[Senate Hearing 118-507]
[From the U.S. Government Publishing Office]
S. Hrg. 118-507
WHAT IS THE FDA DOING TO REDUCE THE
DIABETES AND OBESITY EPIDEMICS IN
AMERICA AND TAKE ON THE GREED OF
THE FOOD AND BEVERAGE INDUSTRY?
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HEARING
OF THE
COMMITTEE ON HEALTH, EDUCATION,
LABOR, AND PENSIONS
UNITED STATES SENATE
ONE HUNDRED EIGHTEENTH CONGRESS
SECOND SESSION
ON
EXAMINING WHAT THE FOOD AND DRUG ADMINISTRATION IS DOING TO REDUCE THE
DIABETES AND OBESITY EPIDEMICS IN AMERICA, FOCUSING ON THE FOOD AND
BEVERAGE INDUSTRY
__________
DECEMBER 5, 2024
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Printed for the use of the Committee on Health, Education, Labor, and
Pensions
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Available via the World Wide Web: http://www.govinfo.gov
__________
U.S. GOVERNMENT PUBLISHING OFFICE
57-667 PDF WASHINGTON : 2025
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BERNIE SANDERS (I), Vermont, Chairman
PATTY MURRAY, Washington BILL CASSIDY, M.D., Louisiana,
ROBERT P. CASEY, JR., Pennsylvania Ranking Member
TAMMY BALDWIN, Wisconsin RAND PAUL, Kentucky
CHRISTOPHER S. MURPHY, Connecticut SUSAN M. COLLINS, Maine
TIM KAINE, Virginia LISA MURKOWSKI, Alaska
MAGGIE HASSAN, New Hampshire MIKE BRAUN, Indiana
TINA SMITH, Minnesota ROGER MARSHALL, M.D., Kansas
BEN RAY LUJAN, New Mexico MITT ROMNEY, Utah
JOHN HICKENLOOPER, Colorado TOMMY TUBERVILLE, Alabama
ED MARKEY, Massachusetts MARKWAYNE MULLIN, Oklahoma
TED BUDD, North Carolina
Warren Gunnels, Majority Staff Director
Bill Dauster, Majority Deputy Staff Director
Amanda Lincoln, Minority Staff Director
Danielle Janowski, Minority Deputy Staff Director
C O N T E N T S
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STATEMENTS
THURSDAY, DECEMBER 5, 2024
Page
Committee Members
Sanders, Hon. Bernie, Chairman, Committee on Health, Education,
Labor, and Pensions, Opening statement......................... 1
Cassidy, Hon. Bill, Ranking Member, U.S. Senator from the State
of Louisiana, Opening statement................................ 4
Witnesses
Califf, Robert, M.D., Commissioner, United States Food and Drug
Administration, Silver Spring, MD.............................. 5
Prepared statement........................................... 7
Summary statement............................................ 11
Jones, Jim, Deputy Commissioner, Human Foods Program, United
States Food and Drug Administration, Silver Spring, MD......... 11
Prepared statement........................................... 6
Summary statement............................................ 11
ADDITIONAL MATERIAL
Statements, articles, publications, letters, etc.
Sanders, Hon. Bernie:
Statement for the Record, Senator Robert P. Casey, Jr........ 37
WHAT IS THE FDA DOING TO REDUCE THE
DIABETES AND OBESITY EPIDEMICS IN
AMERICA AND TAKE ON THE GREED OF
THE FOOD AND BEVERAGE INDUSTRY?
----------
Thursday, December 5, 2024
U.S. Senate,
Committee on Health, Education, Labor, and Pensions,
Washington, DC.
The Committee met, pursuant to notice, at 10:02 a.m., in
room 562, Dirksen Senate Office Building, Hon. Bernard Sanders,
Chairman of the Committee, presiding.
Present: Senators Sanders [presiding], Casey, Baldwin,
Kaine, Hassan, Smith, Hickenlooper, Markey, Cassidy, Murkowski,
Braun, Marshall, Tuberville, and Budd.
OPENING STATEMENT OF SENATOR SANDERS
The Chair. 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, it 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.
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 percent
of our population. 10 percent of our population, and about 90
percent of those with type 2 diabetes are obese. 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 percent over the past 6 years. This amounts
to about 10 percent of our total healthcare expenditures. That
is an unbelievable and unsustainable amount of money.
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 percent of people
with type 2 diabetes are overweight or obese. These two
epidemics go hand in hand. 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 1970's, 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 percent
of adults in the United States today are obese? And in my view,
the answers to these questions are not very complicated.
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
percent of our Nation's food supply. 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.
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 percent.
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.
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 13th, 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
2023. The FDA missed that deadline.
On December 6th, 2023, FDA announced that this proposed
rule would be made public in June 2024. The FDA missed that
deadline. On July 5th, 2024, the FDA announced that this
proposed rule will be made public by October 2024. The FDA
missed that deadline. I have been told that on November 21st,
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 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 percent. Similar labels were put into effect in
Peru in 2019, and Israel, and Mexico, in 2020, in Uruguay in
2021. And in Brazil, Columbia, Argentina, and Venezuela, from
2022 to 2024.
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 percent in 1965 to 12 percent in 2023. Smoking rates
among teens dropped even more significantly. That effort was a
major success.
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,'' or, ``High in
nicotine,'' ``High in carcinogens.'' They say, ``Cigarettes
cause lung cancer, emphysema, and may complicate pregnancy.''
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 percent. This is not a radical idea.
In the 1980's, 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.
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 for
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. 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.
We thank Dr. Califf and Mr. Jones for being with us.
Senator Cassidy, the mic is yours.
