FDA Bans Red Dye 3: What It Means for Your Food and Health

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On January 15, the Food and Drug Administration (FDA) under the Biden administration officially revoked authorization for the use of red dye 3 in foods and drugs. This decision effectively bans the additive from food products and medications, marking a significant shift in regulatory policy.

The move has drawn attention from various health advocates, including Human Services (HSS) secretary nominee Robert F. Kennedy Jr., who has previously spoken out against artificial food additives. His “Make America Healthy Again” website states his commitment to banning hundreds of food additives and chemicals that other countries have already prohibited.

Red dye 3 has been under scrutiny for decades, with many manufacturers voluntarily removing it from their products. However, it has remained in circulation in various food and drug products in the U.S. Understanding its presence in everyday foods and the reasons behind its ban is essential for consumers looking to make informed dietary choices.

What Is Red Dye 3?

Red dye 3, also known as red dye No.3 or erythrosine, is a synthetic dye derived from petroleum. It is primarily used to give foods a bright, cherry-red color, making them more visually appealing.

The FDA banned red dye 3 from use in cosmetics and topical drugs in 1990 under the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This clause prohibits the use of color additives in the U.S. if they are found to cause cancer in animals or humans when ingested. Research has shown that high doses of red dye 3 can cause cancer in rats, although human studies have yet to reach the same conclusion.

According to Scott Keatley, RD, co-owner of Keatley Medical Nutrition Therapy, “This ingredient doesn’t add anything to the food aside from the red and pink vivid colors, which neither enhances flavor, enhances nutrition, nor improves shelf life.”

Which Foods Contain Red Dye 3?

Although many companies have already phased out red dye 3 from their products due to growing consumer concerns, the additive is still found in various food items. According to an FDA exposure analysis, some of the most common foods containing red dye 3 include:

• Baking decorations
• Ice cream cones
• Frostings and icings
• Frozen dairy desserts
• Soft candy and gummies
• Meal replacement drinks and bars
• Cookies
• Toaster pastries
• Ice pops
• Baby foods
• Hard candy

Why Is Red Dye 3 Considered Harmful?

The FDA’s decision to ban red dye 3 is based on legal regulations rather than new scientific discoveries. The agency cited the Delaney Clause, which prohibits the approval of color additives that have been linked to cancer in animal studies. However, the FDA acknowledged that no human studies have conclusively linked red dye 3 to cancer.

Wade Syers, D.Soc.Sci., a Michigan State University Extension food safety specialist, explains, “This news is not surprising because the Food, Drug, and Cosmetics Act prohibits the authorization of color additives that have been found to induce cancer in humans or animals. Red dye No.3 has been found to induce cancer in male rats under certain conditions, but there is no evidence that it causes cancer in humans.”

Beyond cancer concerns, red dye 3 has also been linked to potential behavioral issues in children. A 2021 report from the California Office of Environmental Health Hazard Assessment found that children who consumed red dye 3, along with other artificial food dyes, were more likely to experience hyperactivity and difficulty focusing.

However, Keatley warns against overestimating the risks. “We don’t consume much red dye No.3 over the course of a day, a week, or a month. Comparing our intake to those of rats in studies is apples to oranges. More pressing concerns should be emissions from trucks and cars, lack of physical activity in schools, and the consumption of primarily junk food.”

In response to health concerns associated with Red Dye No. 3 (erythrosine), many countries have adopted alternative coloring agents in food and pharmaceutical products. These alternatives often include both natural and synthetic dyes that are considered safer for consumption.

What Happens Next?

The FDA has given manufacturers until January 15, 2027, to fully remove red dye 3 from their products. In the meantime, consumers who are concerned about their exposure can check ingredient lists for “Red 3” and opt for products free from synthetic food dyes.

Insiders Health Tip

Natural Alternatives:

• Beet Juice Extract: Provides a deep red hue and is commonly used in products like beverages, candies, and baked goods.
• Carmine (Cochineal Extract): Derived from cochineal insects, this dye imparts a vibrant red color and is utilized in various foods and cosmetics. However, it may not be suitable for individuals adhering to vegetarian, vegan, or certain religious dietary restrictions.
• Anthocyanins: Pigments extracted from fruits and vegetables such as red cabbage, purple sweet potatoes, and grapes, offering red to purple shades.
• Paprika Extract: Sourced from red peppers, this extract provides an orange-red color and is used in snacks, sauces, and processed meats.

Synthetic Alternatives:

• Allura Red AC (Red 40): A widely used synthetic dye that delivers a bright red color. It’s approved in many countries, though some regions require warning labels due to potential health concerns.
• Ponceau 4R (Cochineal Red A): A synthetic red dye permitted in Europe, Asia, and Australia but not approved for use in the United States.
  Wikipedia

The choice of alternative depends on factors such as regulatory approvals, desired shade, stability, and consumer preferences. Many manufacturers are increasingly opting for natural colorants to meet the growing demand for clean-label products.

It’s important to note that regulations and accepted substitutes can vary significantly between countries, influenced by local food safety authorities and cultural preferences.

As regulatory bodies continue to review the safety of food additives, staying informed about the ingredients in everyday foods remains crucial. With growing awareness and consumer demand for cleaner food options, this ban marks another step toward a healthier food supply in the U.S.