The FDA (Food and Drug Administration) is facing increasing pressure to ban certain artificial food dyes, specifically Red No. 3 and Red No. 40. These synthetic color additives are commonly found in various processed foods, including beverages, snacks, cereals, and candies. The agency hasn’t re-evaluated the safety of Red No. 40 in over a decade, raising concerns about potential health risks. Jim Jones, the FDA’s deputy commissioner for human foods, acknowledged the delay and hinted at potential action regarding a petition to revoke Red No. 3’s authorization.
Frank Pallone Jr., a Democratic representative, has urged the FDA to ban Red No. 3, a petroleum-derived dye that imparts a bright cherry color to food and drinks. He expressed concerns about the presence of this potentially harmful chemical in food consumed by children, especially during the holiday season. Pallone emphasized that while food companies are responsible for ensuring product safety, they only need to meet existing FDA standards, allowing products containing Red No. 3 to remain on the market.
Robert F. Kennedy Jr., President-elect Donald Trump’s nominee for health secretary, has alleged a link between food dyes and cancer. However, he hasn’t specified any potential actions regarding artificial food dyes if confirmed. Kennedy has criticized certain FDA departments, including nutrition, for inadequately protecting children’s health.
The FDA regulates over three-quarters of the U.S. food supply and approves all color additives before their use in food products. Currently, nine out of 36 approved color additives are synthetic dyes, including Red No. 3 and Red No. 40. While these dyes are also used in pharmaceuticals, they undergo separate approval processes for each application. In 1990, the FDA banned Red No. 3 from cosmetics and topical drugs due to its carcinogenic potential at high doses in animal studies, but maintained that it poses no risk to humans in food.
Several dyes permitted in U.S. food are banned or require warning labels in other countries. The European Union mandates warning labels on products containing Yellow No. 5 (tartrazine), Red No. 40 (Allura Red AC), and Yellow No. 6 (sunset yellow) due to potential adverse effects on children’s activity and attention. This difference highlights the precautionary principle adopted by some countries, prioritizing safety over potentially inconclusive data, contrasting with the U.S. approach. Experts argue that artificial food dyes primarily serve a cosmetic purpose, enhancing product appeal for consumers.
The FDA asserts the safety of approved artificial food dyes when used according to recommendations, but some experts and consumer groups contend that evidence warrants a ban, particularly due to potential harm to children. An FDA advisory committee reviewed the link between artificial food dyes and hyperactivity in 2011 and 2019, concluding that no causal relationship exists in the general population. However, conflicting conclusions persist among regulatory agencies and scientists regarding research findings.
A 2012 review of studies suggested that while artificial food colorings aren’t the primary cause of ADHD, they might contribute to some cases or exacerbate symptoms. The European Food Safety Authority found inconsistencies in research findings in 2008. A comprehensive 2021 review by the California Office of Environmental Health Hazard Assessment concluded that synthetic food dye consumption can cause hyperactivity and other neurobehavioral problems in some children, with varying sensitivity levels.
Red No. 40 and Red No. 3 were approved in 1971 and 1969, respectively, based on animal studies. While subsequent research included human trials, the available scientific evidence regarding long-term or subtle effects, like behavioral changes, remains limited due to insufficient government funding for post-market research on synthetic food additives.
The FDA lacks a formal post-market review process for approved food additives, potentially allowing unsafe substances to remain in the food system despite new research findings. This contrasts with Europe’s two-decade-long practice of post-market chemical reviews. The FDA held a public meeting in September 2024 to discuss enhancements to its post-market assessment process for food chemicals, including color additives, extending the public comment period to January 2025.
Several states are taking action by introducing or passing legislation to ban certain artificial food dyes. California’s School Food Safety Act will ban six FDA-approved artificial food dyes in public school food and drinks by 2027. Illinois and New York are also considering bans on Red No. 3. These state-level initiatives might pressure food manufacturers to remove these dyes nationwide to avoid logistical complexities. Some manufacturers, like Kraft and Nestlé, have already voluntarily removed artificial dyes from certain products in response to public pressure.
An FDA ban on these dyes would involve declaring them unsafe and issuing a decision prohibiting their use in food. While the FDA acknowledges potential sensitivities in some children to food dyes, it maintains that the totality of scientific evidence supports their safety for most children. However, the ongoing debate and increasing pressure from states and consumer groups might ultimately lead to a federal ban on these controversial food additives.
