The Center for Food Safety and Applied Nutrition (CFSAN) of the US FDA conducted a review to determine the impact of studies conducted in dogs on decisions regarding the safe use of food and color additives that have been the subject of petitions submitted to the Office of Food Additive Safety (OFAS). The Toxicological Principles for the Safety Assessment of Food Ingredients (Redbook 2000) provides guidelines for conducting toxicology studies in rodents (rats or mice) and dogs. We searched our database of food additive (FAPs) and color additive petitions (CAPs) with one or more dog studies and identified 87 and 75 petitions, respectively. Dog studies were determined to be decisive in making a safety decision for 32% of FAPs and provided supportive information for 36% of FAPs. Dog studies were determined to be decisive in making a safety decision in 48% of CAPs and provided supportive information for 15% of CAPs. These preliminary findings indicate that dog studies have contributed to safety assessments of food and color additives; however, there has been a significant decline since the year 2000 in the number of dog studies submitted to US FDA for this purpose. Further analyses are aimed at identifying factors (e.g. study design, etc.) that influence the value of dog studies in regulatory decisions. US FDA is interested in identifying alternatives to the dog study that can be incorporated into safety testing strategies for food additives and color additives and that are consistent with US FDA’s goal of modernizing toxicology.