Speaker 1 (03:24):
Congratulations. Our bill last night.
Bernie Sanders (03:32):
The Senate Committee on Health, Education, Labor and Pensions will come to order. If there is a mantra that exists in this committee, I think on both sides of the aisle, is that an ounce of prevention is worth more than a pound of cure. And that is going to be what we'll be discussing today.
(03:57)
In America, it is no secret to anybody that we have a major obesity epidemic as well as an epidemic in diabetes. They are both directly related and they are both getting worse. More than 35 million Americans have type 2 diabetes, over 10% of our population, 10% of our population. And about 90% of those with type 2 diabetes are obese.
(04:27)
Diabetes is not only a serious illness unto itself, but it is a contributing factor to heart disease, stroke, amputations, blindness, and kidney failure. And the cost of treating these illnesses is staggering. According to the American Diabetes Association, the total cost of diabetes in the United States was nearly $413 billion, $413 billion, up 27% over the past six years. This amounts to about 10% of our total healthcare expenditures. That is an unbelievable and unsustainable amount of money. And when we talk about the type 2 diabetes epidemic and the huge increase in new cases, we must also talk about the epidemic of obesity in our country. Some 90% of people with type 2 diabetes are overweight or obese. These two epidemics go hand in hand.
(05:37)
The time is long overdue for us to pose some very simple questions, and that is what this hearing is about today. How did it happen that according to the CDC, the rate of childhood obesity in America has tripled since the 1970s and has gotten so bad that one out of every five children in our country is now obese? How has it happened that over 40% of adults in the United States today are obese? And in my view, the answers to these questions are not very complicated.
(06:18)
For decades, Congress and the FDA have allowed large corporations to make huge profits by enticing children and adults to consume ultra- processed food and beverages loaded up with sugar, salt, and saturated fat. There is growing evidence, including testimony that we have heard right here in this committee, that these foods are deliberately designed to be addictive, similar to cigarettes and alcohol, and lead to a higher rate of type 2 diabetes. Shockingly, according to a study published in the British Medical Journal, ultra-processed foods make up an incredible 73% of our nation's food supply.
(07:08)
Bottom line, much of the food that we as Americans are now consuming are making us unhealthy and are contributing to the fact that our life expectancy is significantly lower than that of many other wealthy countries. None of this is happening by accident. The food and beverage industry is spending $14 billion a year on advertising to push these unhealthy products onto the American consumer. Even worse and really unacceptable, $2 billion of this money is spent to directly advertise these unhealthy products to our children in order to get them hooked on these foods at an early age.
(07:58)
According to the Rudd Center for Food Policy and Obesity, children and teens view about 4,000 food and beverage ads on television each year, an average of 10 advertisements per day. Last year, for example, Coca-Cola spent $327 million on advertising in the United States alone while it raked in more than 9.5 billion in profits. Not one of these ads will tell you that a 20 ounce bottle of Coke contains more than 15 teaspoons of sugar, 15 teaspoons of sugar, over twice the recommended daily limit for kids. Not one of these ads will tell you that drinking one can of Coke a day could increase your chance of getting type 2 diabetes by up to 26%.
(08:49)
Given this reality, which has been widely discussed by scientists and doctors for decades, this really is not new news, the question then arises, what has the Food and Drug Administration, the FDA done to address these epidemics which have impacted the health of millions of Americans and cost us hundreds of billions of dollars each year? As far as I can tell, the answer is not much.
(09:20)
Way back in 2010, the National Academy of Medicine recommended that the food and beverage industry be required to put nutrition labels on the front of their products that the American people could easily understand. That was in 2010. On June 13, 2023, the FDA announced that it would propose a rule to require the food and beverage industry to put nutrition labels on the front of their products no later than October of 2023. The FDA missed that deadline. On December 6, 2023, FDA announced that this proposed rule would be made public in June of 2024. The FDA missed that deadline. On July 5, 2024, the FDA announced that this proposed rule will made public by October of 2024. The FDA missed that deadline. I have been told that on November 21, 2024, after more than 14 years of inaction, the FDA finally sent this proposed rule to the Office of Management and Budget for their review, but has still not been made public. That is unacceptable. In 2016, Chile, 2016 Chile implemented a law mandating warning labels on the front of unhealthy food and beverage products. After this law was implemented, calories consumed from these products went down by 24%. Similar labels were put into effect in Peru in 2019, in Israel and Mexico in 2020, in Uruguay in 2021, and in Brazil, Colombia, Argentina, and Venezuela from 2022 to 2024.
(10:59)
Nearly 30 years ago, the FDA and Congress had the courage to take on a tobacco industry whose products killed over 400,000 Americans every year, including my father. And as a result of these actions, smoking rates among adults dropped from 43% in 1965 to 12% in 2023. Smoking rates among teens dropped even more significantly. That effort was a major success.
(11:34)
Now is the time for us to seriously combat the type 2 diabetes and obesity epidemics in this country. In order to do that, we must have the courage to take on the greed of the food and beverage industry, which every day is undermining the health and well-being of our children. For starters, we need strong front-of- package food labels so that all consumers, especially children, can be warned as to which products are harmful to their health. Tobacco labels in the United States do not say high in tar, high in nicotine, high in carcinogens. They say, "Cigarettes cause lung cancer, emphysema, and may complicate pregnancy."
(12:21)
And let's be clear, not only must we put strong warning labels on unhealthy food and beverages, we must also ban junk food ads targeted to children. The National Institute of Health has estimated that if the United States banned fast food advertising marketed to children, we could cut the childhood obesity rate by 18%. This is not a radical idea. In the 1980s, Quebec banned junk food advertising to children under 13. Last summer, the World Health Organization called for countries to substantially reduce the marketing of junk food to children, and Norway announced that it would be banning all food and beverage advertisements to kids. Ireland, Portugal, South Korea, Spain, Taiwan, and several other major countries have either seriously restricted or banned junk food ads targeted to children. Not a radical idea.
(13:16)
And finally, in my view, we have got to substantially, and this committee has dealt with this a whole lot, reduce the outrageously high prices of diabetes and weight loss drugs, Ozempic and Wegovy. In April, I introduced legislation to enact a federal ban on junk food advertising targeted toward children and to require the FDA to put strong warning labels on products high in added sugar, salt, and saturated fat.
(13:46)
So today is an important hearing. We're dealing with the health and well-being of many millions of our people. We're dealing with the need to substantially cut back on the hundreds of billions of dollars we now spend on diabetes. So we thank Dr. Califf and Mr. Jones for being with us. Senator Cassidy, the mic is yours.
Bill Cassidy (14:13):
Thank you, Chair Sanders. Near one in three Americans live with obesity including 14 million children. Nearly one in 10 have type 2 diabetes, one of many chronic diseases obesity is associated with, and obesity costs lives and results in $173 billion in healthcare spending per year. When Obamacare was passed, there was a McKinsey report that said that unless we address the burden of chronic disease we'll never control healthcare costs. And obesity is one of those things that was listed as those drivers of chronic disease. All this says that we must have solutions for both obesity and for the complications of which we have spoken.
(14:53)
A great place to start is the nation's food supply and the changes in Americans diet over decades. According to the Annals of Internal Medicine, 37% of adults consume an unhealthy diet. Now, I'm pleased to say that reducing obesity, particularly among children is bipartisan. The incoming Trump administration is indicating that combating obesity, promoting healthy foods is a top priority. Many of President Trump's concerns around food transparency are echoed by Democratic colleagues including Chair Sanders. In the new majority, I am excited to work with President Trump and colleagues on this dais to examine these issues, crafting policies to enhance the health of Americans.
(15:33)
Today we'll hear about the FDA's desire to implement a mandatory front-of-package label. Now, it's out of ordinary that we are holding a hearing before FDA has even released a formal proposal, but it's an important conversation. We must recognize, however, that food labeling reforms are not the end-all, be-all, which is to say they are not a silver bullet solving the nation's health and obesity issues. The committee needs to look at all factors leading to obesity and how Congress can use its resources to promote a healthier lifestyle.
(16:07)
This means examining FDA's role in reviewing the safety of chemicals, ingredients that go into our foods. It's important that FDA take a close look at existing review frameworks so foods are safe to consume. We also need to examine how Congress can better support robust scientific research on food ingredients, and I look forward to discussing this with FDA leadership. I also want to hear from FDA about the progress it has made in improving food safety duties. Under the Biden-Harris administration, FDA faced enormous challenges in regulating food safety, including the 2022 infant formula shortage, which severely impacted American families. These challenges led FDA to complete the largest reorganization in its history, and it's important that Congress provide oversight.
(16:54)
Beyond FDA, we know that the National Institutes of Health, NIH, habitually underfunds nutrition and obesity research despite its overwhelming impact on the health of our country and impact on related medical conditions. Should there be more NIH funding looking at genetic predisposition? I think so. This is something I'll examine as Chair of Health Committee in collaboration with the Trump administration.
(17:20)
I thank our witnesses for being here. I look forward to a productive discussion on how we can make America healthy again.
