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What is Yellow #5 FDA? Understanding Tartrazine, Safety, and the 2025 Phase-Out

4 min read

In 2025, the U.S. Food and Drug Administration (FDA) announced plans to phase out synthetic food colorings, including the widely used FD&C Yellow No. 5. This petroleum-derived dye, also known as tartrazine, has been subject to long-standing debate regarding its safety, prompting many to ask: what is yellow #5 FDA?

Quick Summary

Yellow 5, or tartrazine, is a petroleum-derived synthetic dye historically used in food, drugs, and cosmetics. The FDA is now phasing it out due to health concerns like allergies and hyperactivity in some individuals.

Key Points

  • Petroleum-derived: FD&C Yellow No. 5, or tartrazine, is a synthetic dye made from petroleum-derived chemicals.

  • FDA phase-out: In 2025, the FDA announced plans to phase out Yellow #5 and other synthetic dyes from the US food supply by the end of 2026.

  • Health concerns: It is linked to allergic reactions (like hives and asthma), especially in those with aspirin sensitivity, and hyperactivity in some children.

  • Broad usage: Yellow #5 has been used in a wide array of products, including soft drinks, candy, medications, and cosmetics.

  • Labeling requirements: Drug products containing Yellow #5 must declare its presence and include a warning statement about potential allergic reactions.

  • Natural alternatives: Turmeric, annatto, and beta-carotene are common natural substitutes for artificial yellow colors.

In This Article

What is Yellow #5 (Tartrazine)?

FD&C Yellow No. 5, commonly known by its chemical name tartrazine, is a synthetic lemon-yellow food dye derived from petroleum. It is one of the most widely used artificial colors worldwide due to its vibrant hue and stability. For decades, the U.S. Food and Drug Administration (FDA) permitted its use in a variety of products, from processed foods and beverages to medications and cosmetics. However, its history is marked by regulatory scrutiny and ongoing public health discussions, culminating in the 2025 FDA decision to begin its removal from the U.S. food supply.

Yellow #5 in Dyes and Lakes

Yellow #5 is available in two main forms for industrial use: as a water-soluble dye and a water-insoluble lake. Dyes are used for coloring products with sufficient moisture, while lakes are ideal for products lacking moisture, such as coatings for drug tablets or cosmetic powders.

Regulatory History and the 2025 FDA Announcement

FD&C Yellow No. 5 was first approved for food use by the FDA in 1969. For many years, the FDA maintained that while reactions to color additives are possible, they are rare. However, mounting evidence and public pressure have shifted the regulatory landscape. Studies, including the notable Southampton studies in the UK, have highlighted potential links between artificial food dyes and hyperactivity, particularly in children.

In April 2025, the FDA announced a landmark move to phase out synthetic, petroleum-based dyes, including Yellow #5, from the national food supply. This initiative aims to transition the food industry to natural color alternatives. The mandate includes a timeline for removing dyes like Yellow #5 and others, with manufacturers expected to comply by the end of 2026. This regulatory change marks a significant shift towards addressing consumer health concerns and aligning with the stricter regulations already in place in many other countries, such as those in the European Union.

Products Containing Yellow #5

Despite its impending phase-out, Yellow #5 has been ubiquitous in the consumer market for decades. Manufacturers have used it to create visually appealing products, from candies to condiments. Some common products containing Yellow #5 include:

  • Foods: Soft drinks, sports drinks, candy, breakfast cereals, snack foods (chips, crackers), packaged desserts, and instant puddings.
  • Beverages: Powdered drink mixes, energy drinks, and flavored alcoholic beverages.
  • Medications: Prescription drugs, over-the-counter medicines (like vitamins and antacids), and capsules often contain Yellow #5 for easy identification. The FDA requires specific labeling for drugs containing Yellow #5, including a warning about potential allergic reactions.
  • Cosmetics: A variety of cosmetic and personal care products, including soaps, mouthwashes, and cosmetics, have historically used Yellow #5.

Potential Health Effects and Concerns

Allergic Reactions

One of the most well-documented issues with Yellow #5 is its link to allergic-type reactions in a small percentage of susceptible individuals. Symptoms can include hives (urticaria), skin rashes, and asthma. People with aspirin hypersensitivity appear to have a higher incidence of sensitivity to tartrazine.

