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OCR for page 51
Current Food Labeling
OVERVIEW OF THE U.S. SYSTEM FOR
REGULATING FOOD LABELING
The United States has no single system for regulating food labels. The
federal government operates two major food labeling programs that differ in their
requirements and in their modes of operation. In addition, the states may, in some
circumstances, impose labeling requirements that go beyond those established
by the federal government. To complicate the picture further, the authority to
regulate food promotion practices that extend beyond the label, such as media
advertising, lies with a third federal agency. Finally, many foods in grocery stores
and supermarkets, and foods sewed in restaurants and institutional settings are
sold without any nutrition information at all.
This complex picture can be explained in historical and political terms, and
many of its features are not irrational. It may be appropriate to rely chiefly
on state and local authorities to oversee restaurants and educational, medical,
social, and penal institution food senice operations. Similarly, consumers and
producers alike might come to resent the cost and complications of a regimen
that requires all produce, meat, poultry, and seafood to be packaged and sold in
a form that would require conventional labeling. Other features of the splintered
U.S. system for regulating food labels, however, are certainly subject to question.
That, however, is not the focus of this report. The purpose of this chapter is
to describe how food labels are currently regulated so that readers can better
understand how food labels came to be the way they are and better assess the
recommendations for reform that are made in Part II of this report.
51
OCR for page 52
52
NUTRITION LABEllNG
The two federal agencies whose activities are of central interest are the
Food and Drug Administration (FDA) and the U.S. Department of Agriculture
(USDA). Although FDA regulates a larger share of the retail food market,
it is easier to define the two agencies' responsibilities by first describing the
jurisdiction of USDA. Through its Food Safety and Inspection Service (FSIS),
USDA regulates the labeling of meat and poultry products pursuant to the
Federal Meat Inspection Act SEMI Act, 21 USC § 601, et seq.) and the Poultry
Products Inspection Act (PPI Act, 21 USC §451, et seq.~. ~JSDA's jurisdiction
does not extend to the packaging of fresh meat and poultry at the retail level.)
Operating under the Federal Food, Drug, and Cosmetic Act (FD&C Act, 21
USC §321), FDA is responsible for regulating the labeling of virtually all
other foods. It could be said that FDA has jurisdiction over the center aisles
of the supermarket, while USDA regulates the side counters. This summary,
however, overlooks the daily section, the large (and growing) produce section,
whose products rarely bear conventional labels, and the increasingly important
seafood counter, both of which theoretically fall under FDA jurisdiction, as do
the growing number of foods prepared on the supermarket premises, such as
bakery products and salad bars.
The laws under which FDA and USDA operate differ in their histories,
provisions, and modes of implementation. Some, but not all, of these differences
have importance for this study and for the implementation of the Committee's
recommendations; these are discussed in greater detail below. For the purposes
of the present discussion, it suffices to note that all three laws~the EMI Act, the
PPI Act, and the FD&C Act—say virtually nothing about nutrition and provide
little guidance as to the information about nutrient content that USDA or FDA
may require on food labels. In both systems, decisions about the information to
prescribe on food labels have to a large extent reflected administrative judgments.
The laws administered by FDA and USDA disguise a more fundamental
difference in their modes of operation, a difference that influences enforcement
capacity and may also explain some of the reported variations in substantive
policy. Although specific requirements are not obvious in the language of the
FIJI and PPI Acts (e.g., 21 USC §607(d), (e)), USDA has always taken the
position Hat a manufacturer must obtain approval in advance for any label it
wishes to use on a meat or poultry product, as well as for any change it wishes to
make in an approved label (Kushner et al., 1990~. Research has not disclosed any
challenge to this position. Indeed, many producers of USDA-regulated products
probably favor the current system of prior label approval, which at least ensures
certainty. In practical terms, under the USDA system no meat or poultry product
bears a label that fails to meet the agency's requirements.
This label review system is a relatively small part of USDA's extensive
program for regulating meat and poultry products. The ESIS work force exceeds
9,000 employees, most of whom are engaged in on-site inspection of production
activities. Fewer than two dozen employees are engaged in the review and
OCR for page 53
CUMENT FOOD LABELING
53
approval of labels. They process a caseload of about 130,000 requests for label
approval each year (Crawford, 1990~.
The USDA system displays another notable feature. Because each manu-
facturer must secure approval for its label, USDA has had less reason than FDA
to issue formal regulations detailing its requirements. Although the agency has
evolved clear policies regarding such matters as nutrition labeling, they typically
cannot be found in the Code of Federal Regulations (CFR). Most are spelled
out in the FSIS Standards and Labeling Policy Book and policy memoranda
(USDA, 1989), which are available publicly and, therefore, are sources of guid-
ance to applicants. Reliance on these forms of guidance has meant that USDA
can, in theory, be more adaptable than FDA because it generally does not need
to revise existing regulations before requiring or allowing new information on
the labels of the foods it regulates. On the other hand, the failure to incorpo-
rate key policies in regulations may limit awareness of them and surely inhibits
public discussion of their merits.