OPENING STATEMENT OF SENATOR CASSIDY
Senator Cassidy. Thank you, Chair Sanders. Near 1 in 3
Americans live with obesity, including 14 million children.
Nearly 1 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. A
great place to start is our Nation's food supply and the
changes in Americans' diet over decades. According to analysis
on internal medicine, 37 percent 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.
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 in
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. This means examining FDA's role in
reviewing the safety of chemicals and 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 that has
been 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.
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 HELP Committee in
collaboration with the Trump administration.
I thank our witnesses for being here. I look forward to a
productive discussion on how we can make America healthy again.
The Chair. Thank you, Senator Cassidy. Our witnesses today
are Dr. Califf and Mr. Jones. Dr. Califf is the Commissioner of
the U.S. 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.
STATEMENT OF ROBERT CALIFF, M.D., COMMISSIONER, UNITED STATES
FOOD AND DRUG ADMINISTRATION, SILVER SPRING, MD
Dr. Califf. 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.
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. 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. 6 in 10 Americans have at least one chronic disease,
and 4 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.
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 percent of our food supplies considered
ultra-processed. 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. 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 percent 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.
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's 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.
There is good reason to be concerned about the chemicals
that are routinely included in much of our food. The 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, in no small part, so that we could take on the issues
of nutrition and chemicals in our food supply. 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.
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.
[The prepared statement of Dr. Califf follows.]
prepared statement of robert califf and jim jones
Introduction
Chair Sanders, Ranking Member Cassidy, and Members of the
Committee, thank you for the opportunity to testify before you today to
discuss efforts to reduce the chronic disease burden in America and the
Food and Drug Administration's (FDA or the Agency) front-of-package
nutrition labeling initiative.
This is an important time to testify before this Committee on a
growing and vitally urgent issue facing Americans: chronic disease,
including diet-related chronic disease. The food we eat is exacerbating
America's tragic title for the lowest life expectancy among large high-
income countries. \1\
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\1\ ``How does U.S. life expectancy compare to other countries?''
Peterson-KFF Health System Tracker, https://
www.healthsystemtracker.org/chart-collection/u-s-life-expectancy-
compare-countries/.
Chronic diseases, including heart disease, cancer, and diabetes,
are the leading cause of disability and death in America. They are also
the leading drivers of the Nation's $4.5 trillion in annual health care
costs. Nearly everyone knows and cares for someone with a chronic
disease: 6 in 10 Americans have at least one chronic disease and 4 in
10 have two or more chronic diseases. \2\ Unfortunately, the toll of
diet-related chronic diseases is even greater for racial and ethnic
minority groups, those with lower socioeconomic status, and those
living in rural areas. The burden of diet-related chronic diseases
translates into astronomical health care and economic costs as well.
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\2\ https://www.cdc.gov/chronic-disease/about/index.html.
While there are myriad factors influencing health, the science is
well settled to support that poor nutrition--including insufficient
consumption of fruits, vegetables, and whole grains, as well as
excessive consumption of saturated fat, sodium, and added sugars--
increases the risk of diet-related diseases. Improving what we eat can
be an effective remedy for diet-related disease, but changing diets is
hard when challenged by externalities like finances, access to healthy
food, education, health care, safe housing, job opportunities,
neighborhood design, and transportation. Consequently, improving the
American diet to help ensure food is a vehicle for wellness requires a
whole-of-government and whole of society effort, including serious
action from industry to be part of the solution.
Ultra-Processed Foods and Poor Health Outcomes
The health impact of ultra-processed foods (UPF) is at the
forefront of many current discussions about nutrition. FDA agrees that
the clear association between UPF and poor health outcomes is cause for
major concern. Foods deemed ultra-processed are usually characterized
by industrial processing, the presence of additives such as flavors or
colors, and nutrients intended to make them appetizing (saturated fat,
sodium, and added sugars).
There is still a lot we need to learn about UPF. For example,
nutritious foods such as whole grain bread may be considered ultra-
processed but are not necessarily associated with negative health
outcomes and indeed have shown to be beneficial. \3\ Yogurt and tofu
are other examples. Additionally, infant formula and some medically
necessary foods would also be considered UPF under some definitions,
but are absolutely essential, nutritious foods. It is important that we
better understand why and how UPF may be negatively impacting health to
help inform targeted policies and avoid overly broad and impractical
messages for consumers.
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\3\ https://pubmed.ncbi.nlm.nih.gov/38417577/.
Still, we are not waiting idly for these answers. Later this month,
FDA is convening a workshop with the National Institutes of Health
(NIH) and a principal focus is to identify key priorities and critical
next steps for research on UPF to help accelerate higher quality
research. We are also aggressively taking policy steps where the
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evidence is clear.
A common characteristic of UPF is containing high levels of
saturated fat, sodium, and added sugars. There is already substantial
evidence of harm when these nutrients are overconsumed. In fact, much
of the potential harm of UPF could be offset by taking actions that
affect these nutrients. \4\ FDA's efforts to better inform consumers
through work on front-of-package nutrition labeling as well as on
updating the claim ``healthy,'' and our efforts to reduce sodium across
the food supply, and strengthen our chemical safety review program, may
help.
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\4\ https://www.sciencedirect.com/science/article/pii/
S2667193X24000401.
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FDA's New Nutrition Center of Excellence--Advancing Food as a Vehicle
for Wellness
FDA is well equipped to help lead the charge in improving nutrition
in the U.S. On October 1, FDA undertook the largest reorganization in
the Agency's recent history to establish the new, unified Human Foods
Program (HFP), which included standing up a Nutrition Center of
Excellence (NCE). Helping to ensure food is a vehicle for wellness is
the vision of FDA's HFP, led by Jim Jones, FDA's first Deputy
Commissioner for Human Foods.
