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U.S. Department of Health and Human Services

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MARCH 7, 1990

Good afternoon.

One of the first letters I received after being named Acting Commissioner
came from Ellen Haas, inviting me to speak before this conference today.

Naturally, I jumped at the chance to address this thirteenth National Food
Policy Conference. The FDA's food labeling hearings had just concluded, and
I knew that we would have news to report. In the first two months of 1990,
however, there has been so much news concerning food labeling and food
safety, that it's difficult to know exactly where to begin.

So let me start by formally and publicly thanking Ms. Haas for organizing
this conference, which has attracted such a superbly qualified group of
speakers. A tip of the hat is also due to the National Food Processors
Association, a "cooperating sponsor" of this two-day meeting.

Its an honor to share the stage with Drs. James Heisler and Virgil Brown.
Dr. Heisler, I'm looking forward to hearing more about the results of the
food labeling study you conducted on behalf of the National Food Processors
Association. My understanding is that, in general, the results of your
study are consistant with what the public has been telling us about food

Dr. Brown, it's particularly important that you are here this afternoon. I
want to acknowledge that the past few weeks have marked a difficult time in
the relationship between the American Heart Association and the FDA.

I also want to say that our longstanding relationship is as important to me
personally as it is to the FDA as an institution. I'm hopeful that sessions
such as this one will help us "clear the air."

We worked diligently with the AHA for nearly two years, meeting and
corresponding regularly to discuss the HeartGuide program. After much
energy and deliberation, we felt obliged last January to publicly express
our concern about the direction of that program.

Our action was not precipitous; in fact, hindsight tells me that the AHA
would have been better served has we acted more promptly. In voicing our
reservations about the HeartGuide program however, it's important to
emphasize that the FDA has always agreed with the goals of the AHA program.
We simply had serious reservation about the means chosen to reach those

I've discussed the HeartGuide very recently with Dr. Weisfeldt, President of
the AHA. Although he understands our continuing reservations about the
program, I hope he also knows that we intend to keep the lines of
communication open. We will continue to seek the support of the AHA for our
comprehensive food labeling initiative now underway.

During our luncheon session today, Secretary Sullivan outlined the major
elements of that initiative. I'm delighted that the Secretary could join us
today. We at the FDA are truly excited by his commitment to reforming the
Nations food label, for we strongly agree with Dr. Sullivan that the Federal
Government should step up and take the lead on food labeling.

My pleasant task during this session is to fill on some of the details of
our food labeling plans. But first, let me set forth the general principles
on food labeling -- in short, where we stand.

Above all, the FDA is committed to the principle that consumers should have
access to food label information that is true, substantiated, and not
misleading. This information has become increasingly important as the links
between diet and health grow clearer.

Second, the FDA is committed to listening to -- and working with -- all
parties that have a stake in food labeling issues. Our four national food
labeling hearings, complemented by 50 district consumer exchange meeting,
should provide ample proof of that commitment.

But there comes a time when we have to stop listening and start taking

That's why another general principle is FDA's commitment to be vigilant in
assuring that the information on food labels is true and not misleading.
The FDA is renewing its commitment to the American people, which means we
will be acting aggressively against label statements that make
unsubstantiated claims or that are otherwise misleading.

These general principles have governed our re-examination of food labeling,
and they will continue to guide us as we proceed. Secretary Sullivan
outlined for you earlier today our initial areas of attention.

As many of you may remember, our food labeling initiative is focusing on
five general topics: (1) Nutrition label content, (2) Nutrition Label
Format, (3) Ingredient Labeling, (4) Food Descriptors and Food Standards,
and (5) Health Messages.

We are placing high priority on mandatory nutrition labeling because this
information is crucial in helping consumers choose appropriate and healthy
diets. Already, 60 percent of the sales of FDA-regulated packaged foods
carry nutrition labeling. Much of this is furnished voluntarily.

But it's time to increase the proportion greatly. In addition to the
obvious public health benefits, nutrition labeling represents an area of
almost universal interest among the thousands of comments generated by our
food labeling initiative.

So we will be moving toward mandatory nutrition labeling on most packaged
foods, with reasonalbe exceptions for foods produced by small businesses and
for foods that provide little nutritional value.

We expect to be proposing several changes in the content of nutrition
labeling as well. Let me provide a sense of our current thinking on some of
these issues.

Saturated fatty acids and cholesterol: Virtually all of the recent dietary
guidelines from the Federal Government and the National Academy of Sciences
have recommended that, to decrease their risk of cardiovascular diseases,
most Americans should reduce their intake of total fat, saturated fatty
acid, and cholesterol. To help consumers follow dietary guidelines for
these food components, the FDA would like to see saturated fatty acid and
cholesterol content added to the current declaration of fat in the nutrition

Calories from Fat: Most of the recent dietary recommendations have linked
fat intake to caloric intake by advising that total fat intake be reduced to
no more than 30 percent of calories. This recommendation applies to the
total fat intake over one or more days, not to individual foods. To help
consumers calculate their fat intake, therefore, FDA is considering
requiring the nutrition label to declare the number of calories derived from

Dietary Fiber: Dietary recommendations to reduce fat intake go hand in had
with advice to increase the intake of complex carbohydrates and fiber.
Increased consumption of dietary fiber has been tied to a reduction in
cancer and cardiovascular hear disease alike, and so FDA will be considering
a proposal to require fiber content as part of nutrition labeling.

