FDA banned Red Dye 3, used in more than 3,000 products in US. (Image generated by Copilot)
FDA banned Red Dye 3, used in more than 3,000 products in US. (Image generated by Copilot)

Everything you need to know about Red Dye 3, the dye just banned by FDA

According to the Environmental Working Group (EWG), this dye is found in about 3,000 products sold in the United States.

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The U.S. Food and Drug Administration (FDA) announced a ban on Red Dye 3 (FD&C Red No. 3), an artificial colorant widely used in foods and ingested drugs. This additive has been the subject of controversy for more than three decades due to studies linking it to the development of cancer in animals. The move is a significant step forward in food additive regulation and represents a victory for consumer advocacy groups.

What is Red Dye 3?

Red Dye 3, also known as erythrosine or E127 in Europe, is a synthetic colorant derived from petroleum. It is used to provide a bright pink or red color in products such as candy, canned fruits, beverages, medicines and even vegetarian bacon substitutes. According to the Environmental Working Group (EWG), this dye is found in about 3,000 products sold in the United States.

Why is Red Dye 3 banned?

The ban is based on three factors. First, the scientific evidence. Animal studies have shown that Red Dye 3 can cause thyroid cancer in male rats. Although FDA argues that the relevance to humans is inconclusive, the Delaney Clause prohibits any additive shown to be carcinogenic in humans or animals, regardless of dose.
The second aspect is the regulatory history. Since 1990, the use of FD&C Red No. 3 has been banned in cosmetics and topical medications due to allergy risks and potential carcinogenicity.
And finally there is the pressure from advocacy groups. In 2022, associations such as the Center for Science in the Public Interest (CSPI) formally called for a ban of the additive in foods and drugs.

Impact of the ban

Manufacturers of products containing Red Dye 3 have until January 2027 to reformulate foods and until January 2028 for drugs. This measure will affect popular products such as candy, beverages and oral medications, which will have to eliminate the dye or find safer alternatives.

The United States has been slower than other economies to act against Red Dye 3. For example, the European Union banned its use in 1994, and countries such as Japan, China, the United Kingdom, Australia and New Zealand have implemented similar restrictions. This reflects the need for stricter regulation of food additives to ensure consumer safety.

In addition to the risk of cancer, recent studies suggest that synthetic dyes, including Red Dye 3, may have neurobehavioral effects in children, such as worsening symptoms associated with Attention Deficit Hyperactivity Disorder (ADHD). A report from the state of California highlighted how these dyes can alter neurotransmitters and affect memory, learning and brain activity.

The ban on FD&C Red No. 3 is an important step toward the elimination of harmful additives in food and drugs in the United States. While consumers will not be exposed to this dye as of the established deadlines, other synthetic dyes and chemicals in everyday consumer products remain to be addressed.

What the experts say

Carl Tobias, a former FDA legal consultant and now a professor at the University of Richmond, told AFP it was "hard to square" the agency's mission of protecting American health with the prolonged delay in reaching the decision.

"There's pretty extensive lobbying, there always has been, and some of it is sometimes effective," he said, calling the ban a "step in the right direction."

CSPI also hailed the FDA's decision as long overdue, and expressed hope that it would pave the way for broader action on other harmful chemicals in food.

"They don't add any nutritional value, they don't preserve the food -- they're just there to make food look pretty," Thomas Galligan, a scientist with CSPI, told AFP.


For more information on safe food and regulations, visit FDA.gov.


With information from AFP
 

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