FDA Bans Red Dye After 56 Years of Approving It

A popular red dye causes thyroid cancer in rats. This has been known for a long time. This dye is still used in thousands of foods, including candy, cereals, cherries in fruit cocktails and, for example, in strawberry-flavored milkshakes. Rats are not humans but we share many cellular and systemic similarities. Appropriate studies to show that the dye is safe for human consumption have not been done. Red 3, also known as FD&C Red No. 3, erythrosine, or E127, has been a staple in the food, cosmetics, and pharmaceutical industries since its FDA approval in 1969. This synthetic dye is commonly found in a variety of products, including candies, beverages, baked goods, cereals, maraschino cherries, gelatin desserts, and certain medications. Recent scientific findings have raised alarms about the potential health risks associated with its consumption.

The Growing Concerns Over Red 3

In light of mounting evidence linking Red 3 to significant health risks, California took a “bold” step in 2023 by banning its use in food products. (The California ban was after 54 years of assuming it safe. Is that bold?)  Following this state-level action, the FDA announced a nationwide ban on January 15, 2025. A bold move by the FDA after 56 years. This decision will take effect for food and dietary supplements by January 15, 2027, and for pharmaceuticals by January 18, 2028. The impetus for these regulatory changes stems from concerns over the dye’s potential carcinogenic effects.

Is the Ban Due to “Concerns” or Due to Evidence?

I get so sick of weasel words. Consider this statement: The impetus for the ban was largely influenced by a color additive petition submitted by the Center for Science in the Public Interest (CSPI) in 2022, which highlighted substantial evidence of Red No. 3’s carcinogenic potential12. Although there is no established direct link between Red No. 3 and cancer in humans, the FDA’s decision aligns with the Delaney Clause of the Federal Food, Drug, and Cosmetic Act, which mandates that additives shown to cause cancer in animals cannot be authorized for use in food products.

Does the FDA agree that humans are animals? Or does it think humans may be plants? In other words, how can it still say that there is “no established direct link between Red No. 3 and cancer in humans” when there is an established link between the dye and cancer in animals?

While the agency acknowledges that substantial evidence from animal studies indicates a carcinogenic potential of Red No. 3—specifically in laboratory rats—it maintains that there is “no established direct link” between the dye and cancer in humans. This distinction is rooted in several key factors:

Differences in Biological Response

Species-Specific Responses: The FDA has noted that the mechanisms by which Red No. 3 induces cancer in male rats do not necessarily apply to humans. This is a common consideration in toxicology, where responses to substances can vary significantly across species due to differences in physiology, metabolism, and hormonal regulation[26].

Rebuttal: Since Red No. 3 disrupts thyroid hormone regulation in rats, it raises concerns about similar effects in humans, given the fundamental similarities in endocrine systems across mammals. Also, there are numerous instances where animal studies have accurately predicted human health risks. For example, substances like benzene and formaldehyde were identified as carcinogenic in animals before being recognized as risks to human health. This historical context suggests that dismissing animal study findings as irrelevant may overlook critical warnings about potential dangers.

Exposure Levels: The agency also points out that typical human exposure levels to Red No. 3 are significantly lower than those used in the animal studies that demonstrated carcinogenic effects. This lower exposure may reduce the risk of similar outcomes in humans[27].

Rebuttal: The argument for caution is strengthened by considering cumulative exposure levels and the vulnerability of specific populations, such as children. Given that Red No. 3 is prevalent in many food products consumed by children, who may metabolize substances differently than adults, there is a compelling case for stricter regulations.

Method of Action

The assertion that Red No. 3 disrupts thyroid hormone regulation in rats is supported by evidence from various studies, which indicate that the dye has multiple mechanisms of action that can lead to thyroid dysfunction.  Mechanisms of disruption include:

1. Iodine Absorption Inhibition: Red No. 3 has been shown to inhibit the thyroid gland’s ability to absorb iodine, which is essential for synthesizing thyroid hormones[28]. This inhibition leads to decreased levels of hormones such as thyroxine (T4) and triiodothyronine (T3), resulting in thyroid dysfunction[29].
   