The NCE elevates and empowers FDA's action on nutrition science,
policy, and initiatives to play a central role in a broader, whole-of-
government approach to reduce the burden of diet-related chronic
diseases, improve health equity, and ensure the nutritional adequacy
and safety of infant formula and other critical foods. A key
characteristic of the NCE is expanding collaborations--inside and
outside the Federal Government--to help achieve shared goals. The NCE
also focuses strategic leadership and coordination of FDA's nutrition
work and is prioritizing the Agency's ongoing efforts to encourage
industry to offer more nutritious foods and help U.S. consumers make
more informed food choices.
FDA's nutrition work provides significant dividends: for every
dollar we invest in nutrition, we see a return of $119 in nutrition-
related health benefits. \5\ Even relatively modest investments can
still have broad public health impact. We are eager to grow and
strengthen the NCE to more adequately address diet-related disease and
health equity and give these issues the attention they deserve.
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\5\ https://reaganudall.org/operational-evaluation-fdas-human-
foods-programs.
Front-of-Package Nutrition Labeling and Additional Actions to Advance
Public Health
Empowering Consumers through Front-of-Package Nutrition Labeling
Front-of-package (FOP) nutrition labeling is one avenue that could
quickly and easily inform U.S. consumers about the levels of certain
nutrients in foods, such as saturated fat, sodium, and added sugars
which can increase the risk of diet-related diseases when consumed in
excess and are commonly found at high levels in UPF. It could
complement the Nutrition Facts label by displaying certain nutrition
information right on the front of the food package, so it is
immediately visible at the point of decision-making. It also has the
potential to be as iconic as the Nutrition Facts label. For these
reasons, publishing a proposed rule on FOP nutrition labeling is a
priority for FDA.
There is tremendous value in getting the FOP nutrition labeling
regulation right the first time. So, our effort to develop an FOP
nutrition label has been vigorous and deliberative. FDA has done
extensive research, analysis, and drafting, using all available tools
and resources, to support a proposed FOP nutrition labeling rule so
that it can benefit consumers.
As part of this effort, FDA built the scientific basis to inform
our development of a proposed regulation to require an FOP nutrition
label. We updated our thorough review of the scientific literature
published in recent years by researchers in the United States and
around the globe, foreign health agencies, and governmental bodies
(such as the National Academy of Medicine). The literature review
highlights that FOP labels have been widely found to be a useful tool
in helping consumers identify and select healthy foods. With those
research findings in hand, we then prepared our own research agenda.
We conducted two rounds of focus groups with U.S. adult food
shoppers and conducted an experimental research study with over 9,000
consumers from diverse populations to ensure that everyone, including
those most at risk for diet-related diseases, was adequately
represented. The FOP schemes we tested align with insights from our
focus group testing, review of the scientific literature, review of
schemes from other countries, and with our legal authority. Findings
from the scientific literature and the consumer research FDA conducted
indicate that:
FOP labels can help consumers identify healthy foods;
Consumers prefer simple, interpretive FOP labels;
FOP labels appear helpful for those with lower
nutrition knowledge; and
FOP labels complement the Nutrition Facts label.
Alongside our research efforts, we undertook extensive outreach to
facilitate an open and transparent process, so all interested parties
had the opportunity to share their views. During this process we heard
from consumer and public health groups, academia, health care groups,
community members, as well as food companies and food trade
associations. This included numerous individual meetings, four
roundtable listening sessions, coalition meetings, and a public meeting
on FOP Nutrition Labeling hosted by the Reagan-Udall Foundation for the
FDA. \6\
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\6\ https://reaganudall.org/news-and-events/events/front-package-
labeling.
The goal of these engagements was to hear interested parties'
points of view and learn from their experiences with FOP nutrition
labeling. While we are limited in the extent of information we can
share with interested parties when developing a rule, we continue to
share information as we are able, and we have an FOP webpage that is
routinely updated. For example, our literature review and detailed
information about our consumer research is available on the webpage.
\7\ We have also discussed our plans to develop a FOP nutrition label
with our federal partners and had numerous discussions with foreign
health officials in countries that have adopted FOP nutrition labeling
to learn more about how their labels were designed, implemented, and
evaluated.
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\7\ https://www.fda.gov/food/nutrition-food-labeling-and-critical-
foods/front-package-nutrition-labeling.
Finally, we carried out the many steps to develop regulations,
including an economic analysis, peer review of the data, and a legal
analysis. We look forward to being able to discuss the details of our
research and our proposal with the Committee and the public soon. We
are confident it will reflect the research and what we have learned
from consumers, academics, health advocates, and the food industry, as
well as many others.
Providing a Refreshed Tool for Consumers by Updating the ``Healthy''
Claim
FOP nutrition labeling is one part of a suite of nutrition
initiatives FDA is prioritizing. FDA also is working to finalize
updates to the definition of the ``healthy'' nutrient content claim to
reflect current nutrition science in the very near future. Voluntary
claims like ``healthy'' on food labels can convey information to
shoppers at a quick glance and help consumers identify foods that are
the foundation of a healthy dietary pattern. FDA is also developing a
``healthy'' symbol that would be a graphic representation of the claim
and is engaging with interested parties to find ways to support use of
the claim and future symbol.
Fostering a Healthier Food Supply by Lowering Sodium
FDA continues to make great strides to help reduce sodium across
the food supply, which has the potential to be one of the most
important public health initiatives in a generation. In 2021, we issued
Phase I voluntary sodium reduction targets, and we are seeing promising
progress toward those targets. \8\ We are very encouraged that our
initial assessment of the Phase I targets showed that, in 2022, 40
percent of the Phase I targets had already been reached or were within
10 percent of meeting the targets. Additionally, recently released
National Health and Nutrition Examination Survey (NHANES) 2021-2023
data show sodium intake levels at 3,113 milligrams (mg) per day, down
from over 3,300 mg/day prior to 2021. This appears to be one of the
largest decreases in decades and aligns with the trends we saw in our
preliminary assessment--a very positive signal for the Agency's
investment in sodium reduction efforts.
