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1
Summary
In 1973 the Food and Drug Administration (ADA) took the first steps to
establish the current U.S. framework for the nutrition labeling of foods. For most
packaged foods, FDA's regulations allowed information on nutrition content to
be provided voluntarily, but prescribed a standard format. Nutrition labeling
was made mandatory, however, on any food to which a nutrient was added or
for which a nutrition claim was made. Not long afterward, the U.S. Department
of Agriculture's (USDA) Food Safety and Inspection Service (FSIS) issued
similar policy guidance for nutrition labeling on meat and poultry products.
By 1990, over half of all packaged foods sold in the United States bore some
type of nutrition labeling. The changes in food labels begun in the 1970s then
represented a fundamental shift in regulatory philosophy and a major advance
in consumer information, but from the perspective of 1990, they seem modest,
incomplete, and outdated.
Criticism of the nutrition content of food labels grew intense in the 1980s.
This criticism was spurred by two related developments. First, scientific in-
vestigation had convincingly demonstrated important linkages between dietary
habits and the prevalence of chronic diseases, most notably cardiovascular dis-
ease, cancer, stroke, diabetes, and obesity. And at the same time, it was shown
that Americans' diets were excessively abundant in such components as calo-
ries, fat, cholesterol, and sodium. The second development was a response to
the first: American consumers became increasingly attentive to choices among
foods. Food producers and manufacturers responded to this interest by develop-
ing foods whose composition could be promoted as reflecting this new learning
about nutrition and health. Thus, in the late 1980s the expanding use of the cur-
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2
NUTRITION LABELING
rent nutrition labeling system further highlighted its inadequacies. The release
of two landmark reports, The Surgeon General's Report on Nutrition and Health
and the National Research Council (NRC) report, Diet and Health: Implications
for Reducing Chronic Disease Risk, led to renewed efforts to reform nutrition
labeling in the United States.
In 1990, the rules governing food labeling are seriously dated Some foods
subject to FDA food standards remain exempt from full ingredient labeling.
No nutrition information appears on at least 40 percent of all packaged foods;
nor does it accompany major segments of the food supply, including fruits,
vegetables, meats, poultry, seafood, and restaurant meals. Furthermore, the
information that nutrition labeling does provide is incomplete and misfocused.
The current system emphasizes the presence and levels of micronutrients,
disclosure of fiber and cholesterol contents is not required, and information
about fat is incomplete. In addition, advertising and label claims of nutritional
value or disease avoidance have proliferated-with seemingly little control. It is,
therefore, understandable that critics of the current system have charged that
government regulation has ignored major segments of the food supply, been
concerned with the wrong nutrients, and tolerated nutrition claims in advertising
and labeling that are at best confusing and at worst deceptive economically and
potentially harmful.
There have been earlier efforts to reform the current rules for nutrition la-
beling. In 1979, the U.S. Department of Health, Education, and Welfare, USDA,
and the Federal Trade Commission ~C) held hearings and considered possible
changes in many areas of food labeling (44 Fed. Reg. 75,990 76,020, Dec. 31,
1979~. In the past 12 years, members of the U.S. Congress have introduced
legislation to overhaul FDA's and USDA's nutrition labeling regulations. Many
private organizations have also put forth proposals for improved food labels
generally and their nutrition content in particular.
PURPOSE AND SCOPE OF THE STUDY
In 1989 the Committee on the Nutrition Components of Food Labeling was
assembled by the Food and Nutrition Board (FNB) of the Institute of Medicine to
consider how food labels could be improved to help consumers adopt or adhere
to healthy diets. The sponsors of the study the Public Health Service, U.S.
Department of Health and Human Services (DHHS), which includes FDA, and
FSIS, USDA were motivated by the shared judgment that changes in eating
habits can improve the health of Americans and a conviction that food labeling
can materially aid wise dietary choices.
The Committee was charged with addressing the following tasks: assessing
the implications of the current knowledge of nutrition and health for food
labeling; recommending the content and the appropriate format for food labels,
taking into account the scientific data base as well as the means to communicate
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Representative terms from entire chapter:
nutrition information
SUMMARY
3
effectively with the public and, after examining current laws and regulations
governing ingredient and nutrition labeling, proposing options for modifying
current policy. The Committee was directed to use the findings of He Surgeon
General's and N}
4
N=RTTION LABELING
as to the information about nutrient content that must or may appear on food
labels; the current rules reflect the informal judgments of FDA and USDA.
USDA and FDA regulate food labels in very different ways. USDA requires
that manufacturers obtain prior approval of any label they wish to use on a
meat or poultry product. USDA labeling policies are spelled out In the FSIS
Standards and Labeling Policy Book and policy memoranda In theory, no
USDA-regulated products fail to comply, because USDA reviewers simply
withhold label approval.
