In early 2025, the U.S. Food and Drug Administration (FDA) made a significant move by officially revoking the use of FD&C Red No. 3 in food products. This synthetic coloring agent, known for its bright cherry-pink hue, has long been a staple in various processed foods, candies, and even medications. The decision marks a turning point in how food color additives are regulated, especially in light of growing health concerns.

What Is FD&C Red No. 3?

FD&C Red No. 3, also known as erythrosine, is a synthetic dye derived from coal tar or petroleum. It’s been widely used to give foods a vibrant red or pink color. Before the ban, it was commonly found in:

  • Candies – especially those with bright red or pink coloring
  • Baked goods – including cakes, cookies, and pastries
  • Snack foods and cereals – processed products often targeted at children
  • Dairy and frozen desserts – such as strawberry-flavored milk or ice cream
  • Medications – including some strawberry-flavored cough syrups

Why Is the FDA Banning It?

The FDA’s decision to ban FD&C Red No. 3 is based on a provision in the Federal Food, Drug, and Cosmetic Act known as the “Delaney Clause.” This clause, named after Congressman James Delaney, who championed it in 1958, prohibits the approval of any food additive found to cause cancer in humans or animals. Although Red No. 3 had already been banned from use in cosmetics and topical drugs since 1990, it remained permitted in foods and orally ingested medications—until it was just banned this year.

Scientific studies dating back to the 1980s linked high doses of Red No. 3 to thyroid tumors in lab rats. More recently, a comprehensive literature review titled “Potential Impacts of Synthetic Food Dyes on Activity and Attention in Children: A Review of the Human and Animal Evidence,” published in Environmental Health, examined 25 studies involving artificial food colors. The review found that a majority of the studies reported a link between consumption of synthetic dyes and neurobehavioral outcomes in children, including hyperactivity and attention issues.

In response to growing scientific evidence and pressure from public health advocates, the FDA announced the ban and gave manufacturers time to reformulate their products. For food items, the transition deadline is January 2027, while for orally ingested drugs, the deadline extends to January 2028.

What Are Artificial Colors, and Why Are They Used?

Artificial food colors are man-made chemicals added to food and drinks to improve visual appeal and ensure color consistency. They serve several purposes:

  • Enhancing appearance – making products look more appetizing
  • Restoring color – lost during processing or storage
  • Creating uniformity – natural colors may vary batch to batch
  • Brand identity and marketing – especially to attract children

While artificial colors are effective and inexpensive, growing concerns over health and safety have put them under increased scrutiny.

Has the FDA Banned Other Food Dyes Before?

Yes, Red No. 3 isn’t the first color additive to be banned by the FDA. Here are a few historical examples:

  • Orange No. 1 – banned in the 1950s after children became ill from candies containing the dye
  • FD&C Red No. 2 – banned in 1976 due to cancer concerns
  • Multiple others – have seen restrictions or bans as scientific knowledge has advanced

In fact, U.S. Health Secretary Robert F. Kennedy has hinted that more artificial food colors may be subject to review or bans in the coming years.

What Are the Alternatives to Red No. 3?

Manufacturers now face the challenge of replacing Red No. 3 in their product formulas. Several alternatives are available:

Natural Color Sources:

  • Beetroot extract (betanin) – offers red and pink tones
  • Anthocyanins – derived from berries and grapes
  • Carmine – a red pigment from insects (though not suitable for all consumers)

Other Synthetic Colors:

  • FD&C Red No. 40 (Allura Red) – widely used, though it also faces ongoing health scrutiny

Blended Color Solutions:

  • Mixing approved colors to replicate the original shade

Though these alternatives may increase production costs, they allow manufacturers to continue offering visually appealing products without compromising safety.

What About the Halal Status of Red No. 3?

For Muslim consumers, the Halal status of food colorings is a key concern. Red No. 3, being synthetically produced from petroleum or coal tar, is generally considered Halal by many Islamic scholars and certifiers.

In Indonesia, for example, the Halal Product Assurance Agency (BPJPH) lists Red No. 3 among ingredients with minimal risk of contamination, thus exempting it from mandatory Halal certification in some contexts.

However, confusion can arise when the term “Red No. 3” is mistakenly associated with carmine, which is derived from insects and not Halal under many standards. IFANCA considers synthetic Red No. 3 Halal when supported by proper documentation, such as a valid Halal certificate.

References:

  1. Miller, Mark D., et al. “Potential Impacts of Synthetic Food Dyes on Activity and Attention in Children: A Review of the Human and Animal Evidence.” Environmental Health 21, no. 1 (2022): 45. https://doi.org/10.1186/s12940-022-00849-9.
  2. S. Food and Drug Administration. “FDA to Revoke Authorization for the Use of Red No. 3 in Food and Ingested Drugs.” Constituent Update, January 15, 2025. https://www.fda.gov/food/hfp-constituent-updates/fda-revoke-authorization-use-red-no-3-food-and-ingested-drugs.
  3. S. Congress. Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 348(c)(3) (Delaney Clause). Accessed July 7, 2025. https://uscode.house.gov/view.xhtml?req=(title:21%20section:348%20edition:prelim).

Dofactora Iskandar is a Halal industry professional with a Master of Food Science (MFS) from Cornell University. Leveraging his scientific background, Dofactora has worked as a Halal auditor and trainer for the past eight years.