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David A. Kessler, M.D. - National Food Editors and Writers Association

Remarks by
David A. Kessler, M.D.
Commissioner of Food and Drugs

National Food Editors and Writers Association

Washington, D.C.

October 3, 1991

Good Afternoon.

In a few weeks, the Food and Drug Administration will propose the most
sweeping revision of the food label in the Nation's history.

The changes will be comprehensive, and they will be designed to improve the
health of all Americans.

Yet I am here today not to talk about the specifics of those proposals -- I
will make sure that we have ample time to do that in November.

Instead, what I want to do today is to step back a little -- before people
stake out their positions on specific elements of those proposals.
I want to discuss with you the broader issues that underlie what the coming
food labeling changes are all about.

And, for that matter, what the Food and Drug Administration is all about
these days. What we are trying to accomplish. And what we stand for.

For a minute, I will leave aside the importance of the Nutrition Labeling and
Education Act which is the basis of the FDA food labeling reform.

I would argue that what is really at stake has much more to do with the will
of this agency to carry out its mission than it does with specific actions,
specific regulations, and individual products.

I say this because of my firm conviction that, until the FDA can ensure that
it is a resilient and strong advocate of the American consumer, we will never
be able to give the public what they deserve. And what they deserve is full
confidence that we are doing our job.

Consider for a moment the problems, as I saw them, when I joined the FDA late
last year.

Here's a sample of what I was confronted with: cholera coming up the coast,
the AIDS epidemic, questions about the safety of blood and blood products,
methadone, salmonella, generic drugs, products of the new biotechnology, drug
residues in milk, shellfish.

To make matters worse, the last several years have not been kind to the FDA.
There was a period during which agency resources steadily eroded. The
generic drug scandal sent shock waves through the FDA and industry. Morale
at the FDA was low, and it was not helped by the eroding respect for
employees of the Federal government. But I was even more concerned that the
FDA had lost the respect of the industries whose products we regulate.

Let me be clear on this point. I do not view industry as a bunch of
"scofflaws," to use Mr. Dingell's incisive term. Just the contrary. I
believe we are healthier today because of the energies of those who grow,
process and sell the food that sustains us.

But, slowly and almost inexorably over the years, the FDA had reached the
point where it was no longer viewed as a force to be reckoned with.

The proverbial line in the sand -- the line beyond which those regulated must
not go -- was drawn inconsistently, or it was not drawn at all.

On those occasions when it did manage to draw the line, FDA did not always
muster sufficient incentive to keep industry from straying over the line.

In my first speech as Commissioner, I told some 1200 food and drug lawyers
and other experts that I take the statute very seriously. That's probably
what they expected me to say.

Some of those same lawyers were doubtless in the audience last April, when I
told a group of food industry representatives that I place a high priority on
enforcing the law. Again, what would you expect from the head of the FDA?

A few moments later I announced that the U.S. Attorney's office in
Minneapolis was filing a seizure action, on FDA's behalf, against Procter &
Gamble's Citrus Hill Fresh Choice orange juice.

In that instant, I believe that people began to understand what I meant by
providing adequate incentive not to cross the line.

Despite months of negotiations and years of warnings, some had not yet come
to understand that FDA regards the use of the term "fresh" on highly
processed products as false and misleading -- and confusing to consumers.

Still, some argued, "That was only one action." A prominent consumer
activist in town said, "One action does not a policy make."

But as the summer unfolded, FDA observers began to comprehend that the Citrus
Hill action had much less to do with freshness than it did with the way we
enforce the law.

I know that you and your colleagues are interested primarily in FDA's
regulation of the food supply -- and we acted quickly last spring to remove
misleading claims from the food label.

I am sure that you have been following our actions on "no cholesterol"
labeling, and our position that "percent fat free" labeling is equally
misleading.

But the need to raise the enforcement profile of the FDA extended well beyond
the food industry. We've also taken actions against other industries. In
the end, however, I would argue that FDA's seizures of condoms, collagen, and
breast implants, over the last several months, have as much to do with the
FDA's overall commitment to protect the public health as they do with the
medical devices themselves.

The compound effect of these enforcement actions is to send a message to
industry: This agency means business.

The public should take heed as well. I want Americans to realize that what
we have done -- what we are doing -- will permeate the entire FDA. A number
of strong food actions will make the food industry sit up and take notice.
But, ultimately, it is the evidence of a strong agency that will instill the
sense that the FDA is once again a force to be reckoned with:

-- a decisive agency that removes dangerous products from the market quickly;

-- that reviews innovative technologies promptly yet thoroughly;

-- and that protects consumers and promotes the public health.

One former Commissioner said that the agency is a large, slow-moving object
that bleeds profusely when hit. But what people tend to forget is that large
objects can gain considerable momentum. When turned around and pointed in the
right direction, this kind of object can be a strong force for change.

