{"id":7407,"date":"2026-03-05T08:36:25","date_gmt":"2026-03-05T14:36:25","guid":{"rendered":"https:\/\/toxinfreeusa.org\/?p=7407"},"modified":"2026-03-06T20:42:05","modified_gmt":"2026-03-07T02:42:05","slug":"is-beetroot-red-food-dye-a-bait-and-switch","status":"publish","type":"post","link":"https:\/\/toxinfreeusa.org\/is-beetroot-red-food-dye-a-bait-and-switch\/","title":{"rendered":"Is Beetroot Red Food Dye a Bait-and-Switch?"},"content":{"rendered":"\n
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In 2025, the new FDA administration led by Health and Human Services (HHS) Secretary Robert F. Kenneday, Jr., focused one of their first initiatives on removing petroleum-based food dyes from the U.S. food system. There was a call for the food industry to quickly develop natural colors as safe alternatives.<\/p>\n\n\n\n

Unfortunately, we found that at least one of the colors approved and being fasttracked by the FDA, \u201cBeetroot Red,\u201d is produced using genetic engineering.<\/p>\n\n\n\n

Phytolon\u2019s Beetroot Red dye is produced with an extreme form of genetic engineering known as Synthetic Biology (SynBio). Yet the company, on its website, claims the dye is \u201cnon-GMO\u201d and \u201cnatural\u201d. This is false and misleading.<\/strong> Phytolon\u2019s Beetroot Red dye would not qualify for certification by the Non-GMO Project, nor would it be allowed in USDA Certified Organics.<\/p>\n\n\n\n

We must stop this before it sets a precedent for other GMO foods and ingredients developed using newer technologies. If the FDA allows Phytolon to label SynBio food dyes as \u201cnatural,\u201d it opens the door for ingredients produced through any new, unregulated genetic engineering technique to make false and misleading \u201cnatural\u201d claims.<\/p>\n\n\n\n

The FDA opened a public comment docket for Beetroot Red. GMO\/Toxin Free USA submitted a formal comment of objection to the FDA. Below is our full submission\u2026<\/p>\n\n\n

<\/path><\/svg><\/div>\n\n\n

FDA Comment Tracking Number mme-2r2f-kect<\/em>

GMO\/Toxin Free USA comments on Listing of Color Additives Exempt From Certification; Beetroot Red<\/strong><\/p>\n\n\n\n

Document ID FDA-2024-C-1085-0003<\/p>\n\n\n\n

Submitted by GMO\/Toxin Free USA, PO Box 8273, New Fairfield, CT 06812<\/p>\n\n\n\n

Date: 03\/05\/2026<\/p>\n\n\n\n

Introduction<\/strong><\/p>\n\n\n\n

We oppose the FDA\u2019s amending the color additive regulations to provide for the \u201csafe use of beetroot red for the coloring of human foods.\u201d While the attempt to shift the food industry away from petroleum-based dyes is commendable, replacing one synthetic food dye with another synthetic food dye is not acceptable. Under no circumstance should genetically engineered Synthetic Biology (SynBio) food dyes be allowed to be labeled as \u201cnatural.\u201d Further, no products made with SynBio food dyes should be allowed to claim \u201cno artificial colors.\u201d<\/p>\n\n\n\n

We have reviewed the petition submitted to the FDA by Phytolon for approval of its new Beetroot Red food dye produced with genetic engineering technology known as SynBio, and observed several flaws and weaknesses in the submission, including the design of the short term \u201csafety study,\u201d and a lack of response to FDA\u2019s feedback and required followup. <\/p>\n\n\n\n

Phytolon has failed to provide adequate proof of safety of synthetic Beetroot Red for long-term human consumption and we are deeply concerned about the potential adverse health effects.<\/p>\n\n\n\n

A summary of our findings is below:<\/p>\n\n\n\n

Our Analysis of Data Submitted by Phytolon to FDA in Connection with SynBio Beetroot Red Food Dye Petition<\/strong><\/p>\n\n\n\n

