Resolving the contradiction of giving permission by saying, “It causes cancer in animals, but not in humans.”
The U.S. Food and Drug Administration (FDA) announced on the 15th (local time) that it will ban the use of Red No. 3 dye in food, beverages and drugs. CNN reported that this action was taken more than 30 years after scientists discovered that this pigment was related to causing cancer in animals.
Red Dye No. 3 is a petroleum-derived synthetic color additive chemically known as erythrosine. It is used to impart a bright cherry red color to foods and beverages. It is added to bubble gum, candy, cereal, strawberry-flavored milkshakes, strawberry-flavored yogurt and jellies, as well as some cold medicines and vitamins.
This measure is in response to a petition submitted in November 2022 by several public interest groups, including the Center for Science in the Public Interest (CSPI) and the Environmental Working Group (EWG), citing a link with cancer. The US state of California has already banned the use of this additive in October 2023.
According to the FDA, manufacturers using Red No. 3 in foods and drugs must reformulate their products by January 15, 2027, and January 18, 2028, respectively. Food and beverages imported into the United States must also comply with these requirements.
The FDA’s move brings the United States closer to the European Union’s (EU) food standards, which banned the use of Red No. 3 except in some maraschino cherry products in 1994. Japan, China and Australia have completely banned the use of Red No. 3. On the other hand, in Korea, limited use is permitted for about 20 items, including jellies, snacks, candies, gum, ice cream, bread, rice cakes, chocolate, sausages, juice, carbonated drinks, sauces, and salted fish.
Red No. 3 coloring is found in at least dozens of candy, food and beverage products, but popular brands either do not use the additive or have already stopped using it. In the case of candy company Ferrara, it will begin phasing out the use of this additive from early 2023. A Ferrara spokesperson said in an email that less than 10% of its products contain the additive. Instead, some companies use Red No. 40, which is considered a healthier alternative.
However, California last September banned the use of Red 40 in food and beverages sold in public schools due to concerns about its link to behavioral and attention disorders in children. One study found a potential link to promoting immune system tumor growth in mice, and another study found that the pigment contains benzene, a known carcinogen.
The FDA’s latest action is not a recognition of these research results, but a result of accepting criticism that it selectively applies the Delaney Clause of the Federal Food, Drug, and Cosmetic Act. The Delaney Clause “prohibits the FDA from approving color additives that cause cancer in animals or humans when ingested.”
In 1990, the FDA banned the use of Red No. 3 pigment in cosmetics and topical medicines after animal testing showed that Red No. 3 was carcinogenic to rats at high doses. However, it did not lead to the cancellation of the food license, based on the logic that this pigment does not cause cancer in humans.
The FDA claimed that although it had reevaluated the safety of this ingredient several times since its initial approval in 1969 based on non-human animal testing, there had been no studies proving a link between Red Dye No. 3 and human cancer. “The relevant exposure levels to Red 3 in humans are much lower than those that would generally cause the effects seen in male rats,” the FDA said. “It is not supported by scientific information.”
However, several other studies have raised doubts about the safety of Red No. 3, including a 2012 report that found a link between the additive and animal cancer. That same year, researchers concluded that artificial colors “may not be the primary cause (of attention deficit hyperactivity disorder), but may significantly affect some cases, in some cases pushing children over the diagnostic threshold.”
In 2021, the California Office of Environmental Health Hazard Assessment (OEHH) published research showing that Red No. 3 dye may make children vulnerable to behavioral problems such as attention deficit disorder. The report also concluded that then-current federal standards for safe consumption of food dyes may not be protecting children’s brain health.
The FDA explained that this decision was not the result of scientific research, but the result of legal interpretation. The Delaney clause applies not only to humans but also to cases of causing cancer in animals, and its purpose is to correct what has been overlooked so far.
Professor Jennifer Pomeranz (Public Health Policy and Management) at New York University’s Graduate School of Global Public Health said, “According to the Delaney Clause, if cancer occurs not only in humans but also in animals, its use in food must be banned.” “It is unreasonable not to ban Red No. 3,” he pointed out. Dr. Thomas Galligan, chief scientist for food additives and supplements at the Center for Science in the Public Interest, said the FDA’s decision “ends the regulatory paradox of Red No. 3,” but added, “It allows it to remain in foods decades after it was discovered to cause cancer in animals.” “There is a long way to go to reform this broken system,” he pointed out.
Source: kormedi.com
