On January 15, 2025, the FDA announced their decision to revoke the authorization for the use of FD&C Red No. 3 in food and ingested drugs. This will be effective January 15, 2027, for food products and January 18, 2028, for ingested drugs. Manufacturers will need to reformulate and remove Red 3 in order to meet these dates.
FD&C Red No. 3, also referred to as FD&C Red 3, Red 3, Red #3, or Erythrosine, is a synthetic food dye that imparts a bright pink or red color to products like food and beverages. Within the Pharmaceutical and Nutraceutical industry, FD&C Red 3 is used to color tablets and capsules, among other applications.
This amendment to current FDA color additive regulations is in response to a 2022 petition filed by a number of non-governmental organizations (NGOs) and consumer groups, led by the Center for Science in the Public Interest (CSPI). The FDA received almost 35,000 comments on this petition in its 60-day public comment period in 2023.
The FDA’s decision to ban Red 3 was based on the Delaney Clause, enacted in 1960 as part of the Color Additives Amendment to the Federal Food, Drug, and Cosmetic Act (FD&C Act). The Delaney clause prohibits FDA authorization of a food additive or color additive if it has been found to induce cancer in either humans or animals.
Two studies have showed that exposure to high levels of FD&C Red #3 caused cancer in laboratory male rats. Because of this link in rats in a laboratory setting, the Delaney Clause obligates the FDA to reassess and remove approval for Red 3 in food and ingested drugs for humans.
The studies cited by the petition and reviewed by the FDA specifically found that the cancer caused in rats exposed to high levels of Red 3 is due to a rat-specific hormonal mechanism. The way that FD&C Red #3 causes cancer in male rats does not occur in humans.
Synthetic Colors Under Fire: California has already passed two recent bills targeting synthetic colors.
Several states, including Pennsylvania and Oklahoma among others, have introduced bills to prohibit or restrict synthetic colors and/or titanium dioxide from use in food and beverages.
Legislative activity isn’t limited to the state level. Federal bills regarding synthetic colors and ultra-processed food labeling have also been filed in both the House of Representatives and the Senate.
If your brand is preparing to address the new FDA action by removing Red 3 but is not prepared to make a full conversion to natural colors, developers can look to other synthetic colors as alternatives. Red 40 offers a similarly stable and cost-effective red across applications. Red 40 won’t match the intensity of Red 3’s bright, almost neon, pink, but is an excellent option for brands seeking minimal process, formula, or cost impacts.
To find the best Red 3 substitute or fully convert products to natural colors, several technical considerations will come into play to ensure successful color performance. Heat, acidity, processing, ingredient interaction, and light exposure can all impact natural color stability depending on the color source.
As a leading global color manufacturer, Sensient’s decades of expertise and unique blending capabilities open the door to custom shades in both the natural and synthetic realms. Brands, developers, and manufacturers can lean on our deep pool of color resources and experience to find the best solutions for Red 3 replacements and synthetic color conversion.
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