FDA announces measures to out petroleum-based food dyes

FDA announces measures to out petroleum-based food dyes | Image Credit: © sharafmaksumov - © sharafmaksumov - stock.adobe.com.

This week, the FDA and the US Department of Health and Human Services announced several new measures to phase out all petroleum-based synthetic dyes from the United States' food supply.¹

According to a press release from the federal agencies, 6 steps will be implemented over the coming weeks and years. The actions are:

• Establishing a national standard and timeline for the food industry to transition from petrochemical-based dyes to natural alternatives.
• Initiating the process to revoke authorization for 2 synthetic food colorings—Citrus Red No. 2 and Orange B—within the coming months.
• Working with industry to eliminate 6 remaining synthetic dyes—FD&C Green No. 3, FD&C Red No. 40, FD&C Yellow No. 5, FD&C Yellow No. 6, FD&C Blue No. 1, and FD&C Blue No. 2—from the food supply by the end of next year.
• Authorizing 4 new natural color additives in the coming weeks, while also accelerating the review and approval of others.
• Partnering with the National Institutes of Health (NIH) to conduct comprehensive research on how food additives impact children’s health and development.
• Requesting food companies to remove FD&C red No. 3 sooner than the 2027-2028 deadline previously required.

The deadline for red No. 3 was announced on January 15, 2025, by the FDA to remove the color additive from food and ingested drugs.² According to previous coverage by Contemporary Pediatrics, a 2022 petition cited various data including 2 studies that demonstrated cancer in laboratory male rats that were exposed to high levels of FD&C red no. 3. The FDA noted the way the dye causes cancer in male rats does not occur in humans, and that claims that the "use of red no. 3 in food and ingested drugs puts people at risk are not supported by the available scientific information," wrote the agency at the time of the announcement.

Red No. 3 specifically gives certain foods and drinks a signature, bright red color often found in candy, cakes, and cupcakes, as well as cookies, frosting, icing, and ingested drugs, among other foods.³

"The FDA is asking food companies to substitute petrochemical dyes with natural ingredients for American children as they already do in Europe and Canada,” said FDA Commissioner Marty Makary, MD, MPH, in a statement. "We have a new epidemic of childhood diabetes, obesity, depression, and ADHD. Given the growing concerns of doctors and parents about the potential role of petroleum-based food dyes, we should not be taking risks and do everything possible to safeguard the health of our children.”¹

The FDA stated, in partnership with the NIH Regulatory Science and Research Program, will enhance nutrition and food-related research to inform regulatory decisions better.

In a statement, HHS Secretary Robert F. Kennedy, Jr. stated, "For too long, some food producers have been feeding Americans petroleum-based chemicals without their knowledge or consent. These poisonous compounds offer no nutritional benefit and pose real, measurable dangers to our children’s health and development. That era is coming to an end. We’re restoring gold-standard science, applying common sense, and beginning to earn back the public’s trust. And we’re doing it by working with industry to get these toxic dyes out of the foods our families eat every day.”

References:

1. HHS, FDA to phase out petroleum-based synthetic dyes in nation's food supply. FDA. Press release. April 22, 2025. Accessed April 24, 2025. https://www.fda.gov/news-events/press-announcements/hhs-fda-phase-out-petroleum-based-synthetic-dyes-nations-food-supply

2. Fitch, J. FDA bans red no. 3 in food and ingested drugs. Contemporary Pediatrics. January 15, 2025. Accessed April 24, 2025. https://www.contemporarypediatrics.com/view/fda-bans-red-no-3-in-food-and-ingested-drugs

3. FDA to revoke authorization for the use of red no. 3 in food and ingested drugs. FDA. January 15, 2025. Accessed April 24, 2025. https://www.fda.gov/food/hfp-constituent-updates/fda-revoke-authorization-use-red-no-3-food-and-ingested-drugs