An Update from FDA’s Deputy Commissioner for Human Foods

Summary

At the 47th Annual National Food Policy Conference, Deputy Commissioner Jim Jones of the US FDA discussed the agency's reorganization and focus on food safety, chemical safety, and nutrition. He highlighted the importance of collaboration with the food industry, regulatory counterparts, and consumer advocacy groups to ensure a safe and nutritious food supply. Jones emphasized the FDA's commitment to a risk-based approach, the need for greater awareness on import safety, and the development of action levels for heavy metals in food. He also touched on the FDA's efforts to improve nutrition through labeling initiatives and sodium and sugar reduction targets, stressing the necessity of stakeholder partnerships for public health improvements.

Takeaways

• 🌟 Jim Jones, the first-ever Deputy Commissioner for Human Foods at the US FDA, has been leading a newly redesigned human foods program since September of the previous year.
• 🛠️ Deputy Commissioner Jones has a background at the US Environmental Protection Agency, where he led significant programs including the overhaul of the Toxic Substances Control Act.
• 🔍 Jones is committed to transparency, as evidenced by his quick response to a FOIA (Freedom of Information Act) request, which was the fastest the questioner had ever received in their professional career.
• 🍽️ The FDA's proposed reorganization aims to create a unified human foods program, focusing on wellness through food safety, chemical safety, and nutrition, with implementation hoped for in fiscal year 2024.
• 🛡️ The FDA's approach to food safety involves a systematic risk management strategy, prioritizing interventions that have the greatest opportunity to prevent disease and illness.
• 🌐 The success of the new human foods program will be measured by the safety of the US food supply, and the FDA is working closely with the food industry and other stakeholders to achieve this.
• 🚫 The FDA is not resourced or organized to rely solely on compliance actions to ensure food safety; instead, it seeks a partnership approach with the industry based on mutual understanding and shared responsibility.
• 📋 The FDA is working on finalizing the 'Safe Production of Water for Use on Produce' rule and the 'Traceability' rule under the FSMA (Food Safety Modernization Act) to improve food safety and response to foodborne illness.
• 🔬 The 'Closer to Zero' program is an FDA initiative aimed at addressing heavy metals in food, particularly focusing on developing health-protective and feasible action levels for industry.
• 🍎 The FDA is also focusing on nutrition, with efforts to reduce sodium and added sugars in the food supply, and is considering the development of a healthy symbol for food packaging to help consumers identify healthier options.
• 🤝 Collaboration and leveraging the expertise of stakeholders and partners are key to achieving the FDA's goals for food safety and nutrition, emphasizing the need for a unified approach.

Q & A

What is the significance of the 47th Annual National Food Policy Conference?

The 47th Annual National Food Policy Conference is an important event where key stakeholders in the food industry gather to discuss policies, safety measures, and innovations that impact the food supply and public health.

Who is Jim Jones and what is his role at the FDA?

Jim Jones is the first-ever Deputy Commissioner for Human Foods at the US Food and Drug Administration (FDA). He has been leading a newly redesigned human foods program since September of the previous year, bringing his experience from the US Environmental Protection Agency.

What is the FDA's new approach to food safety under Jim Jones' leadership?

Under Jim Jones' leadership, the FDA is focusing on making food about wellness through ensuring food safety, enhancing food chemical safety, and improving nutrition. The agency is working towards a systematic risk management approach to achieve these goals.

What is the FDA's stance on the use of 'Generally Recognized As Safe' (GRAS) self-determinations by manufacturers?

The FDA views the GRAS self-determination process as a weakness in the system because it allows for self-certification without mandatory notification to the FDA. However, the agency has created a voluntary mechanism for manufacturers to submit their GRAS notices for review, and the majority do so.

How does the FDA prioritize its resources for addressing different food safety issues?

The FDA prioritizes its resources based on a risk management approach, focusing on issues where intervention has the greatest opportunity for the prevention of disease and illness.

What is the FDA's strategy for dealing with imported foods to ensure they meet safety standards?

The FDA is working on ensuring that imported foods are produced with the same level of safety as domestically produced food. The Foreign Supplier Verification Program (FSVP) requires importers to verify that the food they import meets all applicable safety requirements.