CARCINOGENICITY<\/strong><\/p>\n\n\n\n

The Ames test is a widely used, rapid bacterial assay that determines if a chemical compound or material is mutagenic\u2014meaning it can cause DNA mutations. It detects whether a substance induces genetic mutations, acting as a preliminary screening tool for identifying potential carcinogens. <\/p>\n\n\n\n

The initial Ames test, a standard regulatory requirement, was positive. Yet, the positive genotoxicity findings are dismissed without adequate justification. The petitioner’s follow-up investigations of removing ascorbic acid, adding catalase and testing purified fractions, are mechanistic studies, not regulatory safety studies. The petitioner’s explanation that this was due to a pro-oxidant effect from ascorbic acid, and thus “not relevant to the in vivo<\/em> situation,” is a significant weakness as they do not demonstrate the test article is non-genotoxic in vivo. While the petitioner performs follow-up testing, e.g., mammalian erythrocyte Pig-a gene mutation assay, in vivo <\/em>mutagenicity assessment using duplex sequencing in liver, stomach, and intestine tissues collected from Pig-a gene mutation assay, the FDA acknowledges that, \u201cFollow-up testing cannot entirely mitigate the concerns raised by an Ames-positive finding, and some residual risk remains in the absence of an adequate carcinogenicity assessment.\u201d <\/p>\n\n\n\n

The FDA suggests, \u201crodent carcinogenicity studies\u201d be used, which the petitioner fails to provide. For such rodent carcinogenicty studies the the FDA recommendation is, “The test animal should be exposed to the test substance 7 days per week for 104 consecutive weeks (two years), or for the life span of the animal.”  https:\/\/www.fda.gov\/food\/guidanceregulation\/guidancedocumentsregulatoryinformation\/ingredientsadditivesgraspackaging\/ucm078388.htm#ftnIV<\/a><\/p>\n\n\n\n

Yet, the petitioner only provides 90 day subchronic toxicity data which is inadequate to assess carcinogenicity, or even chronic toxicity. After such necessary rodent trials are completed, the enrollment of healthy human subjects in first-in-human trials would be the next necessary step before FDA approval. As long-term toxicity\/carcinogenicity, reproductive toxicity, and developmental toxicity studies are lacking, this directly contradicts the core principle of food additive safety, which requires a full battery of tests to establish an ADI. <\/p>\n\n\n\n

The memo concludes safety based on “weight of evidence” despite these major gaps. In the “Summary and Conclusions” (Section XIV), the FDA reviewer explicitly states: “…an acceptable daily intake (ADI) for betanin could not be established because the information available to FDA did not permit that, in particular because of the lack of data from long term oral toxicity studies, as well as developmental and reproductive toxicity studies on betanin.\u201d  These are not minor omissions. Chronic toxicity\/carcinogenicity, reproductive, and developmental toxicity studies are fundamental pillars of food additive safety assessment, especially when a new production method (genetically engineered yeast) is involved. By the FDA’s own admission, the data package is insufficient to set an ADI, which is the primary goal of such a safety evaluation. Concluding that the additive is safe <\/strong>without<\/em><\/strong> this data is a logical contradiction.<\/strong> The “weight of evidence” is being used to fill data gaps that are explicitly designed to be filled by these very studies.<\/p>\n\n\n\n

FLAWS IN SHORT TERM STUDY – INCONSISTENT DOSING<\/strong><\/p>\n\n\n\n

According to the memo, \u201cPhytoPurple concentrations in prepared diets of groups 2 to 4 were analyzed in weeks 1, 6, and 12 and the mean sample concentrations were within or equal to 65-85% of target concentrations based on the responses of betanin and iso-betanin.\u201d This level of inaccuracy, up to a 35% error, severely compromises the study’s validity, making it impossible to establish a reliable No-Observed-Adverse-Effect Level (NOAEL). A range of 65-85% means the animals in the high-dose group, for example, may have received a dose intended for the mid-dose group. This degree of inaccuracy undermines the dose-response assessment and the reliability of the derived NOAEL (3581 mg\/kg\/day for males). If the dose is unknown, the NOAEL is meaningless.<\/strong><\/p>\n\n\n\n