That momentum exists, here and now, at the FDA. There is a compelling case
to be made that strong enforcement provides the greatest possible incentive
to ensure compliance with the food and drug laws of this Nation.

This is especially true for an agency that, by the real-world limitations on
its resources, cannot place an FDA cop on every manufacturing corner.

You should not infer from the breadth of FDA's enforcement responsibilities,
however, that our recent actions represent a patchwork of unrelated events.
On the contrary: one fundamental principle unites them all.

Simply put, we want consumers to have the information they need to make
informed choices -- information that is accurate, information that tells the
whole story.

With that principle in mind, let's examine the actions we have taken so far.

Here is a partial list:

o We moved into the drug promotion area, reaching an agreement with
Bristol-Myers to cease publication of a promotional publication in the guise
of a medical journal. Information presented in a peer-reviewed journal is
one thing; promotional information is quite another.

o We have issued several warnings to Ciba-Geigy about its violative promotion
practices of various products including the drug Actigall. As a result, the
firm has recently announced that it is restructuring the way it markets
prescription drugs and it has committed itself to stop using celebrities for
the promotion of medicines.

o We seized a brand of breast implants because it was mislabeled and because
it was being improperly promoted. Women were not receiving the kind of
information they need to make informed decisions.

o We seized natural skin condoms, after their manufacturer ignored our
requests for labeling changes to warn against use of these condoms to prevent
sexually transmitted diseases. The label did not adequately inform consumers
that, unlike those made of latex, natural skin condoms do not present a
barrier to certain viruses -- including the HIV virus.

o We have seized several injectable collagen products because their
manufacturer failed to include a warning in their labeling about the possible
link between injectable collagen and connective tissue diseases. We acted
because physicians must have the full story about the medical devices they
prescribe for their patients -- and patients in turn must be fully informed.

o Last week, the Agency mandated that women considering breast implant
surgery be provided with information on the risks of breast implants before
they have surgery. When women come to the FDA and tell us that they have
been lulled into believing that these implants are without risk, something is
wrong.

Taken together, these actions show that we mean business.

It is axiomatic that the FDA must protect American consumers by ensuring that
products are safe and effective, properly labeled, and produced according to
good manufacturing practices. But that is not enough. FDA must also help
see that products are used properly and to their fullest advantage.

Nowhere is the potential value of information greater than in the field of
nutrition. Where food is concerned, it is no exaggeration to say that
Americans for a long time have been and still are "nutrition-ignorant."

There is a burgeoning interest in food and nutrition, and that is a good
sign. But the public's understanding of nutrition matters remains relatively
superficial.

The FDA has a long standing responsibility for the food label -- one that
dates to 1906. It has a much more recent mandate to educate people about the
nutrition and the food label: the Food and Drug Administration Act of 1988,
and of course the Nutrition Labeling and Education Act of 1990.

As we go about revising the nation's food label, our primary responsibility
is to ensure that consumers have accurate and useful information about the
food they eat. The role of the FDA is not to tell people what do eat, but to
make informed choice possible.

As I spend more time on the job and observe the interactions among the
various players in the food and drug arena, the role of the individual in
sound nutrition is becoming clearer to me. So is the role of government.

We as a people, as a Nation, have an opportunity to improve our health -- and
the health of our families -- as never before. The way we take care of
ourselves, whether we exercise, what we eat: each of these activities can
affect our health -- and each is within our individual control.

But individuals cannot control the accuracy of information, of claims, on
marketed products. That is where government comes in. The government must
ensure that the information people rely on to make decisions that affect
their health is absolutely reliable.

Health claims, "descriptors" -- whatever appears on the label -- must be
accurate and must tell the whole story. The bottom line is that words on the
food label must have meaning.

What manufacturers must understand -- and understand more clearly than they
have in the past -- is that the claims they make to sell products, the words
they use to increase market share, are the very same words American consumers
use in making decisions that affect their health.

There is no place for marketing gimmicks on the food label.

Food manufacturers have a special trust -- an obligation to ensure that their
products are appropriately labeled. Put yourself in the position of someone
who has just had a heart attack. When that person enters the supermarket, and
wants to alter his or her diet, a lot is at stake -- an enormous lot.

Moreover, the claims of manufacturers have an even greater effect on a public
that is just learning some of the basics of nutrition. It's one reason why
we are so vulnerable to half-truths like claims of "no cholesterol" on
high-fat products. And thus FDA's role in ensuring that food labels are
accurate takes on an additional significance.

It's true that, to date, FDA has acted primarily against misleading claims.
It's equally true that there is a negative aspect to all misleading claims.

Yes, these actions have captured the public's attention. Nothing incenses
average consumers more than the notion that they are being misled or
manipulated.

It is also clear that the FDA has heightened public consciousness of
labelling excesses. As consumers begin to understand that they have been
misled by food labels, neither brand loyalty nor market share is likely to
increase.

We need to shift away from the negative. We must turn the current situation
around, and emphasize the positive good that can come from a true and useful
food label.