FDA has no legal authority to approve food labels in advance. It relies
on detailed formal regulations and informal advice to describe its requirements.
Manufacturers of FDA-regulated foods can use a new label and take the risk Hat
FDA will subsequently challenge its product as being mislabeled. As a result,
compliance with FDA policies depends on attentive monitoring and is resource
dependent.
Although the substantive requirements of the two agencies do not differ
dramatically in the area of nutrition, they do differ in some details. Moreover,
there can be uncertainty as to which agency's requirements apply to a particular
food. For example, the amount of meat in a pizza determines which agency has
jurisdiction. A modest change in product composition can result in a change in
jurisdiction.
Evolution of Nutrition Labeling of Foods
FDA's nutrition labeling regulations have undergone relatively few changes
since 1973. These regulations derive their authority from the FD&C Act, which
states nothing about nutrition. The Act requires that every food label must
contain the name of the food, a statement of net quantity of contents, and Be
name and address of the manufacturer or distributor. In addition, most FDA-
regulated foods must also list ingredients in descending order by weight. The Act
also prohibits label statements mat are false or misleading. A unique provision
of the Act (section 201(n)) specifies that, in determining whether the labeling of
a food is misleading, consideration should be given to whether it fails to reveal
material facts about the consequences of using the product. This provision, and
FDA's general power to adopt regulations to enforce the Act, formed the basis
for the agency's 1973 nutrition labeling rules on packaged food labels.
It was the 1969 White House Conference on Food, Nutrition, and Health,
convened to respond to reports of widespread malnutrition in America, that
motivated FDA's initiative. The final report of the conference addressed the
regulation of food composition and labeling, criticizing FDA's approaches to
standards of identity, marketing of substitute foods, and label statements relating
to nutrition and long-term health. The report stressed the need to help consumers
make wise food choices by providing more nutrition information on food labels.
SUMMARY
s
In response to the report, FDA initiated the adoption of regulations govern-
ing voluntary nutrition labeling for packaged foods. The regulations specified
how nutrition information was to be provided if manufacturers chose to include
it, and prescribed that nutrition labeling was required when a nutrient was added
or a nutrition claim was made. In 1973, the goal was to enable consumers to
select a diet adequate in vitamins, minerals, and protein. Thus, labels were re-
quired to provide information on the food's contribution to the desired daily
consumption of these nutrients. To convey this information FDA cleat the
U.S. Recommended Daily Allowances (U.S. RDA), which were based on the
Recommended Dietary Allowances (RDA) established by FOB but reduced them
to a single set of numbers applicable to healthy adults.
FDA's 1973 regulations prescribed a uniform sequence and format for dis-
closure of nutrition information in terms of serving size; servings per container;
number of calories; amount of protein, carbohydrate, and fat (in grams per
serving); and percentage of the U.S. RDA for protein, Titanic A, vitamin C,
thiamin, riboflavin, niacin, calcium, and iron. A manufacturer also could list a
number of other vitamins and minerals. A separate regulation allowed, but did
not require, disclosure of fatty acid composition and cholesterol information,
but only with an accompanying statement that such information was provided
to assist individuals who were under the care of a physician. Information on the
label about sodium content was required in 1984.
To convey nutrition information, FDA chose a numeric format over other
alternatives. This choice seems to have been based more on informed intuition
than on extensive testing of utility. FDA's scheme effectively limited the cov-
erage of nutrition labeling. It did not have authority to require labeling on most
meat and poultry products. Foods sold in restaurants and other food service
operations were excluded. The agency's original plan to require nutrition label-
ing for fruits and vegetables, albeit with modified conditions, was withdrawn in
1975.
Although USDA has never adopted formal regulations governing nutrition
labeling of meat and poultry products, it has evolved policies for such labeling
that paralleled those of FDA. They are found in the FSIS Standards and Labeling
Policy Book and policy memoranda. Policy Memorandum 039 allows a product's
label to state that the food can help reduce or maintain body weight or to make
a claim regarding caloric content as long as it provides nutrition information.
Policy Memorandum 086, which sets forth USDA's required format for declaring
nutrition information, allows either an abbreviated listing (calories, protein,
carbohydrate, and fat [in grams] per serving) or the longer FDA version. USDA
has also allowed provision of information about cholesterol and fatty acid content
as part of either format.
The more significant differences between the two agencies concern the
philosophy and manner of implementation. FDA has typically encouraged
manufacturers to provide information even when it is not required, whereas
6
Nl~RITlON L4BEl~NG
USDA has been chiefly concerned with ensuring the accuracy of whatever
information appears on meat and poultry products.
Deficiencies in Current Federal
Requirements for Nutrition Labeling
Critics of current nutrition labeling cite its limited coverage, the failure
to keep pace with current knowledge of the relationship between nutrition and
long-term health, the amassing of information about fats and fiber, incomplete
information about ingredients, misleading or undefined statements about the
levels of nutrients, lack of uniformity, and inadequate consumer education
efforts.
