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US FDA bans red food coloring dye 30 years after Europe

Red Dye No. 3 is an iodine-based compound, which is believed to contribute to its effects on thyroid function.

A variety of food colorings, added to beakers of water Image by Skoot13 — CC BY-SA 3.0
A variety of food colorings, added to beakers of water Image by Skoot13 — CC BY-SA 3.0

A widely-used red food dye has been banned (‘finally banned’ many medics will utter with relief – the color additive is made from petroleum) by the U.S. Food and Drug Administration (FDA). The ban is due to evidence of a possible impact on the thyroid gland (despite a potential cancer association, the FDA have not banned the colorant for this reason). The FDA is revoking the authorization for the use of FD&C Red No. 3 based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

While orange is the color of the moment in the U.S. (at least with the occupant of the White House), yet red is the color of the moment within the wider U.S. government.

Erythrosine fades out

However, this ban does not come in immediately. Manufacturers who use FD&C Red No. 3 in food and ingested drugs will have until January 15, 2027 or January 18, 2028, respectively, to reformulate their products.

FD&C Red No. 3, also referred to as Red Dye No. 3, Red Dye 3, and erythrosine (disodium salt of 2,4,5,7-tetraiodofluorescein), is a synthetic food dye that gives certain foods and drinks a bright, cherry-red color, and is found in certain candy, cakes and cupcakes, cookies, frozen desserts, and frostings and icings, and ingested drugs. The FDA will no longer allow for the use of FD&C Red No. 3 in food and ingested drugs. On January 15, 2025, the FDA issued an order to revoke these authorizations.

Products impacted

The products implicated are extensive, and include strawberry Ring Pops, MorningStar Veggie Bacon Strips and Double Bubble Original Twist gum. Vegan “meats,” including imitation bacon and sausages commonly contain the dye.

The FDA’s new ban will impact thousands of products already on the market. This extends to many candy brands, which rely on Red Dye No. 3 to produce bright red or pink colors.

History

The colorant was discovered by Swiss chemist Karl Kussmaul at the University of Basel in 1876 and it became commercialized by the firm Bindschedler & Busch company for dyeing wool and silk. It later was adopted as a food dye in the U.S. in 1906. Red is a color often associated with power and social status.,and it soon became a popular additive to aid the marketing of many food stuffs.

The dye was also used in many other countries, although in light of medical concerns it was effectively banned within the European Union in 1994 (reference E127). It has taken the U.S. a further 31 years to cometo the same conclusion.

Gensis of the ban

The start of the process to have the dye outlawed by 2027 began in 2022 when the FDA determined that data presented in a color additive petition show that this ingredient causes cancer in male laboratory rats exposed to high levels of FD&C Red No. 3 because of a hormonal mechanism.

Some states have instigated bans ahead of the federal clause. California, for instance, banned red No. 40 from foods and drinks sold in public schools in September due to concerns over links to behavioral and attention difficulties among children.

Long overdue

Commenting on the ban, Dr. Jerold Mande, adjunct professor of nutrition at the Harvard University T.H. Chan School of Public Health tells CNN: “Today’s action by FDA is long overdue, is a small step in the right direction, and hopefully signals a renewed effort by FDA to do its job despite the many barriers the food industry places in its way.”

Another shade of red

A different red dye, No. 40, is used in cereal, beverages, gelatins, puddings, dairy products and confections. This dye is not subject to a ban or to any restrictions. Red 40 does not appear to present the same risk to a human thyroid as No. 3.

In addition, alternatives to Red 3 include cochineal / carmine (made from insects, specifically female species of Dactylopius coccus where the insect bodies are boiled in an ammonia to create the dye) and pigments from purple sweet potato, radish, and red cabbage, as Time magazine reports.

Due to stricter European Union regulations on food colouring, the colour of M&M’s are less bright than ones sold in the United States. Source: by APK – Own work, CC BY-SA 4.0

Other dyes

Other food coloring dyes are not affected. Blue 1 and Blue 2 frequently appear in beverages and confections. Green 3 adds vibrancy to packaged foods. Yellow 5 and Yellow 6 bring golden hues to snacks and cereals. Citrus Red 2 brightens orange peels, while Orange B remains limited to hot dog casings.

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Written By

Dr. Tim Sandle is Digital Journal's Editor-at-Large for science news. Tim specializes in science, technology, environmental, business, and health journalism. He is additionally a practising microbiologist; and an author. He is also interested in history, politics and current affairs.

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