RELIANCE ON PUBLISHED STUDIES ON NATURAL BEETROOT JUICE OR NATURAL BETALAINS<\/strong>
<\/strong>
<\/strong>The petitioner relies heavily on published studies on beetroot juice or betalains. Yet, these studies are flawed because: <\/p>\n\n\n\n

    \n
  1. They did not use the specific test article, the fermented genetically engineered product. <\/li>\n\n\n\n
  2. The concentration of betanin in the tested material was unknown. Even the FDA admits, in Sections VI, VII, XI, these limitations. Such as: 1. “the concentration of specific betalain like betanin was unknown in the dosing solution.” (Section VI). 2. “this acute study… failed to provide the concentration of betanin…” (Section VII). 3. “these studies had limitations to draw any conclusions on the study endpoints.” (Section VII). 4. “all these clinical studies were conducted with betalains and beetroot preparations and the level of betanin is unknown…” (Section XI). <\/li>\n<\/ol>\n\n\n\n

    The petitioner cannot use studies to support the safety of a specific well-characterized test article, the fermented genetically engineered Beetroot Red, if the concentration of the active component, betanin, in those studies is unknown. The matrix, whole beetroot juice vs. purified fermented product, is different, and the dose is unknown. These studies cannot substitute for robust studies on the actual fermented genetically engineered product in question.

    ALLERGENICITY<\/strong>
    <\/strong>
    <\/strong>The actual genetic sequences are redacted, making it impossible to run through known allergen databases to assess allergenicity.

    Additional Concerns<\/strong><\/p>\n\n\n\n

    1. Concerns Regarding Synthetic Biology and Process Integrity<\/strong><\/h4>\n\n\n\n

    The safety profile of this additive is inextricably linked to its production host. Using Saccharomyces cerevisiae<\/em> introduces specific risks that are not present in soil-grown beets.<\/p>\n\n\n\n

    Residual Host Cell Proteins (HCPs):<\/strong> Even with high-level purification, there is a risk of residual yeast proteins remaining in the final dye. For individuals with yeast allergies or sensitivities, this poses a direct health risk. Even trace amounts of residual yeast proteins can trigger reactions in sensitive individuals.<\/p>\n\n\n\n

    Potential for Unintended Metabolic Byproducts:<\/strong> The use of multi-gene biosynthetic pathways (including genes like BvDODA1<\/em> and BvCYP76AD1<\/em>) inserted into a yeast host represents a high degree of processing. This is a radical departure from simple extraction. The stability of these engineered pathways over long-term industrial cycles and the potential for unintended metabolic byproducts must be scrutinized more heavily than traditional food colors.<\/p>\n\n\n\n

    Novel Protein Exposure:<\/strong> The biosynthetic enzymes used to create the dye are not typically consumed by humans in high concentrations or in this isolated form. The presence of biosynthetic enzymes (such as the glucosyltransferases used to stabilize the dye) has not been sufficiently evaluated for potential allergenicity in the human gut or the impact on the microbiome.<\/p>\n\n\n\n

    Established Concerns About Contamination:<\/strong>  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 similar contamination for Phytolon\u2019s GMO Beetroot Red dye. Thorough contamination and safety testing must be performed.<\/p>\n\n\n\n

    2. Misleading Labeling <\/strong>  <\/p>\n\n\n\n

    While the resulting pigment may be chemically similar to that found in traditional beets, the method of production and the proposed marketing of this ingredient as “natural” raise significant safety, transparency, and allergenicity concerns that have not been sufficiently addressed.<\/p>\n\n\n\n

    The characterization of this additive as a “natural” color or as \u201cno artificial color\u201d is fundamentally misleading to the consumer. This dye is not “sourced from nature” in the traditional sense; it is a product of Synthetic Biology (SynBio), synthesized in industrial fermentation vats using genetically engineered Saccharomyces cerevisiae <\/em>yeast.

