SUMMER 2010

EATING
YOUR WAY TO
HEALTH
PETER J. PITTS MARY CHRIST-ERWIN
Global Head Partner
Regulatory and Health Policy Porter Novelli Public Services
 Eating Our Way to Health | 2 PORTER NOVELLI | AMPLIFY

IMAGE (TOP TO BOTTOM) PROVIDED BY CREATIVE COMMONS/FRAPESTAARTJE; BEN STEPHENSON, VICCI

 PETER J. PITTS MARY CHRIST-ERWIN
Global Head of Regulatory and Health Policy Partner
Porter Novelli New York Porter Novelli Public Services, Washington, DC
Peter.Pitts@portenovelli.com | 212.601.8208 Mary.Christ-Erwin@porternovelli.com | 202.973.3601

WHAT ABOUT
BETTER HEALTH
Through Better Nutrition?
A new report by the Institute of Medicine (IOM) and the National Research Council (NRC) says
the U.S. Food and Drug Administration (FDA) isn’t able to deal with the nation’s food supply
problems.

To conclude that the FDA needs to do more more efficiently does not, shall we say, provide a
memorable “aha!” moment.

The report offers Congress – which commissioned the report – some food for thought as it
prepares to tackle FDA reform this year. The IOM concludes that in order for the FDA to better
ensure food safety, legislative and organizational changes may be necessary. Most notably, it
says, Congress should consider taking legislative action to provide the FDA with the additional
authority it needs to fulfill its food safety mission. Within the FDA, authority over field activities
should shift from its Office of Regulatory Affairs to its Office of Foods. Such a change will
ensure that responsibility lies with well-trained personnel with specialized expertise in food
safety and risk-based principles of food safety management, says the IOM.

Thus far, government efforts to promote better food safety have been made with expanded
recall powers and more numerous inspections. But more needs to be done.

America’s health also depends on having better information about the food they’re eating –
particularly in today’s era of genetically modified foods with nutritional nanotechnology,
probiotics and other functions. Reformers must recognize this new reality and ensure that the
FDA reform capitalizes on using food as a potent tool for better health.