Vitamin Declaration: Although concern about the relationship between diet
and chronic diseases have increased since the current nutrition labeling
format was established in 1973, concerns about diseases caused by nutrition
deficiency have decreased. To free up precious space on the nutrition
label, the FDA will consider making optional rather than mandatory the
declaration of some vitamins.

Serving Sizes: Many public comments have pointed out difficulties with
serving sizes, including the inconsistency of serving sizes as a basis for
nutrition declarations and claims, unreasonably small serving sizes, and
fractional serving sizes. Because we are concerned about this issue, we
will develop proposed criteria for determining consistent serving sizes for
the purposed criteria for determining consistent serving sizes for the
purposes of nutrition labeling.

U.S. Recommended Daily Allowances: The U.S. RDA's currently in use for
nutrition labeling were based largely on the Recommended Daily Allowances
developed by the National Academy of Sciences in 1968. The Academy has just
published the tenth edition of these RDA's and it is clearly time FDA to
update the RDA values used in nutrition labeling.

Concerning the need for nutrition labeling, the views of the public have
generally coincided with public health needs. There is also a growing
consensus that the format for nutrition labels needs updating. We're eager
to work on this problem, and to have a new format tested with consumers by
next year. Perhaps Dr. Heisler will have some comments on that. But there
are other areas where the public health issues are less clear, or where
opinions diverge.

One such issue involve "standardized foods." Comments on these foods, which
must adhere to official "recipes", have been decidedly mixed. Some comments
have emphasized the continuing value of food standards in protecting against
economic fraud. Others have pointed out that existing food standards may be
standing in the way of innovation that could make standardized foods

Let me illustrate this point with the example of cheddar cheese, whose food
standard of identity requires a fat content of 50% of solids, by weight. A
manufacturer wishing to lower the fat content of cheddar-type cheese would
have two options. The company could call the lower-fat product 'cheddar
cheese substitute" if it were nutritionally equivalent. Alternatively, the
firm could apply for a Temporary Marketing Permit, which allows the company
to deviate from the Standard of Identity.

However, the company could not label the product "low-fat cheddar cheese"
the most satisfactory solution from a marketing viewpoint, because of the
fat content required by the standard of identity for and food called
"cheddar cheese."

Thus, a labeling requirement once viewed as protecting consumers is now
being criticized for depriving consumers of a lower-fat food that can be
called cheddar cheese. While the standard itself could be modified to allow
for lower-fat versions, this may not be an easy administrative task. The
lesson is that food standards and labels must evolve along with our
expanding knowledge of nutrition.

Let me conclude my thoughts on our labeling initiative by summing up. In
one year, as the Secretary announce, we expect to have proposals on several
of the most important food labeling issues.

For mandatory nutrition labeling, and revised nutrition label content-- we
expect to have formal proposals by mid-1990.

For definitions of food descriptors and improved ingredient labeling, we
plan to publish proposals by the end of the year.

By early 1991, we plan to publish a final policy on health messages. We
also expect to be well into market research that will help us identify a new
label format.

Let me provide additional details about a subject I just mentioned. It's
intimately related to food labeling initiative, but is further along. I'm
referring to our reproposal on health messages.

In dealing with health messages, our task from the start has been something
of a balancing act: to protect consumers from false and misleading claims on
food labels, while fostering the availability of accurate information.

Last month, FDA published its long-anticipated reproposal of Federal
regulations to govern health claims on food. This document replaces FDA's
1987 proposal, which proved to be too permissive.

If finalized in its current form, the reproposal would establish the first
six topics that may be appropriate candidates for health claims. They are:

fiber and cancer,
fiber and heart disease,
fats and cancer,
fats and heart disease,
sodium and high blood pressure, and
calcium and osteoporsis.

It is worth pointing out that, on the basis of current scientific
understanding, these associations appear to represent the six most promising
links between improved dietary habits and good health. As nutrition science
progresses, other areas of association may well emerge and would also become
candidates for health messages.

The reproposal also specifies criteria for permissible health-related food
labeling. If the reproposal were finalized, such labeling would have to be:

truthful and not misleading;
limited to describing the relationship between a particular food component
and a chronic disease;
consistent with a sound total diet; and supported by FDA-approved summaries
of the health message -- both in scientific and in lay language.

