California’s OEHHA releases draft report questioning the safety of FDA approved certified colors

OEHHA issued the report at the request of the California legislature that has been considering legislation that could include warning labels and a stepwise ban for the use of synthetic food dyes in the state of California. 

The assessment covers the seven most commonly consumed synthetic food dyes in the U.S.

• FD&C Blue No. 1
• Blue No. 2
• Green No. 3
• Red No. 3
• Red No. 40
• Yellow No. 5
• Yellow No. 6.

OEHHA notes these synthetic food dyes are added to many foods, beverages, over-the-counter medications, and vitamins in the US, especially those intended for children.  After evaluating the toxicology, epidemiology, clinical, and exposure literature and databases, and conducting its own exposure assessment, the agency calls into question the safety of these FDA approved certified colors.  The draft OEHHA report concludes a “comparison of the recent animal studies on neurotoxicological outcomes with the older studies that serve as the basis for FDA ADIs indicates that current ADIs are not adequately protective of children.”

OEHHA is also the lead agency that implements Proposition 65. Neurotoxicity is not a recognized toxicology endpoint under Proposition 65 and the draft report would not be expected to lead to the listing of these certified colors under Proposition 65.  If the OEHHA recommendations are finalized as presented in the draft report, the report could incentivize the California Legislature to renew efforts to place restrictions in California on the use of these FDA authorized colors in foods, dietary supplements, and OTC drugs.  OEHHA is accepting public comments for the draft report through October 13, 2020.

Authored by Martin Hahn and Xin Tao

1. OEHHA, “Announcement of Release of the Public Review Draft of “Health Effects Assessment: Potential Neurobehavioral Effects of Synthetic Food Dyes in Children,” available at: https://oehha.ca.gov/risk-assessment/public-comment-period-general-info/announcement-release-public-review-draft-health?utm_source=Synth%20Food%20Dye&utm_campaign=Proposition%2065%20-%20Proposed%20Maximum%20Allowable%20Dose%20Levels%20for%20Chlorpyrifos&utm_medium=email (accessed on August 31, 2020).