FDA Just Banned Red Dye No.3: What's Next for Synthetic Food Dyes in the U.S?

FDA Bans Red Dye No.3 in Crackdown on Synthetic Food Dyes

In a landmark move for food safety, the U.S. Food and Drug Administration (FDA) has officially banned Red Dye No. 3 (Erythrosine), a widely used synthetic food dye found in candy, baked goods, and medications. This decision follows growing scientific evidence linking the dye to potential health risks.

Though it was banned in cosmetics in the U.S. since 1990, Red Dye No. 3 remained permitted in foods and drugs until now. The FDA’s latest action sends a strong message: it’s time to rethink synthetic food dyes in the American food supply.

Next Up: FDA Reviews Citrus Red No. 2 & Orange B Synthetic Dyes

As part of a wider regulatory overhaul, the FDA is also initiating the process to revoke approval for two additional synthetic food dyes:

• Citrus Red No. 2 – A dye used to colour orange peels in some citrus fruits

• Orange B – Previously used in sausage and hot dog casings

  
  

FDA and HHS Plan Full Phase-Out of Petroleum-Based Synthetic Food Dyes

This isn’t just about one dye. The FDA, in collaboration with the U.S. Department of Health and Human Services (HHS), is planning a gradual phase-out of petroleum-based synthetic food dyes including:

• FD & C Yellow No. 5 (Tartrazine)

• FD & C Yellow No. 6 (Sunset Yellow FCF)

• FD & C Green No. 3 (Fast Green FCF)

• FD & C Red No. 40 (Allura Red AC)

• FD & C Blue No. 1 (Brilliant Blue FCF)

• FD & C Blue No. 2 (Indigo Carmine)

This initiative aims to:

• Promote natural alternatives (e.g., beetroot, spirulina, turmeric)

• Enhance transparency in food labelling

• Address growing health concerns related to synthetic food dyes

This could mark the beginning of a global shift in food safety standards, particularly concerning the use of synthetic food dyes in processed products.

FDA Fast-Tracks Natural Alternatives to Synthetic Food Dyes

To support the industry’s transition away from synthetic food dyes, the FDA is fast-tracking the review of promising natural alternatives such as:

• Calcium Phosphate

• Galdieria Extract Blue (a microalgae-derived colour)

• Gardenia Blue

• Butterfly Pea Flower Extract

These natural solutions offer safer, more sustainable options for manufacturers looking to reformulate while maintaining product appeal.

Industry Impact: Moving Away from Synthetic Food Dyes

The movement away from petroleum-based synthetic food dyes represents a significant opportunity and challenge for the food and beverage industry.

Brands, especially those selling into or exporting to the U.S., should be prepared to:

• Reformulate using FDA-approved natural alternatives

• Stay up to date with synthetic food dye phase-out timelines

• Update product labelling and marketing strategies

• Consider global alignment with EU and U.S. standards

Synthetic Food Dyes in Malaysia: Are We Aligned?

Stay tuned for our next post, where we’ll explore into Malaysia’s current regulations on synthetic food dyes and how they align with global trends. Whether you're a consumer, manufacturer or regulatory professional, this is an update you won’t want to miss. Follow us for more insights coming your way!

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