FDA Rethinks Red No. 3: Unpacking Health Risks and Legal Implications

Child receiving lollipop from person in open car.

The FDA is weighing a ban on red dye No. 3, a common food additive linked to cancer and behavioral issues in children, sparking debate over its continued use in American products.

At a Glance

  • FDA considering ban on red dye No. 3 due to potential health risks
  • The dye is already banned in cosmetics and several countries
  • California banned red dye No. 3 in 2023; other states may follow
  • Consumer groups and some politicians urge FDA action
  • FDA decision expected soon following Senate hearing

FDA Scrutiny of Red Dye No. 3

The Food and Drug Administration (FDA) is currently reviewing a petition to ban Red Dye No. 3, a synthetic food coloring agent widely used in candies, drinks, and other products. This petroleum-based additive, known for its vivid cherry-red hue, has come under intense scrutiny due to mounting health concerns. The review is part of a broader initiative to reassess the safety of artificial food colorings in the United States.

Red dye No. 3, also known as Erythrosine, has been a subject of controversy for decades. In 1990, the FDA banned its use in cosmetics due to evidence of carcinogenicity in lab rats. However, the dye remained approved for use in food and pharmaceuticals, a decision that has puzzled health advocates and some medical professionals.

Health Concerns and International Action

The potential health risks associated with red dye No. 3 extend beyond its carcinogenic properties. Research has indicated a possible link between the consumption of this dye and behavioral issues in children, including symptoms associated with attention deficit hyperactivity disorder (ADHD). These concerns have led several countries, particularly in the European Union, to ban or severely restrict its use in food products.

“It’s been banned from skin products since the 1990s. So I wonder why is it not allowed in skin products? You know, something you can’t put on your face — yet a kid can eat it,” said Dr. Marc Siegel, clinical professor of medicine at NYU.

In the United States, California took a significant step in 2023 by banning the manufacture, sale, or distribution of products containing red dye No. 3. This move has inspired similar legislative efforts in other states, including Illinois and New York, signaling a growing awareness and concern about the potential risks associated with this food coloring agent.

Regulatory Challenges and Industry Response

The FDA’s ongoing review of red dye No. 3 highlights the complexities of food safety regulation in the United States. Unlike Europe, the FDA lacks a formal post-market review process for substances already in the food supply, which has led to frustrations among FDA officials and health advocates alike. During a recent Senate hearing, FDA representatives expressed concern over limited resources for conducting thorough food chemical safety reviews.

“[Food dyes] are a priority, 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,” said FDA Commissioner Dr. Robert Califf.

The food industry’s response to these developments has been mixed. While some companies, such as Kraft and Nestlé, have voluntarily removed artificial dyes from their products in response to public pressure, others argue against state-level bans. The National Confectioners Association, for instance, has opposed such bans, claiming they undermine FDA authority and create confusion in the marketplace.

Looking Ahead

As the FDA nears a decision on the petition to ban red dye No. 3, the outcome could have far-reaching implications for the food industry and American diets. With nearly 3,000 foods containing this additive, according to the Environmental Working Group’s Food Scores database, a ban would necessitate significant reformulation efforts across the food sector.

“With red 3, we have a petition in front of us to revoke the authorization board, and we’re hopeful that in the next few weeks, we’ll be acting on that petition,” said Jim Jones, the FDA’s deputy commissioner.

The FDA’s decision will likely be influenced by a range of factors, including scientific evidence, public health considerations, and regulatory precedents such as the Delaney Clause, which prohibits the use of color additives found to induce cancer in humans or animals. As the agency weighs these complex issues, consumers, health advocates, and industry stakeholders alike await a ruling that could reshape the landscape of food coloring in America.