By contrast, FDA has never operated a system of prior approval for food
labels, and any assertion of such authority now would surely be considered
beyond the agency's powers. Instead, FDA has relied on publication of its
labeling requirements, typically in the form of regulations, coupled with informal
advice giving and periodic threats of enforcement against products whose labels
fail to comply with those requirements. This mode of operation means that
industry compliance with federal requirements depends on close monitoring by
the agency and the ability to initiate enforcement against violative products.
Because FDA does not approve food labels, its system allows issues of
labeling policy to remain unresolved, sometimes for many years. A manufacturer
of meat or poultry products can always discover USDA's position on a new
labeling initiative—for example, the use of a new descriptor because it must
seek approval, and the agency must provide a response. A "no" response may,
in fact, mean only that USDA has not yet formulated a policy but operationally,
the answer is clear. In the FDA context, however, a manufacturer that wishes
to use a new label, even one that appears to challenge the spirit of the agency's
regulations, can use it and hope that the agency will not challenge its product as
being mislabeled. FDA's lack of formal policy on an issue does not necessarily
deter a practice unless the agency is prepared to take enforcement action. The
system therefore allows FDA to ignore practices that it finds objectionable but
is not prepared to challenge. It also ensures that the agency may not be aware of
label changes until after they are adopted, because manufacturers are not obliged
to submit copies of their labels on a regular basis.
These contrasting systems for regulating the contents of food labels might
only be a curiosity if the jurisdictions of the two agencies did not overlap.
The boundary between them, however, can sometimes be elusive. USDA shares
jurisdiction with FDA over food labels for products containing meat and poultry,
because the FD&C Act ostensibly applies to all food. The FMI and PPI Acts
OCR for page 54
54
Nl~RITION LABELING
authorize USDA to exempt from their requirements food products that contain
meat or poultry only in a relatively small proportion, and accordingly the agency
has determined that products containing less than 3 percent raw meat, 2 percent
cooked meat, or 2 percent cooked poultry are subject only to PDA regulations. In
addition, FDA exercises limited jurisdiction over products that remain subject to
USDA's primary control. For example, no USDA-regulated product may contain
a food or color additive that has not been approved by PDA (Kushner et al.,
1990~.
The potential overlap in jurisdictions can exaggerate the consequences of
policy differences between the two agencies. A modest change in composition
may cause a product to cross the jurisdictional boundary. For example, a pizza
product containing cheese but little meat will fall under FDA's control, and
thus escape USDA's requirement of advance label approval (GAO, 1988~. For
manufacturers whose product lines are under the jurisdiction of both agencies,
labels for similar products may be subject to different substantive requirements
as well as different approvalprocedures (Kushneret al., 1990~.
It should be stated, however, that suggestions of serious conflict between
FDA and USDA in substantive labeling requirements often appear to be un-
supported on close review. The Committee found few instances in which FDA
expected different information on food labels than USDA required or allowed.
USDA's rules for nutrition labeling of meat and poultry products have generally
tracked, although sometimes not immediately, FDA's regulations. In the Com-
mittee's judgment, the more important difference between the two systems lies
in their contrasting modes for establishing and enforcing labeling requirements.
It is important to reemphasize that both FDA and USDA have jurisdiction
over more than the printed label attached to a product. Under the FD&C Act,
FDA's authority extends to all "labeling" for foods, a term that includes labels
and other wntten, printed, or graphic matter on or accompanying a food. Thus,
the agency presumably has the power to regulate most of the in-store point-
of-purchase information that is provided about foods. The test is whether the
material "accompanies" the product; virtually any material supplied by the
manufacturer or displayed by the retailer near the food would qualify. USDA's
authority is comparably broad, but it does not customarily require prior approval
of point-of-purchase labeling for meat and poultry products.
Thus, food "labeling" encompasses a broader range of communicative
devices than the printed labels affixed to products. Current FDA and USDA
nutrition information requirements, however, are chiefly directed at product
labels, and it is these requirements on which this report focuses. It is important,
however, to understand that both agencies have the authority to challenge labels
and labeling that make claims that conflict with or go beyond the content of
current regulations or policies. Both agencies use statements made on off-
package labeling to determine whether nutrition information is required on a
product's label. In many of the contexts discussed in this report, the distinction
OCR for page 55
CUMENT FOOD lABELING
55
between labels and Labeling is not important. The legal outdone of the two
agencies to regulate labeling may prove decisive when foods are sold without
conventional labels (for example, produce) or in packaging Hat no federal
agency currently attempts to regulate (for example, foods sold by some limited-
menu restaurants).