Bernie Sanders (17:30):
Thank you, Senator Cassidy. Our witnesses today are Dr. Califf and Mr. Jones. Dr. Califf is the commissioner of the US Food and Drug Administration. He served previously in the Obama administration as well as right now in the Biden administration. Dr. Califf, thank you very much for being with us.
Dr. Califf (17:53):
Chair Sanders and Ranking Member Cassidy and members of the committee, thanks for the opportunity to testify to discuss the agency's efforts to reduce the chronic disease burden in America and the role of our nutrition initiatives such as the proposed front-of- package labeling rule contribute to these efforts.
(18:12)
I've had the great honor to serve as the commissioner of the FDA not once but twice. I came back to FDA because I believe strongly in its mission and workforce. Americans have entrusted us with regulating industries that bear the responsibility of producing and distributing products that are safe and improve health. While all the work FDA does is crucial, the greatest public health advancements we can make would be to improve the diet of Americans and eliminate the use of tobacco.
(18:44)
The food we eat is contributing to America's unfortunate position with the lowest life expectancy among large high-income countries. I want to stress this, last place among large high-income countries in life expectancy. Nearly everyone knows and cares for someone with a chronic disease. Six in 10 Americans have at least one chronic disease, and four in 10 have two or more chronic diseases. I am deeply aware of this because my 35-year clinical career has been spent in direct care of suffering people with cardiovascular disease.
(19:20)
We all know that eating a nutritious balanced diet is a challenge for many people. Products that may appear nutritious could be loaded with sodium. People can exceed the recommended daily limit for added sugars with a single 16 ounce bottle of soda. And over 70% of our food supply is considered ultra-process. As a recent Wall Street Journal editorial put it, "Americans eat unhealthy food because the food system is designed to feed it to them." Meaningful change can only happen with serious action by Congress, the industry, and multiple state and federal agencies. And of course, we're here today because this includes a major role in accountability of the FDA.
(20:06)
FDA is trying to do its part within its authorities and budget, but successful change in the trajectory of our health depends on reaching a societal consensus that we will do this together. When we pull the levers at our disposal, specific actions by FDA can have sweeping effects. When we required trans fat to be labeled on the nutrition facts label in 2006, we saw a nearly 80% drop in consumption because consumers picked different foods and industry reformulated their products. Establishing a front-of-pack label could be another landmark policy. Displaying certain nutrition information right on the front of the package would allow Americans to quickly and easily identify how foods can fit into a healthy dietary pattern.
(20:55)
The health impact of ultra-processed foods is at the forefront of current policy considerations, and the clear association between ultra-processed food and negative health outcomes is a major concern. While there are still much we need to understand, ultra-processed foods are usually high in saturated fat, sodium and added sugars, and there is already substantial evidence of harm when these nutrients are consumed in excess. We are not waiting to act where the evidence is clear. In addition to front-of-pack nutrition labeling, FDA is working to reduce sodium across the food supply, update the "healthy" claim on food packages, and strengthen our chemical safety review program.
(21:38)
There is good reason to be concerned about the chemicals that are routinely included in much of our food. FDA has limited resources to deal with this issue despite repeated requests for funding for much-needed additional experts to do the evaluations. There are years of work under each of these initiatives that are performed by highly qualified and dedicated staff in the face of multiple limitations in the existing science, extensive legal hurdles, and direct opposition from powerful industry forces. We have just completed the largest reorganization in FDA's history and no small part so that we could take on the issues of nutrition and chemicals in our food supply.
(22:20)
As you know, I'll be leaving FDA at the change of administrations, but I can assure you that our people at FDA want to do more and we need your partnership. As a cardiologist, I've spent most of my career dealing with the tragedy of premature death and disability, but my time in Washington has made me aware of how hard it is to address these policy issues. Our nation's complex financial and industrial interest, combined with our national instinct to favor individual freedom to choose even if the choice is one that impairs health, make it difficult to take actions that have been successfully deployed by many other countries. And I believe these differences directly lead to better health and longer life in every other large high-income country compared with ours. In my opinion, finding a better consensus on these issues in America is not just an opportunity but a necessity for the future of our country. Thanks for the opportunity to testify today and we'll be happy to answer your questions.
Bernie Sanders (23:21):
Thank you very much. Mr. Jones, did you want to add anything to that?
Mr. Jones (23:25):
No, thank you.
Bernie Sanders (23:25):
Okay. Thank you again, Dr. Califf. I agree with much of what you said in your testimony. I agree with much of what Senator Cassidy said. But the problem is that the issue we're talking about today is not a new issue, is it? 2010, the National Academy of Medicine recommended that the food and beverage industry be required to put nutritional labels that the American people could easily understand on the front of their packages. According to the CDC, the rate of childhood obesity in America has tripled since the 1970s. And from where I'm standing here, the FDA has not responded in any way with the urgency of the crisis.
(24:24)
How long does it take to put a bloody label on a product? And by the way, we'll talk about that in a moment. I don't know if you're going to be telling us after years and years of research and focus groups what that label will look like. But the bottom line here is I would like you to tell me why when countries around the rest of the world with fewer resources than we do are able to put labels on their product warning parents about the dangers of those products to their kids, how come the most powerful and wealthiest nation in the world is unable to do that? Dr. Califf.
Dr. Califf (25:01):
With your permission, I'm leaving soon.
Bernie Sanders (25:05):
I heard that.
Dr. Califf (25:06):
Not from this meeting, but from my job. So I'm going to provide editorial comments and Mr. Jones can provide you a lot of facts. You asked how long does it take? Let's talk about tobacco. We were instructed to do that many years ago. We have lost in court on that issue and we're finally winning now it looks like. But the point I want to make is what sounds simple given the current state of judicial affairs, First Amendment rights, the fact that corporations have the same rights as individuals, every little thing we do unless specifically in detail instructed by Congress, it's not just that we lose in court, but we lose years when that happens.
Bernie Sanders (25:52):
Let me… Again, I apologize for interrupting, but don't have endless amounts of time. I understand all that. But are you going to tell us with a straight face that you have come before this committee and the American people and say, "Hey, we have a major, major crisis. We are losing lives. We're spending huge amounts of money. People's limbs are being amputated. We have got to act"? And have you pointed a finger at those people who are the cause of the problem? Have you had the courage to take on a very powerful food and beverage industry? There are 15 teaspoons of sugar in this product. How many parents in America know this when they give it to their kids? Say, "Here, have a Coke. Go out and play ball." Have you done your job and your predecessors, not just you, have you done your job in alerting the American people to the danger and rallying members of Congress to stand up to the special interests who are causing these problems?
Dr. Califf (26:49):
With all due respect, I've been working on this problem for all of my career. This is what I've done. And I think I have talked about this very specifically. I think we all wish that we had gotten to the goal
Dr. Califf (27:00):
… sooner that you described, I'm not contesting that. But I do believe in an appropriate discourse with this committee. We need to carefully reflect on the issues in play right now that would allow this to happen. And I'm really heartened to hear the bipartisan support for this because much of what we try to do frankly gets blocked-
Bernie Sanders (27:22):
By whom?
Dr. Califf (27:22):
… along the way and we'll talk about this.
Bernie Sanders (27:23):
By whom? Let's be honest here. The food and beverage industry spends hundreds and hundreds of millions of dollars on lobbying and on campaign contributions. You tell me the role that they are playing in destroying the health of America's children?
Dr. Califf (27:40):
Well, I'm not going to contest your comment about the amount of money spent on lobbying. I think it's probably accurate. I don't have figures on that, but a lot of the changes, those of us who are interested in better health would like to make, are blocked at the level of legislation for reasons that you'd have to tell me-
Bernie Sanders (27:58):
I'm not still not hearing you. What is the reason that our kids are unhealthy? What role does this industry play? Even now you're getting out of office. Are you prepared to tell us that this committee, this congress needs to take on the food and beverage industry whose greed is destroying the health of millions of people?
Dr. Califf (28:15):
Well, I'm not going to castigate the people that work in the food and beverage industry.
Bernie Sanders (28:20):
You're not.
Dr. Califf (28:21):
No. What I will say-
Bernie Sanders (28:21):
That is your job.
Dr. Califf (28:22):
No, it's not to castigate. It's to point out how to make progress in this area. We have an industry that if you tried to change it overnight, there are farmers all over the United States who would not be able to grow the crops they're currently growing. So there needs to be a plan and it needs to be implemented in a mature, thoughtful way across the country. I'm 100% in favor to change-
Bernie Sanders (28:44):
The Academy of Medicine in 2010, how many years does it take to do it? 14 years enough time. How many kids have died and gotten sick during those 14 years?
Dr. Califf (28:55):
It's not just kids, it's adults of course. And I want to see it change as much as anyone, but we have to do it in a way that considers all the factors that are involved in making change-
Bernie Sanders (29:05):
Protecting the interest of the food and beverage industry. Senator Cassidy,
Bill Cassidy (29:09):
I will allow Senator Tuberville to go first.
Senator Tuberville (29:12):
Thank you, Mr. Chairman. Thanks both 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.
(29:29)
So I want to ask you about Red 3 and Red 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 40 are safe for kid's ingestion. Do both of you stand behind that, Dr. Califf?