    Consumers associate “beetroot red” with a whole-food source. Labeling a vat-grown, bioengineered pigment as “natural” or “beetroot-derived” or \u201cno artificial color\u201d obscures the reality of its synthetic origin and deceives consumers.

    Call for Rigorous Safety Testing<\/strong>
    <\/strong>
    <\/strong>There is a dearth of independent, peer-reviewed, long-term feeding studies that confirm the safety of these specific fermented betalains compared to their traditionally extracted counterparts.<\/p>\n\n\n\n

    Before final approval is granted, the following must be mandated:<\/p>\n\n\n\n

    1. Long term safety testing to comply with the FDA\u2019s request for a long term rodent feeding study.<\/p>\n\n\n\n

    2.  Proteomic Analysis: Rigorous testing to prove the absolute absence of residual yeast DNA and allergenic proteins.<\/p>\n\n\n\n

    3. Clear Labeling Standards: Strict enforcement of labeling that prevents the use of “natural” or \u201cno artificial colors\u201d for any ingredient produced via Synthetic Biology.<\/p>\n\n\n\n

    4. Allergen Warnings: Mandatory disclosure if the product was manufactured using a yeast-based fermentation process, to protect sensitive populations.

    Conclusion<\/strong><\/p>\n\n\n\n

    The push for “sustainable” colors should not come at the expense of consumer transparency and safety.<\/strong> The agency must prioritize thorough long term safety testing and the “Right to Know” for consumers who wish to avoid Synthetic Biology. The agency must ensure that the allergen screening for these novel additives is as rigorous as those for pharmaceutical-grade biologics. We urge the agency to require clear labeling that distinguishes between plant-extracted pigments and those produced via Synthetic Biology, prohibiting the labeling of synthetic dye as \u201cnatural\u201d or as \u201cno artificial colors\u201d.<\/p>\n","protected":false},"excerpt":{"rendered":"

    In 2025, the new FDA administration led by Health and Human Services (HHS) Secretary Robert F. Kenneday, Jr., focused one of their first initiatives on removing petroleum-based food dyes from the U.S. food system. There was a call for the food industry to quickly develop natural colors as safe alternatives. Unfortunately, we found that at …<\/p>\n","protected":false},"author":13,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_genesis_hide_title":false,"_genesis_hide_breadcrumbs":false,"_genesis_hide_singular_image":false,"_genesis_hide_footer_widgets":false,"_genesis_custom_body_class":"","_genesis_custom_post_class":"","_genesis_layout":"","footnotes":""},"categories":[58],"tags":[],"class_list":{"2":"type-post","6":"category-the-non-toxic-sleuth","7":"entry"},"acf":[],"_links":{"self":[{"href":"https:\/\/toxinfreeusa.org\/wp-json\/wp\/v2\/posts\/7407","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/toxinfreeusa.org\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/toxinfreeusa.org\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/toxinfreeusa.org\/wp-json\/wp\/v2\/users\/13"}],"replies":[{"embeddable":true,"href":"https:\/\/toxinfreeusa.org\/wp-json\/wp\/v2\/comments?post=7407"}],"version-history":[{"count":3,"href":"https:\/\/toxinfreeusa.org\/wp-json\/wp\/v2\/posts\/7407\/revisions"}],"predecessor-version":[{"id":7411,"href":"https:\/\/toxinfreeusa.org\/wp-json\/wp\/v2\/posts\/7407\/revisions\/7411"}],"wp:attachment":[{"href":"https:\/\/toxinfreeusa.org\/wp-json\/wp\/v2\/media?parent=7407"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/toxinfreeusa.org\/wp-json\/wp\/v2\/categories?post=7407"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/toxinfreeusa.org\/wp-json\/wp\/v2\/tags?post=7407"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}