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\8\ https://www.fda.gov/food/nutrition-food-labeling-and-critical-
foods/sodium-reduction-food-supply#progress.
In August 2024, we started the next phase by issuing draft Phase II
voluntary sodium reduction targets. \9\ Together, the Phase I and Phase
II targets would support reducing average sodium intake by about 20
percent from previous levels. FDA is receiving public comments on the
draft Phase II targets and looks forward to finalizing them.
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\9\ https://www.fda.gov/food/food-labeling-nutrition/sodium-
reduction-food-supply.
Together, FOP nutrition labeling, the ``healthy'' claim and symbol,
and helping to reduce sodium in foods work cohesively as part of a
government-wide approach to better inform consumers, improve nutrition,
and reduce diet-related chronic diseases. These efforts can also help
consumers more easily identify foods recommended by the Dietary
Guidelines for Americans and may assist them in reducing consumption of
certain nutrients that can be found in foods that are commonly
considered ultra-processed.
Ensuring Food Chemical Safety and Protecting Human Health
FDA recognizes that there is also significant attention and concern
around the presence of certain additives, such as flavors or colors,
that are another common characteristic of UPF. During our public
meeting in September on the Development of an Enhanced Systematic
Process for FDA's Post-Market Assessment of Chemicals in Food, \10\ FDA
heard from a wide range of interested parties regarding UPF, the
chemicals they contain, and the potential role these chemicals may play
in chronic disease. Congress, state legislatures, and others have made
clear that food chemical safety is a priority we need to address. We
agree, and we are committed to leading the way on food chemical safety.
---------------------------------------------------------------------------
\10\ https://www.fda.gov/food/workshops-meetings-webinars-food-
and-dietary-supplements/public-meeting-development-enhanced-systematic-
process-fdas-post-market-assessment-chemicals-food.
Under the new HFP, we are leveraging our scientific expertise and
developing a more nimble and systematic approach to evaluating
chemicals in the food supply. In particular, the Agency now has an
office specifically dedicated to post-market assessments and is
developing a process for conducting post-market assessments of
chemicals previously evaluated for use in foods, which was discussed at
the public meeting in September. FDA uses toxicity and biological data,
along with data to estimate exposure, to support regulatory decisions
allowing or restricting uses of substances according to our safety
standard of reasonable certainty of no harm. This general approach
assures there is an adequate margin between doses that can cause
---------------------------------------------------------------------------
adverse effects and the exposure level in food.
FDA recognizes that there is a clear nexus between our nutrition
goals and chemical safety goals. And we will act when data demonstrates
a chemical in food causes harm. As an example, in 2015 FDA revoked the
``generally recognized as safe'' status of partially hydrogenated oils
(PHOs) because various studies consistently linked PHOs consumption
with heart disease. However, to date, the literature connecting UPF-
related adverse health effects to specific food chemicals is neither
robust nor settled. FDA continues to monitor the food supply, evaluate
new science, and take action when we find that a chemical causes a food
to be unsafe.
The workload in the food chemical space has increased and become
more complex. There has been a proliferation of new scientific data and
methods, increased development of new food ingredients, technological
advancement in new sustainable food contact materials, and other
innovations. There are also important gaps that need to be addressed as
we undertake the work to strengthen our food chemical safety
activities. We know that use patterns and use levels of chemicals and
ingredients have changed over time, so we need updated exposure and
safety data, including from industry, to support our reassessment work.
Access to these data would allow FDA to take any necessary regulatory
actions in a timely manner to protect consumers and help ensure food
safety.
Closing
All people in this country should be able to live better, longer,
and more productive lives--free of the burden of preventable food and
diet-related illness, disease, and death. Giving people nutrition
information via labeling, and improving the quality of our food supply,
are of paramount importance. Change cannot happen soon enough.
Nutrition labeling is an important tool, but we need more than one
lever to help Americans build healthier diets. We must continue to
learn more about UPF, develop a stronger chemical safety review
program, and build on the success of other nutrition initiatives like
updating the ``healthy'' claim and sodium reduction.
Finally, when it comes to food, FDA shoulders an enormous
responsibility, but we do not act alone. Improving the food supply and
advancing nutrition is a shared responsibility. Industry must also do
more to offer healthier foods; it is in everyone's best interests for
the U.S. food supply to be a source of wellness. We at FDA are firmly
committed to working with this Committee and Congress, with our
regulatory partners, and with all of those who play a role in the
nutrition of the U.S. food supply, to tackle head-on the challenges we
face in our increasingly complex food system.
Thank you for the opportunity to testify today. We will be happy to
answer your questions.
______
[summary statement of robert califf and jim jones]
This is an important time to testify before this Committee to
discuss the Agency's efforts to reduce the chronic disease burden in
America and the role our nutrition initiatives, such as the proposed
front-of-package labeling rule, contribute to these efforts. The food
we eat is contributing to America's title for the lowest life
expectancy among large high-income countries. Nearly everyone knows and
cares for someone with a chronic disease: six in ten Americans have at
least one chronic disease, and 4 in 10 have two or more chronic
diseases. This burden translates into astronomical health care and
economic costs.
While there are myriad factors influencing health, the science is
well settled to support that poor nutrition--including insufficient
consumption of fruits, vegetables, and whole grains, as well as
excessive consumption of saturated fat, sodium, and added sugars--
increases the risk of diet-related diseases. Consequently, improving
the American diet to help ensure food is a vehicle for wellness
requires a whole-of-government and whole of society effort, including
serious action from industry.