Dr. Califf (29:57):
I'm going to refer that to Mr. Jones.
Senator Tuberville (30:00):
Okay.
Mr. Jones (30:00):
We have not evaluated Red 40 in over a decade. Over a decade ago-
Senator Tuberville (30:05):
What? We have not-
Mr. Jones (30:06):
At FDA. We have not evaluated the safety of Red 40 in over a decade. So over a decade, that was the conclusion that FDA made.
Dr. Califf (30:14):
But we have evaluated… We are in the process of evaluating Red 3 and you may want to comment on that.
Senator Tuberville (30:21):
Well, let me say this. Red 3 has been known to cause cancer in cosmetics, but we still allow it to be put in our food. I don't understand that. Go ahead.
Mr. Jones (30:32):
So Red 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 actually, we'll be acting on that petition and a decision should be forthcoming.
Senator Tuberville (30:44):
Tell us that process. How does that work? The timeline? If we know something's deadly for anybody that ingest it, how do we continue to just study that and not say, "Hey, enough's enough"?
Mr. Jones (30:57):
So Red 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, and 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 a challenge to 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.
Senator Tuberville (31:58):
I hope the FDA feels a responsibility to humans. Dr. Califf, you've 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 it constantly about the dyes. I mean, dyes are just coloring. It has nothing to do with the taste or anything like that.
Dr. Califf (32:20):
Yeah, a couple of things. So first of all, it is a priority and I want to point out, listen carefully to what Mr. Jones said. We don't have data in humans that number three 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 'cause if something caused cancer right away it would be obvious.
(32:52)
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 requests 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.
Senator Tuberville (33:30):
Okay. I want to ask you this, and I think everybody in here wants 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?
Mr. Jones (33:51):
The biggest distinction between the US 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, but 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.
Dr. Califf (34:41):
There's a real lesson here from… I don't know if you eat Froot Loops. I grew up every once in a while eating Froot 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 Froot Loops bright were taken out for the reasons that you give, 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 things come off. Just a point I'm going to make over and over and I apologize, but I think it's really important that we work together on this.
Senator Tuberville (35:32):
Thank you for your points.
Bernie Sanders (35:34):
Senator Murray.
Senator Murray (35:35):
Thank you very much Mr. Chairman. As we all know, chronic diseases, we've been talking about heart disease, diabetes, are the leading cause of disability and death in America, and it's all too common as the Chairman talked about. We have about one in 10 people in Washington state, about one in 10 Americans suffer from diabetes. So we do need evidence-based approaches to advance nutrition and to prevent and treat chronic diseases like diabetes. Dr. Califf, earlier this year I got to hear directly from you at our Senate Appropriations hearing about your plans to stand up the new human foods program including a new Nutrition Center of Excellence. Can you or Mr. Jones talk about how FDA is utilizing research from NIH and other federal agencies to scale up what we know about preventing and treating chronic diseases like diabetes and to better inform our food policy?
Dr. Califf (36:34):
Quick editorial point of view and then Mr. Jones can give the details. This is the largest reorganization in our history as far as we know. 8,000 people changed. It was widely embraced. Maybe contrary to some statements I've heard about federal employees widely embraced by the workforce at FDA to do this reorganization because people recognized they needed a focus on this and a better structure to do it. It involves the entire inspectorate, the entire human foods program, and as many people requested, we brought in a leader Mr. Jones to head the whole thing up. So it's a very high priority.
(37:13)
A quick comment on NIH and it's very important that we not tell at FDA NIH what to do. There is a lot of nutrition research at NIH, but it's spread across all the disease and body parts areas, as I call it. We very much need this sort of basic research on obesity per se, as an element. And there's some tremendous research by particularly our investigator named Kevin Hall on ultra-processed foods. Very important to us. But we're going to have a big meeting next month or this month I guess now, between FDA and NIH on the research agenda. So look forward to that.
Senator Murray (37:57):
Mr. Jones.
Mr. Jones (37:58):
Thanks. And one of the reasons we established this as a Nutrition Center of-
Bernie Sanders (38:01):
Sorry, if you could hold that mic a little bit closer, please.
Mr. Jones (38:04):
You hear me now?
Senator Tuberville (38:04):
Press it again.
Mr. Jones (38:06):
One of the reasons we established a nutrition center of excellence was because we realized that we were not going to have the kind of resources that ideally one would want. And so the center is going to work with other entities within the federal government, including NIH, but other entities in the federal government in particular, USDA, as well as universities to make sure that we are fully taking advantage of and collaborating around the research portfolio on nutrition across the country. We work very closely with NIH and as Dr. Califf said, in two weeks where we are co-hosting with them a research symposium that's going to be focusing on what does the research agenda for ultra-processed food need to look like.
Senator Murray (38:45):
Okay. I also want to ask you while you're here about the modernization of the Cosmetics Regulation Act that we passed, but for a long time, harmful substances have made their way into makeup, lotion, hair care products, and many other products that people use every day. And the FDA had no power to take any actions. So back in 2022, we passed my bipartisan Modernization of Cosmetics Regulation Act known as MOCRA, which empowered FDA finally with the tools that needed to better ensure cosmetic products are safe. It was the biggest change to FDA's authority to cosmetics since 1938. Now it's been two years since the enactment, and I wanted to hear from you on how implementation is going and how the FDA is working to improve the safety of personal care products. The law actually required FDA to issue good manufacturing practices for facilities that manufacture cosmetic products. Since it's been two years, the FDA has not put out any good manufacturing practices. So tell me where we are with this.
Dr. Califf (39:51):
Sure. So first of all, I want to thank you. I worked on this in 2016. It took a long time to get the legislation and it's much appreciated and much needed. There's been actually a good partnership with industry to make this happen, but we have stood up the registration of facilities and products. Some Americans may not believe this, but there was no record of what cosmetics were being put on the market before this. And we've now got a listing and also a complaint system that didn't exist, when there are adverse events they can be sent.
(40:24)
So GMP is on the list to work on, and I know that's not a great time to talk to Congress about budgets, but the budget that was allocated to this was a small fraction of the estimates by everyone involved and what it would take to actually meet the requirements of Congress. So this is going to need to be looked at in terms of if we want this to get done in a timely fashion, there actually is time and material of qualified experts to get the work done. We're doing everything we can to use internal resources like we use the drug complaints system to register adverse events that saved a lot of money compared to doing it de novo.
Senator Murray (41:05):
Well, I'm out of time, but I just want to let the committee know I'm going to be following up on this, making sure that FDA is very aggressive implementing the law that we passed two years ago.
Bernie Sanders (41:16):
Senator Cassidy.
Bill Cassidy (41:18):
Thank you, both. First, Dr. Califf, I'm just going far afield from nutrition, but it's just so topical. Hurricane Helene has disrupted the production of saline fluid. I'm a physician. I hear from my local hospitals that there is down to a one to two week supply of saline and other IV fluids. You may tell me that you have to go back and research this, but I have a constituent who has a FDA approved plant elsewhere in the Philippines and I just mentioned him 'cause I learned from him, but others have the same thing, and they cannot get EUA to bring these products in. And indeed they can't even hear from FDA as to why they can't get the EUA. It's always kind of like, "We'll get back to you." Now we need resilience, it kind of reminds me of the delay in getting infant formula in. Are you prepared, and if you're not, I didn't prepare you for this question, but did you have any ability to comment on this?
Dr. Califf (42:12):
I'm a little bit prepared and let me tell you, I'm hyper aware of this. With permission, I have a brother who has pancreatic cancer, he was just in the hospital. I was there and he got one of the two bags of IV fluid he was supposed to get because of the shortage, so I'm very aware of it. I'll say that we have been opening up in order to allow a foreign facility in, we have to make sure that it's going to be safe.
Bill Cassidy (42:35):
No, but if it's FDA approved already, at least I'm told, that seems like that would be a…
Dr. Califf (42:40):
Well, we'd have to get back on the specific incidents, but FDA approved for facilities could cover a wide range of possibilities of whether it's the actual product, how long ago was it, et cetera. So staff really have to make sure that when we import things that it's safe.
Bill Cassidy (42:58):
Can I follow up with you afterwards on that?
Dr. Califf (43:00):
Yes, please do.
Bill Cassidy (43:01):
Yeah, I'd appreciate that. Next, and if I interrupt you, it's not to be rude, but just to kind of get through some questions. One of FDA's primary responsibilities in food safety is inspecting. And I understand that FDA continues to struggle to conduct regular inspections at the pre-pandemic pace. At what point will we back or what steps are you doing to get back to these more regular safety inspections?
Dr. Califf (43:30):
So first of all, let me say, I mean, as you all know, the day I was confirmed was the day of the Abbott recall. That was my welcome back to the FDA. And it was immediately obvious that we had many, many good people working between the human foods program and the Inspectorate who were in the wrong configuration, and this has led to this massive reorganization. A major part of the reorganization is to get more, we call them investigators. You would think of the term inspectors, out in the field and make sure that they are highly valued. Among the many difficulties we have. And I used to manage a global clinical trials organization that did studies of therapeutics. Our investigators are flying government style and staying in hotels that their colleagues who are doing inspections for the industries are not staying in. So we're really upgrading the status of the investigators so that when they arrive at a place they're prepared and ready and building information systems.
