On August 28, 2020, the Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency announced its release of a draft report on the potential neurological impacts of synthetic food dyes in children. In particular, the report analyzed the following seven most commonly consumed food dyes in the U.S.:  (1) FD&C Blue No. 1; (2) FD&C Blue No. 2; (3) FD&C Green No. 3; (4) FD&C Red No. 3; (5) FD&C Red No. 40; (6) FD&C Yellow No. 5; and (7) FD&C Yellow No. 6.  All of these color additives are approved for use in food at 21 CFR Part 74.

The report, which consists of a review of the scientific literature and a risk assessment, was commissioned by the California legislature in 2018 after concerns surfaced regarding the neurobehavioral impacts of these dyes on children, in particular attention deficit hyperactivity disorder (ADHD) and other behavioral outcomes.

Overall, the report concluded that “synthetic food dyes may cause or exacerbate neurological behavioral problems in some children.” And, although its exposure assessment found that “[n]one of the child intake estimates based on a daily serving size of sampled foods exceeded US FDA ADI’s [average daily intake] for food dyes,” it cautioned that the studies forming the basis for FDA’s ADIs were “many decades old and were not capable of detecting the types of neurobehavioral outcomes measured in later studies.” Further, while acknowledging the need for more research on the topic and detailing recommendations for the direction of future research, the report concludes that “at a minimum . . . the neurobehavioral effects of synthetic food dyes in children should be acknowledged and steps taken to reduce exposure to these dyes in children.” A public comment period on the draft report will run until October 13, 2020. Keller and Heckman has extensive legal and scientific experience in assessing the safety of color additives. Please let us know if you are interested in submitting comments.