The clear association between ultra-processed food (UPF) and
negative health outcomes is cause for major concern. While there is
still much to understand, UPF are often high in saturated fat, sodium,
and added sugars and there is already substantial evidence of harm when
these nutrients are consumed in excess. FDA is not waiting to act where
the evidence is clear. Establishing a front-of-pack (FOP) nutrition
label could be a landmark policy. Displaying certain nutrition
information right on the front of a package would allow Americans to
quickly and easily identify how foods can fit into a healthy dietary
pattern. FDA has done extensive research, analysis, and drafting, using
all available tools and resources, to support a proposed FOP nutrition
labeling rule so that it can benefit consumers.
In addition to front-of-package nutrition labeling, FDA is working
to reduce sodium across the food supply and update the ``healthy''
claim. FDA is already seeing progress toward its sodium reduction
targets and recently released data show sodium intake levels have
decreased.
Another common characteristic of UPF is the presence of certain
additives, such as flavors or colors. FDA is committed to leading the
way on food chemical safety. Under the new Human Foods Program, we are
leveraging the agency's scientific expertise and developing a more
nimble and systematic approach to evaluating chemicals in the food
supply.
All people in this country should be able to live better, longer,
and more productive lives--free of the burden of preventable food and
diet-related illness, disease, and death. Improving the food supply and
advancing nutrition is a shared responsibility. Industry must also do
more to offer healthier foods. FDA is firmly committed to working with
this Committee and Congress and with all of those who play a role in
the nutrition of the U.S. food supply, to tackle head-on the challenges
we face in our increasingly complex food system.
______
The Chair. Thank you very much. Mr. Jones, did you want to
add anything to that or----
Mr. Jones. No, thank you.
The Chair. 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 1970's. And from where I'm
standing here, the FDA has not responded in any way with the
urgency of the crisis. 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. With your permission, I'm leaving soon.
The Chair. I heard that.
Dr. Califf. 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, we--it's not just that we lose in
court, but we lose years when that happens----
The Chair. Let me--yes, 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 become--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
and 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. 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 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 tried to do, frankly, gets blocked along the way.
The Chair. 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. 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 that those of us who are interested in better
health would like to make are blocked at the level of
legislation for reasons such as----
The Chair. But I'm----
Dr. Califf [continuing]. You have to tell me.
The Chair [continuing]. Still not hearing you. What is the
reason that our kids are unhealthy? What role do these 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. Well, I'm not going to castigate the people
that work in the food and beverage industry. What I'm----
The Chair. You're not?
Dr. Califf. No. What I will say----
The Chair. That is your job.
Dr. Califf. 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 percent in favor of change.
The Chair. The Academy of Medicine in 2010. How many years
does it take to do it? 14 years is enough time? How many kids
have died and gotten sick during those 14 years?
Dr. Califf. 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----
The Chair. Protecting interests of----
Dr. Califf [continuing]. That are involved to make a
change.
The Chair [continuing]. The food and beverage industry.
Senator Cassidy.
Senator Cassidy. I will allow Senator Tuberville to go
first.
Senator Tuberville. Thank you, Mr. Chairman. Thanks both
for being here. We can, obviously, tell by all the young people
in there, 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.
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 our kids' ingestion. The
both of you stand behind that?
Dr. Califf.
Dr. Califf. I'm going to refer that to Mr. Jones. Okay.
Mr. Jones. We have not evaluated Red 40 in over a decade,
over a decade ago.
Senator Tuberville. Wow. We have not?
Mr. Jones. We have not. We 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. But we have evaluated--we are in the process of
evaluating Red 3, and you may want to comment on that.
Senator Tuberville. 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. 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, we'll actually--we will be acting on that
petition and a decision should be forthcoming.
Senator Tuberville. Tell us that process. How does that
work, the timeline? If we know something's deadly for anybody
that ingested, how, how do we continue to just study that and
not say, hey, enough's enough?
Mr. Jones. 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, 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.
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 challenged FDA for many
years, is how to manage around the Delaney clause, where you
have a scenario where, although there may be cancer evidence in
animals, there is also evidence that is not harmful to humans.
Senator Tuberville. I hope the FDA feels a responsibility
to humans. Dr. Califf, you've probably heard quite a bit about
this for the last 4 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. Yes. A couple of things, but, 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 3
causes cancer, but we have it in laboratory animals. And so,
this gets complicated. And I want to remind you of what it
takes to demonstrate that a substance that people eat causes
cancer. You have to study a large number of people over a long
period of time because if something caused cancer right away it
would be obvious.
But in these cases, you need something different. And I
want to point out, we have a very small staff that can do this
based on the budget. We have repeatedly asked for better
funding for chemical safety. I brought Mr. Jones in to head the
Human Foods Program because of his history of working on
environmental issues. I think it is a huge priority. He's an
expert in this. Please look at our request for funding for the
people who do this work. Remember that when we do ban
something, it will go to court. And if we don't have the
scientific evidence, it won't stand up in court. We will lose
in court.
Senator Tuberville. 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. The biggest distinction between the U.S. and
Europe is that they have been doing post-market review of
chemicals now for over 20 years. In the FDA, although we have
authorization to do post-market reviews, there's no statutory
mandate to do them. One of the things that Dr. Califf mentioned
is that as part of this reorganization, we are dedicating an
entire office whose job is to do post-market chemical reviews.
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. 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 don't--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.
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 how
things come off. Just a point I'm going to make over and over
and I thank you. I apologize, but I think it's really important
that we work together on this.
Senator Tuberville. Thank you. Thank you for your points.
