FDA is rescinding its authorization of food dye Red No. 3 for use in foods and ingested drugs based on results from animal studies and a legal technicality, teeing up reformulations for numerous CPG products.
FDA’s decision to prohibit the use of Red No. 3 follows a 2022 color additive petition from the Center for Science in the Public Interest (CSPI), the Center for Food Safety, the Environmental Working Group and 21 other organizations requesting the agency review evidence suggesting the ingredient was carcinogenic, including two male rat studies where animals developed cancer after ingesting large amounts of the food additives.
The 1960 Delaney Clause of the Federal Food, Drug and Cosmetic (FD&C) Act requires the FDA to prohibit food or color additives on the ground that the ingredient induces cancer in humans or animals.
Similarly, the FDA used the Delaney Clause in 2018 to prohibit the use of 7 synthetic flavors and flavor enhancers — including synthetically derived benzophenone, ethyl acrylate, eugenol methyl ether (methyl eugenol), myrcene, pulegone, pyridine and styrene — in response to a food additive petition.
Food and beverage companies have until Jan. 15, 2027, to reformulate foods and beverages with Red No. 3, and foods imported to the US will need to comply with the rule, the agency stated.
Did the FDA cave to public pressure?
In a Senate hearing last month, FDA’s Deputy Commissioner for Human Health Jim Jones alluded that the agency was leaning toward prohibiting Red No. 3 in foods and beverages because these animal studies triggered the Delaney Clause but pulled back on the ingredient being unsafe for human consumption.
“The scientific consensus is that the mechanism of carcinogenicity in rats is not applicable in humans,” Jones noted.
“Even though we do not believe there is a risk to humans, under the Delaney Clause of the FD&C Act, Red Dye 3, because it is known to cause cancer in laboratory animals, should not be authorized,” Jones added.
The FDA reached “a tipping point” about consumer concerns on synthetic food dyes, explained Anna Rosales, senior director of government affairs and nutrition at the Institute of Food Technologists.
“Maybe consumers did not understand the difference between an animal study and a human study, and they read an animal study, and they said ‘Oh goodness, that causes cancer or has a risk of cancer in animals. I do not want to consume that,” she elaborated.
FDA’s Red No. 3 decision could portend more state additive bans
FDA’s Red No. 3 announcement follows a string of decisions from the agency amid the last days of the Joe Biden administration and ahead of the Donald Trump administration.
The move to prohibit Red No. 3 in food and drugs “is not a total surprise” as “provocative agency actions” often happen ahead of major leadership changes, noted Rend Al-Mondhiry, partner and co-chair of the regulatory group at law firm Amin Wasserman Gurnani.
FDA’s decision could lead to more state legislators banning ingredients ahead of federal action, Al-Mondhiry added.
In late 2023, California banned four food additives – including Red No. 3 – and followed the legislation up a year later with a similar ban for foods and beverages in schools. Illinois and Pennsylvania followed suit with similar bans on food additives, with both similarly including Red No. 3 on their lists.
“California banned Red No. 3 ahead of FDA’s decision in addition to potassium bromate, propylparaben, and brominated vegetable oil (FDA banned BVO last July), so this decision by FDA could further empower California and other progressive states to take decisive action on food ingredients in a more rapid manner than FDA. We are also seeing this with packaging regulation at the state level, and this is a trend that is likely to persist in 2025 and beyond,” Al-Mondhiry elaborated.
CSPI and Consumer Reports applaud FDA and call for further action
The CSPI commended the FDA’s decision and suggested the incoming Trump Administration should take further action on food additives.
CPG companies should “warn parents of the risks that all synthetic dyes pose to their children — right on the label of the package,” CSPI President Peter G. Lurie added in a news release.
FDA makes changes ahead of second Trump Administration
In the months leading up to the second Donald Trump administration, the FDA rolled out a series of new regulations, focusing on claims, label requirements and specific ingredients. FoodNavigator-USA covered several of the high-profile changes in several recent articles, including:
“At long last, the FDA is ending the regulatory paradox of Red 3 being illegal for use in lipstick, but perfectly legal to feed to children in the form of candy,” said Lurie. ”The primary purpose of food dyes is to make candy, drinks and other processed foods more attractive. When the function is purely aesthetic, why accept any cancer risk?"
Similarly, Consumer Report applauded the FDA’s decision in a press release, saying that Red No. 3 “is a known carcinogen” and is “linked to hyperactivity and other neurobehavioral effects in children” in some studies.
“Red Dye 3 poses an unacceptable risk to our health, especially when safer alternatives are readily available. By banning Red Dye 3, the FDA will protect the public by encouraging manufacturers to switch to safer ingredients already used in products sold in Europe and numerous other countries,” said Brian Ronholm, director of food policy at Consumer Reports.
NCA and Consumer Brands Association weigh in on growing ingredient scrutiny
The National Confectioners Association (NCA) reaffirmed its commitment to following FDA guidance, after previously calling out state laws — including Pennsylvania’s proposed food additive ban — as lacking “scientific basis.”
“Food safety is the No. 1 priority for US confectionery companies, and 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 national regulatory framework. We have been saying for years that FDA is the rightful national regulatory decision maker and leader in food safety,” an NCA representative shared in a statement.
The Consumer Brands Association struck a similar tone to NCA, acknowledging FDA’s decision and the agency’s scientific process.
“Food safety is the No. 1 priority for the makers of America’s trusted household brands. Revoking the authorized use of Red No. 3 is an example of the FDA using its risk and science-based authority to review the safety of products in the marketplace. Food and beverage companies will continue to follow the latest science and comply with all food safety regulations to ensure safe and available choices for consumers,” said Sarah Gallo, senior VP of product policy and federal affairs at Consumer Brands Association.
Are more bans on the horizon?
Looking ahead, food and beverage companies must prepare for more ingredient scrutiny to get ahead of potential reformulations, Al-Mondhiry explained.
“Companies in the food and beverage space should prepare for an even more critical look at the food supply with the coming administration. For example, the substances under review may be more expansive than what FDA’s already reviewing as part of its post-market assessment of chemicals in food,” elaborated Al-Mondhiry.