What is the FDA's 'Closer to Zero' program and what is its goal?

The 'Closer to Zero' program is a multifaceted initiative aimed at addressing the realities of the growing environment and responding to the potential risks of early exposure to heavy metals. It focuses on developing health-protective and feasible action levels for industry, starting with foods intended for babies and young children.

What is the status of the FDA's proposal for a unified human foods program?

The proposal for a unified human foods program was submitted by FDA Commissioner Caleff at the end of 2023 and is currently undergoing a formal external review process. The FDA hopes for its implementation sometime in fiscal year 2024.

How does the FDA plan to address the issue of sodium and added sugars in the food supply?

The FDA is developing sodium reduction targets and is in the process of gathering information on how to address the overconsumption of added sugars. They are also considering the development of a healthy symbol for food packages and front-of-package labeling to help consumers make healthier choices.

What is the FDA's approach to collaboration with stakeholders in achieving its goals for food safety and nutrition?

The FDA emphasizes the importance of working closely with the food industry, regulatory counterparts, and consumer advocacy groups. It believes in leveraging the expertise, information, and resources of its network of stakeholders and partners to make a difference in public health.

Outlines

00:00

🎉 Opening Remarks and Introduction of Deputy Commissioner Jones

The script begins with an introduction to the 47th Annual National Food Policy Conference. The speaker expresses gratitude to the attendees and extends a warm welcome to the stage to Jim Jones, the first-ever Deputy Commissioner for Human Foods at the US Food and Drug Administration (FDA). Since his appointment in September of the previous year, Jones has been leading a restructured human foods program. His background includes a significant tenure at the US Environmental Protection Agency, where he spearheaded the overhaul of the Toxic Substances Control Act and various sustainability initiatives. The speaker recounts a positive first impression of Jones and commends his commitment to transparency, exemplified by a prompt response to a Freedom of Information Act request. Despite challenges and differing opinions about the FDA's role, Jones is presented as a figure of hope and optimism for the future of the human foods program.

05:01

🛠️ FDA's Unified Human Foods Program and Food Safety Prioritization

Deputy Commissioner Jones discusses the proposed reorganization of the FDA's food program, emphasizing the importance of a unified approach to human foods. The reorganization proposal, submitted by FDA Commissioner Caleff in 2023, is undergoing external review with the hope of implementation in fiscal year 2024. The new structure aims to focus on wellness through food safety, chemical safety, and improved nutrition. Jones highlights the need for a systematic risk management approach to target interventions effectively. He acknowledges the high safety standards of the US food supply but also the human toll and challenges faced during foodborne illness outbreaks. The FDA's role is not just to police the industry but to work in partnership, emphasizing prevention over reaction. The discussion also touches on the importance of collaboration with the food industry, regulatory counterparts, and consumer advocacy groups.

10:02

🌱 FSMA Implementation and the Challenge of Imported Foods

The script delves into the impact of the Food Safety Modernization Act (FSMA), which introduced a prevention-oriented framework for food safety. The FDA, in collaboration with state and international partners, has been supporting the industry in meeting FSMA requirements. The act places responsibility on the food industry to identify hazards, prevent contamination, and ensure compliance. A significant issue raised is the safety of imported foods, with the Foreign Supplier Verification Program (FSVP) requiring importers to verify that imported foods meet safety standards. The recent Leen cinnamon applesauce incident is cited as an example of the need for greater awareness and enforcement of these requirements. Jones also calls for greater authority to require product testing for contaminants.

15:06

💧 Finalizing FSMA Rules: Water Safety and Traceability

The script discusses two specific FSMA rules: the agricultural water rule (awat rule) and the traceability rule. The awat rule is set to establish a system for assessing potential hazards in water used on produce prior to harvest. The FDA is developing resources to support compliance once the rule is published. The traceability rule requires recordkeeping for certain foods to enable a rapid and targeted response to foodborne illnesses, reducing waste from broad recalls. The rule also necessitates communication and sharing of product traceability information between industry members and the FDA, marking a significant shift in requirements.

