“I hope the FDA feels a responsibility to humans.”
WASHINGTON – Today,U.S. Senator Tommy Tuberville (R-AL) questioned Robert Califf, Commissioner of the United States Food and Drug Administration (FDA), and Jim Jones, Deputy Commissioner of the Human Foods Program at the FDA during a Senate Health, Education, Labor, and Pensions (HELP) Committee hearing. Sen. Tuberville pressed the officials on the long-term effects of using Red Dyes in food and asked what the FDA is doing to ensure Americans are being both protected and informed of the repercussions of ingesting harmful chemicals. Sen. Tuberville called on the FDA to use its resources to restore trust in America’s food and beverage industry.
Read Senator Tuberville’s remarks below or on YouTube or Rumble.
TUBERVILLE: “Thank you, Mr. Chairman.
Thanks both [of you] for being here. We can obviously tell by all the young people in here and even my two boys at home, they really got into this past election because of food safety and health. Because most of our kids are a lot more into health and nutrition than we were growing up, and it’s really gotten out of control.
So, I wanna ask you about Red [Dye] No. 3 and Red [Dye] No. 40, both of you. And get your comments on this—it’s not a conservative or a liberal standpoint. I think we all need to understand as a group about how we’ve gotten to this point. The FDA has a position that food coloring like [Red Dye No.] 40 are safe for a kid’s ingestion.
Do both of you stand behind that Dr. Califf?”
CALIFF: “I’m going to refer that to Mr. Jones.”
JONES: “We have not evaluated Red [Dye No.] 40 in over a decade—over a decade ago.”
TUBERVILLE: “Why? We have not?”
JONES: “We have not. At FDA we have not evaluated the safety of Red [Dye No.] 40 in over a decade. So, over a decade [ago], that was the conclusion that FDA made.”
CALIFF: “We are in the process of evaluating Red [Dye No.] 3. And you may want to comment on that.”
TUBERVILLE: “Well, let me say this, Red [Dye No.] 3 has been known to cause cancer [when used in] cosmetics, but we’re still allow it to be put into our food. I don’t understand that. Go ahead.”
JONES: “So, Red [Dye No.] 3, 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 be acting on that petition—that a decision should be forthcoming.”
TUBERVILLE: “Tell us that process. How does that work? The timeline, you know, if we know something is deadly for anybody that ingests it, how do we continue to just study that and not say, ‘hey, enough, enough.'”
JONES: “So, Red [Dye No.] 3 presents an interesting example for us. It is actually known to be cancer in laboratory animals, rats. But the scientific consensus is that the mechanism of carcinogenicity in rats is not applicable in humans. However, under the FFDCA, which is the law that we implement, any chemical that is shown to be carcinogenic in animals, or humans or should I say humans or animals, cannot be authorized by FDA. It’s called the Delaney Clause. And so even though we don’t believe there is a risk to humans under the Delaney Clause of the FFDCA, Red Dye, because it is known to cause cancer in laboratory animals, should not be authorized. And so that is what has been—has challenged FDA for many years 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.”
TUBERVILLE: “I hope the FDA feels a responsibility to humans.
Dr. Califf, you probably heard quite a bit about this for the last four years that you’ve been serving us. Has this been a priority? Because we hear constantly about dyes. I mean, dyes are just coloring. It has nothing to do with the taste or anything like that.”
CALIFF: “Yeah. A couple of things about so first of all, it is a priority. And I wanna point out, listen carefully to what Mr. John said, we don’t have data in humans that [Red Dye] No. 3 causes cancer, but we have it in laboratory animals. And so, this gets complicated.
And 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 if something caused cancer right away, it would be obvious. But in these cases, you need something different. And I want to point out we have a very small staff that can do this based on the budget.
We have repeatedly asked for better funding for chemical safety. I brought Mr. Jones in to head the Human Foods Program because of his history of working on environmental issues. I think it is a huge priority. He’s an expert in this. Please look at our request for funding for the people who do this work.
Remember that when we do ban something, it will go to court. And if we don’t have the scientific evidence, it will stand up in court, we will lose in court.”
TUBERVILLE: “I wanna ask you this, and I think everybody in here wants to want to hear the answer to this question. We all hear Europe uses different dyes because they’ve come up with their evaluation that it does cause problems for humans.
Do we have a different review system than they do about food dyes or anything put in food?”
JONES: “The biggest distinction between the U.S. and Europe is that they have been doing post market review of chemicals now for over 20 years. In the FDA, although we have authorization to do post market reviews, there’s no statutory mandate to do them. One of the things that Dr. Califf mentioned is that as part of this reorganization, we are dedicating an entire office whose job is to do post market chemical reviews.
We are several decades behind Europeans and our Canadian counterparts because they have legal mandates to reevaluate chemicals that have been authorized at some point in the past. We don’t, but we are going to undertake it. But we are going to definitely struggle with the resources necessary to do that.”
CALIFF: “There’s a real lesson here from, I don’t know if you eat Fruit Loops. I grew up every once in a while eating Fruit Loops. But there’s a real lesson here and I haven’t verified this myself, but it’s widely written that when the dyes that make Fruit Loops bright were taken out for the reasons that you gave. The sales went straight down, and they were put back in.
So, as long as we have a consumer driven system where what people like in the short term is what drives the system, unless we have help from you all, that is clear direction from Congress. Particularly, given the recent Supreme Court decisions.
It’s going to be really hard for us to mandate [that] things [should] come off [the market]. Just a point I’m gonna make over and over, and I apologize. But I think it’s really important that we work together on this.”
TUBERVILLE: “Thank you. Thank you for your points.”
Senator Tommy Tuberville represents Alabama in the United States Senate and is a member of the Senate Armed Services, Agriculture, Veterans’ Affairs, and HELP Committees.
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