EVOLUTION OF NUTRITION LABELING FOR FOODS
FDA Nutrition Labeling Requirements
Labels on over half of all packaged foods sold in the United States currently
provide some Me of nutrition information. The information allowed or required
on FDA-regulated foods is prescribed by regulations that the agency first adopted
in 1973 (38 Fed. Reg. 2125-2132, Jan. 19, 1973~. These regulations have
undergone relatively few changes since they went into effect in 1975, which
helps to explain the present interest in reform. Any assessment of proposed
reforms, therefore, requires some understanding of FDA's original regulations
and the judgments that they reflect. It is appropriate to begin this examination of
current nutrition labeling policy with FDA, because its requirements antedated
and influenced USDA (Kushner et al., 1990~.
FDA derives its authority to regulate food labels from the FD&C Act. That
law was enacted in 1938, when knowledge about nutrition was rudimentary
and most links between diet and chronic disease were unsuspected. Although
the FD&C Act has been amended many times, the provisions governing the
labeling of conventional foods have undergone no significant change since their
enactment. These provisions are written such that their broad language, coupled
with the agency's explicit authority to prescribe regulations for the efficient
enforcement of the Act, has allowed FDA to update the Act's requirements as
processed foods have proliferated and expectations for the types of information
that should appear on food labels have changed (21 USC § 371 Gail.
Under section 403 of the PD&C Act (21 USC § 343), every food label must
contain the name of the food, a statement of the net quantity of contents (typically
net weight), and the name and address of the manufacturer or distributor. Even
today, some foods are lawfully marketed with labels that bear only these three
items of information, although most labels contain more. Most notably, all but
a few FDA-regulated foods must also bear a list of ingredients in descending
order of predominance. The exception, however, is an important one: Foods for
which EDA has established a standard of identity need not list ingredients that
the standard makes mandatory.
In addition to requiring these affirmative statements on food labels, the
FD&C Act prohibits other statements; most significantly, it prohibits statements
that are false or misleading in any particular. A related provision, section 201(n)
(21 USC § 321(n)), specifies Hat in determining whether He labeling of a food
OCR for page 56
56
Nl~RITION LABEllNG
is misleading, "there shall be taken into account . . . not only representations
made or suggested . . . but also the extent to which the labeling . . . fails to
reveal facts material in light of such representations...." This was the U.S.
Congress's way of recognizing that half-truths can often be as misleading as
outright misrepresentations. Section 201(n) was originally treated as guidance
for courts that adjudicated FDA charges of misbranding, but since the 1960s
the agency has, on occasion, invoked this provision and its general rulemaking
power to prescribe affirmative disclosures on food labels. These provisions
provided the authority on which FDA relied in adopting its current requirements
for nutrient information on the labels of packaged foods (38 Few Reg. 2125-
2132, Jan. 19, 1973).
Before the 1973 regulations are discussed, FDA's early attitude toward
health claims for foods and its protracted efforts to control foods offered for their
vitamin and mineral contents should be mentioned. Through the late 1960s, FDA
relied primarily on the FD&C Act's prohibition against misleading labeling to
curb what it considered irrational fortification of foods and the sale of products
that offered ingredients of no proven nutritional value. Moreover, the agency
consistently objected to specific claims that a food or any component could
treat or prevent disease. Agency officials took the position that any product
with a label that explicitly or implicitly claimed utility in preventing or treating
disease, other than nutritional deficiency, was, under the law, a "drug" and,
thus, a product whose safety and effectiveness had to be proved before it could
lawfully be marketed Mutt, 1986~.
Sometimes, the accumulation of knowledge about nutrition and disease
seemed to challenge FDA's uniform opposition to health claims. Following
the publication in 1957 of a major report by the American Heart Association
recommending a reduction in dietary cholesterol and saturated fats, marketers of
many foods began referring to this advice in their labeling. FDA officials viewed
any reference to cholesterol or saturated fat with suspicion and they threatened to
seize products whose labeling featured such references. As the evidence linking
these food constituents to coronary heart disease grew stronger, however, the
agency came under increasing pressure to change its position and by 1970 was
no longer attempting to enforce it (Huts, 1984~.
The I;D&C Act does not, in so many words, require that a label for any
food provide information about nutrient content. However, Congress recognized
as early as 1938 that some nutrient information might be important for certain
products. In section 403a) Of the Act (21 USC §343a)), it authorized FDA
to issue regulations prescribing the information about vitamin, mineral, and
other dietary properties that must appear in the labeling of foods represented for
what the law termed "special dietary use." FDA inaugurated section 4030) in
1941 by adopting regulations governing the labeling of fortified foods, vitamin
and mineral supplements, and other special dietary foods such as infant foods,
hypoallergenic foods, and foods for use in weight control. The 1941 regulations
OCR for page 57
CURRENT FOOD LABELING
57
specified how food components should be described if the manufacturer chose to
feature them, but they did not purport to restrict the type or quantity of nutrients
that could be included or limit other claims that could be made.