Currently, only over half of packaged foods carry nutrition information.
Other foods omitted from nutrition labeling include meat, poultry, and seafood;
eggs; fruits and vegetables; and foods sold in restaurants, institutional food
services, vending machines, and grocery store carryout food bars. In addition,
some foods subject to FDA's standards of identity (official recipes used to define
the composition of standard products) still fail to list all their ingredients.
The content of current nutrition labels is incomplete given current knowl-
edge of the relationship between diet and chronic disease. Labels are not now
required to list cholesterol, saturated, monounsatu~a0, or polyunsaturated fatty
acids, complex or simple carbohydrates, dietary fiber, and potassium, for whose
inclusion there is some support. Many observers believe that labels list too many
vitamins and minerals.
It is not only the nutrition information on food labels that has been
criticized. Listing of ingredients by percentage has been urged. Current provision
for"and/or" ingredient labeling allows manufacturers to declare a number of
ingredients without specifying which ones are actually present in foods. In the
case of fats and oils, it is difficult for consumers to determine the level of
saturated fat in specific foods. Sugars are not currently required to be aggregated
in the ingredient listing.
Confusion is reported about the meaning of both serving size and the
U.S. RDAs. Nutrition information is provided as the amount per serving, but
manufacturers determine the serving size, which has allowed manipulation.
Serving sizes are not uniform within or between product categories. In addition,
serving sizes are frequently expressed in units that consumers do not understand.
The U.S. RDAs, which serve as the reference point for describing micronu~ient
content, have not been updated since 1972.
Finally, EDA's original choice of a numeric display rather than narrative,
graphic, or symbolic presentation of nutrient information remains controversial.
Some groups suggest that current dietary recommendations should also be
included on labels so that consumers can compare these standards with a food's
nutrient composition. There is debate, as well, over how the caloric contribution
SUMMARY
7
of fat can best be shown, either by calories from fat or He percentage of calories
from fat.
CONTEXTUAL FACTORS INFLUENCING
FOOD LABELING REFORM
Current Dietary Patterns of Americans
Since the turn of the century Americans have made extensive changes
in their eating habits. More food is consumed away from home. Snacking is
more common. A wider variety of foods is available year-round. Changes have
occurred in He composition of foods due to improved production methods, new
varieties of foods, and advances in food processing. Records maintained and
surveys conducted by USDA and DHHS confirm these changes.
The primary changes in food energy sources in the past 70 years have been
an increase in the percentage of energy contributed by fats, oils, sugars, and
sweeteners, along with a decrease in the percentage of energy contributed by
grain products. There has been no change in the amount of protein consumed, but
the amount obtained from animal sources has risen. The consumption of fat and
its components (certain fate acids and cholesterol) has increased. Consumption
of whole mink products and eggs has declined, whereas consumption of fats and
oils, primarily salad and cooking oils, has nsen. Current fat intakes are about 36
percent of total calories, compared with the frequent dietary recommendation of
30 percent of total calories from fat. Dietary fats are considered to be a current
public health issue due to their association with coronary heart disease (CHD)
and certain cancers. There has been a significant decrease in the proportion of
carbohydrates obtained from grain products, with an increase in the consumption
of sugars and sweeteners to 50 percent of total carbohydrate calories. No
historical data exist on the amount of fiber available in the food supply, but
current intakes are generally considerably less than the recommended minimum
of 20 g/day. Americans generally consume an adequate amount of most vitamins
and minerals due to new plant vaneties, food fortification, and supplement
use. However, there is concern about general low consumption of several
micronutrients, primarily calcium and iron, and in certain population groups,
vitamins A and C, folate, and zinc.
Food Marketing in the United States
A 1990 U.S. Deparunent of Commerce document, U.S. Industrial Outlook,
suggests that consumers demand foods with convenience, quality, variety, and
healthful attributes. By 1990, an average of 12,000 new food products were being
introduced annually in supermarkets, more than double the number a decade
earlier. Many of these products are targeted directly at a health~onscious public
8
NllTRITlON LABELING
and feature health and nutrition claims on their labels, and more advertising
dollars are being allotted to their promotion. Sales of foods in limited-menu
restaurants and foods for home use purchased in supermarkets have risen sharply,
whereas those from limited-line grocery stores have fallen.
The increasing integration of the food distribution system with trade
throughout the world will continue to affect the U.S. food supply. Current Coder
Alimentarius rules and the scheduled 1992 adoption of food labeling rules by the
12 member nations of the European Community are all likely to have an impact
on trade in the future, as well as the United States Canada Free Trade Agree-
ment. In the area of food processing, growing internationalization has occurred
in food company ownership, and the pace of leveraged buyouts and takeovers
has reduced funds for product research and development.
