Red Dye 3 has been a controversial topic across the food industry for decades. Despite its recognition as a carcinogen, the Food and Drug Administration (“FDA”) has minimally regulated the synthetic substance, allowing its use in various foods consumed daily in the United States. More recently, states have been asserting their autonomy by independently proposing and passing legislation to outlaw all avenues of the formation, distribution, and consumption of Red Dye 3.
Erythrosine, also labeled Red Dye 3, Red No. 3, or FD&C Red 3, is a synthetic colorant made from petroleum that gives products such as food, beverages, and medication a bright cherry-red color.[i] This artificial ingredient has been proven to cause cancer in rats.[ii] Nonetheless, the cancerous additive is still found in over 9,000 U.S. food products.[iii]
Furthermore, multiple studies have linked the consumption of synthetic dyes to behavioral issues in children. A study conducted in California found that 64% of children were adversely impacted by exposure to synthetic food dyes like Red Dye 3.[iv] Unfortunately, the FDA has established acceptable daily intake levels for Red Dye 3 based on older studies that failed to consider the impact of synthetic dyes on children’s behavior.[v]
Congressman James Delaney recognized the severity of consuming Red Dye 3 and proposed the Delaney Clause, which was enacted by Congress in 1958.[vi] As an amendment to the Federal Food, Drug and Cosmetic Act, the Delaney Clause requires the FDA to ban additives that are found to cause or induce cancer in humans or animals.[vii] The clause has found its way into the spotlight amidst substantial debate, with many arguing that it is too restrictive.
In 1990, citing the Delaney Clause, the FDA prohibited using Red Dye 3 in cosmetics and topical drugs due to its association with carcinogenicity in animals.[viii] However, the use of Red Dye 3 in foods and ingested drugs had already been authorized. More specifically, the colorant was first approved for use in food in 1907. In 1960, Congress passed the Color Additives Amendment, requiring the FDA to decide whether dyes were “suitable and safe” for specific uses. In somewhat accordance with the amendment, the FDA listed Red Dye 3 on a provisional list for all uses, with tentative approval pending further evaluation.
In 1969, the FDA permanently approved the use of dye in food but kept it provisionally allowed in cosmetics.[ix] When Red Dye 3 was discovered to cause cancer in rats, the FDA completely banned its use in cosmetics and topical drugs, estimating that it might cause cancer in fewer than 1 in 100,000 people. While the results suggested minimal risk, the FDA still vowed to impose the same ban on food products.
Nevertheless, the FDA never placed the Red Dye 3 ban on food and has self-proclaimed various justifications for continuing allowance of the cancer-causing substance in food. This reluctance to ban Red Dye 3 in food is rumored to be the result of pressure from the food industry, particularly the maraschino cherry industry. Regardless, fifty-five years later, there is still no FDA Red Dye 3 ban on food and drug consumption.
The European Union, China, the United Kingdom, Australia, and New Zealand, among others, have all recognized the dangers of Red Dye 3 and taken appropriate action by banning the harmful substance. The concern of Red Dye 3 consumption is no stranger to the United States, as the FDA is under continuous fire from various advocacy groups, urging the FDA to follow the trajectory of countries across the world in banning the artificial substance.
The Center for Science in the Public Interest (“CSPI”), accompanied by twenty-three other organizations, joined in October of 2022, petitioning the FDA to ban Red Dye 3 from the permanent list of color additives permitted for use in food, dietary supplements, and ingested drugs.[x] CSPI and company administered the petition pursuant to the Delaney Clause, which explicitly prohibits the consumption of carcinogenic additives in the food supply. Although the FDA had 180 days to respond to the petition, it remained radio silent for over a year before issuing a delayed statement, assuring that Red Dye 3 was under review.[xi] Since the tardy response in November 2023, no further updates have been provided.
In 2023, California took action by enacting Assembly Bill 418, the California Food Safety Act. Set to commence on January 1, 2027, the California Food Safety Act prohibits a person or entity from manufacturing, selling, delivering, distributing, holding, or offering for sale a food product for human consumption that contains Red Dye 3.[xii] By passing this bill, California pioneered the way as the first state in the United States to ban harmful synthetic food coloring. As the largest food market in the United States, California’s ban on Red Dye 3 could mean losses of billions of dollars.[xiii]
Following California’s initiative, various states have introduced similar bills to ban Red Dye 3. Considering many other countries have already banned Red Dye 3, the recent rise in state legislation on the matter could significantly impact the import and export of food products.[xiv] In anticipation of stricter quality control on Red Dye 3, companies are implementing more wholesome ingredients as an alternative to the toxic substance.[xv]
While the rest of the country awaits an FDA decision on Red Dye 3, there are two potential avenues to consider. Preferably, the FDA will ban Red Dye 3 at the federal level. Alternatively, more states will follow California’s lead in banning Red Dye 3 at the state level.
