The FDA has issued a new directive today that will prohibit the use of Red No. 3 in food products and ingestible medications.
This dye, which first received approval in 1907, has been prohibited in cosmetics and topical drugs since 1990 due to concerns that it may cause cancer. It is already banned or limited in food products in countries like Australia, Japan, and those in the European Union.
Red No. 3 is commonly found in various food items, such as candies, gums, and baked goods.
Food manufacturers will have until January 15, 2027, to eliminate the dye from their products, while producers of ingestible drugs will be given an additional year, until January 18, 2028, to comply.
The decision to implement the ban follows the Delaney Clause, which is part of the Federal Food, Drug, and Cosmetic Act that was passed in 1960. This clause prohibits the FDA from approving any food or color additives found to cause cancer.
“The FDA cannot authorize a food additive or color additive if it has been found to cause cancer in human or animals,” said Jim Jones, the FDA’s deputy director for human foods, according to NBC. “Evidence shows cancer in laboratory male rats exposed to high levels of FD&C Red No. 3.”
The decision followed a petition from the Center for Science in the Public Interest and 23 other organizations, which provided evidence showing that male lab rats exposed to significant amounts of Red No. 3 developed cancer.
However, the FDA clarified that no similar effects were observed in humans or other animals, stating that “available data does not raise safety concerns for humans.”
Additionally, the agency mentioned that while Red No. 3 is restricted in the U.S., it is still permitted in Canada and Europe, where it is known as erythrosine.
Although Red No. 3 has been banned from use in cosmetics and topical drugs for almost 35 years, it has remained in food and ingestible drugs, despite ongoing concerns.
“The widespread use of red dye No. 3 is particularly concerning since it is found in many products marketed to children who are especially at risk of developing health problems from exposure,” said Brian Ronholm, director of food policy for Consumer Reports, in a statement.
In fact, the FDA had previously planned to ban the dye in food in 1992, but the initiative was postponed due to the significant resources required to remove its approval.
This federal ban follows over a year after the California Food Safety Act was passed, which also banned Red No. 3 and three other food additives in the state. Like the federal order, this law will not take effect until 2027.
Additionally, several states, including New York, New Jersey, Pennsylvania, Maryland, West Virginia, Illinois, and South Dakota, have introduced similar legislation.
{Matzav.com}