20:07

🚫 Addressing Chemical Safety and Reducing Exposure to Heavy Metals

Chemical safety is a key focus, with the 'Closer to Zero' initiative aiming to tackle heavy metal exposure in foods, particularly for babies and young children. The FDA is developing health-protective and feasible action levels for heavy metals like lead, arsenic, and cadmium. The agency's authority to pursue action against any product is clarified, with action levels indicating when the FDA will take legal action. Collaboration with the USDA, manufacturers, and growers is emphasized to identify solutions for reducing heavy metals in food commodities. The script also mentions the need for a systematic framework for reassessing chemicals in food, following the removal of PFOA from grease-proofers used on paper food packaging.

25:08

🍎 Nutrition as a Cornerstone of Food Safety

Nutrition is highlighted as a fundamental aspect of food safety, with the goal of preventing illness and promoting wellness. The FDA is working on two labeling efforts to help consumers identify healthier food options, including finalizing the definition for the nutrient content claim 'healthy' and developing a healthy symbol for food packages. The agency is also focusing on reducing sodium and added sugars in the food supply, with the development of sodium reduction targets and considering limits for added sugars in school meals. The importance of a whole-of-government approach and collaboration with federal partners is underscored.

🤝 Collaboration and Stakeholder Engagement for Public Health Improvements

The script concludes with an emphasis on the importance of collaboration across stakeholders to achieve the goals of the FDA's human foods program. While acknowledging that there may be differing opinions and strategies, finding common ground is crucial for developing solutions that benefit public health. The need for the expertise, information, and resources of various stakeholders is highlighted, as is the importance of working together to make measurable and sustainable improvements to public health.

🗨️ Audience Q&A Session with Deputy Commissioner Jones

Following Deputy Commissioner Jones' presentation, an interactive Q&A session takes place. Questions from the audience address concerns about the FDA's approach to sodium reduction, the updating of qualified health claims, and the use of antibiotics in the poultry supply. Jones acknowledges the challenges and the need for a comprehensive strategy, including learning from international partners and working with various stakeholders. He also discusses the FDA's role in postmarket surveillance of food chemicals and the voluntary submission of GRAS notices by manufacturers.

Keywords

💡FDA

The FDA stands for the U.S. Food and Drug Administration, which is a federal agency responsible for protecting public health by ensuring the safety, effectiveness, and security of human and veterinary drugs, medical devices, tobacco products, and more. In the video, the FDA is a central focus as the Deputy Commissioner for Human Foods discusses the agency's role in food safety and policy.

💡Deputy Commissioner for Human Foods

The Deputy Commissioner for Human Foods is a high-ranking position within the FDA, overseeing the regulation and safety of food products intended for human consumption. In the transcript, Jim Jones, the first-ever Deputy Commissioner for Human Foods, is highlighted for his leadership in the newly redesigned human foods program.

💡Food Safety

Food safety refers to the handling, preparation, and storage of food to prevent foodborne illnesses. It is a primary concern for the FDA and a central theme in the video. The Deputy Commissioner discusses the FDA's efforts to ensure food safety, including the implementation of new programs and regulations.

💡Toxic Substances Control Act (TSCA)

The Toxic Substances Control Act is a U.S. federal law that gives the EPA the authority to require reporting of chemical substances, their production, distribution, use, and disposal. In the transcript, it is mentioned that Jim Jones led the 2016 overhaul of TSCA, indicating his experience in regulatory reform.

💡Food Safety Modernization Act (FSMA)

The Food Safety Modernization Act is a landmark legislation that aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it. The video discusses how FSMA has reshaped the food safety system and the FDA's role in implementing its rules.

💡Chemical Safety

Chemical safety in the context of food involves the control and management of chemicals that may contaminate food products, such as heavy metals. The transcript mentions the FDA's 'Closer to Zero' program, which is an initiative aimed at addressing the potential risks of early exposure to heavy metals in food.

💡Nutrition

Nutrition is the process by which organisms take in and utilize nutrients for growth, maintenance, and reproduction. In the video, the FDA's focus on nutrition is highlighted as a means to promote wellness and prevent diet-related diseases. The Deputy Commissioner discusses efforts to improve nutrition through labeling and reducing sodium and added sugars in food products.