2. Enzyme Blockage: The dye blocks an enzyme necessary for converting one thyroid hormone into another, further contributing to hormonal imbalances. This impairment can result in conditions such as hypothyroidism, where insufficient thyroid hormones are produced[28].
3. Tumor Promotion: Studies have indicated that exposure to Red No. 3 may promote the formation of thyroid tumors in rats. Research has documented enlarged tumorous thyroid glands and abnormalities in hormone regulation among animals exposed to the dye, suggesting a direct link between Red No. 3 and thyroid cancer risk[28].

Test for Normal Thyroid Function

Testing for normal thyroid function typically involves measuring levels of both T3 (triiodothyronine) and T4 (thyroxine), along with TSH (thyroid-stimulating hormone). The TSH test serves as a primary screening tool, indicating how well the thyroid gland is functioning. Normal ranges for T3 are generally around 100 to 200 ng/dL, while T4 levels should fall between 5.0 to 12.0 μg/dL, depending on the specific laboratory standards used. Abnormal levels of TSH, T3, or T4 can indicate various thyroid disorders, necessitating further investigation to determine the underlying cause and appropriate treatment.

Can T3 and T4 Tests in Populations of Humans Determine Red 3 Safety?

The levels of T3 and T4, along with TSH, can provide insights into thyroid function but cannot definitively determine the safety of Red No. 3 (erythrosine) in humans. Although studies have shown that Red No. 3 disrupts thyroid hormone regulation in rats by inhibiting iodine absorption and altering hormone metabolism, these effects may not directly translate to humans due to significant physiological differences between species. For instance, the thyroid response in rats is influenced by much higher serum TSH levels compared to humans, which can amplify the impact of substances like erythrosine on thyroid function.

More on Human vs Rat Thyroid Differences

Research indicates that rats exhibit a significantly heightened sensitivity to thyroid perturbations, with serum TSH levels in rats being approximately 6- to 60-fold higher than those typically found in humans. This difference amplifies the impact of substances like erythrosine on thyroid function in rats, making them more susceptible to changes in thyroid hormone levels when exposed to such compounds[30][31][32]. In contrast, humans have a more complex feedback mechanism regulating thyroid hormones, which may mitigate the effects of similar exposures. While both species can experience elevated TSH levels following erythrosine ingestion, the physiological responses and implications for thyroid health can differ markedly due to these interspecies variations.

Rebuttal on Comparative Sensitivity: The assertion that higher serum TSH levels in rats automatically lead to greater sensitivity to thyroid-active substances like erythrosine is an overgeneralization. While rats may exhibit pronounced changes in TSH levels, this does not inherently mean that their overall thyroid function is more adversely affected by erythrosine compared to humans. The specific physiological context and metabolic pathways involved in thyroid regulation can lead to different outcomes that are not solely dependent on TSH levels. The argument does not address the critical lack of research to find or not find direct evidence linking erythrosine exposure to thyroid dysfunction in humans.

The physiological mechanisms governing thyroid hormone regulation can differ significantly between species. For instance, while elevated TSH levels in rats may lead to increased thyroid hormone production, the same degree of hormonal response may not occur in humans due to their more complex feedback mechanisms and different physiological contexts[31][33]. This does not consider non-thyroid risks, such as neuro-inflammation.

Has Red 3 Caused Thyroid Thumors in Other Animals Besides Rats?

Pigs: Yes. Red No. 3 has been shown to promote thyroid tumor formation in pigs. Observations included enlarged tumorous thyroid glands and abnormalities in hormone regulation following exposure to the dye[28][35]. Study on Thyroid Tumors in Pigs: The article discusses the effects of Red No. 3 and mentions its impact on thyroid tumor development in pigs. You can access it here: The Promoting Effects of Food Dyes, Erythrosine (Red 3) and Rose Bengal B[36].

Butterworth et al. (1976) conducted a study involving four groups of Large White pigs, each consisting of three males and three females, with an average weight of approximately 20 kg. The pigs were fed diets containing erythrosine at varying doses of 0, 167, 500, or 1,500 mg/kg per day over a period of 14 weeks. The results indicated that the treated pigs had lower serum thyroxine levels compared to the control group. Additionally, there were dose-dependent increases in serum levels of protein-bound iodine, non-protein-bound iodine, and protein-bound erythrosine across all treated groups.