From a general marketing standpoint, it is readily apparent Hat nutrition
"sells" food to today's consumer, and it has become an integral part of product
development and marketing strategies. Manufacturers view the principal display
panel of food packages as "real estate," to be reserved for sales promotion
and competition with nvals, and will not willingly surrender it to government
labeling requirements. Although industry can be expected to generally support
labeling changes that will create a more informed consumer choice process, it
will resist changes perceived to disturb consumer perception of product value,
erode consumer ability to evaluate products in the context of total diet, or risk
the disclosure of proprietary formulations.
Consumer Understanding of Nutrition and
Use of Food Labels
No single study has adequately described how dietary patterns are devel-
oped, maintained, and changed; food choices are influenced by social, cultural,
economic, psychological, and physiological factors. Familiarity is a particularly
important factor in choosing foods. Education and income levels have a signif-
icant influence on food choices.
Results of the 1990 Food Marketing Institute (l;MI) survey of consumer
attitudes and shopping behavior indicate that over 70 percent of shoppers
identified taste, nutrition, and product safety as very important factors. Those
on medically restricted diets were more likely to rank nutrition first. Numerous
studies have confirmed that Americans are increasingly interested in nutrition,
including increasing concerns about the health risks associated with sodium,
fat, and cholesterol intakes. They report eating less salt, red meat, butter, whole
milk and eggs.
Motivation is a key factor in how receptive any target audience will be
to new information. Curiosity about a new claim may lead to a specific food
purchase. Medical advice to limit certain food components often leads to closer
attention to nutrition information. However, increased knowledge about nutrition
SUMMARY
9
10
NUT~lTlON LABELING
Analytical Considerations Aflecting Food Labeling Reform
Providing information about the nutrient content of foods on labels requires
an analysis of food composition. Both FDA and USDA currently have require-
ments for label accuracy that reflect the current capacity of analytical chemistry.
USDA permits manufacturers to provide nutrition information derived either by
calculation from analyses based on official methods of the Association of Official
Analytical Chemists (AOAC) or accepted references. USDA has implemented
the Nutrition Label Verification ~V) program, which includes procedures to
verify labels for accuracy, although the degree of accuracy that is required im-
poses analytical problems on food manufacturers. PDA regulations mandate that
all the required and any optional information on the nutrition information panel
must be determined by direct laboratory analysis. A + 20 percent tolerance from
label values is allowed. FDA generally requires that analysis be done by AOAC-
approved methods or by reliable and appropriate analytical procedures set by
the Secretary of DHHS.
Acquisition of reliable food composition data is not easy. Difficulties include
complexities of analytical methods and food composition, differences in the
analytical capabilities of different laboratories, and the need for improved
analytical methods and training of technicians. Current methods vary with
respect to their applicability, convenience, expense, and the degree of analytical
expertise required to perform them. Considerable improvement is needed in the
validation and standardization of methods of food analysis for use in labeling
as well as food composition data bases.
Soluble fiber cannot easily be measured, since it is usually calculated by
determining the difference between total dietary fiber and insoluble dietary fiber,
which is subject to considerable imprecision compared to a direct measurement.
Thus, the method remains controversial. Measurement of total carbohydrate
per serving for food labeling purposes is generally performed indirectly by
determining the amount remaining after protein, ash, moisture, and fat are
subtracted, resulting in potential inaccuracy and imprecision. Recent advances in
the methods used to measure complex carbohydrates will allow for potentially
more accurate measurement of various carbohydrate components. Total fat is
currently measured routinely, and methods exist for the accurate measurement
of cholesterol. Suitable methods exist for the measurement of most minerals
in foods, although standardization and validation are needed. Considerable
development is required to obtain reliable analytical methods for many vitamins
in foods, because of natural variability, especially in plant sources.
The application of direct analytical analyses to nonpackaged foods, includ-
ing meat, poultry, seafood, fruits, and vegetables, and foods sold in restaurants,
is impractical. The need to expand public access to information about the nu-
trient content of foods suggests the desirability of using appropriate data base
information as an alternative to direct analyses for these foods. The USDA Na-
SUMMARY
11
tional Nutrient Data Bank contains reasonably complete data on the composition
of foods, although data are less complete on nutrients for which sound analyt-
ical methods are lacking. Other sources of food composition data complement
USDA data, but these need to be certified by FDA and USDA to be used for
nutrition labeling purposes. At best, however, data bases can indicate represen-
tative information on the composition of foods, which means that Here may be
large differences between data base values and the actual amounts of certain
nutrients in a single sample of food.
The Committee recommends that:
· Label verification by analysis of composite samples should be made at least
twice each year to ensure reasonable accuracy of nutrition labels without
imposing the burden of a complete quarterly analysis.
· FDA and USDA should certify data from the National Nutrient Data Barik
or other appropriate sources regarding the nutrient content of fresh foods
and foods sold in restaurants.