💡Risk Management

Risk management is a systematic process of identifying, analyzing, assessing, and controlling risk. In the context of the video, the FDA uses a systematic risk management approach to prioritize and address issues in food safety, aiming to prevent disease and ensure a safe food supply.

💡Regulatory Compliance

Regulatory compliance refers to the adherence to rules, regulations, and laws governing an industry. The transcript discusses the FDA's role in ensuring that the food industry complies with safety standards and regulations, such as those set forth by FSMA.

💡Public Health

Public health is the science and practice of promoting the health of the public and improving the conditions that affect a community's health. The video's theme revolves around the FDA's mission to protect and promote public health through food safety measures, chemical safety programs, and nutritional initiatives.

💡Stakeholder Collaboration

Stakeholder collaboration involves working together with various parties that have an interest or concern in a particular issue. The Deputy Commissioner emphasizes the importance of collaboration with industry, regulatory counterparts, and consumer advocacy groups to achieve the FDA's goals for food safety and nutrition.

Highlights

Introduction of Jim Jones, the first-ever Deputy Commissioner for Human Foods at the US Food and Drug Administration (FDA).

Jim Jones' background includes leadership in the Environmental Protection Agency and involvement in the 2016 overhaul of the Toxic Substances Control Act.

Jones has been leading a newly redesigned human foods program at FDA since September of the previous year.

The FDA's proposed reorganization aims to create a unified human foods program to impact food safety.

The unified human foods program is currently undergoing a formal external review process.

The vision for the new program includes focusing on wellness through food safety, chemical safety, and improved nutrition.

The new organizational framework will support a systematic risk management approach to food safety.

The success of the human foods program will be measured by the safety of the US food supply.

Imported foods need to be produced with the same level of safety as domestically produced food.

The FDA is requesting additional authority from Congress to require product testing for contaminants in foods.

Finalizing the Agricultural Water Rule to assess potential hazards in water used on produce prior to harvest.

Traceability final rule requires recordkeeping for certain foods to respond quickly to foodborne illness.

Closer to Zero program aims to reduce exposure to heavy metals in foods, especially for babies and young children.

FDA is working on a systematic framework for prioritizing chemicals for reassessment in food.

Improving nutrition is considered a key strategy in food safety and disease prevention.

FDA is working on labeling efforts to help consumers identify healthier food options.

Sodium reduction targets are being developed by FDA to lower sodium intake in the food supply.

Added sugars are being targeted for reduction in the food supply to combat obesity and chronic diseases.

Collaboration with stakeholders is essential for the FDA to achieve its goals in food safety and nutrition.

Postmarket surveillance of food chemicals is a challenge due to the GRAS (Generally Recognized As Safe) self-determination by manufacturers.

The FDA is reviewing the New York bill regarding the disclosure of GRAS determinations.

Transcripts

today so again thank you for being here

once again welcome to the 47th Annual

national food policy conference and now

to kick off our program I'm pleased to

Welcome to the stage the US Food and

Drug administration's first ever Deputy

Commissioner for human foods Jim Jones

um since September of last year Deputy

Commissioner Jones has taken the Helm of

a newly redesigned human foods program

at FDA he's a longtime veteran of the US

Environmental Protection Agency where he

led the

2016 U overhaul of the toxic substances

control act as well as several National

level sustainability programs including

the environmental preferable purchasing

program and the presidential green

chemistry Awards challenge uh I first

met Deputy Commissioner Jones when he

served on the Reagan Udall foundation's

expert panel charged with evaluating

fda's human foods

program and like many of you I I was

very impressed with the report that they

they put out uh uh in in part of that

process but what I was really impressed

with with Deputy Commissioner Jones uh

was when his name first surfaced uh

people that couldn't agree on whether

FDA should be funded uh were were in uh

uh just just wrapped a uh um Harmony

about uh what a great choice he he was

to to lead the humans Foods program and

um since his appointment um you know

I've been really impressed by his

commitment to transparency uh recently I

received the fastest response to a foyer

request I've ever received in my

professional career as a public interest

Advocate and uh maybe it's just subject

matter but but I you know I'd like to

think maybe he had something to to do

with that um so we know there are a lot

of strong opinions about what FDA is

doing uh and and he's definitely got his

work cut out for him but uh he's given

us uh hope for you reason for cautious

optim M and we are thrilled to have him

with us today Deputy Commissioner Jones

thank you for being

[Applause]