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 “FOOD FOR THOUGHT IS NO
SUBSTITUTE FOR THE REAL THING.”
IMAGE PROVIDED BY CREATIVE COMMONS/SIMON SHEK
An informed consumer makes better, healthier
choices. And nowhere is this more true or
important than when it comes to the foods we
buy, the meals we prepare and the snacks we
eat. Knowledge about health unleashes the
power of health. More information leads to
better choices.
Our nation is facing a crisis and its name is
obesity. Many experts believe that nearly two-
thirds of American are overweight – many of
them children. And the battle is clearly being
fought on the home front. Seventy-six percent
of all meals are prepared at home. If we can
help America shop healthfully, we can begin
to turn the tide against the enemy of obesity.
Back in July 2003, the FDA-issued Task Force
on Consumer Health Information for Better
Nutrition Initiative report concluded that
government efforts to fight poor nutrition –
and the conditions and diseases like obesity
and hypertension that go along with it –
would be doomed unless the agency provided
consumers with better information about
their food.
“A better-informed public, supported by
effective, science-based regulation of health
information, would be expected to make better
Eating Our Way to Health | 4
- WALT KELLY
nutritional choices,” the 2003 report said.
The statement remains a sound hypothesis
and a noble mission, but, unfortunately, the
road to better health through better nutrition
remains paved only with good intentions.
This needs to change.
Most lawmakers seem to think that shuffling
the responsibilities of government agencies
charged with regulating public health is the
answer.
Present FDA reform efforts have fallen prey
to this brand of thinking. For instance, the
IOM/NRC report called for the creation of a
new “single food agency” as the cure-all for
the FDA’s food problems.
The debate over a single food agency simply
distracts reformers from changes that could
improve Americans’ health - like improved
dissemination of nutritional information.
As Americans stroll through supermarket
aisles, they must have accurate, helpful and
understandable information about the most
important nutritional and health implications
of the products on the shelves.
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In 1990 Congress passed the Nutrition
Labeling and Education Act (NLEA), which
established the FDA-regulated Nutrition
Facts Panel (what most civilians refer to as
“the food label) “to assist consumers with
healthy dietary practices.” The fact that the
“E” in NLEA remains silent continues to
go sadly unrecognized, unreported – and
unaddressed. While reading food labels has
become a routine aspect of every trip to the
grocery store, the FDA has done little to
advance the equally important educational
component of the law. And that’s a real
disservice to the public health.
The future of nutrition and diet/disease
relationships is evolving very rapidly. Science
is exploring opportunities for improving
the health consequences of nutrition that
range from a better understanding of the
impact of general dietary patterns for the
U.S. population as a whole to the specific
understanding of how an individual’s
genetic makeup interacts with food and
the environment – dubbed “nutritional
metabolomics” – increasing the ability to
“design” foods and diets for individuals to
maximize health.
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IMAGE PROVIDED BY CREATIVE COMMONS/REDJAR
As part of the NLEA, Congress gave the
FDA the option of establishing a different
standard for health claims for dietary
supplements labels as compared with
that which Congress had provided for
conventional foods. The FDA determined
that the best course of action was to use the
same standard for both dietary supplements
and conventional foods. This decision was
motivated by public health considerations:
All consumers eat conventional foods and
most use dietary supplements; inconsistent
standards would lead to consumer confusion
and biased consumption choices. So, current
regulations for health claims apply equally to
dietary supplements and conventional foods.
In setting the rules for health claims,
Congress provided for the FDA to authorize
health claims when the agency determined,
based on the totality of publicly available
scientific evidence (including evidence
from well-designed studies conducted in a
manner consistent with generally recognized
scientific procedures and principles), that
there is significant scientific agreement (SSA),
among experts qualified by scientific training
and experience to evaluate such claims that
Eating Our Way to Health | 5
IMAGE PROVIDED BY CREATIVE COMMONS/PICKINJIM2006
the claim is supported by such evidence.
Under existing regulations, health claims
are put in place through a petition process
by which the FDA reviews the science that
both supports and opposes the claim, and
determines whether to authorize the claim
through notice-and-comment rulemaking.
The tension between First Amendment
protection of commercial speech and
appropriate regulatory oversight has not only
delayed claims from moving forward but has
hindered industry’s ability to communicate
about its products health benefits.
Scientifically supported claims need to move
forward. The FDA has the authority - but has
chosen not to use it, instead falling back on
the old excuse of “more data required.”
One of the key issues crippling the nutritional
claims process is our current philosophy
of holding food science to a drug science
model. Today it’s almost impossible to get
a health claim approved, for example, as
observational data simply isn’t acknowledged
as sufficient. New research methodologies
are critically needed and it’s imperative that
government, universities and appropriate
scientific organizations come together to put
the best and brightest minds to the task of
Eating Our Way to Health | 6
navigating a path forward to new ways – and
new means – of designing, analyzing and
interpreting food and nutrition research.
There needs to be more expertise at the table –
the usual suspects are not getting the job
done. The fundamentals of what’s in our food
and why has been discussed ad nauseum –
but only to the extent of what’s wrong with our
food supply versus what’s right and how we
reconcile an obese population with consumer
demand for more convenient, great tasting,
affordable and healthy options.
Informed consumers make better choices,
certainly. But consumers are generally
provided only part of the story. Nanotech,
probiotics, etc. are critically important
moving forward if industry (with appropriate
government oversight) is to deliver against the
multiple demands being made upon the food
supply for enhanced nutrition with contained
calorie levels and safety. The nutrition side
of the story requires varying degrees of
processing, a word that, today, fundamentally
means “bad” or at least “less healthy.” Food
science and technology experts must be
brought to the table to help policy makers,
public health officials and other involved
constituencies understand how food is both
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 “LET YOUR FOOD BE YOUR MEDICINE,
AND YOUR MEDICINE BE YOUR FOOD.”
produced and protected. Not only would this
be an important addition to the nutrition and
obesity debates, it can offer (in context) all
of the exciting things that are happening in
enhanced nutrition and safety.
Today, the generally accepted strategy is to
impose parameters and regulations versus
striving to understand what consumers
respond to and how to better design programs
and policies that positively influence behavior.
We all need to look at who is communicating
effectively with consumers, learn from those
best practices, identify research gaps and
focus on how public/private partnerships can
work together to create a small-steps plan
to advance with purpose and impact. For
example, First Lady Michelle Obama’s “Let’s
Move” initiative lays out all of the things
industry should do to restage, modify and
innovate the food supply, but to what degree
are those with the expertise and ability to
execute on these objectives involved? What
will these changes require? What will they
cost? And what is the time frame in which they
can happen? From nutrition and food safety
policy to educational initiatives, our national
conversation has become a series of edicts
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- HIPPOCRATES
IMAGE PROVIDED BY CREATIVE COMMONS/EMPRACHT
that, given history, will become the sound
and the fury, signifying – and achieving –
nothing. The time for sound bites is over.
We’ve learned over and over again that
information, clearly communicated, can
change even the most entrenched behavior –
that people will make better, healthier choices.
And when coupled with appropriate public
health policies and consumer protections,
industry responds to the demands of
consumers and the new insights of science.
The public health challenges are great, but
the opportunities to make a real difference
for the health of the public have also never
been greater.
Making foods “safer” is important and the
IOM’s recommendations should be heeded,
but delay in communicating about the health
benefits of foods is a real disservice to public
health. Lawmakers are rightly concerned
about the FDA’s ability to ensure the safety of
the nation’s food supply. But a safe food supply
means little if consumers lack appropriate
information about the food they’re eating.
Reformers should act accordingly.
Eating Our Way to Health | 7
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Front cover image (top to bottom) provided by Creative Commons/Joelogon, Bruno Girin, Orangejack
Back cover image (top to bottom) provided by Creative Commons/Dno1967, Oskay, Oskay