The Food and Drug Administration announced the banning of artificial food color Red Dye No. 3, which has been identified as possessing carcinogenic properties.
Manufacturers have until Jan. 15, 2027, or Jan. 18, 2028, to cease usage of the dye.
“The FDA is revoking the authorization for the use of FD&C Red No. 3 as a matter of law, based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act),” the FDA announced Wednesday. “The FDA is amending its color additive regulations to no longer allow for the use of FD&C Red No. 3 in food and ingested drugs in response to a 2022 color additive petition.”
Despite the ban, the notice stressed that scientific evidence doesn’t show a clear link between Red No. 3 and cancer.
It noted the petition that led to the ban cites “two studies that showed cancer in laboratory male rats exposed to high levels of FD&C Red No. 3 due to a rat specific hormonal mechanism. The way that FD&C Red No. 3 causes cancer in male rats does not occur in humans.”
“Claims that the use of FD&C Red No. 3 in food and in ingested drugs puts people at risk are not supported by the available scientific information,” the notice read.
Red 3 was banned for cosmetic use and topical drugs in 1990, but the ban did not extend to ingestible products.
A statement from the National Confectioners Association to the Washington Examiner celebrated the ruling.
“Food safety is the number one priority for U.S. 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,” it read.
The FDA struggled with how to handle the Delaney Clause to the Federal Food, Drugs, and Cosmetic Act of 1958, which holds that the FDA cannot approve a color additive that shows cancer in humans or animals. Red No. 3 presented a scenario where the cancer found in animals doesn’t translate to cancer in humans, but it ultimately erred on the side of caution.
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During a congressional hearing, FDA Commissioner Robert Califf said that it’s difficult to truly know Red No. 3’s carcinogenic effects on humans, as it doesn’t have enough funding for a study of that scale.
“I want to remind you of what it takes to demonstrate that a substance that people eat causes cancer. You have to study a large number of people over a long period of time because something caused cancer right away, it would be obvious, but in these cases, you need something different,” said Califf. “And I want to point out, we have a very small staff that can do this based on the budget.”