The Chair. Senator Murray.
Senator Murray. Thank you very much, Mr. Chairman.
You know, 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 1 in 10 people in
Washington State, about 1 in 10 Americans suffer from diabetes.
So, we really 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. 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 to focus on this and a better structure to do it. It
involves the entire inspectorate at the entire Human Foods
Program.
As many people requested, we brought in a leader, Mr.
Jones, to head the whole thing up. So, it's a very high
priority. 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.
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. Mr. Jones.
Mr. Jones. 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, and 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 2
weeks 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. Okay. I also want to ask you, while you're
here, about the Modernization of the Cosmetics Regulation Act
that we passed. 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 action.
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 2 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 requires--actually, required FDA to issue good
manufacturing practices for facilities that manufacture
cosmetic products. Since it's been 2 years, the FDA has not put
out any good manufacturing practices. So, tell me where we are
with this?
Dr. Califf. 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
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. 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
what was allocated to this was a small fraction of the
estimates by everyone involved of what it would take to
actually meet the requirements of Congress.
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 complaint system to register adverse events.
That saved a lot of money compared to doing it de novo.
Senator Murray. 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 2 years ago.
The Chair. Senator Cassidy.
Senator Cassidy. Thank you both. First, Dr. Califf, I'm
just going to go far field 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 because I learned
from him, but others have the same thing, and they cannot get
an 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 you're not,
I didn't prepare you for this question, but do you have any
ability to comment on this?
Dr. Califf. 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 who 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.
Senator Cassidy. No, but if it's FDA approved already, at
least I'm told, well, that seemed like that would be a----
Dr. Califf. Well, that we'd have to get back on the
specific incident, but FDA-approved 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.
Senator Cassidy. Can I follow-up with you afterwards?
Dr. Califf. Yes, please do.
Senator Cassidy. I'd appreciate that.
Next, and I won't--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. 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
system.
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 are guided. AI is a 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.
Senator Cassidy. Now, but it sometimes begs the question
because before these positive steps, you had a higher rate of
inspection, and after these positive steps, you continued to
have a lower rate of inspection. It begs the question of like,
were the steps positive?
Dr. Califf. 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----
Senator Cassidy. If you look at your decline in
investigator/inspector workforce, what percent of decline have
you had?
Dr. Califf. 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.
Senator Cassidy. But then let me ask you, again.
Dr. Califf. But now, we're now on a positive slope.
Senator Cassidy. Limited time. So, to what degree can you
attribute the loss of workforce to the decreased inspections?
Is that the sole thing, or?
Dr. Califf. Well, during the pandemic there were other
factors. Like, we had to be able to get----
Senator Cassidy. But now post pandemic?
Dr. Califf. 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.
Senator Cassidy. 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. Again, just very quickly, a lot of it is
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.
The Chair. Thank you.
Senator Baldwin.
Senator Baldwin. 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.
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.
We're here today because of the health of American families
and children 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.
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. 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. Sure. Thank you, Senator. So, 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, 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, as so
long as the name itself is not misleading. And we have a fair
amount of research--well, a compelling amount of research that
consumers are not misled.
The Chair. I'm sorry, Mr. Jones, can you talk into the mic.
I'm not hearing you.
Mr. Jones. 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 comment on that. And as you
pointed out, we said we encourage manufacturers of these
products to identify that they are not nutritionally equivalent
to a dairy product. We have gotten a fair amount of comment
that is not adequate, and then we are taking that comment under
consideration.
Ultimately, I can't say where we will land on 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. 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 what's already a
complex marketplace for dairy products and plant-based
alternatives?
Dr. Califf. 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. And so, we'd certainly agree that whether
it's us or USDA, that needs to be taken into account.
The Chair. Senator Hickenlooper.
Senator Hickenlooper. Thank you, Mr. Chair. Thank both of
you for your service. I was at a round table in Colorado a
while ago, and throughout, one of our constituents referred to
Dr. Califf which I thought was a really--given the fact that he
still has somewhat of an accent, I thought that would be an
interesting way to magnify that.
I do appreciate the fact because 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 is resolved that, but certainly, a
significant part of the complaints we've heard so far this
morning it's a lack of people being able to respond to
inquiries, to complaints, to opportunities to redress some of
these health-related issues.
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 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.
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 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, could become much more
severe.
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. 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.
I want to come back to comment on that in a second. But
there's no question. I mean, this is what I do for a living.
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. I'm from
South Carolina, so I feel like I can say this. It's not so much
in the culture in South Carolina.
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. And 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. And 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.
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 and we have access to it.
We look at the raw data and analyze it ourselves at the
FDA. 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. We agree. I'm going to throw out
another question. You have to answer quickly because I'm 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 it's estimated that, obviously,
the number of type 2 diabetes patients is going to rise
astronomically in the next 40 years, maybe 70 percent.
How do we prioritize the research that--and as you will
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. Well, again, far be it for me to tell NIH how
to allocate his research dollars. But I will point out diabetes
is an interesting example because there's a National Institute
of Diabetes and Digestive and Kidney Disease, NIDDK, which is
very diabetes-focused. And I feel like they do a very good job.
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.
Senator Hickenlooper. Thank you.
The Chair. Senator Murkowski.
Senator Cassidy. Can I just interject real quick for a
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. Completely agree on, and much appreciated. And
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.
The Chair. Senator Murkowski.
Senator Murkowski. 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 are talking about, 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.
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 Glavin, 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. And we're going to see those health
outcomes in those kids and in those families.
That is something that I think we need to do a better job
in addressing, is how, how we are making sure that in rural
areas, our kids and our families are not subjected to these
food deserts or 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. We have this focus
group that effectively comes back--this is last year--and it
concluded that most focus groups participants struggled to
grasp the scientific language used by the FDA.