So our strategy for dealing with labeling involves not only enforcement, but
revamping the entire label so that it is accurate and helpful.
By the time we have finished, more than 90% of processed packaged food will
feature mandatory nutrition labeling.

We expect three basic results:

o First, we will change the kind of information supplied on the nutrition
label, and in some ways we expect to provide greater flexibility.

The net result should mean a food label that is not only more useful, but one
that provides information that is oriented more toward health.

This is altogether appropriate in a nation where nutrient deficiencies have
virtually disappeared, but where excesses -- calories, fat, cholesterol --
present real health problems.

o Second, label terms used to describe foods -- food "descriptors," we call
them -- will serve as a kind of verbal "shorthand" on the label, to help
consumers more easily understand what the package contains.

Congress has directed that the approach be simple: on the order of, "If FDA
doesn't define it, food companies cannot use it."

By the time we are done, there will be uniformity of descriptors -- and
consistency of terms. The result: increased confidence in the label. We
believe that the new descriptors will provide the food industry with an added
incentive to develop new food products -- perhaps healthier food products.

Let me say a few words about product development. Right now, I have the
feeling that many manufacturers are tempted to change their labels without
necessarily altering the product. Well defined rules will provide a
stationary target for industry -- fixed standards against which to judge
their products.

It's as if, increasingly, "marketeers" have been driving developments in
food; under the new rules, food scientists and nutritionists should have
greater say.

Firms will not have to worry about those who push the line by cutting corners
or applying misleading descriptors.

o Third, health claims. The Nutrition Labeling and Education Act provides --
for the first time ever -- the specific statutory authority to allow food
label claims about the relationship between the food and specific diseases or
health conditions.

This represents a monumental shift in labeling philosophy.
A bit of history is in order. Until 1984, the FDA dealt with
disease-specific health claims for food products in what might be called an
"anti-information" mode: we treated them as drugs. A food product making
such a claim on its label was deemed to be misbranded -- unless the claim was
backed up by an approved new drug application.

The last several years have been a period of transition -- a time of coming
to grips with how to manage health claims. We are now squarely in a
"pro-information" mode. The November proposals will establish how, and on
what grounds, health claims will be appropriate.

Let me say a few words about another important part of the food labeling
initiative: making the food label more "user-friendly." Our research tells
us that consumers don't find the current format particularly comforting.

FDA has therefore designed six alternative label formats, and we have been
testing them with consumers. The results to date have been somewhat
puzzling: Americans find the current format the most useful -- though they
like it the least. The alternative format consumers like the most is the
one they have found the least useful. You figure it out!

At any rate, we are conducting additional follow-up studies of these six
formats, to find the one that works best.

My colleagues will hand out sample labels after my talk, in case you want to
make them available to your readers. We would welcome your thoughts as well.

What it all comes down to is this: through the new food label, FDA is going
to play a significant role in nutrition education for Americans.

Earlier this afternoon I said that Americans have been, as a group,
"nutrition ignorant." And I consider myself part of that group.

I confessed in my first speech as Commissioner my total ignorance of what a
gram really means.

Many of my advisers counselled against that confession. "You can't do it,"
they said. "You're a doctor, and a lawyer -- and the Commissioner of Food
and Drugs, to boot."

At that time, I didn't know that my recommended daily intake
of sodium was 2400 milligrams or less. I didn't realize that my total daily
intake of fat should not exceed 70 grams -- and much less did I understand
that a mere 25 grams should be saturated fat.

If I didn't know these things, it's reasonable to believe that many other
consumers don't know them, either.

The FDA has a role to play in helping consumers understand the importance of
good nutrition, and the relationship between diet and health. We have a
responsibility, through the Nutrition Education and Labeling Act, and we
intend to take that responsibility seriously.

Educating consumers about nutrition is a complex and long-term project. It
won't happen overnight. But it will happen.

You and your colleagues who report about nutrition and food policy play a
large part in this process, and you are doing your job well. You have my
pledge, today, that the FDA is committed to making the label an important
public health tool -- and you have my further commitment that we will do
everything in our power to inform consumers about its use. My goal this
afternoon has been to give you an overview of FDA's overall commitment to
make certain that Americans have the information they need to make
intelligent choices about the products they use.

Let me go over the main points once again.

First, the FDA will introduce, over the next several years, an entirely new
system of conveying information on the food label.

Second, the agency expects that this new labeling framework will encourage
innovation in the food industry -- and will result in the development of new
and healthful food products.

Third, the food industry and the American public alike should know that the
FDA is absolutely committed to the goals of the Nutrition Labeling and
Education Act of 1990.

FDA will create the entire new framework for food labeling in this country.

We will be equally diligent in seeing that the new framework is put into
place -- and that it is respected.

The FDA is serious about food labeling. We are up to the task of
transforming the American food label, and we have the will to make it happen.

Thank you.