Over the next two decades, the types of special dietary products marketed
and the claims made for them grew in number and variety. By the early 1960s,
FDA officials had concluded that the 1941 regulations needed updating, and
in 1966 the agency proposed a far-reaching set of changes. In addition to
proposing to limit the foods that could be fortified and to restrict the nutrients that
could be used in fortification, FDA proposed to curtail the number of allowable
formulations of dietary supplements of vitamins and minerals. It alto proposed
to ban statements on vitamin and mineral supplements Hat Americans' diets
were nutrient deficient, that common foods did not supply adequate amounts
of nutrients, or that routine vitamin or mineral supplementation was prudent.
The agency's most provocative proposal was to treat all products that supplied
significantly more than the Recommended Dietary Allowance (RDA) of any
nutrient as "drugs." The administrative hearings on these proposals lasted from
1967 to 1969, and decisions about the content of final regulations were still
pending at the close of the decade.
Space does not allow, nor does the context warrant, a full account of the
ensuing 5 years of litigation over the substance and legality of FDA's proposals
for vitamin-mineral supplements. The final chapter of the story, however, is
noteworthy. In 1976, for the first time since its passage, Congress amended the
1938 FD&C Act to withdraw authority from FDA, forbidding it to restrict as
unneeded or useless—the kind or amounts of vitamins and minerals that can be
added to foods or sold as supplements (Merrill and Hutt, 19803.
While any summary of FDA's early food labeling policies involves over-
simplification, it is nonetheless fair to describe the agency as being concerned
chiefly with protecting the consumer's pocketbook by maintaining the compo-
sition of basic foods and discouraging the sale of processed substitutes. The
agency started with the assumption that traditionally formulated foods and meals
prepared in the home would ensure headthy diets. Furthermore, it displayed lit-
tle confidence in the ability of consumers to make wise dietary choices. These
policies, however, began to undergo significant change.
In 1969, President Richard Nixon convened the White House Conference
on Food, Nutrition, and Health, largely in response to reports of widespread
malnutrition among Americans. While this topic was the focus of the conference,
the final report also addressed the regulation of food composition and labeling
(WHC, 1970~. The report criticized FDA's approaches to food standards of
identity, the marketing of substitute foods, and label statements relating to
nutrition and long-term health. While the report stressed the importance of sound
nutrition, it emphasized He need to help consumers make sound nutritional
choices by requiring more information on food labels. Among the conference
participants were several individuals who soon after became officials of ADA,
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58
NUTRITION L4BELING
and its recommendations had an immediate impact on the agency's policies
(Wodicka, 1990~.
By 1973, FDA had adopted several amendments to its regulations that
reflected a new emphasis on providing consumers with information needy to
make informed dietary choices. Under the FD&C Act (21 USC §343(i)) the
label of a standardized food does not need to contain a list of any marKlatory
ingredients but must contain a list only of those optional ingredients specified by
FDA. The agency urged manufacturers to list all ingredients voluntarily (21 CFR
§101.6~. Then, it began (although it has not yet completed the task) to amend
existing standards of identity to classify most previously mandatory ingredients
as optional and to require that they be listed on the label (Huts, 1984~.
FDA's most important initiative was its adoption of regulations governing
nutrition labeling for pacl~ged foods. These regulations, He coverage and
current adequacy of which are the focus of this report, did not (and still do
not) require nutrition labeling of all foods within the agency's jurisdiction.
Among other considerations, uncertainty about its legal authority to mandate
across-the-board nutrition information led the agency to set more modest goals.
The regulations specified how nutrition information was to be provided if a
manufacturer chose to do so. The regulations also required that certain foods
have nutrition labeling. If a nutrient were added to, or any nutrition claim was
made for a food, its label had to provide nutrition information in a prescribed
format.
Because these regulations established the framework for most of the nutn-
tion information that currently appears on the labels of packaged foods, whether
regulated by FDA or USDA, their examination in furler detail is useful. It
is important to emphasize that FDA's 1973 regulations had a different focus
from those of current proposals to reform food labels. In the early 1970s, fed-
eral health officials were preoccupied about reports of undernourishment in the
United States, and FDA officials wanted to ensure that consumers were provided
with sufficient information to enable them to select a diet that was adequate in
vitamins, minerals, and protein. At the same time they remained eager to curb
excessive consumption of these nutrients. These complementary views produced
agreement on a label that focused on a food's contribution to the desired daily
intake of vitamins, minerals, and protein. Thus, the prescribed nutrition infor-
mation panel featured those nutrients, among others, and most of them were de-
scribed in terms of the percentage of the U.S. Recommended Daily Allowances
GAS. RDA) provided in a serving. The U.S. RDAs were a creation of FDA,
based on the 1968 RDA established by the Food and Nutntion Board of the
National Research Council (NRC, 1968) but simplified to facilitate label disclo-
sure.
EDA's regulations prescribed a uniform sequence and format for nutrition
information. The label was to set forth the following, in the indicated order: (1)
serving size for the food; (2) the number of servings in the container, and per
OCR for page 59
CURRENT FOOD LABELING
59
serving (3) the number of calories; (4) the amount of protein (in grams); (5)
the amount of carbohydrate (in grams); (6) the amount of fat (in grams); (7)
the amount of protein (expressed as a percentage of the U.S. RDA); and (8) the
percentage of the U.S. RDA of each of seven micronutrients (vitamin A, vitamin
C, thiamin, riboflavin, niacin, calcium, and iron). The regulations also allowed
a manufacturer to list any of a dozen other vitamins and minerals, in terms of
the percentage of the U.S. RDA in a serving (21 CF~ § lOl.9(c)).