here thank you

Thomas it's been uh fascinating I I was

an assistant administrator at the UPA

which arguably is a higher rank but

nobody ever called me assistant

administrator was that guy or something

else and but there seems to be an

absolute Fascination in the FDA world to

use the term Deputy Commissioner I was

on my I I keep telling my staff Jim call

me Jim call me Jim Deputy Commissioner

Jones Deputy Commissioner I was on a I

had to do a call one day with my we were

I was driving and my wife was driving

and I was doing the call and it was on

speaker phone and she just could not

stop chuckling at how many times Deputy

Commissioner Jones was mentioned but

um I should take it as a

compliment it's great to be with you all

today and I know for many of you the

proposed reorganization of our food

program and how it will impact our

approach to food safety continues to be

of significant interest as you're likely

aware the proposal for a unified human

foods program was submitted by FDA

commissioner caleff at the end of 2023

it's currently undergoing a formal

external review process required of all

major federal

reorganizations we are very hopeful that

implementation can occur sometime in

fiscal year

2024 our vision for this work is already

taking shape we are focused on making

food about Wellness through ensuring

food safety enhancing food chemical

safety and improving

nutrition once the structures in place

we will have an organizational framework

that supports and facilitates a

systematic risk management approach to

achieving these

goals as we are currently resourced

prioritization in risk management is how

we can zero in on those issues where

intervent intervention has the greatest

opportunity for the prevention of

disease and

illness the success of the new human

foods program will largely be measured

by the safety of the US food supply and

while we are fortunate that ours is

among the safest Food Supplies in the

world for every food born illness

outbreak and contamination event

there is a human toll which can be

devastating for those individuals

impacted and their

families and each time the credibility

of the FDA and that of the entire food

safety system is questioned and consumer

confidence in the safety of foods is

diminished during these events there is

also a call for FDA to do more to police

the food

industry but we are neither resourced

nor organized to rely exclusively on

compliance actions as the incentive for

industry to meet its

responsibilities moreover catching

industry at failing is not the most

effective way to achieve our goal of

having a safe food

supply the food safety system is a

partnership based on the mutual

understanding that is that is in

everyone's best interest for the food

supply to be safe and

nutritious and as we work toward these

goals it is Essen IAL that we work

closely with the food

industry with domestic and foreign

regulatory counterparts and with

consumer advocacy

groups the focus on prevention of

disease and

illness attributed to food was

solidified 13 years ago when the food

safety modernization act ushered in the

reshaping of the food safety

system fsma gave FDA substantial new

authorities and responsibilities and a

framework for a prevention oriented

system to improve Public

Health through nine foundational rules

and over over 70 guidance documents the

FDA get together with our state and

international Partners has worked over

the last decade plus to support industry

in meeting the requirements of

fsma fsma also made clear that the food

industry is responsible for identifying

hazards and implementing practices to

prevent

contamination having systems in place to

respond to food safety failures and

ensuring they comply with all relevant

requirements one area where we and

Industry need to do a better job as

Imports to help ensure that imported

foods are produced in a manner that

provides the same level of protection as

as expected of domestically produced

food fsma

called for a fundamental shift in the

Imports

Paradigm under the foreign supplier

verification program or fsvp

importers are required to put in place a

program for verifying that the food that

they import meets all the applicable

safety

requirements our inspection activities

for the past few years indicate that

many import importers are unaware of

this

requirement the recent Leen cinnamon

cinnamon applesauce incident highlights

the need for greater Awareness on the

part of Industry of these requirements

and the need for FDA to give greater

attention to fsvp

implementation

another clear strategy is end product

testing this can immediately help

Safeguard the food supply and ensure

that foods with unexpected levels of

heavy metal such as lead do not make it

to

Market because FDA cannot require

companies to conduct this type of

testing we have asked Congress for

additional authority to require product

testing of foods for contaminants and to

make the records available for

FDA I'd like to also spend a minute or

two on two phys on two F fsma rules the

awat rule and the traceability rule this

spring we'll be finalizing the a water

rule through this Ru making we are

leading the world and laying out a

system for assessing assessing potential

hazards that could impact the safety of

water used on produce prior to harvest

and a risk- tiered approach for

addressing these hazards in order to