(44:39)
So very quickly, I know we're going to be short on time. We want an information infrastructure so that when they're in a place, they're guided. AI is big part of this, guided to focus their attention where it's needed so they can do more inspections. We're going to get into, I know later in this hearing, the state relationships. The states do a lot of inspections and there's also intelligence from other countries that doesn't substitute for an FDA inspection, but can be very helpful. So we're working on every part of that to increase the reach and magnitude of inspections.
Bill Cassidy (45:14):
Now, but sometimes it begs the question because before these positive steps, you had a higher rate of inspection and after these positive steps, you continue to have a lower rate of inspection. It begs the question of were the steps positive?
Dr. Califf (45:30):
Well, we had a lot of loss of key people during the pandemic. Everything I've told you about the lives of the Inspectorate and then flying around in the pandemic, not exactly a choice job compared to other options. It really took dedicated, hard-working-
Bill Cassidy (45:49):
So if you look at your decline in investigator inspector workforce, what percent of decline have you had?
Dr. Califf (45:56):
I can't give you the exact number. We can get back to you, but I can tell you it's on the way… We were actually losing net people-
Bill Cassidy (46:02):
But then let me ask you, 'cause-
Dr. Califf (46:03):
We're not on a positive slope with these changes-
Bill Cassidy (46:06):
… limited time. So to what degree can you attribute the loss of workforce to the decreased inspections? Is that the sole thing or the-
Dr. Califf (46:14):
Well, during the pandemic there were other factors, like, we had to be able to get into the place.
Bill Cassidy (46:17):
But now, post pandemic.
Dr. Califf (46:18):
Now I think it's just a matter of personnel and time allocated. But I know we're working with your people on some details on this.
Bill Cassidy (46:29):
So I'm just going to ask you if you don't mind, then later as a question for the record, provide us the metrics that you're using to judge the kind of progress of this. Is it all personnel? That's understandable if it's still system related despite these changes in systems, that would be something for us to know.
Dr. Califf (46:46):
Again, just very quickly, a lot of it's personnel, but I describe some other system characteristics that are characteristics of the government that make it hard for the inspectors to do their work. It's going to take us a while to fix those because these are government-wide policies.
Bill Cassidy (47:01):
Okay.
Bernie Sanders (47:03):
Okay, thank you. Senator Baldwin.
Senator Baldwin (47:06):
Thank you, Mr. Chairman and, Dr. Califf, thank you for joining us today. It's critical that the FDA provides consumers with clear and accurate nutritional information at the grocery store by enforcing labeling standards and upholding the agency's own rules for standards of identity. For years, I have worked with farmers and dairy processors to address the misuse of terms like milk and butter on plant-based foods. In addition to introducing the Dairy Pride Act, I've repeatedly asked the agency to enforce labeling standards and even secured funding for the FDA to dedicate to this purpose. So I'm very disappointed by the lack of progress made at FDA.
(47:58)
In 2023, the FDA published draft guidance that enables misleading product labels to remain on store shelves. The update merely provides voluntary guidance on nutritional labeling to plant-based processors violating both FDA's rules for standards of identity and the Administrative Procedures Act. It's hard to believe that plant-based alternatives would willingly highlight the nutritional disadvantages of their products compared to real milk. So we're here today because of the health of American families and children's is at risk due to insufficient nutrition. Studies consistently show that consumers mistakenly believe that plant-based alternatives are nutritionally equivalent or even superior to dairy products. And at the same time, the inappropriate substitution of non-dairy alternatives has been linked to a range of health issues in children and in infants. So understanding this, how does the FDA justify the voluntary approach outlined in the guidance?
Dr. Califf (49:15):
I guess it's only appropriate. This is our first conversation. I guess this will be our last on the same topic, and I'm going to ask Mr. Jones to give the details here. Our narratives are not exactly the same as you know, but, Mr. Jones.
Mr. Jones (49:33):
Sure. Thanks, Senator. So I'm hearing there are two issues I think you're raising. One is using the term milk and the other one is the nutritional equivalence. And I'll try to address both of them. So if a plant-based milk alternative is labeled as milk, instead of, for example, soy milk, that would be a violation that is not allowable. The law doesn't prohibit the term milk in the labeling of such products so long as so as the name itself is not misleading. And we have a compelling amount of research that consumers are not misled-
Bernie Sanders (50:05):
I'm sorry, Mr. Jones. Can you talk in-
Mr. Jones (50:06):
I'm sorry.
Bernie Sanders (50:07):
I'm not hearing you very-
Mr. Jones (50:07):
I'm sorry. Consumers are not misled by using terms such as soy milk or oat milk. They understand that it is not milk. They're purposefully seeking such products because they're not milk. So on the issue of using the term milk, you have to use it. You have to characterize what it is derived from. So it has to say soy milk or oat milk, you can't just say milk on such a label. As it relates to nutritional equivalence, the guidance that you described, we were taking comments on that. And as you pointed out, we said, "We encourage manufacturers of these products to identify that they're nutritionally equivalent to a dairy product." We've gotten a fair amount of comment that that is not adequate. And then we are taking that comment under consideration. Ultimately, I can't say where we will land that issue, but the nutritional equivalence issue is very much on our radar. And as I said, we've gotten a fair amount of comment along the lines that you've described around nutritional equivalence.
Senator Baldwin (51:06):
Well, it would be cleared up if they didn't use the term milk. right. But let me go on. We are also seeing a rise in the availability of cell-based lab-grown products using dairy terms in stores. Does the FDA have a plan to ensure that these products are labeled in a clear way that avoids any additional consumer confusion in what's already a complex marketplace for dairy products and plant-based alternatives?
Dr. Califf (51:42):
Well, when we talk about a cell-based product, it's really important that we know exactly which one, because in general, we regulate the safety of these products, but USDA regulates the label of these products. And so we have to know which ones you're talking about. But I think above all else, it's going to be important that the labels accurately reflect what the product is. So we'd certainly agree that whether it's US or USDA, that needs to be taken into account.
Senator Baldwin (52:17):
Right.
Bernie Sanders (52:22):
Senator Hickenlooper.
Senator Hickenlooper (52:25):
Thank you, Mr. Chair. Thank both of you for your service. I was at a roundtable in Colorado a while ago, and throughout one of our constituents referred to Dr. Khalif, which I thought was a really, given the fact that he still has somewhat of an accent, I thought it would be an interesting way to magnify that. And I do appreciate the fact 'cause you have been resilient in seeking more funding and many of the complaints that we're having are because there's a clear manpower shortage. I'm not saying everything has resolved that, but certainly a significant part of the complaints we've heard so far this morning is a lack of people being able to respond to inquiries, to complaints, to opportunities to redress some of these health-related issues.
(53:21)
Let me talk a little bit about sugar connections and dementia. Obviously, you talked a little bit about how almost three-quarters of our food supply is made up of ultra-processed foods, and recently the researchers are starting to see a possible connection between ultra-processed foods with higher rates of diabetes, and then later in life there seems to be a connection to dementia. And I understand the limitations of science, and that's one of the big challenges for you all, that, every time science leads you in one direction, the unbelievable pressures
Senator Hickenlooper (54:00):
… of profits in corporate quarterly earnings pushes you or presses back in a powerful way. But even as the science is evolving, there is pretty good evidence that diabetes leads to a higher rate of inflammation, damaged blood vessels, which all seem to be a part of the impairment of our cognitive efforts as we get older. Again, this is already a problem. It could become much more severe.
(54:33)
Dr. Califf and Mr. Jones, has the FDA come across this connection while conducting research on the impacts of sugar, and how should the FDA and other public health organizations be responding?
Dr. Califf (54:48):
Well, this relates back to Senator Murray's question because, as you know, we don't have much of a research budget. We're not a research organization, so we're very dependent on other entities, particularly NIH, but also the industries that are regulated, and I want to come back to a comment on that in a second.
(55:05)
But there's no question. I mean, this is what I do for a living as a … I'm a cardiologist. I've been talking about this for 30 years, and the data's getting stronger and stronger. I happen to have two sons, as you know, that live in Colorado and four grandkids. You're in a state where it's in the culture to eat better. It's normal in Colorado to eat healthy food.
(55:29)
I'm from South Carolina, so I feel like I can say this. It's not so much in the culture in South Carolina, and you see it in the difference. There's a report last month. We're now up to a 24-year difference in life expectancy depending on where you live in the United States. Senator Cassidy's from Louisiana, no offense, but very similar to South Carolina in eating habits.
(55:55)
So the evidence is very clear that, and I don't think any experts disagree, there's some general things you should do, exercise, eat less fat, sugar, and lower sodium. As long as we're in an argument about whether the government should mandate things or whether people should have a choice, and that's not resolved, we're up to the culture of the place that you live.
(56:23)
Now, one final comment about your question about research. One noticeable thing to me, and I readily admitted when I took the job I was not an expert in food. I've learned a lot in my two stints at FDA. But one really big difference is when the medical products industry does research, by law, if it's done on human beings, it is made public. We have access to it, and we look at the raw data and analyze it ourselves at the FDA.