Health Risks Associated with Red 3

Over the past few decades, research has increasingly pointed to the adverse health effects of Red 3. While direct links to cancer in humans remain unproven, animal studies have consistently indicated its carcinogenic potential.

1. Thyroid Dysfunction: One of the primary concerns is that Red 3 disrupts thyroid hormone regulation. Studies show that it inhibits iodine absorption by the thyroid gland and blocks essential enzymes involved in hormone conversion, leading to increased risks of thyroid disorders.

2. Tumor Promotion: Animal studies have revealed that exposure to Red 3 can lead to thyroid tumor formation. Research involving rats and pigs demonstrated enlarged tumorous thyroid glands and significant hormonal imbalances after exposure to the dye.

3. Neurotoxicity: Evidence suggests that Red 3 may have detrimental effects on brain health. Research indicates that it increases oxidative stress—damaging tissues—and reduces antioxidants that mitigate this stress. Additionally, it has been linked to neuroinflammation and neuronal damage in rodent studies[34].

Method of Neurotoxicity – Reactive Oxygen Species (ROS) Generation: Erythrosine promotes the formation of reactive oxygen species, which can lead to oxidative stress within cells. Studies indicate that exposure to erythrosine results in a significant decrease in glutathione (GSH), a critical antioxidant, while increasing malondialdehyde (MDA), a marker of lipid peroxidation and cellular damage 24. This imbalance can compromise cellular integrity and function.

Cell Death Mechanisms: The cellular response to erythrosine exposure includes both apoptotic and necrotic pathways. In certain studies, high doses of erythrosine have been shown to induce necrosis characterized by extensive membrane disintegration and cellular debris, while lower doses may trigger apoptosis, evidenced by increased caspase activity[35]. This dual mechanism indicates that erythrosine can lead to cell death through multiple pathways depending on the concentration used.

Regulatory Momentum and Historical Context

The scrutiny surrounding Red 3 is not new; it first emerged in the 1980s when studies began linking the dye to thyroid tumors in male rats. Although it was banned in cosmetics in the U.S. in 1990 due to these findings, its use in food continued amid industry lobbying efforts. In contrast, the European Union restricted its use in processed cherries as early as 1994.

California’s recent ban reignited discussions about Red 3’s safety and prompted advocacy from over two dozen organizations for federal action. This culminated in the FDA’s nationwide ban in January 2025. While the FDA acknowledges a lack of direct evidence linking Red 3 to cancer in humans, it cites sufficient animal study data as justification for regulatory action under the Delaney Clause of the Federal Food, Drug, and Cosmetic Act.

The Delaney Clause mandates that any substance shown to cause cancer in humans or animals must be banned from use as a food additive. This legal framework underscores the importance of consumer safety over industrial interests.

It Took Over Over Half A Century!

Well, yes. For 56 years the FDA has been calling Red 3 safe to ingest. The FDA has been aware of the potential risks associated with Red 3 since at least the late 1980s. Specifically, the first significant study linking Red 3 to thyroid tumors in male rats was published in 1987. This study prompted the FDA to begin scrutinizing the dye’s safety, leading to its eventual ban in cosmetics in 1990 due to cancer concerns. Over the years, the FDA reassessed the safety of Red No. 3 multiple times. In 1992, the FDA announced its intention to remove authorization for Red No. 3 based on findings from studies indicating potential carcinogenic effects in male rats, but this process was delayed. From the publication of that initial study in 1987 until the FDA’s nationwide ban on January 15, 2025, it took over 35 years for regulatory action to be taken against Red 3 in food and pharmaceuticals. Although the FDA acknowledged that animal studies indicated a carcinogenic potential, it maintained that there was no direct evidence of cancer risk in humans. Nonetheless, the agency’s decision to revoke authorization for Red 3 was based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act, which prohibits any food or color additive found to induce cancer in humans or animals. The timeline highlights a prolonged period during which scientific evidence regarding the risks of Red 3 accumulated but did not lead to immediate regulatory changes until recent advocacy efforts and state-level actions, such as California’s ban in 2023, reignited public and governmental scrutiny on the dye’s safety.