FDA and USDA should allow considerable flexibility in the selection of
analytical methods for label verification of nutrient content.
In proposing an alternative (nonofficial) analytical method, suitable verifi-
cation must be required (e.g., recovery of samples and analysis of reference
materials). In addition, appropriate quality control procedures should be
used in each analysis.
· Development of additional standard reference materials for use in food
analysis should be encouraged.
· Funding should be provided for the development of improved analytical
methods, establishment of programs for the testing of methods through
interlaboratory studies, and development of additional standard reference
materials.
· Completion and expansion of the USDA National Nutrient Data Bank
should be continued.
LABELING COVERAGE
Mandatory Nutrition Labeling
Although nutrition knowledge will continue to evolve, there is now sufficient
consensus on diet and long-term health to serve as a basis for changes in food
labeling. The Surgeon General's report and the NRC Diet awl Health report
indicate that consumers must make changes in both the dietary components and
the food groups they eat, if they are to reduce their risk of chronic disease. In
order to achieve the recommended dietary adjustments, consumers must be able
to make informed choices in their daily selection of foods. The current lack
of relevant, consistent information across Be full spectrum of food products
26
NUTRITION LABELING
label design. Although many facets of food labels are regulated, manufacturers
nonetheless have considerable choice in the information that they include and
the manner in which it is displayed within the constraints of label and package
size. Growing consumer interest in nutrition and specific nutritional components
has led many manufacturers to feature the desirable characteristics of products.
Common examples in this practice are so-called nutrient content descriptors,
such as low-calorie, fat-free, no cholesterol, fiber-rich, and lite.
The proliferation of these descriptors and the growth in their usage have
drawn attention from regulatory bodies, health professionals, and competitors.
On the one hand, their popularity signals an encouraging interest among con-
sumers about the links between nutrition and long-term health. On the other
hand, the potential for confusion, exaggeration, and outright deception has
prompted some to argue that nutrient content claims should be forbidden al-
together.
The problem stems in part from failure of the current system to regular
such claims in a systematic way. Users of many content descriptors have no
official definition against which to basis their claims. USDA reviews all labels
individually and does not approve a label that carries an unapproved claim.
FDA lacks standard definitions for most of the descriptors in common use, and
at times is hampered in its efforts to prevent the use of terms in the absence
of formal definitions. FDA has often relied on compliance with informal advice
which depends on manufacturers' knowledge and their willingness to adhere to
informal policy. Compliance with FDA's criteria is as likely to be related to
the practices of competitors as to the views of agency officials. The problem
is compounded when one agency has defined a descriptive term in official
guidelines, but the other has not' or in the case where there are descriptors
whose meanings the two agencies dispute. Without official uniform definitions
of common descriptors, food manufacturers are able to exploit consumer interest
in foods that appear to be healthful. For example, the tend lite or light has
been used to imply fewer calories, reduced fat, lower sodium, improved texture,
flavor, or color, and even the amount of breading, depending on the product.
There are other practices that border on the deceptive. Although it is common
to highlight desirable components of foods, rarely is there any effort to provide
balanced information about other undesirable characteristics. For example, it
may be literally truthful to label a food as containing no cholesterol, but even
so, this may mislead consumers if it also contains substantial amounts of total
fat and saturated fatty acids, particularly for unsophisticated consumers who
equate cholesterol with fat. The responsible, restrained use of content descriptors
may provide benefits to consumers who use them to hastily compare the main
nutritional features of various foods. To promote the proper use and to aid
consumer understanding of such descriptors, it is important Hat appropriate
word definitions and criteria for their use be established. It is also important
SUMMARY
27
that the definitions established be the same for both agencies. Such quantitative
descriptors are widely used and thus are of particular concern.
The Committee readily age on these elementary propositions. It found
the challenge of formulating definitions for the growing variety of content
descriptors in common use considerably more difficult. Each example that it
undertook to evaluate seemed to present distinctive issues, and the judgments
reflected in existing agency regulations and guidelines governing the use of
specific terms seemed heavily influenced by precedents that cannot readily be
appreciate It quickly became clear that the Committee's work schedule would
not allow the sort of in-depth study of agency policy and commercial practice
that would be necessary to formulate recommendations for defining individual
terms.
The Committee was also persuaded that the agencies themselves probably
cannot expect to establish formal definitions for all of the terms that inventive
marketers are likely to adapt or invent to describe the nutrient content of foods.
The goal should be to define a core set of the terms used to describe the most
important food components fat, cholesterol, carbohydrates, Sber, and sodium.
The agencies have made progress toward this goal.
The Committee was concerned that further progress would be slowed if the
agencies had to treat each component and associated set of descriptors—as
presenting a unique problem. Accordingly, the Committee attempted to develop,
and suggest for the agencies' consideration, a possible general framework for
assigning nutrient values to such terms as low, very low, and reduced.