(56:50)
The food industry does massive amounts of research that we have no access to, and we don't know what they're doing. We don't know what's guiding their decisions, and it would be a lot better if the research that was done on human beings by the food industry was made public.
Senator Hickenlooper (57:07):
We agree. We agree. I'm going to throw out another question you have to answer quickly about out of time. But the University of Colorado Denver Diabetes Research Center runs a program to recruit young faculty into diabetes-related research and estimated that obviously the number of type two diabetes patients is going to rise astronomically in the next 40 years, maybe 70%.
(57:31)
How do we prioritize the research that … And as you say, the NIH is doing all these different pieces of research that are all disconnected, whereas we see diabetes or obesity really being a common connector. We had a hearing yesterday with the Global Down Syndrome Foundation looking at all the different places that we're not spending enough, doing enough to interconnect all that research.
Dr. Califf (57:57):
Well, again, far be it from me to tell NIH how to allocate its research dollars, but I will point out diabetes is an interesting example because there's a National Institute of Diabetes, Digestive Disease, and Kidney Disease, NIDDK, which is very diabetes-focused, and I feel like they do a very good job.
(58:14)
The general issue of a 16-year-old who's obese and might develop diabetes later and what to do about a normal human being who's not sick, doesn't have a disease yet, is a big issue that I think needs more attention.
Bernie Sanders (58:30):
Thank you. Senator Murkowski.
Speaker 2 (58:34):
Can I just interject for point of clarification? That 24-year difference you speak of is not entirely attributable to diet or to nutrition. It's many other things, for example, gunshot wounds. So just to make that point.
Dr. Califf (58:47):
Completely agree and much appreciated. There's going to be a big presentation next month from the group in Seattle that generates all these statistics. I would really urge people to tune into that because it will cover all of the different intersection of all these issues that are creating these discrepancies.
Bernie Sanders (59:06):
Senator Murkowski.
Senator Murkowski (59:07):
Thank you. Thank you, Mr. Chairman. Gentlemen, welcome. Dr. Califf, you probably know I'm going to be talking about genetically-engineered salmon. You're not going to be disappointed here this morning. But before I go to that question, we're talking about access to healthier foods, and I know that we all recognize that in parts of rural America, certainly in places in my state, healthy food is hard to come by. It's expensive, and it is just a real challenge to make sure that people are getting the good, healthy, nutritious diet that they need.
(59:43)
They got subsistence food that are greatly helpful, but when you have a 24-pack of Costco water costing $99, I've got the picture on my phone, in the community of Golovin, I think it was, 99 bucks for water in a community that lacks just good, solid, safe drinking water. So this contributes to you got to get your liquids from somewhere else and when it's cheaper to drink pop or you call it soda, I call it sugar water, we know what we're going to see. We're going to see those health outcomes in those kids and in those families.
(01:00:25)
That is something that I think we need to do a better job in addressing is how we are making sure that in rural areas, our kids and our families are not subjected to these healthy food deserts. Talking about GE salmon, and I have to take you back to the food labeling because this was what we had required. We wanted to make sure that there was labeling of genetic-engineered salmon that was unambiguous In its labeling.
(01:00:59)
We have this focus group that effectively comes back. This is last year. It concluded that most focus groups' participants struggled to grasp the scientific language used by the FDA. So you go back to the language. For those of you who have no clue what genetically-engineered salmon is, let me ask you if this makes sense to you.
(01:01:25)
When the fact sheet is out there about how GE salmon is different from other fish, it says, "GE salmon has been genetically engineered to reach a growth marker important to the aquaculture industry more rapidly than its non-GE, farmed-raised Atlantic salmon counterpart. It does so because it contains an rDNA construct that is composed of the growth hormone gene from a Chinook salmon under the control of a promoter, a sequence of DNA that turns on the expression of a gene from another type of a fish called an ocean pout."
(01:01:55)
What is that all about? Nobody knows. So the question then, they say, "Well, it sounds a little bit concerning. It sounds not normal." So what we have tried to do is make clear that if the FDA is going to allow the sale of this genetically-engineered salmon, that there is clear labeling requirements to differentiate between wild-caught and GE salmon. Do you think we're there yet, Dr. Califf, with a clear, unambiguous?
Dr. Califf (01:02:32):
First of all, just a quick comment on your first statement. In the health statistics that I described, there has been a precipitous decline in Native American and Alaskan populations in terms of life expectancy just in the last few years, which is even more dramatic than what we're seeing before, so your point-
Senator Murkowski (01:02:53):
And a rise in obesity, as you well know.
Dr. Califf (01:02:53):
Your point about water and access to healthy food in rural communities is especially important here, and I acknowledge that. On the labeling, it would sure be better if we could come up with words that people can understand. I do take exception. You said no one understands it. What was described in that label actually is scientifically accurate, and everything that's in the label is part of normal machinery in every living organism.
Senator Murkowski (01:03:20):
So I get that-
Dr. Califf (01:03:21):
But what could a consumer do with it? Your point is well-taken.
Senator Murkowski (01:03:24):
And if I'm a consumer in the grocery store, that, to me, means nothing. Let me ask quickly about another concern. You've heard me talk about GE salmon for a long time, but now I'm concerned about cell-cultured seafood grown in a lab. We've got Frankenfish over here. Now we've got Petri fish.
(01:03:43)
I know some companies are pursuing FDA approval for the cell-cultured, but I'm curious about FDA's position about the future of cell-cultured proteins and how lessons that we've learned about the confusion surrounding GE salmon can be applied here. So if either of you care to comment to that?
Dr. Califf (01:04:03):
I'll make a quick comment, and then I'd actually be very interested in what Mr. Jones has to say about this. You and I, we do have a difference of view. Our climate is changing. We're seeing radical changes in growth patterns. Just an example right now is the pulp in oranges is a problem because of the climate changes in Florida, and we're going to need to take some action on that to fix it.
(01:04:26)
So I think exploring and learning about approaches to creating food which is resilient to these kinds of changes in a global population, which is going to be in dire need of nutrition, is a very important thing to do. Now, we've learned a lot about how to scientifically assess and deal with the manufacturing process, and so I think we're going to get better and better at it.
(01:04:52)
I don't know where it's going to end up, but I would love to have a food system that gave nutritious food at a low cost to everyone in the US, for sure, but just as importantly, ultimately to global populations who are going to be driven out of their homes by the rising tides and the heat waves that we're now seeing around the world.
Senator Murkowski (01:05:12):
Well, and my time has expired, but I will just say to that point, a fish as a living species out there is different than an orange on a tree. When these genetically-engineered species get into the wild stocks and mix with them, then you have Native people, those who rely on our wild harvests that have their fisheries jeopardized as well.
Dr. Califf (01:05:40):
Well, I can testify that a lot more about this than I do. You caught the bigger salmon when I went salmon fishing with you.
Senator Murkowski (01:05:45):
Bingo. You're invited back.
Bernie Sanders (01:05:48):
Senator Kaine.
Senator Kaine (01:05:50):
Thank you, Mr. Chair. Dr. Califf, in your verbal presentation at the beginning of this hearing, you concluded by saying there's some challenges if the US were able to do things that other nations do in the area of ultra-processed foods, either because of they have a different legal climate or they have different views about individual freedoms, then we might have more success in battling this.
(01:06:14)
I was intrigued by that, though that was not the questions I was going to ask you. But since you were referring to some things that other nations do, I thought I would just ask you what are some strategies that are being pursued by other nations that are successful?
Dr. Califf (01:06:30):
I actually think this is, for so much of the things that have frustrated me at the FDA, this is the core issue. We have a unique stubbornness of individualism in the US, which is phenomenally great in many ways, but when it comes to public health, it's a real problem because other countries know that we're interdependent when it comes to public health. That is, if you present, and I'll just use my experience at Google where I worked-
Senator Kaine (01:06:59):
But I really want to get to specifics, too.
Dr. Califf (01:07:01):
Okay. So yeah. So here's the example. If you want to influence someone's behavior to eat healthy food, you don't present them with a chart with a bunch of numbers on it. You show them a picture of a graphic image that has an emotional impact. That's what the advertising on the other side is doing. Froot Loops does not show commercials of one Froot Loop with all the constituents of the Froot Loop. It shows beautiful pictures of Froot Loops and nice people eating them with an emotional impact. We're not allowed to do that. Even in some of our more recent dealings, we have been instructed that, at the FDA, we just provide information. The one case that's an exception was tobacco where we were instructed to do it, and we still lost in court the first time. It set us back five years. So much of this has to do with the environment that people are living in.
(01:07:54)
I mentioned I am Colorado-prone because of my family. People in Colorado are not as obese as the rest of the country, and they exercise more. So if you're in that environment, you're going to be more likely to behave that way. [inaudible 01:08:10]-
Senator Kaine (01:08:10):
Have other nations already embraced front-of-package labeling of the way the FDA is trying to do?
Dr. Califf (01:08:15):
Absolutely. Not just labeling, but warning signs.