The explanation accompanying the regulations did not always spell out the
agency's reasons for the choices it had made. Contemporary statements by I;DA
officials indicated little more than that the list of required nutrients was consistent
with the opinions of professional nutritionists consulted by the agency (Stakes,
1972~. Among the major constituents, only protein was to be described in terms
of recommended intake, and it seems clear that EDA officials were not concerned
about excessive protein consumption but, rather, about deceptive claims for
protein content. The agency required that protein be listed, by percentage of the
U.S. RDA, "unless the product contained no substantial amount of protein." In
that case, protein could be omitted (21 CFR § lOl.9(c)C7~(ii)~.
FDA's regulations required the disclosure of total fat content but not fatty
acid composition. A separate regulation that addressed this subject allowed
manufacturers to include information about fatty acid composition, with certain
conditions (21 CPH §101.25). If the fatty acid composition was listed, the
regulations specified that it was to be described in terms of polyunsaturated,
saturated, and percent calories from fat. Furthermore, reflecting FDA's long-
standing opposition to label claims about saturated fats and coronary heart
disease, the regulations provided that if fatty acid composition was listed, the
label also had to include the following statement: '`Information on fatty acid
content is provided for individuals who, on the advice of a physician, wish to
modify their total dietary intake of fatty acids" (Dunning, 1973~. The agency
adopted the same position regarding cholesterol. Stating cholesterol content was
optional, but if it were included the manufacturer had to add a similar statement
that the purpose was to assist individuals who were under a physician's care (21
CF1( § 101.25).
Sodium was treated somewhat differently. Under the 1973 regulations,
listing of sodium (in milligrams per seeing) was optional, but it could also
be listed in the absence of full nubidon labeling (21 CF~ § lOl.9(c)~8)(i)).
The objective was to encourage the provision of sodium information without
subjecting manufacturers to the expense of determining the amounts of other
nutrients in a food. However, rules adopted in 1984 required sodium to be
declared when nutrition information was provided.
FDA's 1973 regulations reflected important decisions regarding the format
of nutrition labels. First, the agency specified that nutrition information, when
provided, was to appear on the information panel or principal display panel
of the package (21 CF~ §101.2~. Another regulation had previously fixed the
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60
NUrRlTION LABEIJNG
location of these label components (21 CF1{ §101.1~. The goal was to make
sure that nutrition information appeared in the same location on similar foods
and in roughly the same position on all foods, so that it would be "more easily
found and read by consumers under normal conditions of purchase and use" (37
Fed. Reg. 6493 6497, Mar. 30, 1972~.
Second, for the presentation of nutrition information, FDA chose a numeric
format over verbal and pictorial alternatives. This choice was based in large part
on studies the agency had commissioned by the Consumer Research Institute
(CRI) Johnson, 1973; Wells, 1972~. The agency apparently had already decided
that the U.S. RDAs should provide the framework for describing nutrient content;
it asked CRI to test three approaches for communicating this information. One
format, the one Rat was chosen, presented the information numerically as a
percentage of the U.S. RDA. One of the two rejected, the so-called verbal
format, described the content of individual nutrients as fair, good, and excellent.
In the other, We pictorial format, the proportion of the U.S. RDA provided by
a serving was expressed by small circles, stars, or smiling faces. According to
an FDA official, all three formats were understood by uneducated, low-income
consumers as well as by educated consumers, although the former group had
greater difficulties with He verbal design. Consumers found me pictorial format
least desirable; many thought it condescending (Johnson, 1973~. See Figure
3-1 for an example of a nutrition information panel based on current FDA
regulations.
FDA's original nutrition labeling regulations embodied several decisions
that ensured that its system would not be comprehensive. Because of its under-
standing with USDA, FDA could not make its regulations applicable to meat and
poultry products. Foods sold by restaurants and other food service institutions
2% LOWFAT MILK
Nutrition Information Per Serving
SERVI NG SIZE ONE CUP
SERVINGS PER CONTAINER 8
CALORIES 120
PROTEIN ..............
CARBOHYDRATE......................
FAT
SODI UM
8 GRAMS
1 1 GRAMS
5 GRAMS
130 mg
Percentage of U.S.
Recommended Daily Allowances (U.S. RDA)
PROTEIN 20 RIBOFLAVIN 25
VITAMIN A 10 NIACIN *
VITAMIN C 4 CALCIUM 30
THIAMINE 6 IRON ~
'CONTAINS LESS THAN 2% OF THE U.S. RDA FOR THESE NUTRIENTS
FIGURE 3-1 Sample nutrition information panel for 2% low-fat mild (Y2 gallon) under
current FDA regulations (minimum requirements).
