized as safe (GRAS) ingredients. In the US, food additives and color additives are subject to pre-market approval by the FDA and require a listing in Title 21 of the Code of Federal Regulations. This is achieved through the food and color additive petition processes, which are conducted primarily by the FDA Office of Food Additive Safety (OFAS) in the Center for Food Safety and Applied Nutrition. The speaker will introduce the food and color additive petition processes and the basics of petition review. Then, they will discuss the regulatory requirements for GRAS ingredients. GRAS ingredients are those whose use is generally recognized to be safe among qualified experts, and the underlying safety data must be generally available and reflect a consensus of scientific opinion. GRAS ingredients do not require pre-market approval but must meet the same safety standard (i.e., reasonable certainty of no harm under its conditions of use) as food and color additives. Once a manufacturer makes a GRAS conclusion supported by publicly available information, they may submit a GRAS notice to FDA’s GRAS Notification Program. The speaker will highlight considerations for manufacturers when making a GRAS conclusion and the best practices for submitting a GRAS Notice to FDA. This session will give food industry professionals a foundation to understand the complexities of ensuring that a food ingredient is lawful to market in the US. Participants will gain a greater understanding of the FDA approach to food ingredient regulation and will leave with resources to help them seek the appropriate regulatory status for ingredients. Speaker: Katie Overbey, PhD