Senator Kaine (01:08:18):
Yeah, warning signs. Here's one that I know is controversial, and I've heard arguments on both sides. How about programs like SNAP benefits? A lot of SNAP benefits are used for very unhealthy foods. Do other nations that have supplemental food programs like SNAP benefits-
Dr. Califf (01:08:34):
I can't honestly say I know exactly what the other nations do here, but I know that this is a USDA program, as you well know. It's vitally important. We have so many children in the US who their parents can't afford their own diet. I know there was a battle over this issue last time around. It would be one of the most important things I think that could be done. Here, the US government has the purchasing power, so why not purchase healthy food? It makes a lot of sense.
Senator Kaine (01:09:08):
There are programs that do incentives for the purchase of healthy foods, but there's also some evidence to suggest that even in the same neighborhood, families that use SNAP benefits versus those who don't, the SNAP benefit purchases are generally less healthy than those who don't use SNAP benefits.
Dr. Califf (01:09:25):
Again, and I hope I get asked about the weight-loss drugs. I know we need to move on here, but-
Senator Kaine (01:09:29):
All right. I'm going to ask you about that since I have a minute 21 left.
Dr. Califf (01:09:33):
Okay. What's going on here is that the food industry has figured out that there's a combination of sweet, carbohydrate, and salt that goes to our brains and is very … I think it's addictive. Now, that's my opinion. I think it's the same neural circuits that are involved in opioid addiction and other kinds of addiction that we have, and they've studied this. Again, we don't have access to their research data like we do in the human medical products arena.
(01:10:04)
So if you're a person without much financial means and you're walking into a grocery store and the inexpensive, ultra-processed food is half the cost of the fruits and vegetables and it's carefully configured to really hit that brain. The way to think about this, if you ever tried to eat one potato chip, it's almost impossible. There's a reason for this.
(01:10:33)
There's a lot more research that needs to be done because we couldn't uncover the addiction circuits until the GLP-1s came along because what they're doing is actually interfering with this circuit between the gut and the brain that tells you, "Eat more." There are actually three or four pathways involved here that are really fascinating that we're going to learn a lot more about.
(01:10:55)
But here's a way to think about it. The food is probably addictive and again-
Senator Kaine (01:11:02):
And engineered to be addictive.
Dr. Califf (01:11:03):
… this is not an FDA policy. This is my opinion, having looked at it.
Senator Kaine (01:11:07):
Thank you. Thanks, Mr. Chair.
Bernie Sanders (01:11:12):
Let me just take a moment before Senator Braun goes. You just said the most important point of the hearing. You said that the food industry is producing products which are unhealthy and addictive. The question, of course, is that's exactly what's going on. What the hell have we done about it over the last 15 years? Senator Braun.
Senator Braun (01:11:35):
Thank you, Mr. Chairman. I would agree with that 100%. The whole system, and I've been on this committee all six years. It's the one thing I'll miss in the US Senate because it's the most important discussion is our wellbeing, and it's built upon no attention to wellness and prevention and expensive remediation. It's evolved that way over the last 20 to 30 years, and the FDA happens to be at the most visible point of where you got to intercede.
(01:12:11)
Is it worth it to keep pushing expensive drugs when we give no attention to wellness and prevention? I want to give you a little quick … I've done it several times on this platform. 16 years ago when I was sick and tired of hearing how lucky I was my premiums are only going up five to 10% each year, had 300 employees at the time. It's now five times that many employees. Imagine of the geometric cost of healthcare, when I said, "Enough is enough."
(01:12:47)
We built a system on prevention and wellness, created healthcare consumers out of my employees, and cut costs by way over 50%. Anyone in the audience not had a premium increase in the last 16 years on your health plan? You may want to put an application into the company I used to run. That is how much you can get done if we get off the paradigm of where we've let huge corporations, food industry, especially the remediation business, which is driven by big corporate hospitals and insurance companies, keep driving the dynamic.
(01:13:34)
When I gave my employees a free biometric screening, we cut diabetes off before it was going to become symptomatic. Any of the blood serum indicators that play into heart disease, you're catching it before it happens. Why are we still in a system that has nothing to do with an ounce of prevention being worth a pound of cure? You happen to be in the agency that has to deal with it all the time in terms of what the new modality is that's going to keep treating expensive remediation.
(01:14:16)
Where do we turn the tide to where we make your agency less relevant because you don't have to do as much of it because we're preventing it rather than trying to remediate it?
Dr. Califf (01:14:27):
I just want to tell you how much I appreciate the way you frame that because I was going to bring up … You said we're at the forefront. My favorite article of all time in the medical literature in the New England Journal of Medicine from Alistair Wood is entitled, Playing Kick the FDA: Risk-Free to Players, but Hazardous to Public Health. I urge you all to read it. It's a 14-year-old article, but it relates to what you said.
(01:14:56)
You've missed a lot of this discussion, but this is a systemic problem that does need to be addressed, and it would actually be great. I'm on record. I've been quoted on this. I've had this nightmare that I was head of this agency that my great-grandkids read about called the FDA where a society let people gain essentially a pound of weight every year. And then to fix it, they invented a drug at $20,000 a year to try to deal with it. That would be a very bad legacy to leave behind, so I hope this will be fixed.
(01:15:32)
I do want to point out to you this. You are about to become governor of the state, as I know it, that doesn't look good in this regard. So I think a lot of people are going to be watching whether you can change this. You said it well. If you're running a health system today, and I used to be an executive in a health system, you make your money by doing expensive procedures after the sickness has come.
Senator Braun (01:15:58):
Glad you brought up that point because here you're on the pulpit. Finally, Senator Sanders and I have put out a transparency and competition bill because my last question is going to be for Mr. Jones. I talked about wellness and prevention. The other key element is on the scratches and dents for those that can afford it. Insurance was never intended to be more than indemnification. Now you've got MBAs running it, and it's about high premiums and keeping claims low. That's got to change.
(01:16:31)
How important, Mr. Jones, would it be for all of us to have a little skin in the game, to have at least the incentive to shop around for when we need some type of prescription or modality? Do you think that the way we've evolved to where it's been an atrophied healthcare consumer that wants immediate results and wants either the government or their employer to pay for it, how much importance is it going to be to where there's a little skin in the game on the part of all of us when it comes at least to healthcare maintenance on the minor level?
Mr. Jones (01:17:13):
Well, my jurisdiction of the FDA is the food side, so I think that Dr. Califf is probably better equipped to answer that question.
Senator Braun (01:17:20):
Go ahead, Dr. Califf.
Dr. Califf (01:17:21):
Just opinion, I think my read of the cognitive behavioral literature, which is extensive on this, is that people need choice, but if you give them too many choices, they can't figure out what to do. So we've got to find a balance of options, but not so many that people are lost and then they just revert.
Senator Braun (01:17:43):
That's a good point. In the one-two punch of what's worked now for 16 years, I know that's part of the solution. It makes costs for government go down through Medicare and Medicaid and the private side as well. I think it's something where we can get the best of both worlds. Thank you, Mr. Chairman.
Bernie Sanders (01:18:04):
Thank you. Senator Hassan.
Senator Hassan (01:18:07):
Thanks so much, Mr. Chair and Ranking Member Cassidy, for this hearing. It's good to see you, Commissioner, and I thank you for being here today.
(01:18:14)
Dr. Califf, food companies spend over one and a half billion dollars a year targeting children with advertisements for unhealthy nutrient-poor foods, and we've been talking about the impact of that. These companies also target parents by marketing their products with misleading health claims. For instance, many high-sugar beverages are marketed as "all-natural" options for children, which can mislead parents into thinking that the products are somehow a nutritious choice.
(01:18:43)
So, Dr. Califf, what is the FDA doing to address misleading junk food advertisements that target children and their parents?
Dr. Califf (01:18:51):
Two-fold response to that. First of all, the term, healthy, is a very important term, and it's way out-of-date. We are in the process of redefining the term, healthy, and putting it there for people with a nice-looking symbol so that people can readily identify what a generally healthy food is from one that's not. So that's important.
(01:19:18)
I've already discussed, I think, the difficulty we have with advertising in general. We are very restricted in our ability to restrain people with First Amendment rights, and the advertising industry is very clever at how to do this in a way that's very hard for us to enforce.
Senator Hassan (01:19:37):
I do understand that. I hope you are working across government with some of the other agencies that might have more different authorities than you do.
Dr. Califf (01:19:45):
One of my themes for today highlighted by recent Supreme Court decisions is there's nothing better than a very explicit law by Congress if you want us to take this on.
Senator Hassan (01:19:56):
Understood. I do think there are some options you have for misleading or truly false statements if you work with other agencies. You mentioned that the FDA is working on a proposal to require food companies to display easy-to-understand nutrition information on the front of food packages. This change would help people identify healthy food options on the shelf.
(01:20:17)
I understand that the FDA researched options for new food labels but did not test how the new labels might impact teens who often make food purchases independently from their parents. So how will the FDA ensure that any updated food packaging rules also help young people make healthier decisions?
Dr. Califf (01:20:36):
I think Mr. Jones and I both would view that in the process of researching this, studies in teens are important, and those are going to follow on as we go through this. But there's also all is not lost because studies were not done directly in teens. Mr. Jones has a set of stats here that I think are important to get on the record.