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CURREVT FOOD LAsELlNG
61
were also excluded, chiefly, but not solely, because of problems of enforcement
(DHEWtUSDAIE1C, 19793. The agency originally contemplated labeling for
fresh fruits and vegetables, albeit with modifications, but it eventually exempted
them from the regulations, ostensibly on the grounds of infeasibility (38 Bed.
Reg. 32,78~32,787, Nov. 28, 1973~. FDA never finalize a later proposal to
extend nutrition labeling to produce (40 Fed. Reg. 8214-8217, Feb. 26, 1975~.
In sum, FDA's 1973 nutrition labeling regulations applied only to retail
packaged foods other than meat and poultry products. Even for these retail
packaged foods, the agency's requirements were not universally binding. By
their terms, the regulations required nutrition labeling on a packaged food only
if the manufacturer of a food added a nutrient or made a nutrition claim for the
product.
The decision to make nutrition labeling essentially voluntary was carefully
considered. Although it was not spelled out in the preamble, almost surely one
of FDA's reasons for this was uncertainty about its legal authority to require
affirmative disclosure of nutrient information on foods for which no nutritional
claim, implicit or express, was made (Wodicka, 1990~. The agency's chief source
of power in the FD&C Act, in addition to its general power to adopt regulations
for the efficient enforcement of the Act, was the section 403(a) prohibition
against misleading labeling, coupled with section 201(n), which, arguably, is
activated by what manufacturers chose to say about their products. FDA had
other reservations as well, however, as its preamble in the Federal Register
explained:
The Commissioner has concluded that insufficient information is known about the
nutrient content and variability of some foods, and that the analytical methodology
and capacity of some food manufacturers, processors, and distributors is inadequate
to permit adoption of a requirement at this time that all foods bear nutrition
labeling. Experience under this new regulation is required before expansion to all
foods on a mandatory basis can be considered (38 Fed. Reg. 212~2132, Jan. 19,
1973).
Although changed in some details, FDA's current nutrition labeling regula-
lions still make nutrition labeling mandatory only for foods to which a nutrient
has been added or for which a nutrition claim has been made.
USDA Nutrition Labeling Requirements
Soon after FDA issued its final nutrition labeling regulations, USDA
proposed a similar set of requirements for meat and poultry products (Mussman,
1974~. However, the department never completed this nllemaking. Its system of
prior label approval allows it to effect compliance with deparanental policies
without issuing regulations, and apparently, USDA officials concluded that it
was preferable to set forth its policies in a less formal fashion. USDA's current
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CURRENT FOOD lABELING
63
and both say relatively little about the lope of information USDA may require
on labels, the universal acceptance of USDA's prior approval system, coupled
with the broad language of these statutes, would appear to put any such doubts
to rest.
DEFICIENCIES IN CURRENT
REQUIREMENTS FOR FOOD LABELS
For 15 years, nutrition labeling has been used to provide consumers win
information to make more informed food choices, primarily to avoid certain
nutrient inadequacies. Critics of the current system stress the need to provide
information to help consumers manage their total dietary pattern in line with
current dietary recommendations (ADA, 1990; AIN/ASCN, 1990; CNCFL,
1989; CSPI, 1989; DHEW/USDA/FI C, 1979; DHHS, 1988; FDA, 1978,
1989a,b; FNLG, 1989; GAO, 1988; ORC, 1990; U.S. Congress, 1989a,b). Their
criticisms of current food labels fall into several categories:
Nutrition labeling should be mandatory; currently, it is not required on
all packaged foods and is not used in conjunction with the sale of other
important classes of foods.
Nutrition panel information is not uniform across all food products.
Current nutrition labeling as well as efforts to make labeling changes
should be accompanied by a consumer education program.
Nutrition panel information includes some nutrients that should not or
do not need to be listed, while other information is omitted.
Ingredient labeling is incomplete and misleading.
Current format is too confusing and complex.
Label disclosures of nutrient contents are misleading and are not based
on established standard definitions.
Foods Not Currently Covered or Exempted from
Nutrition Labeling Regulations
Recent estimates are that about 60 percent of packaged products regulated
by FDA have nutrition labeling; for USDA, more than 35 percent of regulated
packaged products carry nutrition labeling. This means that almost half of all
packaged foods do not bear nutrition labeling. Moreover, nutrition information is
not required on or in conjunction with the sale of fresh and frozen meats, poultry,
eggs, and seafood; fruits and vegetables; foods prepared and sold for immediate
consumption by restaurants, carryout food bars, and many supermarkets; and
most foods sewed in institutional settings.
Many consumer and health and nutrition organizations have called for
mandatory nutrition labeling of all foods under FDA and USDA jurisdiction,
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NUT]UTION LABELING
either based on current law or mandated by new legislation. These groups also
argue that FDA and USDA requirements for such labeling should be uniform.
