FDA’s Decision on Banning Red Dye No. 3 in Food – Jay Lee’s U.S. Report (141)

FDA's Decision on the Use of Red 3 Dye in Food

– U.S. Column #141 by Jay Lee

Consumer Groups Demand Withdrawal of Approval Due to Cancer Risk

Animal Test Results...May Not Apply to Humans, Making the Decision Complex

By Jongchan Lee, CEO of J&B Food Consulting

In a recent U.S. Senate hearing, senior officials from the Food and Drug Administration (FDA) expressed their concerns about the limited resources available for reviewing the safety of food chemicals and answered questions regarding why dyes considered unsafe are still allowed in the U.S. food supply chain. In particular, the FDA's stance on Red 3 and Red 40 dyes and the ongoing process of determining whether Red 3 should be banned in food products were discussed.

On December 5, 2024, the Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing with senior FDA officials, where bipartisan senators questioned whether the FDA was doing enough to ensure the health and safety of the U.S. food supply chain.

FDA Commissioner Dr. Robert M. Califf and Deputy Director of the Human Food Division Jim Jones were questioned about the lack of action by the FDA regarding the spread of diet-related chronic diseases caused by "greed in the food and beverage industry." Senators asked them about the two controversial synthetic food dyes, Red 3 and Red 40, which may have negative effects on children's neurological behavior. Some evidence suggests that Red 3 may be carcinogenic.

Ahead of the hearing, in November, 23 Congress members sent a letter to the FDA urging them to ban Red 3 in food products. Additionally, a California food safety law enacted in October 2023 will ban Red 3 in food sold or produced within the state, effective January 2027. Similarly, a California school food safety law passed in August 2024 will ban Red 40 in foods served in public schools, effective December 2027.

In this context, Senator Tommy Tuberville asked whether the FDA still stands by its position that Red 40 and Red 3 are safe for children, and why Red 3, which has been banned in cosmetics due to cancer concerns, is still allowed in the U.S. food supply. In response, Jim Jones stated that the safety of Red 40 has not been evaluated in over a decade, but previous assessments concluded that Red 40 is safe.

However, Red 3 is currently undergoing an FDA evaluation, prompted by a petition from consumer advocacy groups submitted in November 2022. This petition urges the FDA to withdraw its approval for the use of Red 3 in food. It remains uncertain when the FDA will take action and make a decision regarding this petition.

Although animal tests have shown that Red 3 may be carcinogenic, the current scientific consensus is that its carcinogenic mechanism may not apply to humans, which complicates the safety decision.

Due to the FDA's limited resources, evaluating the safety of food dyes is a difficult reality. With the possibility of President Trump's return to power, there is concern that the FDA may prioritize the interests of corporations over public health. U.S. exporters should closely monitor how Trump's policies may align with consumer safety regulations related to the FDA.

Tags: #FoodAdditives #FoodDyes #Red3 #Red40

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