In 2011, FDA’s Center for Food Safety and Applied Nutrition convened its Food Advisory Committee to consider the subject of children’s consumption of food dyes and its possible association with hyperactivity.  The Committee concluded that, based on all available data, no causal link could be established between children’s consumption of synthetic color additives and adverse behavioral effects including hyperactivity, and that  additional labeling information on foods containing color additives was not necessary.   However the committee recommended that FDA conduct additional research to further investigate any potential developmental or behavioral effects in children from exposure to certified color additives.  The full transcripts and materials presented to the Committee are online on the FDA website at:http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/FoodAdvisoryCommittee/ucm149740.htm.

One of the committee’s research recommendations was that FDA conducts an exposure assessment of consumption of certified color additives from foods.  Following up on that recommendation, the agency conducted a comprehensive exposure assessment of each FD&C color additive approved for use in food in the U.S.  This assessment was based on (1) the amount of FD&C color additive in food from the analysis of over 580 representative food products, and (2) data from the 2007-2010 National Health and Nutrition Examination Survey (NHANES) of food consumption by U.S. consumers.

Based on this information, FDA developed exposure estimates for each FD&C color additive for the U.S. population aged 2 years or more, children aged 2-5 years, and teenage boys aged 13-18 years.  Children aged 2-5 years were chosen since they would be expected to have the highest exposure to FD&C color additives per body weight.  Teenage boys aged 13-18 years were chosen because this population group would be expected to consume the greatest amount of food containing FD&C color additives.  This exposure assessment was presented at the 248th National Meeting of the American Chemical Society, on August 13, 2014, and is available online at the link above.

Additional Information:

• Poster available in (PDF - 848KB)
• Article: Exposure Estimate for FD&C Colour Additives for the US Population