FDA Bans Red Dye No. 3: A Long-Awaited Step Toward Public Health

Breaking News: FDA Announces Nationwide Ban on Red Dye No. 3

In a significant move to protect public health, the Food and Drug Administration (FDA) has issued a nationwide ban on the use of Red Dye No. 3 in food, beverages, and ingestible drugs across the United States. The ban, effective January 15, 2027, follows decades of research and advocacy linking the synthetic dye to potential health risks, including cancer and neurobehavioral effects.

Red Dye No. 3, a synthetic coloring agent approved for use in 1907, has been a subject of controversy for years. While it was banned in cosmetics and topical drugs in 1990 due to its potential carcinogenic properties, it remained widely used in food products, over-the-counter medications, and prescription drugs. Its presence in candies, baked goods, snacks, and fruit-flavored juices and sodas has raised concerns among health experts and consumers alike.

The FDA’s decision to ban Red Dye No. 3 comes after years of lobbying by public health groups such as the Center for Science in the Public Interest (CSPI), the Center for Food Safety, and the Environmental Working Group (EWG). These organizations cited animal studies showing that high doses of the dye led to thyroid tumors and cancer in rats. The ban is seen as a victory for public health advocates who have long pushed for stricter regulations on food additives.

A Troubling History: Red Dye No. 3 and Its Link to Cancer

Red Dye No. 3 has been under scrutiny for its potential health risks for decades. Animal studies have consistently shown that the dye may cause cancer, leading to its ban in cosmetics and topical drugs over 30 years ago. However, its continued use in food and medications has been a point of contention.

The Delaney Clause, a federal law, prohibits the FDA from approving any food or color additive shown to cause cancer in humans or animals. Despite this, Red Dye No. 3 remained in use in food products, with the FDA allowing it under certain limits. Public health experts argue that the dye should have been banned decades ago, given the evidence from animal studies.

Kelsey Costa, a registered dietitian and founder of Dietitian Insights, explained, “By this standard, Red Dye No. 3 should have been prohibited from use in food decades ago.” The delay in banning the dye highlights the challenges of regulating food additives, often influenced by powerful lobbying groups and the need for overwhelming evidence of harm.

Public Health Advocates Celebrate a Decades-Long Fight

The FDA’s decision to ban Red Dye No. 3 is the result of relentless efforts by public health champions. Groups like CSPI, the Center for Food Safety, and EWG have petitioned the FDA for years, citing the dye’s potential risks. The EWG, in particular, has been vocal about the dangers of synthetic dyes, calling the ban a “significant move to protect public health.”

Ken Cook, president and co-founder of EWG, praised the efforts of activists like Michael Jacobson, who co-founded CSPI in 1971. “We wouldn’t be celebrating this historic decision today without the relentless leadership of public health champions like Michael Jacobson and others who took up this fight decades ago on behalf of consumers,” Cook said.

The ban also aligns with state-level actions, such as the 2023 California Food Safety Act, which prohibited Red Dye No. 3 and other unsafe additives. Several states have since introduced similar legislation, prompting the federal government to act.

The Science Behind the Ban: Red Dye No. 3 and Health Risks

Red Dye No. 3 has been linked to several health concerns, including cancer and neurobehavioral effects. Animal studies have shown that high doses of the dye can lead to thyroid tumors and cancer in rats. While animal studies don’t always directly apply to humans, the lack of recent research on the dye’s effects in humans has raised red flags among experts.

In addition to cancer risks, some studies have suggested that synthetic food dyes like Red No. 3 may contribute to hyperactivity in children. This association led to a ban in California and other states, further fueling the push for federal action. Public health advocates argue that stricter regulatory oversight is needed to protect vulnerable populations, particularly children, who are often exposed to high levels of synthetic dyes through artificially colored foods and beverages.

Costa noted that exposure levels to Red Dye No. 3 among children in the U.S