The U.S. Food and Drug Administration (FDA) is revoking its authorization for the use of Red No. 3 (also known as erythrosine) in food and ingested drugs.

This decision, announced January 15, 2025, is based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act, which prohibits the use of any food or color additive found to cause cancer in humans or animals. While studies have not conclusively linked Red Dye No. 3 to cancer in humans, the FDA's action follows evidence of tumors in lab rats.

The ban will be phased in, with compliance deadlines of January 2027 for food manufacturers and January 2028 for drug manufacturers. 

Key Themes and Information --

FDA Action and the Delaney Clause:

The FDA's decision to ban Red No. 3 is a direct result of the Delaney Clause. The clause mandates that any substance inducing cancer in animals or humans must be prohibited.

The official FDA statement says, “The FDA is amending its color additive regulations to no longer allow for the use of FD&C Red No. 3 in food and ingested drugs in response to a 2022 color additive petition.”

This is not the first time the Delaney Clause has been used for a ban, the FDA previously revoked authorizations for certain synthetic flavors based on the same clause in 2018.

The FDA acknowledges that the mechanism of cancer development observed in male rats is not applicable to humans and that relevant exposure levels are "typically much lower than those that cause the effects shown in male rats." despite the lack of evidence of cancer in humans, "FDA must prohibit any food additive shown to cause cancer in humans or animals."

The decision was characterized as a "matter of law" (according to a quote by FDA Deputy Commissioner Jim Jones).

Background on Red Dye No. 3:

Red Dye No. 3 is a synthetic food dye made from petroleum, giving foods and drinks a bright cherry-red color. It has been used in the US since 1907, with FDA approval in 1969.

It was previously banned in cosmetics and topical drugs in 1990 due to studies showing it caused cancer in lab rats. However, that ban did not extend to food.

The dye is used in a range of products, including candies (e.g., Pez, Jelly Belly), baked goods (e.g., Entenmann’s Little Bites), dairy and frozen desserts, maraschino cherries, some strawberry-flavored beverages, and certain medications (e.g., cough syrups).

Although not as widely used as other dyes, the U.S. food and drug industry used over 200,000 pounds of Red No. 3 in 2021.

Timeline and Compliance:

Food manufacturers have until January 2027 to remove Red No. 3 from their products.

Manufacturers of ingested drugs have until January 2028 to comply.

This phased approach aims to give companies time to reformulate their products using alternative ingredients.

Consumer and Advocacy Group Response:

Consumer advocates and health organizations like the Center for Science in the Public Interest (CSPI) and the Environmental Working Group (EWG) have been pushing for this ban.

Groups have submitted multiple petitions over the years, highlighting the lack of logic for the dye to be banned from cosmetics but still present in food.

They have expressed that the dye's "purely cosmetic" use is not worth the risk (according to CSP President Peter Lurie) and see this as a "monumental victory for consumer health and safety” (according to Ken Cook, president of the Environmental Working Group).

Advocacy groups have noted that there are numerous petitions pending before the FDA dealing with other chemicals in food and food packaging, hoping the incoming Trump administration will address them.

Industry Response:

Some manufacturers like Abbott (PediaSure) and Dole have already removed Red No. 3 from certain products.

Companies like Kellanova and Ferrara have started the process of reformulating their products, with the latter even stating that its candy corn will be made without Red 3 starting the fall of 2025.

Industry groups, like the National Confectioners Association, have stated that they will comply but are also concerned about the costs and challenges of reformulating. They would also prefer that the FDA as a national authority sets the food standards versus a "patchwork of state regulations".

Concerns have also been raised about the ban, noting that evidence hasn't determined if the dye causes cancer when consumed by humans, indicating the possibility of legal challenges from food manufacturers.

Scientific Findings and Health Concerns

While a link between Red No. 3 and cancer has not been established in humans, the FDA is required to act based on animal studies showing a "carcinogenic response in rats."

Other countries, including those in the European Union, as well as Australia, Japan, China, and New Zealand have already banned or restricted the use of Red No. 3.

Aside from the carcinogenic risk seen in rats, “the short term side effects that we that research has shown allergies, behavioral changes, long term ADHD and potentially could be carcinogenic" according to one source, though these effects are based on limited data.

There is some concern regarding the threshold for harmfulness, with Lisa Moskovitz noting that many people and children consume less than the amount needed to pose health risks.

State-Level Actions:

California has already implemented state laws to ban Red No. 3, with the ban also taking effect in 2027.

Other states have introduced or are planning to introduce similar bills.

California has also taken steps to investigate food dyes and ultra-processed foods.

These state-level actions have put pressure on the FDA to also take action.

Robert F. Kennedy Jr.'s Stance

President-elect Donald Trump’s pick to lead the Department of Health and Human Services, Robert F. Kennedy Jr., has taken aim at food dyes, with one source quoting him calling them "poisoning our kids".

Key Quotes:

"The FDA is amending its color additive regulations to no longer allow for the use of FD&C Red No. 3 in food and ingested drugs..." - FDA statement

"Today's action by the FDA marks a monumental victory for consumer health and safety." - Ken Cook, president of the Environmental Working Group

“The FDA is ending the regulatory paradox of Red 3 being illegal for use in lipstick, but perfectly legal to feed to children in the form of candy,” - CSPI President Peter Lurie.

“Food safety is the number one priority for U.S. confectionery companies, and we will continue to follow and comply with FDA’s guidance and safety standards,” - National Confectioners Association statement

“There are plenty of people within FDA who are relishing the opportunity for the agency to act to protect us.” - Scott Faber, senior vice president of government affairs at the Environmental Working Group

The FDA's ban on Red Dye No. 3 marks a significant step in the ongoing debate about food safety and the use of artificial additives. While the ban is driven by the Delaney Clause and animal studies, it reflects a broader trend of increased scrutiny on food colorings and a push for greater transparency and consumer protection.

The ban is likely to impact numerous products and will require significant reformulation efforts from food and drug manufacturers. It remains to be seen how the industry and the new administration will respond to these regulatory changes and whether they will spark further discussions on the safety of other common food additives.