FDA Bans Red Dye 3 On Cusp Of Potentially Big Changes In Food Industry

The Food and Drug Administration is banning dye Red No. 3 in food and oral medicinal products. The substance gives a cherry-red hue to certain foods and medicines. The FDA ban comes on the cusp of potentially bigger changes in the food industry under the incoming Trump administration. Robert F. Kennedy Jr., nominee to be the next secretary of Health and Human Services, signals he wants to reshape the food industry.

The FDA published two major rules on Wednesday. The first lowers permissible nicotine levels in cigarettes. The second bans dye Red No. 3 — also known as erythrosine, a color additive made from petroleum — from foods, dietary supplements and oral medicines, such as cough syrups.

Food manufacturers will have until January 2027 to reformulate their products. Makers of ingested drugs have until January 2028 to do the same. The new rule pertains to more than 3,200 food and medicinal products that contain what is called Red 3.

Officials at the agency cite a statute known as the Delaney Clause, first enacted in 1960, which requires FDA to ban any additive found to cause cancer in people or animals. Jim Jones, the FDA’s deputy commissioner for human foods, said that while there isn’t evidence that Red 3 causes cancer in humans, data “shows cancer in laboratory male rats exposed to high levels of Red No. 3.”

While it’s been known for at least 30 years that Red 3 is carcinogenic in rats and the European Union has largely banned Red 3 as a food additive since 1994, it’s unknown why the FDA only decided to act now, particularly since the agency had removed Red 3 from the list of approved additives in cosmetics 35 years ago, owing to cancer risks. The FDA says its decision Wednesday was made in response to a petition filed by more than 20 food safety and health advocates in 2022 who urged the agency to revoke Red 3’s authorization. Nevertheless, the FDA chose to wait to prohibit the substance in foods and medicines until this week.

The food industry is a key area in which RFK Jr. is likely to seek to drive major change if confirmed as HHS secretary. He has pledged to restructure the FDA’s Center for Food Safety and Applied Nutrition. Kennedy has even suggested he would fire nutritional scientists at FDA once in office. While the FDA regularly reviews the safety of food additives based on what the agency views as rigorous science and research, Kennedy has countered by saying the FDA is not “protecting our kids.”

Besides pushing for bans on certain dyes, like Red 3, and other additives, Kennedy has advocated for reducing the use of pesticides in agriculture, eliminating ultra-processed foods and curbing the use of other products that he says hurt Americans’ health. Kennedy says he wants to “fix” a food ecosystem that he describes as captured by corporate interests.

Whether he’ll be able to accomplish this remains to be seen. Challenging the powerful food industry’s vested interests won’t be easy, as The New York Times reports. Even as seemingly innocuous a ban as the one the FDA is now instituting could face legal challenges from manufacturers. Nonetheless, it would appear that the FDA’s ban on Red 3, implemented in the waning days of the Biden administration, is a shot across the bow to the food sector that could ironically help facilitate Kennedy’s pursuit of further changes.