Red Dye #3: FDA bans food ingredient

Red Dye #3: FDA bans food ingredient

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The US Food and Drug Administration has banned the use of red dye No. 3 in foods, Drinks and medications taken more than 30 years after scientists discovered links to cancer in animals, the agency announced Wednesday.

Red Dye #3, a synthetic color additive made from petroleum, chemically known as erythrosine, gives foods and beverages a bright cherry red color.

The move acts on a November 2022 petition submitted by several advocacy groups and individuals, including the Center for Science in the Public Interest and the Environmental Working Group, which cited links to cancer. The federal agency’s decision also follows California, whose government banned the additive in October 2023.

Manufacturers that use red No. 3 in foods and ingested medications have until Jan. 15, 2027 and Jan. 18, 2028, respectively, to reformulate their products, according to the FDA. Food imported into the USA must also meet the requirements.

Red dye #3 is found in some candies, foods and drinks.

“Today’s action by the FDA is long overdue, represents a small step in the right direction, and hopefully signals a renewed effort by the FDA to accomplish its mission despite the many obstacles placed in its path by the food industry,” said Dr. Jerold Mande, adjunct professor of nutrition at Harvard University’s TH Chan School of Public Health, via email.

The decision represents a “monumental victory” for consumer health and safety,” Ken Cook, co-founder and president of the Environmental Working Group, said in a news release. “We would not be celebrating this historic decision today without the tireless leadership of public health advocates like Michael Jacobson and others who took up this fight on behalf of consumers decades ago.”

Red No. 3 dye is found in at least dozens of candies, foods, and drinks, but some of the most popular brands either never use the additive or have already stopped using it. Less than 10% of confectionery company Ferrara’s products, which makes Brach’s candies, for example, contain the additive since the company began phasing out use of the additive in early 2023, a Ferrara spokesman said by email.

Just Born, the company behind PEEPS, will stop using red dye No. 3 in its production after Easter 2024, according to a spokesperson.

Some companies use No. 40 red dye instead, which is considered a healthier alternative because it is not as commonly linked to cancer in animals.

However, California also banned Red No. 40 from foods and drinks sold in public schools in September amid concerns about a link to behavioral and attention difficulties in children. One study found a possible link to accelerated immune system tumor growth in mice, and other sources say the dye contains benzene, a known carcinogen.

Red Dye #3 is permitted for use in food despite the Delaney Clause of the FDA’s Federal Food, Drug, and Cosmetic Act. The clause “prohibits FDA, in part, from approving a color additive that is taken if it causes cancer in animals or humans when ingested,” the agency said.

The FDA banned the use of red dye No. 3 in cosmetics and topical medications back in 1990 under the Delaney Clause after research in laboratory tests showed the additive to be carcinogenic to rats at high doses. The mechanism by which the dye causes cancer in rats does not occur in humans, so these studies have not raised safety concerns and therefore the FDA has not revoked approval for red dye No. 3 in foods, according to the agency.

According to the agency, the FDA has reevaluated the ingredient’s safety several times since it was first approved in 1969 – based on tests on animals, not humans.

There appear to be no studies supporting a link between Red Dye #3 and cancer in humans, and “the relevant exposure levels to FD&C Red #3 for humans are typically much lower than those associated with the effects shown in male rats “” the FDA said in its constitutive update published on Wednesday. “Claims that the use of FD&C Red No. 3 in food and in ingested medications poses a risk to humans are not supported by the available scientific information.”

But “that doesn’t matter because FDA’s mandate under the Delaney Clause is to keep animal or human cancers out of the food supply,” Dr. Jennifer Pomeranz, associate professor of public health policy and management at New York University’s School of Global Public Health.

The FDA’s decision to revoke approval for the use of red dye No. 3 is a legal matter, the agency said.

Some other studies have raised further doubts about Red No. 3’s safety, including a 2012 report that found a link between the additive and cancer in animals. That same year, researchers concluded that artificial food colorings “are not a major cause of (attention deficit hyperactivity disorder), but they may contribute significantly in some cases, and in some cases may additionally cause an adolescent to exceed the diagnostic threshold.”

In 2021, the California Office of Environmental Health Hazard Assessment study found that red dye No. 3 can make children vulnerable to behavioral problems such as reduced attention. The report also concluded that federal standards for the safe intake of food dyes in effect at the time may not protect children’s brain health. According to the Environmental Working Group, the study found that current legal limits set by the FDA decades ago did not take new research into account.

The FDA’s decision “ends the Red 3 regulatory paradox,” said Dr. Thomas Galligan, senior scientist for food additives and dietary supplements at the Center for Science in the Public Interest in Washington, D.C. But the agency “still has a long way to go to reform the broken system that allowed Red 3 to persist in food.” , decades after it was proven to cause cancer when consumed by animals.”

The ban also moves the food landscape a little closer to that of the European Union, which banned the dye in 1994 with the exception of some maraschino cherry products, Pomeranz said. “Europe follows the precautionary principle in these matters.”

“There is no rational reason on behalf of the FDA why it did not ban red dye No. 3 from foods in the 1990s,” and why the agency “takes so long to ban ingredients with known health effects” is unclear said Pomeranz via email.

According to the Center for Science in the Public Interest, at least 10 other states in addition to California have passed laws aimed at banning red dye No. 3 from foods.

“Americans are getting sick because of our food,” Mande said. Although the United States is one of the wealthiest nations, the country ranks 49th out of 204 countries in overall life expectancy.

“This is because food companies have lost sight of their core mission, which is to provide food we can live on, and are instead focusing solely on their profits,” Mande added. “Unfortunately, the U.S. government is not funding the research needed to determine the exact health risks posed by Red Dye #3. Industry is working with Congress to block funding for necessary research.”

The National Confectioners Association said in a statement that food safety is a top priority for U.S. confectionery companies.

“Our consumers and everyone in the food industry want and expect a strong FDA and a consistent, science-based national regulatory framework,” the association said via email. “For years, our industry has called for greater transparency, more funding and more human resources so that the FDA can continue to fulfill its mission, and it is time to put politics aside and work together to fund the FDA at a level that will you enable continues his work.”

Food and beverage companies will continue to be guided by the latest science and comply with all food safety regulations to ensure safe and available choices for consumers, Sarah Gallo, senior vice president of product policy and federal affairs at the Consumer Brands Association, said in a statement via email.

The FDA has already required manufacturers to list red dye No. 3 as an ingredient on food labels. So if you’re concerned about avoiding products containing the dye until the ban goes into effect, check the ingredient lists before purchasing. Red No. 3 dye is also listed as “Red 3” and “FD&C Red No. 3.”

Artificial food colorings are mainly found in highly processed foods and drinks that cannot be prepared at home, Pomeranz said. Avoiding these products is another way to eliminate red dye No. 3 from your diet. The Center for Science in the Public Interest recommends parents also avoid all numbered dyes, such as yellow #5 and red #40.

Use this quiz to find out how much highly processed foods you may be consuming.

For For medications that aren’t topical, look for dyes in the “Inactive Ingredients” section of the drug label or package insert, or look for dye-free versions of some medications, recommends Consumer Reports. However, always talk to your doctor before changing medications.

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