Industry groups have expressed concern over the potential for a multiplicity
of food labeling rules by the states and have argued that food labels throughout
the United States should bear uniform information that is subject to supervision
and enforcement by FDA and USDA. However, many proponents of nutrition
labeling changes have opposed preemption of state labeling laws and expressed
concern that efforts to achieve uniformity could extend beyond nutrition and
ingredient information on food labels into areas such as food safety.
Virtually all groups urge that legislative or regulatory reforms of food Labels
should include a comprehensive consumer education component developed and
funded jointly by the public and private sectors.
Deficiencies in Information About Nutrient Content
There is considerable public health interest in several food components
that are currently not required on the standard nutrition information panel,
including cholesterol; saturated, monounsa~a~, and polyunsaturated fatty
acids; complex carbohydrates; fiber; and potassium. Although current rules
allow voluntary declaration of some of these food components, none of this
information is now mandatory.
Fat and Cholesterol
Current FDA and USDA regulations permit the voluntary inclusion of fatty
acid and cholesterol contents, in addition to total fat content, as part of nutrition
labeling (21 CER § 101.25; USDA, 1985~. The rules allow a food label to include
information on fatty acid content if the food contains 10 percent or more fat
on a dry weight basis and not less than 2 percent of fat in an average serving.
If any claim about fatty acid and/or cholesterol content is made for a product,
full nutrition information becomes mandatory. ~ addition, current regulations
on fat content require an accompanying statement, for example, "Information
on fat [and/or cholesterol, where applicable content is provided for individuals
who, on the advice of a physician, are modifying their dietary intake of fat
[and/or cholesterol, where applicable]." However, FDA has not enforced He
requirement for several years and the disclosure now rarely appears on food
labels.
Health professional and consumer groups have called for more compre-
hensive information about fat and cholesterol to be included on food labels.
Suggestions for expanded fat information include mandatory disclosure of satu-
rated, monounsaturated, and polyunsaturated fatter acids, and cholesterol. Some
also urge that each fat component be disclosed by weight (in grams), number of
calories, and/or percentage of total calories.
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CURRENT FOOD lABE:LING
Carbohydrates
65
Both FDA and USDA require the disclosure of total carbohy~es when
nutrition information is provided (21 CF-R §101.9(c)~5~; USDA, 1985~. Various
consumer groups have called for more complete information on complex and
simple carbohydrates (starches and sugars, respectively). These groups are con-
cerned that high levels of sugar consumption contribute to dental caries, nutrient
dilution, and, potentially, excess calories. Quantitative declaration of carbo
hydrate components has been urged as consumers have become increasingly
concerned about the quantity of sugars they are consuming.
Numerous critics have argued that the amount of sugar and other sweeteners
should be declared by weight, or by both percentage and weight' either on the
nutrition panel or ingredient listing. Many industry groups, however, have ques-
tioned whether current analytical techniques are adequate to support mandatory
disclosure of total carbohy~es, simple carbohydrates (sugars), and complex
carbohydrates.
Fiber
Over the past several years, breakfast cereal manufacturers and other
segments of the food industry have included fiber content declarations on their
food labels as a result of consumer interest. Although not required, FDA
policy currently states that if fiber content is report, it must be expressed
as dietary fiber and declared in grams. Consumer and health advocates support
the mandatory declaration of fiber content on the nutrition information panel.
Sodium and Potassium
Sodium content (in milligrams) is a required component of the nutrition
information panel when it is used voluntarily or a claim is made on the label.
However, sodium content can be declared on a food label without providing
full nutrition information labeling (21 CPR §101.9(c)~8~(i)~. In the absence of
a claim, listing of the sodium content remains voluntary under USDA Policy
Memorandum 049C (USDA, 1984~. FDA applies similar rules to potassium;
however, declaration is voluntary (21 CFE §101.9(c)~8~(ii)~.
For more than a decade, consumer, professional, and industry groups, as
well as legislators, have supported mandatory labeling of the sodium and,
sometimes, potassium contents on all foods. Recommendations from these
groups vary as to whether the total and/or added sodium or salt should be
declared on the nutrition information panel and whether it should be declared
by weight or percent.
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66
Other Nutrients
NllTl~lTION LABELING
Micronutrients of current public health concern (e.g., folate, zinc, and
vitamin B6) have been proposed by venous groups to be required components
of the nutrition information panel. Most groups seem to agree, however, that
federal agencies should have regulatory discretion to add or subtract nutrients
from the required label information as knowledge of dietary patterns and the
relationship of nutrition to long-term health change.
Incomplete Ingredient Information
When the 1938 ED&C Act first mandated the listing of ingredients on most
packaged foods, the requirement was viewed primarily as a means of providing
consumers with basic information about the value of foods. While the listing
of ingredients does not provide direct information about a product's nutrient
composition, it does provide information about the components used to make
the food and about ingredients that consumers may wish to avoid, such as
certain fats. Current interest in the ingredient listing has focused on the health
implications of specific ingredients and consumers' ability to identify and avoid
certain food constituents.
