What is red 40 made of in the USA?

January 12, 2026 •

3 min read

With a 2024 study finding that Red 40 can cause DNA damage in lab animals, consumer awareness about this common food dye has increased. In the USA, red 40, or Allura Red AC, is a synthetic color additive derived primarily from petroleum products.

Quick Summary

Red 40, an azo dye known as Allura Red AC, is a synthetic coloring agent derived from petroleum and coal tars, not insects. It is one of the most widely used certified food additives in the USA, where it is approved by the FDA for use in foods, drugs, and cosmetics.

Key Points

Synthetic Origin: In the USA, red 40 is a synthetic dye, not made from insects, with a chemical structure based on petroleum derivatives.
Azo Dye: The dye is chemically classified as an azo dye, featuring an azo functional group (-N=N-) which contributes to its vibrant color.
Manufacturing Process: It is manufactured through a chemical reaction called azo coupling, which combines specific organic compounds.
FDA Certified: The US Food and Drug Administration (FDA) requires every batch of red 40 to be certified for purity before use in foods, drugs, and cosmetics.
Known as Allura Red AC: The formal name for red 40 is Allura Red AC and is listed on ingredient labels under this or its certified name, "FD&C Red No. 40".
Health Controversy: While approved by the FDA, red 40 has been linked to hyperactivity in sensitive children and has prompted stricter regulations in other countries.
Distinction from Carmine: Red 40 is fundamentally different from carmine, a natural red dye derived from cochineal insects.

The Chemical Composition and Synthesis of Red 40

Red 40, also known as Allura Red AC, is a red azo dye with a specific chemical formula. Azo dyes are characterized by an azo functional group that gives them their color. Unlike the natural dye carmine from cochineal insects, red 40 is synthetic and made through a chemical process.

The creation of Allura Red AC involves azo coupling, combining components typically from petroleum or coal tars, such as a diazotized cresidinesulfonic acid and 2-naphthol-6-sulfonic acid. The final product is a water-soluble sodium salt.

The FDA's Approval and Certification Process for Red 40

In the USA, the FDA regulates color additives like red 40. As a certified additive, red 40 batches must pass FDA testing for identity and purity before use in foods, drugs, or cosmetics.

Key steps in the FDA's process include a safety petition from the manufacturer, batch sample analysis, screening for contaminants, official designation (like "FD&C Red No. 40") for labeling, and post-market monitoring.

Comparison of Red 40 and Carmine

Consumers sometimes confuse red 40 with carmine. The table below highlights their main differences.


Feature	Red 40 (Allura Red AC)	Carmine (Cochineal Extract)
Origin	Synthetic, from petroleum.	Natural, from cochineal insects.
Classification	Certified synthetic azo dye.	Natural, exempt from certification.
Vegan Status	Vegan.	Not vegan.
Labeling	"FD&C Red No. 40" or "Red 40".	"Cochineal extract" or "carmine extract".
Health Concerns	Possible links to hyperactivity, DNA damage.	Potential allergic reactions.

Concerns and International Regulations for Red 40

Despite FDA approval in the USA, concerns about red 40's health effects remain. Studies suggest a possible link to hyperactivity in sensitive children. A 2024 assessment indicated synthetic dyes could have neurological effects, especially in children. Red 40 has also been shown to cause DNA damage in lab animals.

Regulatory approaches differ globally. The EU approves red 40 but requires a warning label about potential effects on children's activity. This has led some international companies to use natural alternatives. The US FDA doesn't require such labels, and while no artificial dyes are banned federally as of 2025, some states are moving towards restrictions. This reflects varying standards in interpreting scientific evidence.

Conclusion: Understanding the Origin of Red 40

In summary, red 40 in the USA is a synthetic, petroleum-based dye made via azo coupling. Known as Allura Red AC, it is different from natural insect-derived dyes. The FDA considers it safe for approved uses with batch certification. However, health concerns, particularly regarding hyperactivity and potential carcinogenicity, have resulted in stricter regulations and warning labels in other countries. This highlights the importance of checking labels and understanding ingredients.

Alternatives to Red 40

Due to concerns about synthetic dyes, natural alternatives are becoming more popular. These include:

Beetroot juice: Provides a red/pink color.
Lycopene: A red pigment from tomatoes.
Anthocyanins: Found in purple corn, cherries, etc..
Paprika: Offers a reddish-orange color.
Carmine: A natural, but not vegan, insect-derived dye.

Exploring these options allows for more informed choices about product ingredients.

The Future of Food Dye Regulation

The safety of red 40 and other synthetic dyes is still debated, with ongoing research and legislative efforts. The FDA may prioritize reviewing food dye safety, and some states are already restricting certain additives. Growing consumer demand for clearer labels and natural ingredients may push manufacturers towards natural alternatives, potentially changing the US market regardless of federal rules.

Visit the FDA's website for more information on color additive regulations

What is Red 40 made of in the USA: Key Takeaways

Origin: Red 40 in the USA is a synthetic dye from petroleum, not insects.
Manufacturing: It's made chemically through azo coupling.
Labeling: Must be listed as “FD&C Red No. 40” or “Red 40”.
Regulation: The FDA certifies each batch for purity.
Health Concerns: Linked to hyperactivity in sensitive children; FDA has not banned it.
International Status: Many countries, like those in the EU, require warning labels.
Alternatives: Natural options include beetroot juice and paprika.

Frequently Asked Questions

No, despite a common misconception, red 40 is a synthetic dye derived from petroleum products and coal tars, not from insects. The red dye that does come from insects (cochineal) is called carmine.

Red 40 is also known by its chemical name, Allura Red AC. On ingredient lists, it may also be labeled as "FD&C Red No. 40," "FD&C Red No. 40 Aluminum Lake," or "E129" in some international products.

In the USA, the FDA considers red 40 safe for its approved uses at specific concentrations. The ongoing debate over potential health effects, such as hyperactivity in children, involves differing interpretations of scientific studies and regulatory standards across different countries.

Yes, many natural alternatives are available, including extracts from beetroot, paprika, purple corn, and tomatoes (for lycopene). However, it is important to note that carmine, also a natural dye, comes from insects.

While not outright banned in many places, regulations vary significantly. Many countries, particularly in the European Union, require a warning label on products containing red 40 to alert consumers about potential effects on children's activity and attention.

The most effective way to avoid red 40 is to carefully read ingredient labels on packaged foods, beverages, and cosmetics. Look for the names "FD&C Red No. 40," "Red 40," or "Allura Red AC." Choosing whole, unprocessed foods and products with natural alternatives is another strategy.

For red 40, the FDA requires a rigorous batch certification program. A sample from every production batch must be sent to the FDA for analysis to ensure it meets purity and identity specifications before it can be used in products.