The Committee's suggested framework would allow He use of quantitative
descriptors limited to two categories high, low, very high, very low- with
demarcations established for each descriptor. A scheme of benchmark ranges
would be established for all quantitative descriptors for each nutrient based
on the RDAs and other recognized dietary recommendation standards, and
benchmark limits would be kept conceptually consistent for all nutrients in
order to simplify the message. The use of comparative descriptors should be
strictly regulated, with clear identification of the products being compared. In
addition, the extent of nutrient modification should be specified and based on a
modification of at least 20 percent' and descriptors should not be allowed for
nutrients unless they are normally present in physiologically significant amounts
(when physiologically significant amount is defined, such as 1 percent of the
maximum allowance used to define the limits for very low). Synonyms of
approved descriptors should not be allowed except by petitioning FDA and
USDA; and descriptors that characterize other features that are not directly
nutritional in nature (e.g., organic, fresh, and napalm should be controlled by
narrowing the conditions for their use. Finally, the Committee believes that
descriptors that imply mitigation or cure of disease or health condition should
be controlled under Be regulations being developed for health claims.
28
NUTRlTlON LABELING
Comparative descriptors, such as reducedfat, are also widely used on many
foods. Often, the compared food is not identified, and just as often the difference
between the products is not described quantitatively. Use of such comparative
terms should require clear identification of the product being compared and
specification of the extent of modification. Descriptors that proclaim the absence
of an undesired component, such as cholesterol free, should not be allowed on
foods that do not normally contain cholesterol. And when used on foods that
contain significant amounts of fat, or another undesired component, such as
sodium, such claims should be accompanied by a disclosure of that fact.
Label Format Options
In 1972, when the voluntary nutrition labeling program was being devel-
oped, PDA investigated the various options that might be used to convey the
nutrition information on the package and decided to use a numeric presenta-
t~on. In 1982, FDA commissioned a study to develop alternative label formats,
but systematic consumer testing was not undertaken. Some research has been
done on the effectiveness of the current label format and various alternatives
. . .
to convey nutrition Information to consumers. Alternative presentations have
included descriptors, graphics nutrient density with and without graphics, food
equivalents calorie-based, and symbols. When any of these alternatives have
been evaluated against the current format, consumers generally say they prefer
the graphic format, yet they also seem to prefer nutrition information stated in
absolute numbers and percentages over the alternatives.
Research on nutrition information provided at the point of purchase suggests
that the form of presentation has an impact on the format judged to be most
useful. Control over the individual's information input rate and ability to process
data at a comfortable pace seem to reduce confusion.
In addition to the recommendations listed earlier on the mandatory and
voluntary disclosure of nutrient content information, the Committee recommends
that
Serving size should be prominently displayed on the nutrition information
panel and should appear in household units.
The amount of the serving should appear in grams or milliliters in paren-
theses following household units.
Nutrient information should appear for the food as it is packaged, with the
option of providing information relevant to the manner in which the food
is prepared
· Macronutrients should be listed in grams or milligrams.
· Macronutrients should be listed first, and then other food components, elec-
trolytes, and micronutrients, or similar food components should be grouped
together, except fiber and cholesterol should not appear in groupings.
SUMMARY
29
· Vanous issues related to placement and prominence of food components on
the nutrition label (e.g., increased prominence of fat components, ordering
of macro- and micronutrients) should be subjected to consumer testing.
· Comparison with dietary recommendations should be optional.
Consumer Testing
Alternative label formats should be subjected to both qualitative and quan-
titative consumer testing prior to issuance of any final nutrition Labeling require-
ments. However, this testing must be carefully structured to produce measurable
results and, given the level of expectation for this process, carried out within a
reasonable period of time. It is also assumed that before any testing procedures
begin, the agencies will have determined through the comment and rulemaking
process the nutrient content information to be conveyed on the label as this will
affect the required nutrition information to be presented in any format tested.
The Committee recommends that:
A brief test panel education program reviewing the current dietary rec-
ommendations and explaining me basics of the new label formats should
precede label format testing.
A formal testing procedure should include: an advisory panel to help de-
termine the formats to be tested; an initial testing phase to include a com-
prehensive, qualitative review by consumers; an in-depth evaluation of He
most preferred choices to assess consumer ability to use label information;
and finally, large-scale surveys to determine consumer acceptance and com-
prehension of label information.
Educating Consumers to Use Nutrition
Information on Food Labels
Two general strategies have been described for promoting dietary change.