keep produce safe the team at EPA at FDA

I make that mistake a fair amount is

currently working on a number of of

fronts to develop resources so that we

are ready to Support Compliance once the

rule is

published another major fisma rule where

a lot is happening is the traceability

final rule which requires specific

recordkeeping for certain

foods successful implementation will

help us achieve a safer food supply that

is equipped to respond quickly and in a

targeted

fashion to food born illness it will

also help reduce the tremendous waste of

food and resources that occurs when

recall Nets recalls cast Nets that are

overly broad because we lack critical

information to Target only the

implicated

product unlike other fisma rules the

traceability rule requires communication

and sharing product traceability

information between members of the

industry and between industry and the

FDA in a way that hasn't been required

in the

past there is no question that this is a

heavy lift we're keenly aware that we

can't achieve the intent of the rule if

the requirements can't be met in the

timeline we have set out with compliance

dates 20 months out we are committed to

working with industry to get this

right sorry lost my page

here

I want to Pivot now to our chemical

safety

programs our closer zero program offers

a great example of where collaboration

can help move the needle on food

safety for those of you not already

familiar closer to zero is a

multifaceted initiative to contend with

the realities of the growing environment

and respond to emerging signs on the

potential risks of early exposure to

heavy metals the corner Stone of this

program is developing guidance to

Industry on action levels that are

Health protective and also feasible for

industry we are working on issuing

action levels on Le for Foods intended

for babies and young children followed

by action levels for arsenic and

cadmium I want to be clear about action

levels and our authorities under the

federal Food Drug and cosmetic act the

agency has authority to Pur pursue

action against any product at the

minimal detectable level of the

contaminant when it is injurious to

health action levels and tolerances

represent limits at or above which FDA

will take legal action to remove

products from the market to help support

reductions in the Commodities used in

food we're working closely with USDA and

in collaboration with manufacturers and

Growers to identify

Solutions we have we plan to expand this

approach Beyond baby foods since

children only eat them for a short

amount of time and we will look to

stakeholders to help us identify other

Foods where action levels would be

appropriate ultimately if we can make

small reductions in heavy metals in

whole swath of Commodities it can result

in a significant reduction exposure to

heavy metals from the overall diets of

our

children food safety is not only about

protecting food from contaminants and in

our new human foods program structure

our work on chemical contaminants and

food additives will be housed in the

office of food chemical safety dietary

supplements and

Innovation and as part of our work work

to enhance food chemical safety we are

embarking on creating a systematic

framework and criteria for prioritizing

chemicals for

reassessment as we have seen in the past

when new data and information become

available postmarket safety reviews can

raise important questions most recently

with our announcement about the removal

of P from G grease proofers used on

paper food P packaging the safety review

is critical to working with industry to

secure a phase out that eliminates the

primary source of dietary exposure to P

from food contact

applications we updated our list of

additives and contaminants we have

targeted for reassessment and in the

year ahead we will continue to share

updates on this list and information

about the development of our framework

criteria the most frequent question I

get is how can FDA influence state

chemical

restrictions my answer is that FDA needs

a more ambitious postmarket chemicals

program we'll also be continuing our

focus on nutrition and in the future

through our dedicated Nutrition Center

for excellence in the new human foods

program in many ways improving nutrition

can be thought of as the outermost limit

of food safety

prevention the goal for our programs is

ex the goal for all of our programs is

essentially the same the prevention of

illness and disease and the promotion of

wellness and across our efforts to

promote food safety we are very

intentional about maintaining access to

foods that are that Supply vital

nutrients

we know that fruits and vegetables whole

grains and dairy are critical for

healthy development and that good

nutrition is essential across the

lifespan right now with all the health

metrics related to diet related to diet

related preventable disease going in the

wrong direction improving Health

improving nutrition offers us one of the

best public health interventions for

reducing chronic illnesses and premature

death providing information is a key

strategy when it comes to helping

support consumer in making decisions

around

nutrition and in the year Ahad we are

work working on two labeling efforts to

make it quick and easy for people

particularly those with lower nutrition

knowledge to identify healthier

foods the first is a long time coming