Companies Using Red 3

1. Bimbo Bakeries: Some Entenmann’s products include Red 3.
2. Conagra Brands: Known for products like Marie Callender’s birthday cake pie and Duncan Hines confetti cake mix.
3. Del Monte: Uses it in some mixed fruit cups.
4. Ferrara Candy Company – Owner of Brach’s, which produces items like Brach’s Candy Corn.
5. General Mills: Uses Red 3 in some Pillsbury and Betty Crocker products.
6. Keurig Dr Pepper: Uses Red 3 in Yoo-hoo strawberry drink, which is being reformulated.
7. Kellanova: Manufacturer of Pop-Tarts and MorningStar products that include Red 3.
8. Ferrara Candy Company: Owner of Brach’s and Jelly Belly products that contain the dye.
9. Krispy Kreme: Some doughnut products contain the dye.
10. Mondelez International: Some Oreo products contain the dye.
11. PEZ Candy, Inc. – Known for its candy products.
12. Tootsie Roll Industries: Uses Red 3 in Dubble Bubble gum.

These companies have publicly stated their plans to reformulate products containing Red 3 in response to the FDA’s ban, which will take effect for food by January 15, 2027, and for pharmaceuticals by January 18, 2028. Lovely. That means at least three more years of cancer causing dye for those who do not read the news. 

Companies That Manufacture or Supply Red 3

1. Ferro Corporation: A major supplier of colorants, including Red 3, for various applications.
2. Daiichi Sankyo Company: This pharmaceutical company has been known to use Red 3 in some of its products.
3. BASF: A global chemical company that produces a variety of food additives and colorants, including Red 3.
4. Sensient Technologies Corporation: Specializes in food colorings and produces Red 3 as part of its offerings. Sensient has developed alternatives to Red 3 and is actively working on solutions for food manufacturers looking to reformulate their products in light of the bans on synthetic dyes like Red 3.
5. American Colors: Another manufacturer involved in producing food colorings, including synthetic dyes.

Financial Contributions to the FDA

Search results do not specify how much each company using or manufacturing this cancer causing subsatance has paid to the FDA over the past 35 years. Typically, companies incur costs associated with regulatory compliance, but specific figures are not publicly disclosed. Perhaps we should change that. Here is an estimate of the value of Red 3 to the FDA:

Fee Structure

1. Certification Fee: The calculation that the certification fee is $0.45 per pound for straight colors, including Red 3, is correct. This fee was increased from $0.35 per pound as of December 9, 2024, reflecting a recent adjustment by the FDA to cover operational costs associated with the certification program [1][3][4].

2. Minimum Fee: The minimum fee for certification has been set at $288, which is also accurate. This minimum applies regardless of the total quantity being certified if it falls below a certain threshold [3][4].

Annual Fee Calculation

– The calculation that for 1,000 pounds, the total annual fee would be:
– Certification Fee: 1,000 pounds imes 0.45 USD/pound = 450 USD
– Since this exceeds the minimum fee, the total annual fee per manufacturer would indeed be $450.

Total Fees Over 35 Years

– The calculation for total fees over 35 years:
– $450 USD/year times 35 years = $15,750 USD
– This is also accurate based on the annual fee calculated.

Estimated Total Fees by Company

– The estimated total fees for each manufacturer over the last 35 years being $15,750 is consistent with the calculations provided, assuming each company produces approximately 1,000 pounds of Red 3 annually.

The estimates presented in your query regarding Sensient Technologies Corporation, BASF, Ferro Corporation, Daiichi Sankyo Company, and American Colors are based on reasonable assumptions about production volumes and current FDA fee structures. However, it’s important to note that these figures are speculative and actual fees could vary significantly based on real production levels and any changes in regulatory fees over time. For precise figures regarding FDA fees paid by each company specifically for Red 3, detailed financial records or disclosures would be necessary.

