Tell the FDA: Replacing Petroleum-Based Dyes with Genetically Engineered Dyes is Not Acceptable

PROPOSED RULE: Listing of Color Additives Exempt From Certification; Beetroot Red
Regulations.gov Document ID: FDA-2024-C-1085-0003
Comment Period: February 6, 2026 to March 9, 2026
Agency: Food and Drug Administration (FDA)

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BAIT AND SWITCH: FROM ONE BAD FDA POLICY TO ANOTHER

FDA IS PROPOSING TO REPLACE PETROLEUM-BASED FOOD DYES WITH NEW GENETICALLY ENGINEERED FOOD DYES THAT ARE NOT SAFETY TESTED, AND CALLING THEM “NATURAL”

Under HHS Secretary Kennedy, the FDA is proposing to allow lab-created, synthetic pigments produced in industrial vats using genetically engineered yeast—to be marketed under the label "natural" or "no artificial colors," without long-term safety testing.

Under new enforcement discretion, the FDA no longer considers Synthetic Biology (SynBio) colors to be "artificial," provided they are not derived from petroleum. This means a product containing lab-grown, SynBio-derived dye can be labeled in a way that misleads consumers to believe it contains naturally farmed, plant-based ingredients.

This regulatory loophole puts corporate profits before the consumers’ right to know, masking the reality that these dyes are synthesized products of genetic engineering/bioengineering rather than simple extracts existing in nature.

Petroleum-based food dyes should have never been allowed into our food supply. But the FDA puts its trust in safety representations from companies that profit handsomely from selling them. Now, decades later, amid mounting evidence linking these petroleum-based additives to neurobehavioral issues and chronic health concerns, the FDA is faced with an urgent need to get petroleum dyes out.

But swapping chemical dependency for dependency on SynBio, an extreme form of genetic engineering, is not the solution. Not only does FDA’s proposal fundamentally ignore the public’s demand for transparency, it is once again relying on corporate safety claims.

Replacing petroleum dyes with SynBio dyes without clear disclosure does not restore the integrity of our food supply. It fails to address the long-term safety implications of consuming novel proteins and will undermine public trust.

ABOUT GMO BEETROOT RED

Historically, "beetroot red" (betanin) was produced by pressing or extracting juice from actual beet roots grown in soil. However, Phytolon’s Beetroot Red—approved by the FDA in February 2026—marks a fundamental shift in how food colors are made.

Instead of being farmed, this dye is produced via SynBio—misleadingly described as “precision fermentation” or sometimes just “fermentation.” But SynBio is nothing like making beer or sauerkraut.

Scientists have taken the genetic "instructions" for red pigment from the beet plant and inserted them into Saccharomyces cerevisiae (baker’s yeast). This genetically engineered yeast is then grown in industrial vats, where it produces the red pigment. While the final molecule is chemically similar to the one found in beets, the process is entirely synthetic, occurring in a laboratory environment rather than through traditional agriculture.

HIDDEN RISKS: RESIDUAL CONTAMINATION & ALLERGENICITY

Because the dye is produced by a living organism (yeast), the final product must be purified to remove the "host cell proteins" (HCPs). Hidden risks include:

• Yeast Allergies: Even trace amounts of residual yeast proteins can trigger reactions in sensitive individuals.
• Novel Enzymes: The biosynthetic enzymes used to create the dye are not typically consumed by humans in high concentrations or in this isolated form, and their long-term impact on the gut microbiome is largely unstudied.
• Independent testing data related to another SynBio product, a milk protein, found that the final product was over 85% fungal proteins - more than 90 of them - that were never before consumed by humans. Those results demonstrate that we should be concerned about the possibility of a similar level of contamination for Phytolon’s GMO Beetroot Red dye. Thorough contamination and long-term safety testing have not been performed.

Tell the FDA that replacing one synthetic food dye with another synthetic food dye is not acceptable. Under no circumstance should genetically engineered SynBio food dyes be allowed to be labeled as “natural.” And no products made with SynBio food dyes should be allowed to claim “no artificial colors.” The FDA’s proposal for Phytolon’s GMO Beetroot Red puts us right back where we started. Get synthetic food dyes out of our food!

The pre-written comment text is editable. We encourage you to make it your own. The deadline for public comment is 11:59PM Eastern Time on Monday, March 9, 2026. Please submit your objection to the FDA’s proposal today.