with a finalization of the definition

for the nutrient content claim

healthy we are considering the comments

received to the ru making as well as the

current dietary guideline

recommendations and nutrition science as

we work to finalize the

role on a separate track from the

definition is our consumer research

related to work to develop a healthy

symbol that could appear on food

packages we're also working on on

issuing a proposed rule for front of use

for front of package

labeling we have conducted extensive

Outreach to get stakeholder input and

are carefully considering the input we

received as well as lessons from

International

experiences once the proposed rule is

issued I encourage you to submit

comments and other information

in addition to labeling we are targeting

two specific Nutri nutrition issues most

people in the US consume too much sodium

and added sugars from processed packaged

and prepared foods and I believe the FDA

industry have a meaningful and Industry

have the meaningful role and

responsibility to help Advance diet

changes and bring down the rates of

obesity and other chronic

diseases for sodium we are currently

developing the second draft second set

of dra

sodium reduction targets the data so far

from our first round of sodium targets

is preliminary but for the most part

encouraging we expect that lowering

sodium in the food supply will be a

gradual iterative stepwise process to

allow for reformulation and to help

consumers pallets adjust we will

continue to monitor the food supply to

see what the impact is we are also

targeting reductions in added

sugars added sugars is a good example of

where we benefit from a whole of

government

approach the science that supported the

dietary guidelines for Americans in 2015

supported our requirement for added

sugars to be declared on the nutrition

facts label and now USDA has proposed

limits for added sugars and School meals

we are still in the information

gathering

phase we are reviewing the comments we

received to our public meeting at the

end of last year and we will continue to

work with our federal Partners in

determining how to address the overc

consumption of added

sugars before I turn it over for your

questions I'd like to emphasize that

none of what we can accomplish can be

done by FDA

alone key to the vision of a unified

human foods program is strengthening our

relationships across our

stakeholders for us to successfully

reach our goal goals for food safety and

nutrition we must Leverage The expertise

of our network of stakeholders and

partners we each bring different tools

information and resources which if we

work together we can use to make a

difference in the health and well-being

of our fellow

Americans This doesn't mean we'll agree

on

everything difference of opinions and

strategies inherent in these types of

conversations but by coming together and

finding common ground we're in a much

better position to identify solutions

that work for as many entities as

possible to make the type of measurable

and sustainable improvements to Public

Health that eisma and the human foods

program has set for us we need the

collaboration of of our wide array of

stakeholders thank you for having me

today and I look forward to our working

[Applause]

together thank you very much for your uh

wonderful overview of what you're trying

to accomplish at the FDA I'm Michael

Jacobson founder of the national food

Museum um you you emphasized that FDA is

going to follow a risk-based approach to

allotting resources to focusing

attention uh Tom freden has estimated

that excess sodium is causing as many as

a 100,000 deaths per year I suspect

that's more deaths than just about

everything else FDA is working FDA

you're working on

combined I'm wondering um how many

dollars how many

FTE are assigned to pressuring industry

and educating consumers to reduce sodium

consumption it's great question and

sodium is definitely a high-risk uh uh

issue for Americans which is why we're

focusing on reducing sodium in the diet

and so our budget does come to us with a

range of restrictions on it and the

dollars that we get for nutrition are

are quite modest I will say um it's

probably this of the three major risk

areas that I talked about uh this

morning nutrition is by far the smallest

and that is associated with the amount

of money that we get for nutrition I

don't have the exact dollar amount on my

head but is absolutely the smallest when

it's compared to chemical food safety or

micro biological food safety has the FDA

had even one

full-time uh staffer working to pressure

industry to lower

sodium so we've got a rather significant

team of numerous people across many

parts of our organization that clearly o

when you add them all up are more than

one FTE I wouldn't say pressure pressure

is not not our statutory Authority is to

pressure it is to um uh help manage the

food supply in a way that makes it

healthier for Americans and that's

that's what our sodium reduction goals

have been about you know I suggest that

you look at the British program from

roughly 2005 to 2010 a successful

program to lower sodium levels that had

media advertising press conferences and

me um um pressure direct pressure on

industry you could call it persuasion if

you like U but it is far far more than

what the FDA is doing to reduce that

awesome death

toll thank you I appreciate that we we'