By this estimate the total value to the FDA over 35 years could be around $79,000, which isn’t much. But wait, there’s more. What about that $3,000 petition fee makers must also pay to the FDA per substance and per formulation change?

To estimate how many petitions BASF might have submitted to the FDA for Red 3 over the past 35 years, several factors must be considered. Red 3 was initially approved for use in food before safety concerns emerged, leading to its ban from cosmetics in 1990 due to its carcinogenic potential. Each time a manufacturer introduces a new formulation or changes the application of an existing color additive, a new petition is typically required. Given that Red 3 has faced scrutiny since the late 1980s, any new uses would necessitate petitions to ensure compliance with safety regulations. The recent petition by the Center for Science in the Public Interest in 2022 ultimately prompted the FDA’s decision to ban Red 3 from food and ingested products, highlighting how advocacy can influence regulatory actions even after long periods of approval.

Estimating Petitions Over 35 Years

Given that BASF is a major manufacturer of color additives, here’s a speculative approach to estimating the number of petitions:

– Assumption of New Uses: If we assume that BASF may have introduced new formulations or products containing Red 3 approximately every 5 years, this would result in about 7 petitions over a 35-year period (from 1990 to 2025).

– Regulatory Changes: If there were significant regulatory changes or new safety data emerging, BASF might have submitted additional petitions beyond just new formulations. This could potentially add 1-2 more petitions.

In total, it may be reasonable to estimate that BASF could have submitted around 7 to 10 petitions regarding Red 3 over the past 35 years, depending on product development and regulatory requirements. However, this is a speculative estimate, and actual numbers could vary based on specific product lines and regulatory interactions. For precise figures, one would need access to BASF’s internal records or detailed FDA documentation regarding their submissions related to Red 3. This may represent another $25,000 per each of the five Red 3 producing companies, that’s makes the product a $204,000 value to the FDA ($125,000 in petitions plus $79,000 in fees) over its lifespan. Still not much, but interesting.

Have These Companies been Making Red 3 for Decades?

• Sensient Technologies, BASF, and Ferro Corporation have been involved in the production of colors and dyes for many decades, likely including Red 3.
• Daiichi Sankyo has a long history as well but is primarily known for pharmaceuticals.
• Information regarding American Colors is limited, making it difficult to confirm their specific involvement with Red 3 over the past 35 years.

Pressure to Approve From Major Customers

Trying to understand why the FDA took 35 years to ban a cancer causing additive, it is reasonable to ask if there is pressure on FDA regulators to look favorably on all products of their major customers. How many other products from Sensient Technologies, BASF, and Ferro Corporation require FDA certification? Here are some general estimates based on industry practices:

• Sensient Technologies: Likely has dozens of certified color additives across various applications (food, beverages, cosmetics).
• BASF: As a large chemical company, they likely have a wide portfolio of excipients and additives requiring certification, possibly numbering in the tens to hundreds depending on their product lines.
• Ferro Corporation: Similar to Sensient, they likely have multiple certified products, though specific numbers are less clear.

In other words, imagine the money to pay your salary as a regulator working for the FDA comes in part from the companies you have to regulate. Do you think there might be some pressure under such a system to not tell your “boss” that it can’t have a certain product?

Can companies go elsewhere if the FDA fails to certify a profitable product?

Companies can classify certain substances as “Generally Recognized as Safe” (GRAS) without FDA approval. This allows them to market products that may not have gone through the formal FDA certification process, provided they can substantiate that the substance is safe based on scientific evidence or consensus among qualified experts. However, this approach does not guarantee that the FDA will agree with their determination if questioned. The FDA does not require notification of GRAS determinations unless a company chooses to submit a GRAS affirmation petition.

FD&C Red No. 3 (also known as erythrosine) was not classified as Generally Recognized As Safe (GRAS) by the FDA. Instead, it has been a regulated color additive, and its safety has been evaluated under the provisions of the Federal Food, Drug, and Cosmetic Act. Red 3 has been approved for use in food and drugs since 1969, but it was banned from cosmetics in 1990 due to evidence linking it to cancer in laboratory animals. The FDA’s decision to ban its use in food and ingested drugs came after decades of scrutiny regarding its safety.