You go back to the language. And for those of you who have
no clue what genetically engineered salmon is, let me ask you
if this makes sense to you. 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.''
What is that all about? Nobody knows. So, the question
then, they say, well, it sounds a little bit concerning. It
sounds not normal. And 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. 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.
Senator Murkowski. The rise in obesity as you said.
Dr. Califf. Well, 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. I get that.
Dr. Califf. But what could a consumer do with it? Your
point is well taken.
Senator Murkowski. If I am 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.
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. I'll make a quick comment, and then I'd be
very--actually, be very interested in what Mr. Jones has to say
about this. You and I probably 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. 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. 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 U.S. 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. 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. And 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 harvest that have their fisheries jeopardized.
Dr. Califf. Well, I can testify that you know a lot more
about this than I do. You caught the bigger salmon when I went
salmon fishing with you.
Senator Murkowski. Bingo. You're invited back.
The Chair. Senator Kaine.
Senator Kaine. 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 U.S. 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.
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. Yes. So, 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 U.S. 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. But I really want to get to specifics, too.
Dr. Califf. Okay. So, yes, 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 Loop 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. And 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 5 years.
Much of this has to do with the environment that people are
living in. 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.
Senator Kaine. Have other nations already embraced front-
of-package labeling of the----
Dr. Califf. Absolutely.
Senator Kaine [continuing]. Way the FDA's trying to do?
Dr. Califf. Not just labeling, but warning signs.
Senator Kaine. 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. I can't honestly say I know about the other--
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 U.S. who can't afford their own
their parents can't afford their own diet. And 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 U.S. Government has the purchasing power. So, why not
purchase healthy food?
Senator Kaine. 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. Again, and I hope I get asked about the weight
loss drugs. I know we need to move on here.
Senator Kaine. All right. I'm going to ask you about that,
since I have 1 minute 21 left.
[Laughter.]
Dr. Califf. 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. And I think it's
the same neural circuits that are involved in opioid addiction
and other kinds of addiction that we have.
They've studied this. Again, we don't have access to their
research data like we do in the human medical products arena.
And 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 and there's a lot more research
that needs to be done because we couldn't uncover the addiction
circuits until the GLP ones came along because what they're
doing is actually interfering with this circuit between the gut
and the brain that tells you eat more. And there are actually
three or four pathways involved here that are really
fascinating that we're going to learn a lot more about. But
here's a way to think about it. The food is probably addictive.
And, again----
Senator Kaine. Engineered to be addictive.
Dr. Califf [continuing]. This is not an FDA policy. This is
my opinion, having looked at it.
Senator Kaine. Thank you. Thanks, Mr. Chair.
The Chair. 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. And the question, of course, that's
exactly what's going on. What the hell have we done about it
over the last 15 years?
Senator Braun.
Senator Braun. Thank you, Mr. Chairman. I would agree with
that 100 percent. The whole system. And I've been on this
Committee all 6 years. It's the one thing I'll miss in the U.S.
Senate because it's the most important discussion, our well-
being. And it's built upon no attention to wellness and
prevention in 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. 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 quickest. 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 5 to 10 percent 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, we built a system on
prevention and wellness, created healthcare consumers out of my
employees, and cut costs by way over 50 percent. Anyone in the
audience not had a premium increase in the last 16 years on
your health plan, 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. 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 a cure? And you happen
to be in the Agency that has to deal with it all the time in
terms of what the new modality is. It's going to keep treating
expensive remediation. 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. I just want to tell you how much I appreciate
the way you framed 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. And it relates
to exactly the--I urge you all to read it. It's a 14-year-old
article, but it relates to what you said, and 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. And that would be a very bad
legacy to leave behind. So, I hope this will be fixed.
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. And 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.
Senator Braun. 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's 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 got MBAs
running it and it's about high premiums and keeping claims low.
That's got to change.
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? And 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. Well, my jurisdiction of FDA is the food side.
So, I think that Dr. Califf is probably better equipped to
answer that question.
Senator Braun. Go ahead, Dr. Califf.
Dr. Califf. 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. And 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. 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.
The Chair. Thank you.
Senator Hassan.
Senator Hassan. Thanks so much, Mr. Chair, and Ranking
Member Cassidy, for this hearing. And it's good to see you,
Commissioner, and I thank you for being here today.
Dr. Califf, food companies spend over $1.5 billion 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. So, Dr. Califf, what is the FDA
doing to address misleading junk food advertisements that
target children and their parents?
Dr. Califf. Two-polled response to that. First of all, the
term ``healthy'' is a very important term, and it's way out of
date. And 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.
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. 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. One of my things for today and 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. 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.
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. I think Mr. Jones and I both would view that in
the process of researching this. Studies and teens are
important, and those are going to follow-on as we go through
this. But all is not lost because studies were not done
directly in teens. And Mr. Jones has a set of stats here that I
think are important to get on the record.
Senator Hassan. Sure.
Mr. Jones. Yes. The design of the studies that we were
relying on were done several years ago. And the choice was made
not to include children or teenagers. 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 percent 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. And so, the combination of the two
led the Agency to choose not to include teens in the sampling
that we did.
Senator Hassan. Okay.
Dr. Califf. 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. 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.
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. I'll have to get back to you on whether it's
all, but we're 100 percent 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.
Senator Hassan. Yes.
Dr. Califf. It's one of the--my theme today is we need to
work together.
Senator Hassan. Yes. 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.
The Chair. Senator Budd.
Senator Budd. Thank you, Chairman. Again, thank you all
both for being here. In November, the American people that 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 either with clear information so that
individuals can make informed choices for their own health.
