The FDA’s Long-Overdue Ban on Red Dye No. 3 in Food and Oral Drugs

(A version of this article was published in the February 2025 issue of Public Citizen’s Health Letter)

In January 2025 the Food and Drug Administration (FDA) finally banned the use of Red Dye No. 3 in food, beverages, dietary supplements and oral drugs.[1] The synthetic food dye “gives certain foods and drinks a bright, cherry-red color, and is found in certain candy, cakes and cupcakes, cookies, frozen desserts, and frostings and icings,” as well as in some oral drugs, according to the agency. In 2021 the food and drug industries used more than 200,000 pounds of Red Dye No. 3.[2]

The ban, which occurred in response to an October 2022 petition led by the Center for Science in the Public Interest (CSPI),[3] is also a long-overdue victory for Public Citizen and the late Dr. Sidney M. Wolfe, the Health Research Group founder. In 1977 Public Citizen filed the first of four lawsuits to force the agency to remove the color additive from the market.[4] In 1984 Public Citizen’s Health Research Group petitioned the FDA to “immediately” ban 10 widely used food, drug or cosmetic dyes, including Red Dye No. 3.[5] Along with 22 other organizations and scientists, Public Citizen was a co-petitioner on the 2022 CSPI petition.

The ban on Red Dye No. 3, also known as FD&C Red No. 3, Red 3, and Red Dye 3, will go into effect on Jan. 15, 2027, for food, and Jan. 18, 2028, for oral drugs.

In 1990 the FDA banned Red Dye No. 3 from use in topical drugs (such as ointments for pain relief) and cosmetics (such as lipstick and skincare products) because of the evidence from laboratory studies completed in the 1980s that it caused thyroid cancer in rats.[6] But the agency never followed through on its pledge to move swiftly against the remaining uses of the dye, which make up most of its use.

In 1990 Wolfe told Malcolm Gladwell, the Canadian author, journalist and public speaker who was then a Washington Post reporter covering the story, “This whole thing has taken a lot of time and wasted a lot of FDA resources…It’s really very simple. [Red Dye No. 3] causes cancer. We should get rid of it.”[7]

The FDA’s long-overdue decision to revoke the authorization of Red Dye No. 3 is based on the Delaney clause of the Food, Drug, and Cosmetic Act. Named after New York Congressman James Delaney and enacted in 1958 as part of the food additives amendment to the act, the Delaney Clause prohibits the approval of a food or color additive that has been found to induce cancer in humans or animals.[8] In the 1980s, Red Dye No. 3 was found to cause cancer in male laboratory rats exposed to high levels of the dye, due to a hormonal mechanism that occurs in male rats. According to the FDA, studies in other animals and in humans have not shown the same effects and “there is no evidence showing [Red Dye No.3] causes cancer in humans.” The Delaney clause was also the basis for the 1990 partial ban on the dye.[9]

The FDA’s belated action to ban Red Dye No. 3 is great news, but the delay is nonetheless inexplicable. It is very disturbing that the ban will take effect in 2027 and 2028 instead of in the 1980s.
 

References

[1] Food and Drug Administration. FD&C Red No. 3. https://www.fda.gov/industry/color-additives/fdc-red-no-3. Accessed February 3, 2025.

[2] Center for Science in the Public Interest. FDA moves to eliminate carcinogenic Red 3 from foods. January 15, 2025. https://www.cspinet.org/press-release/fda-moves-eliminate-carcinogenic-red-3-foods. Accessed February 3, 2025.

[3] Center for Science in the Public Interest, et al. Color additive petition to remove FD&C Red No. 3 from the permanent list of color additives approved for use in food and dietary supplements and for use in ingested drugs. October 22, 2022. https://www.cspinet.org/sites/default/files/2022-10/Red%203%20petition_24%20Oct%202022_FINAL%20%281%29.pdf. Accessed February 3, 2025.

[4] Statement of Public Citizen concerning the proposed ban of Red Dye #3. January 30, 1990. https://www.citizen.org/article/statement-by-public-citizen-concerning-the-proposed-ban-of-red-dye-3/. Accessed February 3, 2025.

[5] Public Citizen. Petition to Food and Drug Administration (FDA) to ban ten widely-used food, drug or cosmetic dyes, all of which have been found to cause cancer. December 17, 1984. https://www.citizen.org/article/petition-to-food-and-drug-administration-fda-to-ban-10-widely-used-food-drug-and-cosmetic-dyes-all-of-which-have-been-shown-to-cause-cancer/. Accessed February 3, 2025.

[6] Gladwell M. Citing law, FDA bans many uses of Red Dye No. 3. Washington Post. January 29, 1990. https://www.washingtonpost.com/archive/politics/1990/01/30/citing-law-fda-bans-many-uses-of-red-dye-no-3/269bcec2-22e4-4baf-85d3-de16b73761f9/. Accessed February 3, 2025.

[7] Ibid.

[8] Food Additives Amendment of 1958. Wikipedia. https://en.wikipedia.org/wiki/Food_Additives_Amendment_of_1958#:~:text=The%20Delaney%20Clause%20is%20a,to%20induce%20cancer%20in%20animals. Accessed February 3, 2025.

[9] Food and Drug Administration. FD&C Red No. 3. https://www.fda.gov/industry/color-additives/fdc-red-no-3. Accessed February 3, 2025.