What Process Did the FDA Use to Approve Red 3 in 1969?

In 1969, the FDA approved FD&C Red No. 3 (erythrosine) through a structured regulatory process that began with manufacturers submitting a petition demonstrating the safety of the color additive for its intended use in food and ingested drugs. This petition included toxicological studies and other relevant data. The FDA evaluated this information, considering factors such as the likely amount of consumption, intended use, and the physical and chemical properties of Red 3. If the evidence supported the additive’s safety, the FDA would issue a regulation authorizing its use. At that time, Red 3 was deemed safe based on the available scientific evidence, primarily from animal studies. However, subsequent research raised concerns about its carcinogenic potential, leading to increased scrutiny and ultimately resulting in the FDA’s decision to ban its use in food and ingested drugs effective January 15, 2025.

Did it do any of its own studies, or just read those submitted to it by the chemical companies?

The FDA’s approval process for FD&C Red No. 3 in 1969 primarily relied on data submitted by manufacturers rather than conducting its own independent studies. When a company seeks to use a color additive, it must submit a petition to the FDA that includes safety data and toxicological studies demonstrating that the additive is safe for its intended use. The FDA evaluates this information along with any existing data to determine whether the substance meets safety standards. In the case of Red 3, the FDA approved it based on the evidence provided by manufacturers at that time, which included animal studies assessing its safety. However, subsequent research raised concerns about its potential carcinogenic effects, leading to increased scrutiny and eventual regulatory action.

The Failed Honor System

The FDA’s reliance on an “honor system” for certain aspects of its regulatory processes has raised concerns regarding the effectiveness and integrity of its oversight. This system primarily involves trusting manufacturers to provide accurate and comprehensive data about their products without extensive verification by the FDA. Critics argue that this approach can lead to significant issues, particularly in the context of medical devices and generic drugs.

How to Fix the Current System

Who would conduct studies for approvals or rejections and how to prevent undue influence:

Key Points about Color Additive Petitions

1. Independent Research Organizations: Studies for product approvals could be conducted by independent research organizations that are funded by a mix of government grants and private sector contributions. These organizations would be responsible for conducting rigorous safety and efficacy testing without direct ties to manufacturers.

2. Regulatory Oversight Committees: A regulatory oversight committee could be established to review the findings from these independent studies. This committee would include experts from various fields (e.g., toxicology, pharmacology, public health) who are free from conflicts of interest, ensuring unbiased evaluations.

3. Transparency Measures: To prevent undue influence, strict transparency measures would need to be implemented. This could include mandatory disclosure of all financial relationships between researchers, regulatory officials, and industry stakeholders. Additionally, any funding sources for studies would need to be publicly disclosed.

4. Public Accountability: Establishing mechanisms for public accountability, such as allowing public comments and peer reviews on study findings before final decisions are made, could further reduce the risk of bias and ensure that consumer interests are prioritized.

By employing independent organizations for study conduct and establishing robust oversight and transparency measures, the integrity of the approval process can be enhanced while minimizing the risk of undue influence from manufacturers.

A Path Forward

The journey from Red 3’s initial approval to its impending prohibition illustrates the ongoing conflict between public health advocacy and industrial pressures. As manufacturers prepare to reformulate their products by the mandated deadlines, there is an opportunity for greater consumer awareness regarding synthetic dyes.

Several companies are already taking proactive steps; for instance, Mars announced plans to eliminate artificial colors from its human food products by 2021, while General Mills has committed to removing artificial colors and flavors from its offerings by 2024.

As we move towards a future with stricter regulations on synthetic dyes like Red 3, harmonizing global standards for evaluating these additives will be essential to safeguard consumer health. The FDA’s actions mark a significant victory for consumer advocacy groups and reflect an evolving landscape where public health considerations are increasingly prioritized over long-standing industrial practices.

In conclusion, while Red 3 has been a common ingredient for decades, growing scientific evidence and regulatory actions highlight the need for vigilance regarding synthetic food dyes and their potential impacts on health. The ongoing dialogue surrounding these issues will be crucial as we strive for safer food environments and informed consumer choices.