Hyperactivity in Children

Studies have linked artificial food colorings, including Yellow #5, to behavioral issues like hyperactivity and attention problems in some children. While the effect is not universal, research suggests that it may exacerbate existing conditions like ADHD in sensitive children. This concern has been a significant driver for stricter regulations globally and the recent FDA action.

Other Health Concerns

Beyond allergies and hyperactivity, researchers have raised other potential concerns:

  • Contaminants: The production of synthetic dyes can result in trace amounts of potentially carcinogenic contaminants, such as benzidine. The FDA sets strict limits on these impurities, but questions about long-term exposure have been raised.
  • Gene Expression: Some studies have explored how Yellow #5 might affect gene expression, suggesting it could cause oxidative stress and cellular damage over time. However, most of this research has been conducted in isolated cells or animal models, and more investigation is needed to understand the implications for humans.

Alternatives to Yellow #5

As the FDA moves to phase out synthetic dyes, consumers and manufacturers are turning to natural alternatives for coloring products. These alternatives are derived from sources such as vegetables, fruits, and spices. Popular natural yellow colorants include:

  • Turmeric: The spice that gives curry its yellow color, turmeric contains curcumin, a powerful antioxidant and anti-inflammatory compound.
  • Annatto Extract: Derived from the seeds of the achiote tree, this extract is commonly used to color dairy products like cheese and butter.
  • Beta-Carotene: Found in carrots and sweet potatoes, beta-carotene not only provides a yellow-orange color but is also a precursor to vitamin A.
  • Saffron: A more expensive option, saffron offers a deep yellow hue and has potential health benefits.

Comparison: Yellow #5 vs. Natural Dyes

Feature Yellow #5 (Tartrazine) Natural Alternatives (e.g., Turmeric, Annatto)
Source Petroleum-derived chemicals Plant-based ingredients like spices and vegetables
Color Stability Highly stable and consistent Less stable; can fade or change color with heat and light
Cost Inexpensive to produce Generally more expensive due to sourcing and processing
Potential Health Concerns Linked to allergies and hyperactivity in sensitive individuals; trace contaminants Fewer health concerns, though allergies to source ingredients are possible
Nutritional Value No nutritional value added May offer additional nutritional benefits (e.g., vitamin A from beta-carotene)

Conclusion

While FD&C Yellow No. 5 has been a staple in the food and drug industries for its stability and low cost, mounting health concerns have led to a significant regulatory shift. The FDA's 2025 announcement to phase out Yellow #5 and other synthetic dyes reflects growing public awareness and a move towards safer, natural alternatives. This change offers a positive outlook for consumer health, particularly for children and individuals with sensitivities, though manufacturers will face challenges in reformulating products. Consumers can prepare for this transition by reading labels carefully and choosing products that utilize natural colorants, aligning their purchasing power with the move toward cleaner ingredients. For more detailed regulatory information, refer to the official eCFR entry for FD&C Yellow No. 5.

Frequently Asked Questions

FD&C Yellow No. 5 is a synthetic, petroleum-derived color additive, also known as tartrazine (E102), that was widely used to provide a bright yellow color to foods, drugs, and cosmetics before the 2025 phase-out announcement.

No, Yellow #5 is not banned yet, but the FDA announced in April 2025 that it will be phased out of the U.S. food supply along with other synthetic dyes by the end of 2026. Existing stock can be sold until expiration.

Potential health risks include allergic reactions like hives and asthma, particularly in individuals with aspirin sensitivity, and hyperactivity in some children.

Historically, Yellow #5 has been found in various products, such as soft drinks (e.g., Mountain Dew), candy (e.g., M&Ms), cereals, snack foods (e.g., Doritos), medications, and certain cosmetics.

Tartrazine is the common name for the chemical compound FD&C Yellow No. 5. It is the same substance, just referred to by different names depending on context or region (e.g., E102 in the European Union).

Natural alternatives include turmeric, annatto extract, and beta-carotene, which are derived from plants and provide natural coloring for food and beverages.

Some studies have suggested a link between Yellow #5 and potential carcinogens, often related to contaminants from the manufacturing process. However, no definitive evidence has proven that Yellow #5 directly causes cancer, and the FDA has set strict limits on contaminants.

The decision was prompted by decades of research raising health concerns, including links to hyperactivity in children, and growing consumer demand for cleaner, more transparent food labeling.

References

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.