Scientific Publications by FDA Staff

Food Addit Contam Part A 2016 May;33(5):782-97

Exposure estimate for FD&C color additives for the U.S. population.

Doell DL, Folmer DE, Lee HS, Butts KM, Carberry SE

Dietary exposures to the seven food, drug, and cosmetic (FD&C) color additives that are approved for general use in food in the U.S. were estimated for the U.S. population (aged 2 years and older), children (aged 2-5 years) and teenage boys (aged 13-18 years) based on analytical levels of the FD&C color additives in foods. Approximately 600 foods were chosen for analysis, based on a survey of product labels, for the levels of FD&C color additives. Dietary exposure was estimated using both 2-day food consumption data from the combined 2007-2010 National Health and Nutrition Examination Survey (NHANES) and 10-14 day food consumption data from the 2007-2010 NPD Group, Inc. National Eating Trends-Nutrient Intake Database (NPD NET-NID). Dietary exposure was estimated at the mean and 90th percentile using three different exposure scenarios: low exposure scenario, average exposure scenario, and high exposure scenario, to account for the range in the amount of each FD&C color additive for a given food. For all populations and all exposure scenarios, the highest cumulative eaters-only exposures in food were determined for FD&C Red No. 40, FD&C Yellow No. 5, and FD&C Yellow No. 6. In addition, the eaters-only exposure was estimated for individual food categories in order to determine which food categories contributed the most to the exposure for each FD&C color additive. Breakfast Cereal, Juice Drinks, Soft Drinks, and Frozen Dairy Desserts/Sherbet (also referred to as Ice Cream, Frozen Yogurt, Sherbet (including Bars, Sticks, Sandwiches)) were the major contributing food categories to exposure for multiple FD&C color additives for all three populations.