Environmental or structural interventions are strategies that encourage positive
behaviors by creating opportunities for action and removing barriers so that
consumers can follow health-promoting behaviors. In terms of dietary change,
modification of some aspect of the food supply or improvement of consumer
access to food would represent such a change. Personal or direct influence
strategies are based on providing information or directing educational efforts,
persuasion, and behavior modification techniques toward individuals or small
groups. Techniques in these areas evolve from simple information transmission
(based on the premise Hat knowledge of the facts will change behavior) to
a variety of direct behavior modification techniques that are designed to lead
directly to He development of heal~-promodng skills and practices.
30
Nlm=70N LABELING
The nutrient composition information provided on food labels should enable
the public to make informed food choices. The provision of nutrition information
on food labels is an amalgam of these two strategies: it is an environments
strategy because the federal government adopted an information provision policy
by allowing not only nutrition information to appear, but also by setting the
rules governing format, content, and placement, a personal-influence strategy
for consumers to have the information to use.
Various public information campaigns aimed at promoting healthy behav-
ior (including those for heart disease, high blood pressure, and cancer) have
focused on enhancing knowledge, changing attitudes, and improving skills. Un-
fortunately, research suggests that improving consumer knowledge and consumer
attitudes alone will not result in adoption of health-promoting practices. Con-
sumers need information to make long-term dietary changes, but they need more
than just information to achieve this goal. Educational resources will be required
to effect behavioral change.
Obstacles to effecting dietary change in consumers include factors that are
both cultural and psychological in nature. Most diet-related health problems
develop gradually, without immediate or dramatic symptoms. Risk factor reduc-
tion and disease prevention through dietary means require an individual to make
long-term and often arduous changes in food habits. However, many Americans
consider themselves reasonably healthy and question whether major alterations
in their dietary habits will be worthwhile in the long non.
A comprehensive national nutrition policy would ensure the availability of
adequate supplies of safe and nutritious foods as well as provide consumers
with the educational means for making informed food choices. A well-designed
nutrition labeling program is an important component of an education program,
but the provision of information is only the first stage in the behavioral change
process. It cannot substitute for a comprehensive nutrition education program.
The Committee recommends that:
.
Public- and private-sector initiatives should be established to help consumers
understand and apply the information on the nutrition label.
· Comprehensive nutrition education programs should be developed in order
to help consumers to understand the information on food labels to enable
them to plan diets and make appropriate food choices.
Costs of Labeling Reform
Any reform of food labeling to provide more complete nutrition information
and any expansion of the coverage of current nutrition labeling requirements will
impose costs on producers, manufacturers, retailers, and ultimately, consumers
regardless of who is recommending reform. It is the Committee's ju~nent that
its recommendations for the content of nutrition labeling would require very little
SUMMARY
31
information that producers do not already possess. The timing of the imposition
of such requirements could affect the cost of compliance. For foods that do not
now bear nutrition labeling of any sort, additional costs will be incurred. The
costs of analysis of these foods may not be trivial, though adequate methods
and laboratory resources are available to analyze, at a reasonable cost, virmally
all packaged foods for all of the nutrition components that the Committee
recommends. Providing point-of-purchase nutrition information on produce and
fresh meat, poultry, and seafood will impose significant new costs on remilers
and consumers. The Committee is recommending that limited-menu restaurants
be required to display point-of-purchase nutrient content information on their
foods and that all other restaurants be required to have such information available
to consumers on request. This recommendation is not likely to entail substantial
additional costs, either for the limited-menu restaurant or consumers. The cost to
require all other restaurants to have their menus evaluated and to offer nutrient
information on request to consumers are considerably less certain. However,
evaluation of the nutrition profile of menus is widely available and inexpensive,
but even modest expense may prove high for small operators.
LEGISLATION AND REGULATION
The charge to the Committee to consider the implications of its recom-
mendations for the current laws governing nutrition and ingredient labeling was
interpreted as an invitation to consider whether the laws or regulations under
which FDA and USDA now regulate food labels need to be changed in order
to implement food labeling reform. It is the Committee's view that Congress
should amend the FD&C, FMI, and PPI Acts to confirm FDA's and USDA's
authority to expand the coverage and revise the content of current nutrition label-
ing requirements. Continuing doubt about the existence of such authority may
impede actions by the agencies and result in court challenges, thus delaying
implementation of needed reforms.
The Committee believes, however, that even without new legislation FDA
could mandate nutrition labeling on all packaged foods. FDA's authority to
prescribe the format and content of nutrition information, when it is required on
food labels, appears well established as a means to prevent misleading labeling.
In addition, FDA's decisions to exempt certain foods from some or all nutrition
information requirements would likely be upheld.
Point-of-purchase nutrition information for produce, seafood, and foods
sold in restaurants would represent a whole new area of regulation for food
labeling. Most experts consulted by the Committee agreed, however, that if FDA
could establish its authority to mandate nutrition labeling on foods in general,
the extension of such a requirement to produce, seafood, and foods sold in
restaurants would also be upheld as a matter of statutory authority. However, the
practical problems associated with this expansion of nutrition labeling would be
32
NUTRITION LABELING
significant. FDA would have to devise an alternative to the conventional package
label and would have to devise an alternative means for determining nutrient
composition. FDA has frequency held the position that it has the authority to
regulate He labeling of produce and foods sold in restaurants, although problems
of enforcement and low priority have led it to refrain from exercising this power.
