The Food and Drug Administration is expected to announce a decision in the next few weeks on whether to revoke approval for the artificial food color Red Dye No. 3, which has been the subject of hot debate for decades due to its carcinogenic properties.
Jim Jones, deputy FDA commissioner for the Human Foods Program, told the Senate Committee on Health, Education, Labor, and Pensions on Thursday that his office is currently in the final stages of reviewing a 2022 petition to revoke approval for Red 3.
“Red three, we have a petition in front of us to revoke the authorization for it, and we are hopeful that within the next few weeks, we will actually, we will be acting on that petition, that a decision should be forthcoming,” said Jones.
More than 20 public health advocates, including Consumer Reports, the Center for Environmental Health, and Breast Cancer Prevention Partners, filed a petition to the FDA to revoke the official color additive listing for Red 3 in November 2022.
Red 3 was banned for cosmetic use and topical drugs in 1990 for its known links to cancer, but it has not been removed from ingestible products.
Jones told the HELP committee that Red 3 has been known to cause cancer in laboratory rats, but the FDA has not prohibited its use in food and beverages because “the scientific consensus is that the mechanism of carcinogenicity in rats is not applicable in humans.”
Although the FDA has delayed taking any action to prohibit Red 3 until now, Jones said a provision of the Federal Food, Drugs, and Cosmetic Act of 1958, the Delaney clause, may require the agency to revoke approval for Red 3 because it is known to cause cancer in animals.
“That is what has challenged FDA for many years,” said Jones, “is how to manage around the Delaney Clause, where you have a scenario where, although there may be cancer evidence in animals, there is also evidence that is not harmful to humans.”
Sen. Tommy Tuberville (R-AL) questioned Jones and FDA Commissioner Robert Califf on Red 3 and Red 40, which have, along with other food dyes, become a key target of President-elect Donald Trump’s Health and Human Services secretary nominee, Robert F. Kennedy Jr.
Although Kennedy was associated with the Left for decades, he has gained significant traction among traditionally conservative players, bringing his “Make America Healthy Again” agenda to the heart of Trump’s GOP.
“It’s not a conservative or a liberal standpoint,” said Tuberville during Thursday’s hearing. “I think we all need to understand as a group about how we’ve gotten to this point.”
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Califf told the committee at multiple points during the hearing that the agency does not have sufficient funding for many independent investigatory activities, heavily relying upon food industry data and partnership projects with the National Institutes of Health.
“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.”