 

Read More
^{[1] https://www.dlapiper.com/en/insights/publications/2025/01/fda-bans-red-dye-no-3
[2] https://theconversation.com/fda-bans-red-3-dye-from-food-and-drugs-a-scientist-explains-the-artificial-colors-health-risks-and-long-history-247757
[3] https://www.fda.gov/industry/color-additives/fdc-red-no-3
[4] https://www.cnbc.com/2025/01/15/fda-bans-red-no-3-artificial-coloring-used-in-beverages-candy-and-other-foods.html
[5] https://www.aljazeera.com/news/2025/1/16/what-is-red-dye-3-and-why-has-the-us-fda-banned-it-in-food-and-drinks
[6] https://www.sc.edu/uofsc/posts/2025/01/conversation-fda-bans-red-3.php
[7] https://www.fda.gov/food/hfp-constituent-updates/fda-revoke-authorization-use-red-no-3-food-and-ingested-drugs
[8] https://www.forbes.com/sites/joshuacohen/2025/01/16/fda-bans-red-dye-3-on-cusp-of-potentially-big-changes-in-food-industry/
[9] https://www.fda.gov/food/hfp-constituent-updates/fda-proposes-increase-color-certification-fees
[10] https://www.biospace.com/press-releases/fda-roundup-november-8-2024
[11] https://www.cosmeticsandtoiletries.com/regulations/regional/news/22925992/fees-increased-on-us-fda-color-additive-certification-heres-what-youll-pay
[12] https://cosmeticobs.com/en/articles/international-66/the-us-fda-increases-colourant-certification-fees-8424
[13] https://www.fda.gov/industry/fda-user-fee-programs/color-additive-certification-fees
[14] https://www.cirs-group.com/en/cosmetics/us-fda-color-additive-certification
[15] https://unblock.federalregister.gov
[16] https://www.plasticstoday.com/medical/fda-seeks-fee-increase-for-color-additive-certification
[17] https://www.cnbc.com/2025/01/15/fda-bans-red-no-3-artificial-coloring-used-in-beverages-candy-and-other-foods.html
[18] https://www.cspinet.org/cspi-news/red-3-fda-finally-bans-cancer-causing-food-dye
[19] https://www.fda.gov/industry/color-additives/color-additive-petitions
[20] https://www.cspinet.org/page/where-red-3-legal-see-where-your-state-stands
[21] https://www.cspinet.org/sites/default/files/2022-12/Dyes%20Red-3-FDA-Delisting-Cosmetics-2-1-90%20(13).pdf
[22] https://www.pbs.org/newshour/health/the-fda-banned-red-3-food-coloring-a-scientist-explains-the-dyes-history-and-health-risks
[23] https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-color-additive-petitions-fda-recommendations-submission-chemical-and-technological
[24] https://time.com/7207125/fda-bans-red-dye-no-3/
[25] https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-questions-and-answers-about-food-additive-or-color-additive-petition-process
[26] https://www.aljazeera.com/economy/2025/1/15/us-bans-dye-red-no-3-from-foods-saying-it-causes-cancer-in-lab-rats
[27] https://www.hindustantimes.com/world-news/usfda-bans-red-dye-no-3-known-to-cause-cancer-in-animals-101736959884703.html
[28] https://www.pbs.org/newshour/health/the-fda-banned-red-3-food-coloring-a-scientist-explains-the-dyes-history-and-health-risks
[29] https://www.inchem.org/documents/jecfa/jecmono/v21je07.htm
[30] https://pubmed.ncbi.nlm.nih.gov/15135213/
[31] https://www.foodstandards.gov.au/sites/default/files/food-standards-code/applications/Documents/A603%20Erythrosine%20SD1%20Hazard%20Assessment.pdf
[32] https://efsa.onlinelibrary.wiley.com/doi/pdf/10.2903/j.efsa.2011.1854
[33] https://pubmed.ncbi.nlm.nih.gov/15135213/
[34] https://pmc.ncbi.nlm.nih.gov/articles/PMC3317784/
[35] https://foodmanifest.com/erythrosine-or-red-3-a-deep-dive-into-its-risks-and-regulations/}