The reproposal also outlines how FDA is likely to exercise its enforcement
discretion during the rulemaking. FDA intends to examine these claims on a
case-by-case basis, according to several criteria listed in the preamble to
the reproposal. FDA will consider the following: (1)whether the scientific
evidence supports the claim; (2) whether the claim is exaggerated; (3)
whether enough of the beneficial food component is present in the food; and
(4) whether the "good" attributes of the food outwiegh the "bad" For
example, a low-cholesterol health message on a food high in saturated fat
would be misleading.

That's the gist of reproposal. Here's what we're doing now to implement
that interim enforcement policy.

First, the FDA's Center for Food Safety and Applied Nutrition is collecting
examples of health claims currently being made on food labels. We will use
these examples to compile a list of potentially violative products to
evaluate for enforcement action.

In addition, the Center is re-reviewing the science base for claims
involving diet and health, largely on the basis of the report of the Surgeon
General and the National academy of Sciences. This review will provide a
sort of scientific yardstick against which we can evaluate health claims as
they arise.

The next step, once these two tasks have been completed, will be to notify
specific companies that we believe certain of their labels warrant top
priority in implementing our interim enforcement strategy. In doing this,
we will seek to identify product labels that illustrate generalized concerns
applicable to other products as well.
So stay tuned.

We expect to begin this process rapidly to help restore a sense of order
into he marketplace for the consumer, while providing a level playing field
for the food industry.

I know that during this conference you have been hearing about eating foods
that there is no lack of food safety issues commanding our attention. Since
the first of the year I've been involved with the color additive FD&C Red
No. 3, Samonella enteritidis in eggs, animal drug residues in milk, and yes,

Because of the nature of this conference, and the audience it has attracted,
the food safety issue I'd like to focus on briefly in the time remaining is
seafood: the Federal role in assuring a safe and wholesome supply of
shellfish ad finfish.

It's particularly appropriate to discuss seafood today, because i know that
several people in this room have voiced doubts about the current allocation
of responsibility for seafood safety.

Those of you who attended today's luncheon heard Secretary Sullivan's strong
conviction about keeping the seafood responsibility where it is now, with
the FDA. Let me take a moment to amplify his remarks.

As the saying goes, nothing succeeds like success. In my opinion the FDA
has been successful in assuring that the Nation's seafood is safe. If we
exclude raw shellfish, which presents a unique set of regulatory challenges,
the evidence establishes that the FDA's seafood program is guaranteeing an
interstate supply of marine protein with an excellent safety record. And
the FDA has achieved these results, I might add, at a fraction of the cost
of more continuous-type inspection programs.

Earlier today Secretary sullivan emphasized the FDA's expertise in seafood.
Another key to safe seafood is the development of methodologies enabling
rapid detection of marine toxins. This is a field in which the FDA has
accumulated considerable expertise -- for instance, to the best of my
knowledge, virtually all current Federal research in this country on
chemical detection of scombrotoxin is being conducted by FDA. The Agency's
scientist are also in the fore front of research on ciguatera
(cig-wa-terr'-a) toxin.

Moreover, the FDA had over the last decade developed an unequaled scientific
infrastructure which is critical to the maintenance and expansion of an
effective seafood program As examples, FDA scientists can clone, sequence,
and synthesize genetic material from viruses, bacteria, and parasites.

In addition to its investigative staff, the FDA headquarters and Three
marine research centers employ scores of microbiologists, analytical
chemists, marine biologist, sanitary engineers and toxicologist -- a vast
human resource which any other agency would find hard to duplicate.

Finally, the FDA has demonstrated its ability as a team player be
cooperating with a variety of official bodies involved in seafood safety.
At present, the Agency is exploring with the National Marine Fisheries
Service some new approaches to seafood inspection based on a system known as
HACCP that has worked so well in FDA's regulation of low acid canned foods.

HACCP refers to the Hazard Analysis and Critical Control Point concept,
which involves the identification and very close monitoring of specific
control points in a processing system. For low acid foods, the principal
control point is the retorting step. Temperature, time, and the pressure
are carefully monitored. If failure were to occur at the retorting step,
botulism could result.

Such a HACCP system can be modified and applied to seafood processing. Both
the NMFS, which operates a voluntary, fee-for-service seafood inspection
program, and the FDA are strongly interested in doing just that. We are
eager to work with the National Oceanic and Atmospheric Agency, the parent
organization of the NMFS, to devise and perfect one system that addresses
the issues of seafood safety and quality.

The FDA also maintains close ties with its sister public health agencies --
most notably, the Center for Disease Control - to track seafood related
illnesses, and with the various State agencies involved in seafood programs.

I must say that I'm pleased that the Administration has demonstrated
confidence in the FDA by requesting an increase of 14 million dollars for
our seafood program. It's entirely appropriate, in my view, that the health
of seafood eaters today remains in the hands of the Nation's number one
public health Department.

There are many other fascinating challenges -- such as pesticides and risk
communication -- that i would discuss with you today if time permitted. But
to preserve the time for my colleagues Dr. Heisler and Dr. Brown, I would
simply like to thank you for your kind time and attention this afternoon.