learn a lot from our International

partners that being said I will say

Congress has been very reluctant to give

FDA money

for advertising or um

marketing hi my name is Shelley

Maniscalco from nutrition and demand

it's very exciting that that um healthy

will be finalized and that will'll be

consistent with the dietary guidelines

taking a food group approach and as well

as um being updated to you know the

current dietary guidance versus years

past I'm wondering what your approach

will be to updating the qualified Health

claims as well as you know they're

currently associated with very very very

old dietary guidelines which have a

limit on total fat and does not you know

distinguish between

um the healthier fats and and saturated

fat as well as different um Nutri

nutrients of Public Health concern yeah

so I have to say I I've yet to spend

much time on the qualified claims yet

but I I've got some folks here who I bet

know the answer to that so maybe at the

break I can connect you with them and we

can get you an answer great thank you I

appreciate it

thanks hi thank you for being here I'm

Dr Katie Wilson executive director of

the urban School Food Alliance so we

represent the largest public school

districts in the country and their

school launch program

we spent two years trying to get

antibiotics out of the poultry system

and The Way We Were purchasing in

procurement and now of course we've

heard all these announcements um like

Chick-fil-A and and it it's really

because the largest supplier in the

country is decided not to do this

anymore and so this whole issue of

antibiotics not for human medicine and

you know we work with the George

Washington um antibiotic resistance

Center and so there's not the science to

show that isn't impacting human uh human

health so as FDA looking at antibiotics

we're really disappointed because of

course it's hurting us in our effort to

take antibiotics out of the particularly

the poultry Supply and School meals is

FDA looking at antibiotics in any way

shape or form or this whole issue of not

used for human medicine so I so the

center for veterinary medicine which is

not in my remit has the lead on that but

I'm actually I'm talking to that

director this afternoon so I'll I'll

pose that question to her and if you

give me your card I can get back to you

on that I'd be grateful thank you yeah

sure take it no one wants to ask a

question I I wanted to ask a follow-up

question on on your um comment about the

postmarket surveillance of of food

chemicals and

um maybe you could comment on the New

York bill that requires the disclosure

of the the secret grass determinations

and kind of how why is that not an

approach that FDA is

prioritizing so grass is an interesting

um um feature of the ffdca the

manufacturers do have the ability if

they meet certain criteria to make a

self-determination that a food is

generally recognized as safe and they

don't actually need to inform the FDA of

that I I personally view that as a a um

weakness in the system in that it it

creates the sense that there isn't any

government oversight our experience is

that the vast majority of Manufacturers

voluntarily submit their grass notices

to FDA for us to review them and

periodically we we will send them a

letter saying this doesn't meet the

criteria um we we have created that

voluntary mechanism because we think it

without it it undermines this the sense

that the that the the food safety the

food system is safe we actually have

very little evidence that manufacturers

are doing a grass determinations and not

noticing us we do some monitoring of the

food supply and so if we were to find a

chemical that wasn't in our in our

inventory either because we had approved

it or because the grass was voluntarily

submitted that would be a sing signal to

us that there was a possible either it

was just a violative ingredient or it

was a self- grath determination but we'd

follow up um we do not find that very

often so it does not seem that the

manufacturers are doing graphs without

giving us notice um so so we we feel

that I'm I'm sure the number is not zero

but we feel that the vast majority of

grass um determinations are being

submitted to FDA we do review them they

get a review the review is fundamentally

the standard of reasonable certainty no

of no harm um and as I said periodically

we find a a grass submission does not

meet that standard and we we post that

that those reviews are available so I I

think grass is a very challenging one

because because it's it's a allows for

the self certification of generally

recognized as safe but as I said we

created a pathway for manufacturers to

voluntarily submit and they seem to for

the most part you know more than the

most part the overwhelming majority do

seem to submit them to FDA for review