In a landmark ruling, the FDA announced it will revoke authorisation for FD&C Red No. 3 (erythrosine) in food and ingested drugs. This decision stems from the Delaney Clause of the Federal Food, Drug, and Cosmetic Act, which requires a ban on additives linked to cancer in humans or animals, regardless of human risk levels under normal use.
The move follows a 2022 petition that highlighted studies showing high doses of Red No. 3 caused cancer in male lab rats. While the cancer-causing mechanism doesn’t occur in humans, the zero-tolerance policy mandated action.
Critics argue that the FDA’s delay – 35 years after banning Red Dye No. 3 in cosmetics – highlights the agency’s slow regulatory progress and raises questions about its ability to act swiftly on emerging health concerns. This criticism is part of a broader wave of scrutiny facing the FDA, as advocacy groups and lawmakers call for faster and more transparent action on food safety. In response, Jim Jones, FDA Deputy Commissioner for Human Foods, defended the agency’s approach, citing its reliance on rigorous scientific evaluation and ongoing efforts to enhance the review process for food additives.
The National Confectioners Association (NCA) expressed support for the FDA’s leadership in food safety. “We will continue to follow and comply with FDA’s guidance and safety standards. Our consumers and everyone in the food industry want and expect a strong FDA and a consistent, science-based regulatory framework,” said an NCA spokesperson.
“For years, our industry has been calling for more transparency, more funding, and more staff resources for the FDA to continue fulfilling its mission, and it’s time to put politics aside and work together to fund the FDA at levels that will allow it to continue its work.”
Similarly, the American Bakers Association (ABA) emphasised its commitment to food safety and collaboration with the FDA.
“The ABA reaffirms commercial baking manufacturers’ unwavering commitment to food safety and consumer trust,” said Rasma Zvaners, VP of Government Relations. “We respect the FDA and its dedication to ensuring the safety of the food supply. ABA remains steadfast in our collaboration with FDA and other regulatory agencies to lead science-based decision-making at the federal level and uphold the highest standards of food safety and quality.”
Meanwhile, consumer advocacy groups have applauded the decision. Scott Faber, senior VP of Government Affairs at the Center for Science in the Public Interest (CSPI), said, “Red 3 has no place in our food, especially in food marketed to our kids. Now, the FDA needs to take the next step and ban other dangerous chemicals lurking in our food.”
Impact on bakery and snack producers
Red No. 3 has long been used in baked goods, frostings, candies, cereals, and snacks to create vivid red hues. The ban – which is effective from January 2027 – challenges manufacturers to reformulate recipes. Many are already transitioning to alternatives like Red No. 40 or natural pigments such as carmine (derived from insects). However, these substitutes have their own challenges: Red No. 40, for instance, has been linked to hyperactivity in children.
The FDA’s revocation also aligns US regulations more closely with international standards. Red No. 3 is highly restricted in the European Union (only allowed in cocktail cherries and preserved fruits) and banned outright in Australia, New Zealand, and California.
Preparing for compliance
Manufacturers have until January 2027 to remove Red No. 3 from food products and until January 2028 for ingested drugs. This timeline aims to minimise disruption while giving companies time to reformulate and adapt supply chains.
California’s 2023 ban on Red No. 3 has served as a testing ground for the transition process. For example, General Mills has already begun reformulating its products to comply with California’s regulations, positioning the company ahead of the curve in meeting upcoming federal requirements.
“We will be in full alignment with California’s law and are actively working to reformulate our products nationwide,” said a company spokesperson at the time.
The FDA’s decision signals a potential turning point for synthetic additives in the food industry. Other dyes, including Red No. 40, Yellow No. 5, and Blue No. 1, are also under scrutiny for health risks, potentially driving a shift toward natural colorants and greater transparency in ingredient sourcing.
For bakeries and snack producers, the ban represents both challenges and opportunities. Embracing innovative, safer alternatives may enhance consumer trust and brand reputation, but the cost and complexity of reformulation will require careful planning and investment.