Mr. Jones (01:20:57):
Sure. Yes. When the design of the
Mr. Jones (01:21:00):
… of the studies that we were relying on were done several years ago. And the choice was made not to include children or teenagers.
Senator Hassan (01:21:08):
Yeah.
Mr. Jones (01:21:08):
The basis for that were a couple fold, one was literature indicates that the most influential factor in children's diet are parental behaviors. And reinforced by that was that about 4.26% of all sources of food for children 12 to 17 are convenience store foods, which is basically where they're going to access when they're doing the shopping.
Senator Hassan (01:21:32):
Right.
Mr. Jones (01:21:32):
And so the combination of the two led the agency to choose not to include teens in the sampling that we did.
Senator Hassan (01:21:39):
Okay.
Dr. Califf (01:21:41):
Since I'm leaving, I'm okay to say this, if we had a bigger budget, we would've studied a lot more things.
Senator Hassan (01:21:47):
No, that is helpful feedback to be sure. And I appreciate the work that you have done. Dr. Califf, one more issue. You and I have talked about this before, and I have stated here before, that the FDA played a role in fueling the opioid epidemic that we have today. And that the FDA still has much work to do to ensure that something like the opioid epidemic never happens again. So I want to focus on a drug labeling issue that we've discussed. For years, the FDA permitted opioid labels to claim that opioids were safe and effective for long-term pain management, despite evidence showing the grave danger of these opioids. Over the last several years, I've called repeatedly upon the FDA to remove these baseless claims from the opioid labels. Last year, the FDA finally released new labeling rules for opioids, which will help doctors and patients alike understand the risk of opioid addiction. One year later, have all the manufacturers complied with the new rule and updated their labels?
Dr. Califf (01:22:52):
I'll have to get back to you on whether it's all, but we're 100% sure that great progress is being made. But I'd have to get back, because I don't have the specifics on that. This is very important. I also want to mention, I was very much in favor of comparative effectiveness requirements for opioids before a new one could get on the market. But we lost that with the Congress. And so it's one of the… My theme today is we need to work together.
Senator Hassan (01:23:18):
Yeah, we do indeed. But we also need to make sure that all of you have the ability and protections to exercise your scientific judgment effectively. Thank you, Mr. Chair.
Bernie Sanders (01:23:30):
Senator Budd.
Senator Budd (01:23:32):
Thank you, Chairman. Again, thank you all both for being here. In November, the American people made their voices heard, they want to restore trust in agencies like the FDA and make it easier for Americans to live a long and healthy life. The guiding principle of the FDA should be to provide the public with clear information so that individuals can make informed choices for their own health. The FDA has broad discretion on when and how to enforce Food, Drug and the Cosmetic Act based on the level of risk it perceives and when a violation might pose a risk to public health.
(01:24:08)
Too often, the FDA acts arbitrarily and inconsistently. So here's an example, when the FDA claimed the authority to regulate electronic cigarettes, it did not inform manufacturers of additional requirements until after the deadline to file and the application was due, essentially creating a de facto ban. So Commissioner Califf, and again, congrats on Duke's win over Auburn last night. I know Tommy or Senator Tuberville has already come and had his comments. I'm not sure that was mentioned or not, but since he's not here, we can say congrats. So glad you're here as a fellow North Carolinian. As new regulations like the front of package labeling are considered, how is the FDA ensuring consistent and timely guidance in that any enforcement actions are done so in an impartial manner?
Dr. Califf (01:25:00):
First of all, yes, if I look a little sleepy, I did stay up and watch the entire game and the post-game interviews, which were priceless. I didn't want to rub it in with Senator Tuberville, that that happened in Senator Marshall's lap, that we lost to Kansas, as you may remember, unfortunately. I mean, Senator Budd, you just actually articulated something that we've been discussing throughout this whole hearing in your view of the right of the individual to make decisions with information from a federal agency. Versus the view that when something is unhealthy, there should be an effort to actually change behavior towards a healthier state.
(01:25:39)
And that's not a decision for FDA to make. We operate within the law. We're more like a referee, where the laws are written by you all. I personally think the FDA is very impartial. And I don't agree with your assessment of the electronic nicotine device. No one anticipated we'd have 27 million applications to deal with. And so when I came back in, we did, just like we have talked about the human foods program, we did an entire assessment of the tobacco program and have reconfigured that considerably. I think we are impartial referees and when we're not, that's where public oversight is needed. So I'd be glad to talk more about the details back in North Carolina.
Senator Budd (01:26:28):
Yeah, glad to do that. Deputy Commissioner Jones, a report showed that newer plant-based proteins contain more sodium and less essential amino acids and vitamin B-12 compared to traditional animal-based meats. So as the FDA considers front-of-package labeling reforms, what is the agency doing to ensure that consumers are aware of key differences between plant-based and animal-based proteins?
Mr. Jones (01:26:54):
Senator, and we were talking about this a little earlier. We have guidance out there related to plant-based alternatives to dairy products. And in that guidance we basically say, we address both what can you call it? But also the issue that you're raising, which is the nutritional equivalence issue. We encouraged manufacturers to voluntarily identify that a plant-based alternative may not be nutritionally equivalent to, in this case, dairy products. We've gotten a fair amount of comment from a number of stakeholders that a voluntary disclosure may not give consumers what they need to know. We have some research that shows that consumers are not fully aware of the nutritional equivalence issue as it relates to plant-based alternatives versus dairy. So we are taking that under consideration. And when we finalize this guidance, we will address that issue.
Senator Budd (01:27:52):
Thank you. Continuing on, in 2022, American families could not reliably access infant formula due to contaminated formula. Ongoing supply chain disruptions made it even worse. So what role will the Human Foods Program play in monitoring supply chain risks that could affect the supply of critical foods like infant formula?
Mr. Jones (01:28:12):
We have done a number of things to reduce the likelihood that that will ever happen again. We'd like that to be close to zero, the likelihood that that ever happens again.
Senator Budd (01:28:22):
Can you be specific on a few things?
Mr. Jones (01:28:23):
But yes, so we have created a critical foods program, a core of individuals within the organization, they're in the Office of Critical Foods, that are responsible for the regulatory oversight of infant formula. We are now getting monthly reports from manufacturers about manufacturing. And so we are able to keep an eye on our store shelves as stocked as they need to be. And they're actually and have been for some time, they're stocked at the levels they were pre the shortage. We have got a group of inspectors who are dedicated to infant formula inspections. Previously we did not have a dedicated group of inspectors. And so now there's a dedicated group of inspectors. Their job is to inspect infant formula manufacturers. They're inspecting infant formula manufacturers annually, even though the law only requires them to be inspected every three years, they're being inspected annually. And they're in very close contact with the programmatic folks in our Office of Critical Foods. So we have done a number of things that we think really dramatically reduce the likelihood of anything like this happening in the future.
Senator Budd (01:29:28):
Thank you.
Dr. Califf (01:29:29):
Senator Budd, if I may, I just want to make the point, supply chain in general is not fixed in this country and it's very worrisome to somebody like me, not just infant formula. I don't think the issue we're going to see in the future with infant formula is what we saw with Abbott whose plant basically, was contaminated. What we're going to see is constituents of infant formula, because of the global supply chain issues, could come in shortage and we don't control that at FDA. We're in dire need of supply chain fixes in the United States for all of the products that we regulate.
Senator Budd (01:30:10):
I'll agree.
Dr. Califf (01:30:10):
Thank you.
Senator Budd (01:30:10):
That's outside the purview of FDA. But again, thank you for the additional time.
Dr. Califf (01:30:15):
Okay.
Bernie Sanders (01:30:16):
Senator Smith.
Senator Smith (01:30:18):
Thank you, Chair Sanders and ranking members. And welcome to the committee, it's good to see you both again. I want to talk a bit about food safety. One of the most important things that we do for Americans, is to make sure that the food we eat is safe and won't make us sick. This is a basic function of government, right? And I think it's also something that's a bipartisan, nonpartisan issue. But so here's the thing, of course, the work of making sure that the food supply is safe, that often happens at the state level by state employees who are doing the inspecting. And in Minnesota, that's the food inspectors at the Department of Agriculture, who conduct over 13,000 inspections a year. So how do we pay for that in Minnesota?
(01:30:56)
Well, the FDA helps, right? Because tax dollars are sent back to Minnesota and all our states to help pay for these inspectors. So here's the challenge, Minnesota's Commission of Agriculture, Tom Peterson wrote me last month raising concerns about proposed FDA cuts to state and local food safety programs. And I've been told that this is going to be a big deal for Minnesota. And I'm sure Minnesota is not alone. So Dr. Califf, if I hear what you're saying, that if Congress doesn't provide adequate funding, then you can't do your job and the Minnesota Department of Agriculture can't do its job and Americans health and safety can suffer.