USDA's authority to expand nutrition labeling of processed meat and
poultry products appears more straightforward. The PHI Act requires a label to
be affixed to any meat product package, although He EMI Act does not grant
general authority to USDA to require affirmative disclosures of infonnabon, nor
is omission of this information classified as misleading. Section 607(c) of the
PHI Act empowers USDA to prescribe the material required in nutrition labeling
to avoid false or misleading statements, suggesting that nutrition information can
be required on meat products whenever the Secretary of USDA concludes that
it is required to prevent the label from being misleading. The same authority
can be assumed under the PPI Act. USDA has ceded the authority to regulate
the packaging of retail fresh and frozen meats and poultry to local agencies.
USDA's authority to prescribe nutrition labeling for meat- and poultry-
containing foods sold by restaurants is more problematic. This uncertainty is of
concern to He Committee, because it believes that both federal agencies should
require nutrition information for foods sold at least by limited-menu restaurants.
Desirability of New Legislative Authority
for Nutrition Labeling
The foregoing discussion suggests why new legislation is, in pnnciple,
desirable. The Committee does recommend that Congress amend the FD&C,
FIJI, and PPI Acts to enlarge and clarify the authority of FDA and USDA, but
it acknowledges that this has costs as well as advantages.
Disadvantages of New Legislation
A drawback to seeking new legislation is the possibility that such an effort
may fail, causing both agencies to rethink their authority to proceed with changes
in existing regulations. The second disadvantage stems from the propensity
of Congress to draft legislation in such detail as to hamper administrative
responses to new problems. Congress could simply require all food to bear
nutrition Labeling and state Hat FDA and USDA are to determine its content.
It seems unlikely, however, that Congress will refrain from specifying the
content of nutrition labeling in detail. Purtherrnore, new legislation could exclude
important categories of foods, such as produce, seafood, meats and poultry, or
foods sold in restaurants. Because the Committee is persuaded that nutrition
labeling should be required for all these foods, it would consider legislation that
categorically exempted or omitted Hem to be unsound in principle and at odds
SUMMARY
33
with efforts to improve the dietary habits and long-term health of Americans. An
additional concern is that new legislation might encumber FDA and USDA with
rulemaking procedures that would delay implementation of regulations requiring
more informative nutrition labeling.
Advantages of New Legislation
An overriding advantage of new legislation is that it could lay to rest any
doubt that FDA and USDA have the legal authority to mandate. nutrition labeling
for all packaged foods and clarify this authority to require nutrition information
in connection with the sale of many foods that currently are not affected by
federal labeling regulations. It would also reduce the incentives to challenge
agency regulations that implement the Committee's recommendations.
New legislation could also expedite the administrative process by confirm-
ing the power of the agencies to proceed by informal rulemaking. And it could
speed executive branch review by setting deadlines for proposing and promul-
gating initial regulations.
Successful reform of nutrition labeling requires that FDA and USDA
work in tandem so that consumers can eventually make food selections in
keeping with recent dietary recommendations. Legislation should mandate that
the requirements of FDA and USDA be uniform and implemented on the same
schedule.
Another justification for legislation is the importance of food labeling
reform. The stakes involved make Congress the appropriate arena for resolving
the critical issues and adjusting to the competing interests.
Design of Food Labeling Legislation
New legislation should clarify the authority of FDA and USDA to mandate
nutrition labeling on all packaged foods and coverage of fruits and vegetables,
fresh and frozen meats and poultry, fresh and frozen seafood, and foods sold in
restaurants.
The next issue concerns what new legislation should provide regarding He
content of labeling. A distinction should be drawn between those components
of nutrition labeling Mat should be required by FDA and USDA regulations
and those that should be mandated by statute. Legislation should limit itself
to prescribing calories per serving, complex carbohydrates, sugars, and those
components whose consumption should be restricted or curtailed (fat saturated
fat, cholesterol, and sodium). All other components to be included in nutrition
labeling should be left to FDA and USDA. The Committee expects that, in
addition, the agencies would agree to requiring protein, fiber, calcium, and iron.
New legislation should direct the two agencies to agree on the same
reference unit for listing nutrition information, presumably a serving of food. It
34
NUTRITION LABELING
SUMMARY
35
and would perhaps induce federal authorities to fashion their requirements to
reflect the interests of the states. Establishment of such a food labeling committee
would not require new legislation, but a congressional mandate would ensure
creation of such a mechanism.
Finally Congress should establish deadlines for adoption of new food
labeling regulations by the agencies.