If the FDA bans Red Dye 3, the food industry will experience immense financial forfeiture as companies will have no choice but to replace their synthetic Red Dye 3 ingredients with FDA-approved alternatives. Regardless of a financial loss, the FDA needs to take this initiative, as it has an obligation to protect public health.[xvi] From a social standpoint, public sentiment towards synthetic additives is growing, causing more brands to feel pressured to include natural and health-conscious ingredients.[xvii] Should the FDA ban Red Dye 3, the positive social impact will not only ease consumers’ peace of mind, but the ban will also create uniformity across the food industry in the United States, enabling companies to streamline compliance rather than navigate varying regulations across different states.
If the FDA somehow escapes the demand to ban Red Dye 3, an increase in state legislation aimed at banning the ingredient is expected. Such actions could lead to further economic disruptions in the trade of products that contain Red Dye 3. Individual bans on Red Dye 3 at the state level create a crisis for companies conducting business in multiple states.[xviii] Without a national ban on such a widely used ingredient, companies must navigate a patchwork of state regulations.[xix] Unlike large companies, small businesses in each state would face significant hurdles, as they do not have the same resources to alter their ingredients in compliance with various states. Nonetheless, the growing consumer focus on health-conscious ingredients creates an initiative for states to respond to their residents by banning Red Dye 3 at the state level.
Ultimately, whether the FDA takes federal action or individual states ban Red Dye 3 due to federal inaction, an industry-wide financial forfeiture is inevitable. In any case, public health should be the priority for any decision-makers who are contemplating the future of this controversial synthetic dye. Regardless of the FDA’s decision—assuming they will eventually make one—companies and consumers should prepare for a substantial shift in the food industry.
[i] See FD&C Red No. 3, Food & Drug Admin. (Dec. 14, 2023), https://www.fda.gov/industry/color-additives/fdc-red-no-3.
[ii] See id.
[iii] See Branded Foods Containing Red Dye 3, Food Data Cent., https://fdc.nal.usda.gov/fdc-app.html (follow “Food Search” link; then search “Red 3” and look to “Branded Foods”) (last visited Nov. 6, 2024).
[iv] See Mark D. Miller et al., Potential Impacts of Synthetic Food Dyes on Activity and Attention in Children: A Review of the Human and Animal Evidence, Nat. Libr. of Med. (Apr. 29, 2022), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9052604/.
[v] See id.
[vi] See Steve Armstrong & George E. Dunaif, Food Additive Reform: Time to Repeal the Delaney Clause?, Food & Drug L. Inst. (2019), https://www.fdli.org/2019/02/food-additive-reform-time-to-repeal-the-delaney-clause/#.
[vii] See Regulation of Cancer-Causing Food Additives—Time for a Change, U.S. Gov’t Accountability Off. (Dec. 11, 1981), https://www.gao.gov/products/hrd-82-3.
[viii] See id.
[ix] See Ali Francis, The Ominous Ingredient in Your Candy Hearts, Bon Appétit Mag. (Feb. 9, 2024), https://www.bonappetit.com/story/red-dye-3.
[x] See Red 3 Petition, Ctr. for Sci. in the Pub. Int. (Oct. 24, 2022), https://www.cspinet.org/sites/default/files/2022-10/Red%203%20petition_24%20Oct%202022_FINAL%20%281%29.pdf.
[xi] 21 C.F.R. § 71.20 (2017); see Francis, supra note ix.
[xii] A.B. 418, 2023 Leg., Reg. Sess. (Cal. 2023) (enacted).
[xiii] See 2027 Challenge: Replacing Red Dye No. 3, Lycored (Mar. 1, 2024), https://www.lycored.com/2027-challenge-replacing-red-dye-no-3/.
[xiv] See id.
[xv] See id.
[xvi] See About FDA: Patient Q&A, Food & Drug Admin., https://www.fda.gov/media/151975/download. (last visited Nov. 6, 2024).
[xvii] See Deniz Ataman, CSPI et al’s Letter to the FDA Urges the Immediate and Formal Removal of Red Dye No. 3, Industry Trade Groups Representing Color Additives Request Comment Deadline Extension, Food Navigator USA. (Apr. 11, 2023), https://www.foodnavigator-usa.com/Article/2023/04/11/CSPI-et-al-s-letter-to-the-FDA-urges-the-immediate-and-formal-removal-of-Red-Dye-No.-3-industry-trade-groups-representing-color-additives-request-comment-deadline-extension.
[xviii] See Sharon Mayl, et al., California Bans FD&C Red Dye #3 and other Additives: Top Points for Industry, DLA Piper (Oct. 24, 2023), https://www.dlapiper.com/en-us/insights/publications/2023/10/california-bans-red-dye-3-and-other-additives.
[xix] See id.
