In a recent Senate hearing, top U.S. Food and Drug Administration (FDA) officials expressed their frustrations about the limited resources the agency is allotted for its food chemical safety review work, responding to questions about why dyes that are widely believed to be unsafe are allowed in the U.S. food supply. Specific insight was given into FDA’s stance on red dyes 3 and 40, and progress on a pending decision about red dye 3’s authorization for food use.

On December 5, 2024, the U.S. Senate Committee on Health, Education, Labor, and Pensions (HELP Committee) held a hearing with top FDA officials, during which senators from both sides of the political aisle questioned whether FDA is doing enough to ensure the U.S. food supply is wholesome and safe.

In the hot seat were FDA Commissioner Robert M. Califf, M.D. and FDA Deputy Commissioner for Human Foods Jim Jones. The officials were probed about FDA’s inaction against the “greed of the food and beverage industry,” leading to an epidemic of diet-related chronic diseases. The senators questioned Dr. Califf and Mr. Jones about a range of issues, including food chemical additive safety—a highly debated topic in recent years.

The Red Dye Debate

Dr. Califf and Mr. Jones were asked specifically about red dye 3 and red dye 40, two controversial synthetic food colorants that are potentially linked to adverse neurobehavioral effects in children. Some evidence also suggests that red dye 3 may be carcinogenic.

Just prior to the hearing, in November, 23 members of Congress wrote a letter to FDA urging the agency to ban red dye 3 in foods, due to its potential harms to human health. Additionally, passed in October 2023, the California Food Safety Act bans red dye 3 from foods sold or manufactured in the state, coming into effect in January 2027. Similarly, the California School Food Safety Act, passed in August 2024, bans red dye 40 from foods offered in California public schools, beginning in December 2027.

In this context, Senator Tommy Tuberville (R-AL) asked whether FDA stands by the position that colorants like red dye 40 and red dye 3 are safe for children to consume, and why red dye 3 is still allowed in the U.S. food supply when it is banned for use in cosmetics due to its possible carcinogenic effects. In response, Mr. Jones stated, “We have not evaluated the safety of red dye 40 in over a decade… over a decade ago, that was the conclusion of FDA [that red dye 40 is safe].”

However, red dye 3 is currently under evaluation by FDA, in response to a consumer advocate petition filed in November 2022 that urges the agency to revoke its food use authorization for the chemical. “We are hopeful within the next few weeks we will be acting on that petition, that a decision is forthcoming,” said Mr. Jones. He and Dr. Califf also explained that, although animal studies have demonstrated carcinogenicity of red dye 3 in animals, the current scientific consensus is that the mode of carcinogenicity in animals is not applicable to humans, adding to the complexity of making a safety decision.

FDA’s Chemical Safety Work Hindered by Resource Constraints and Court Challenges

Dr. Califf went on to stress that it is very time- and labor-intensive to scientifically demonstrate that a chemical consumed by people can cause cancer in humans, and that FDA is limited in its resources to assess the safety of food chemicals. “[Food dyes] are a priority," Dr. Califf said, “…but I want to point out that we have a very small staff and we have repeatedly asked for better funding for chemical safety. Please look at our request for funding for the people who do this work.” He continued, “Remember, if we ban something, it will go to court. If we do not have the scientific evidence to support its ban, we will lose in court.”

Sen. Tuberville also asked why FDA permits so many chemicals in foods that are banned in Europe, such as red dye 3. Mr. Jones explained that the European Food Safety Authority (EFSA) has been conducting post-market chemical safety reviews for more than 20 years, and although FDA has the authority to conduct such reviews, there is no mandate to do so in the U.S. He assured the Senate committee, however, that as a result of FDA’s recent reorganization, under the new Human Foods Program, there is an office dedicated to chemical safety, which is working on a systematic approach to post-market chemical reviews.

“…But we are several decades behind our European and Canadian counterparts because they have legal mandates to reevaluate chemicals that have been authorized at some point in the past,” Mr. Jones said. “We don’t [have the same legal mandate], but we are going to undertake post-market chemical reviews, even though we definitely struggle with the resources needed to do that.”

Mr. Jones has previously alluded to these resource challenges and explained how they are shaping FDA’s chemical safety work. For example, in an October webinar, he said FDA’s post-market chemical review efforts are “very under-resourced compared to what people hope [FDA] is able to do.” He also explained that, because FDA is so under-resourced in this area, the agency is considering the data and findings from the safety reviews of its regulatory counterparts (e.g., in Europe, Canada, and California) in its own post-market chemical review process.  

Calling for Congressional Support in a Consumer-Driven System

Dr. Califf concluded his and Mr. Jones’ responses to the HELP Committee’s line of questioning on chemical safety with an anecdote about popular colorful cereal Fruit Loops, demonstrating the difficulty FDA faces in driving changes to the U.S. food supply in a consumer-driven system. Specifically, after Fruit Loops removed synthetic dyes from its product in the past due to potential health harms, sales were negatively affected, so Fruit Loops reintroduced those dyes.

“Unless we have help, that is, clear direction from Congress, particularly given recent Supreme Court decisions, it’s going to be really hard for [FDA] to mandate that things come off [the market]” Dr. Califf said.