FDA has broad discretion on when and how to enforce the
Food, Drug and Cosmetic Act based on the level of risk it
perceives, and when a violation might pose a risk to public
health. Too often, 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.
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 is 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 in an
impartial manner?
Dr. Califf. 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 happened and Senator Marshall's
left. But 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 toward a healthier state.
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, there were--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. Yes. Glad to do that. Deputy Commissioner
Jones, reports show that newer plant-based proteins contain
more sodium, and less essential amino acids and vitamin B12
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. Senator, 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 comments 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. 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. Yes, sir, we have done a number of things to
reduce the likelihood that will ever happen again. We'd like
that to be close to zero, the likelihood that ever happens.
Senator Budd. Can you be specific on a few things?
Mr. Jones. 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 are 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 3 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. Thank you.
Dr. Califf. 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 had gotten out of--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. I agree that's outside the purview of FDA,
but again, thank you for the additional time.
The Chair. Okay.
Senator Smith.
Senator Smith. Thank you, Chair. Thank you, Chair Sanders,
and Ranking Member. And welcome to the Committee. It's good to
see you both, again. So, 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? Well, the FDA helps,
right? Because tax dollars were sent back to Minnesota and all
our states to help pay for these inspectors.
Here's the challenge. Minnesota's Commissioner of
Agriculture, Tom Petersen, 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.
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.
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?
Dr. Califf. 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
hiring, we're 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. 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. 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. No, I think that's well stated.
Senator Smith. Well, let me get--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 really another point that I want to touch on
briefly, which is that, I mean, 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.
I mean, 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. Please hurry up. I would just--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. This is your chance to speak truth to the
somewhat powerful.
Dr. Califf. 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. Now, who are we protecting when they are
protected from----
Dr. Califf. 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 in, they could not
explain to us any good reason. And other industries came in and
said and we're 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.
I'm really appealing to you to make--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. Thank you very much.
The Chair. Senator Markey.
Senator Markey. Thank you, Mr. Chairman, very much. And to
all the Duke basketball fans here 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 postgraduate basketball
training. But his mother started popping in Larry Bird videos
at age six, just so you-all know. But you're welcome. I'm 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. Yes.
Senator Markey. How important is it for the FDA's work on
nutrition and chronic disease to receive support from the
Secretary of Health and Human Services?
Dr. Califf. It's very important, very important.
Senator Markey. From my perspective, we have a potential
nominee for Secretary of Health and Human Services who has
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 upheld in 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.
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
toward 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. 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
that 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.
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, with that, Mr. Chairman, I yield back.
The Chair. Thank you very much. Let me kind of summarize my
sense where we are. No. 1, 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 1 out of 5 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 crisis.
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. I would say it a bit differently. The general
concepts are in play. The word addiction is a very technical
word.
The Chair. You used the word addiction, did you not?
Dr. Califf. 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.
The Chair. All right. But we have had witnesses here who
have said exactly that in a previous hearing. So, there is
serious opinion----
Dr. Califf. 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----
The Chair. 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. Advertising is powerful. I've had personal
experience with it.
The Chair. 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 U.S. Congress will have the
courage to take on the lobbyists who surround Capitol Hill
representing the interest 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, 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 5 and 10
years shorter than upper income people. Is that true?
Dr. Califf. Yes. Education and wealth are two of the
biggest factors----
The Chair. That's right.
Dr. Califf [continuing]. In these differences.
The Chair. 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 p.m. I ask
unanimous consent to enter Senator Casey's remarks into the
record.
[The following information can be found on page 37 in
Additional Material:]
The Chair. The Committee stands adjourned.
ADDITIONAL MATERIAL
senator robert p. casey, jr.
Thank you Dr. Califf and Deputy Commissioner Jones for being here
today to discuss an issue of critical importance to the health of our
Nation. This will be my last opportunity to speak at a HELP Committee
hearing. I would like to take some time to look back at some of the
success that we've achieved when we worked together and to implore
Members of this Committee next year to work toward a future where no
family needs to worry about how they will afford tomorrow's meal for
their children.
We have talked a lot about encouraging healthy choices, but
maintaining a healthy diet is of equal importance to ensuring that
children and families have access to healthy and high-quality foods.
Access to food has been the focus of much of my work on child
nutrition, including through my work on the Nation School Lunch Program
and the Child and Adult Care Food Program. I have long fought to expand
eligibility and increase reimbursements for these critical programs.
Having sidelined the reauthorization of child nutrition programs
for several years now, Congress leaves on the table immense opportunity
to ensure better access to healthy foods for children and families. But
access to food and helping Americans choose healthier diets cannot be
mutually exclusive goals, and I encourage my colleagues on both sides
of the dais to work toward a shared goal of access to healthy foods.
I also want to highlight an ongoing area where I know our witnesses
remain engaged, which is the safety and security of the infant formula
supply chain. The shortages in 2022, precipitated by several infant
deaths linked to a contamination in a formula plant, highlighted how
vulnerable this critical source of nutrition is.
While we have come a long way since 2022, the supply chain remains
extremely susceptible to disruptions, and there is not a sufficient
sense of urgency around the need to diversify the number of
manufacturers and manufacturing sites and support smaller, newer
entrants to the market. And as we work to ensure a stable supply chain,
we must make every effort to ensure that the infant formulas being sold
in the United States meet the regulatory standards that ensure their
safety and nutritional requirements, to protect our youngest and most
vulnerable infants.
I have served on the HELP Committee since 2009, and remain grateful
for the good work we have done to expand access to health care, promote
innovation in biomedical research and the development of new therapies
to treat different causes of disease, increase access to child care,
and stand up for American workers.
______
[Whereupon, at 11:43 a.m., the hearing was adjourned.]
[all]