FDA bans red dye No. 3 from food, drinks and ingested drugs in the US

FDA bans red dye No. 3 from food, drinks and ingested drugs in the US

FDA bans red dye No. 3 from food, drinks and ingested drugs in the US

The U.S. Food and Drug Administration (FDA) has officially banned the use of red dye No. 3 in food, beverages, and ingested drugs, decades after studies linked it to cancer in animals. The announcement follows a petition by advocacy groups and mirrors a similar move by California in 2023.

Red dye No. 3, a synthetic color additive derived from petroleum and known as erythrosine, is widely used to give products a vibrant cherry-red color. Companies must phase out its use in food by January 15, 2027, and in drugs by January 18, 2028. Imported goods will also need to meet these standards.

The decision is hailed as a significant win for consumer health. Advocates like the Environmental Working Group’s president, Ken Cook, celebrated it as a "monumental victory," attributing progress to the efforts of public health champions. Major candy companies, such as Ferrara and Just Born, have already reduced or eliminated the use of red dye No. 3 in their products.

While red dye No. 40 has been considered a substitute, concerns about its effects on attention and behavior in children have prompted California to ban it in public schools. Studies have also associated it with potential carcinogenic risks in animals.

Red dye No. 3 has long been a controversial topic due to the FDA’s Delaney Clause, which prohibits approving color additives that cause cancer in animals or humans. Although banned in cosmetics in 1990, the dye remained permissible in food and drugs, as the cancer-causing mechanism observed in animals was not deemed applicable to humans.

Recent studies continue to highlight safety concerns, including behavioral impacts on children and outdated federal intake thresholds. Critics argue the FDA has been slow to act, pointing out that Europe banned the dye in most cases in 1994. Advocacy groups stress the need for a stronger regulatory system to prevent delays in banning harmful additives.

For consumers looking to avoid red dye No. 3 before the ban takes full effect, checking product ingredient labels for “red 3” or “FD&C Red #3” is recommended. Limiting consumption of ultraprocessed foods and choosing dye-free medications are also effective strategies.