(01:31:32)
I want to note that in a strong bipartisan showing of agreement, both the House and the Senate appropriations bills for next year's funding fund food safety inspections, so that no cuts would be necessary. And of course, those appropriations bills haven't passed. That's a worry to many of us. And at the same time we've got Elon Musk and the incoming Trump administration saying that they think that they can find $2 trillion in cuts from the budget, which would probably start with non-discretionary funding like at the FDA. So Dr. Califf, could you just comment on this? Is there anything the FDA can do about this at this point? And what do you think we should be thinking about in Congress as we think about making sure that we have the money to do the food safety inspections we need to?
Dr. Califf (01:32:16):
All right, I'm going to try to quickly rattle off five or six key points. And Mr. Jones may want to correct anything that I say. We've talked about this a little bit. Because we were not able to fill all the inspectorate jobs… You all had allocated, I think it's $83 million a year to us to go to the states for what you described. And we completely agree that this interaction of state inspectors and federal inspectors is critical to the safety of our food supply. But because we weren't filling all the inspectorate jobs, we had money left over that we thought was best used to go to the states. We're now hiring the inspectors.
(01:32:55)
And in the reorganization of the Human Foods Program, one of the most important aspects of that, is to make it clear to you all exactly what the money is being spent on. In my job as Commissioner, the medical product side is a lot easier that way because of the user fees. It's very much like running a business. The food side has been more like, there's a lot of money and we try to do the best we can. Now, it's organized in a way where you're able to see it. And so if we're going to have enough of our inspectors, how much can go to the states? The solution to it would be to decide what the right amount is. There are other elements of this. Right now, we can't exchange information with the states. And this is where we need a law to make it possible, because our liability of disclosing commercial confidential information is different than the states.
Senator Smith (01:33:47):
Yeah..
Dr. Califf (01:33:47):
Fortunately, now with a single leader of the program, this allocation of money I think, can be done more rationally. You may want to correct anything I said there.
Mr. Jones (01:33:57):
No, I think that's well stated. Thank you.
Senator Smith (01:33:58):
Well, I appreciate that. And I think my general point is that if we want to have safe food in this country that doesn't make people sick, then we need to make sure that we're keeping track of the inspections we need to do. But you raise another point that I want to touch on briefly, which is that I think it would be a surprise to a lot of Americans that if the FDA has information through a voluntary recall about a product out there that's been contaminated, let's take for example the applesauce contaminated with chromium and lead, that you're barred from sharing that information. And again, Minnesota Department of Agriculture tells me that they were forced to file a freedom of information request to get the information about the sources of lead poisoning when they're also responsible for trying to get these products off the shelves. So this is something I'm sure you know, I've been working on a bill that would get at this, that would allow the FDA to share this information with states and tribes and other local governments.
Dr. Califf (01:35:02):
Please hurry up. I also want to point out this is not just about food inspections. And again, I'll be leaving January 20th, so I can say what I want to say.
Senator Smith (01:35:16):
This is your chance to speak truth to the somewhat powerful.
Dr. Califf (01:35:18):
I think commercial confidential information in the U.S. is also one of the keys to the problems we have with supply chains. There is no reason on earth that I know of, why companies should be able to hide information.
Senator Smith (01:35:29):
Who are we protecting when they are protected from…
Dr. Califf (01:35:32):
I was on a National Academy of Medicine committee right before I was nominated, as you may remember for the second time. We had the industries and they could not explain to us any good reason. And other industries came in and said, "In auto parts, everybody knows exactly where the supplies are coming from." We don't have that. And every time we go to you all to try to get a law passed, something happens, that Senator Sanders may have referred to, and somehow it doesn't get into the law. So I'm really appealing to you to look carefully at what's called commercial confidential, and particularly as it relates to supply chains and inspections as two areas where it would help a lot.
Senator Smith (01:36:23):
Thank you very much.
Senator Markey (01:36:24):
Thank you Mr. Chairman very much. And to all the Duke basketball fans here tonight. This morning, I just want to say you're welcome. We were glad to send Cooper Flagg down from New England down to Duke to get his post graduate basketball training. But his mother started popping in Larry Bird videos at age six, just so that you all know. But you're welcome. Glad to send down the best college basketball player in America from New England. Commissioner Califf and Mr. Jones, thank you for being here today, because healthy, nutritious food is an essential part of making sure we can treat and prevent chronic diseases like heart disease, cancer, and diabetes. And I've been proud to work with my colleagues, including Senator Marshall, on supporting access to healthy foods, as a means of treating chronic disease. Dr. Califf, having experts and committed civil servants is essential for implementing evidence-based strategies for improving American's diet. Is that correct?
Dr. Califf (01:37:30):
Yes.
Senator Markey (01:37:31):
And how important is it for the FDA's work on nutrition and chronic disease to receive support from the Secretary of Health in Human Services?
Dr. Califf (01:37:41):
It's very important.
Senator Markey (01:37:44):
It's very important. And from my perspective, we have a potential nominee for Secretary of Health and Human Services, who was talked a lot about nutrition and chronic disease. Some would say, what he says on diet and importance of healthy foods is reasonable. However, one reasonable opinion does not qualify someone to run the United States Department of Health and Human Services. What should be disqualifying to run the Department of Health and Human Services that oversees every aspect of our healthcare system and whose actions will impact healthcare costs, access and innovation, is a nominee who has been proposed by President Trump, who has spread misinformation about vaccines and fluoridation of our water, questioned the well-proven conclusions that HIV causes AIDS, and falsely claimed that medication for depression is linked to mass shootings.
(01:38:51)
What should be disqualifying to run the Department of Health and Human Services is a history of spreading misinformation about public health measures, like vaccines that result in a measles outbreak, for example, in the deaths of 83 people, many of whom were children and babies. If we are serious about addressing chronic disease, if we are serious about closing gaps in healthcare access and moving towards a healthier America, the Senate should only confirm nominees to serve in the Department of Health and Human Services, who are prepared, qualified, and serious about the responsibility of their roles.
(01:39:34)
In my view, Robert F. Kennedy Jr. has disqualified himself to serve as Secretary of Health and Human Services. And I have serious concern about several other health-related nominees proposed by President Trump to be, as well. We can agree and find value in some opinions. We can agree the greed from any industry has no place in healthcare. We should agree upon that, and we should agree upon that in terms of nutrition and the role that plays in the health of Americans. But what we cannot do, is sign off on nominees who would be a danger to the public health. And that is what my concern is as we move into the new year. And the nomination of Robert F. Kennedy Jr. raises all of those questions which the next Congress is going to have to deal with. So let me, with that, Mr. Chairman, yield back.
Bernie Sanders (01:40:46):
Thank you very much. Let me summarize my sense of where we are. Number one, I'm not quite sure that the urgency of the issue has been made as apparent as it should be. But we are dealing with an extraordinary crisis when one out of five of our kids is obese, when millions of people are struggling with diabetes. When we spend, according to the American Diabetes Association, over $400 billion a year treating diabetes and other related illnesses, we have a major crisi. s Dr. Califf mentioned a few moments ago, and I hope you correct me if I'm misstating the essence of what you said, you said in so many words, that the food industry is designing products, designing food that is unhealthy and addictive. You suggested that these foods impact the brain the way that opioids do. Is that a fair paraphrasing of what you said?
Dr. Califf (01:42:05):
I would say it a bit differently. The general concepts are in play. The word addiction is a very technical word.
Bernie Sanders (01:42:12):
You used the word addiction, did you not?
Dr. Califf (01:42:15):
I used it with several other words around it, that said it was just my opinion, not the view of the FDA as a policy. Because there's a lot of work that needs to be done to nail that down.
Bernie Sanders (01:42:26):
All right. But we have had witnesses here who have said exactly that in a previous hearing. So there is a serious opinion.
Dr. Califf (01:42:34):
There's no doubt that when you eat this ultra-processed food, you want to eat more of it. Whether that's addiction or not is a matter of opinion.
Bernie Sanders (01:42:41):
Sounds to me like it's an addiction. And that's something that is intentionally being done by an industry which spends huge amounts of money, as you've indicated, advertising those products to children. Correct?
Dr. Califf (01:42:55):
Advertising is powerful. I've had personal experience with them.
Bernie Sanders (01:43:00):
All right. So the issue is not complicated. You have an industry that makes huge profits by making our children sick and causing taxpayers to spend huge amounts of money. The question is, whether or not the United States Congress will have the courage to take on the lobbyists who surround Capitol Hill representing the interests of the food industry, whether they'll have the courage to stand up to the campaign contributions from the industry that come flooding into our campaigns. But I would hope that for the sake of our country and the point that you made, a very important point, our life expectancy in the richest country on earth is lower than every other major industrialized country. Is that correct? And the point you made about some states, I would put it in a different way, in that is working-class people have life expectancies between five and 10 years shorter than upper-income people. Is that true?
Dr. Califf (01:44:11):
Yes. Education and wealth are two of the biggest factors in this difference.
Bernie Sanders (01:44:15):
That's right. All right. So this is an issue that we have got to get a handle on. And it will require courage to stand up to some very powerful special interests. I hope that Congress is prepared to do that. That is the end of our hearing today. And I want to thank all of our witnesses for their participation. For any senators who wish to ask additional questions, questions for the record will be due in 10 business days, December 19th by 5:00 PM. I ask unanimous consent to enter Senator Casey's remarks into the record. The committee stands adjourned.