Current FDA and USDA regulations generally require that, except for for
standardized foods, if a food is formulated from two or more ingredients, the
ingredients must be listed on the label in descending order of predominance by
weight (21 CFR § 101.4; 9 CER § 317.2). Each ingredient is to be listed by its
common or usual name, except for spices, flavors, and colors, which generally
may be listed in categorical groupings (21 CF~ §101.22).
Percent Ingredient Labeling
Many groups have proposed Hat the ingredient panel disclose the percent-
age of each ingredient in a food product. Current FDA and USDA regulations do
not require percent ingredient labeling. The possibilities for listing percentages
of ingredients range from listing the major ingredients to listing all of them.
Manufacturers have resisted this proposal, arguing that it would reveal propri-
eta~y formulations.
"AndlOr" Ingredient Labeling
Current EDA regulations allow the use of "and/or" ingredient labeling for
the declaration of leavening agents, yeast nutrients, dough conditioners, firming
agents, and fats and oils (21 CFR 101.4(b)~14~. "Andfor" labeling allows the
manufacturer the flexibility to switch among interchangeable ingredients without
revising food labels, when price, availability, or both vary. Particular attention
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CURRENT FOOD IABE1]NG
67
has focused on the implications of this practice regarding the fat composition
of foods.
Continued use of "and/or" labeling for fats and oils is opposed by groups
which believe Rat consumers should be able to avoid certain fats and oils with
high levels of satiated fatty acids. Many groups argue ~at"and/or" labeling
could continue to be allowed for fats and oils only if nutrition information
labeling is mandatory for total fat and saturate and unsaturate fatty acids.
Some consumer groups have proposed extension of the use of "and/of
labeling to nutritive carbohydrate sweeteners, which would have We effect of
aggregating all sugars under a single entry in the ingredient list. These groups
have expressed concern about the quantity of sugars in Americans' diets and
claim Cat many ingredients being used in foods would not be identified as
sweeteners by consumers. By grouping these ingredients together on the label,
they argue, consumers would realize that, in addition to sugar, over ingredients
(e.g., corn syrup, honey, or molasses) are being used to sweeten a given product.
Confusing and Complex Disclosures
Several critics argue that a number of items currently required or allowed
on food labels create confusion and are difficult for the average consumer to
grasp, including the concept and sizes of servings and the U.S. RDA.
Serving size
A critical element of the nutrition information panel is the serving size
of the food, for "serving" provides the reference unit for declaring nutrient
content. While both agencies require that serving size be declared when nutrition
information is provided, neither FDA nor USDA has established serving sizes
for any class of foods; they allow manufacturers to set the serving size. FDA
regulations define seeing size as Cat reasonable quantity of food consumed as
part of a meal (21 CFR § lOl.9(b)~1~.
There are notable disparities in serving sizes among foods. Some manu-
facturers have clearly manipulated serving sizes to promote perceived or real
benefits from the nutrition information panel (e.g., calories per serving). Some
seeing sizes appear to be altogether unrealistic. For example, a 12-fluid-ounce
(355-ml) can of a carbonated beverage lists two settings per container at 6
fluid ounces (177 ml) each when most individuals would consume the entire
contents at one time. Critics also point to Be lack of unifo~.'ity within product
categories. Different seeing sizes within product categories make comparisons
between similar foods difficult. Concerned about these practices, FDA proposed
a procedure for standardizing seeing sizes in 1974 (39 Fed. Reg. 20,887-20,888,
June 14, 1974), but it never finalized the rule. Professional and consumer orga-
nizations have recommended that FDA and USDA standardize Be serving sizes
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68
NUIRlTION L4BEl~NG
used in nutrition labeling to make comparisons among products easier and to
prevent misleading manipulation.
Consumer groups and some food manufacturers believe that many con-
sumers are unfamiliar with serving sizes expressed in grams and milligrams;
they are more familiar win food measurements in household units, such as
teaspoons and cups.
It has also been argued that all foods that require additional ingredients for
the usual forms of preparation should be required to provide seeing size and
nutrition information for the food in the form that is consumed, not just in the
form that is packaged. For example, since mink is routinely added to breakfast
cereal, the nutrition information panel should be required to provide nutrient
information for both He dry cereal and the cereal as consumed.
U.S. Recommended Daily Allowances
Amounts of protein, vitamins, and minerals per seeing are currently
required to be expressed as a percentage of the U.S. RDA. FDA developed the
U.S. RDAs in the early 1970s for use in nutrition labeling by taking the highest
level of the NRC 1968 RDAs (NRC, 1968) for each nutrient and malting it the
standard for expressing nutrient levels (21 CF~ 101.9(c)~7~. RDAs were updated
in 1974, 1980, and 1989, the current 10th edition (NRC, 1974, 1980, 1989~. The
U.S. RDAs, however, have not been unaged since 1972.
Most professional and consumer groups have recommend that the U.S.
RDA system at least be updated to reflect the 1989 RDAs. Some have also
urged adoption of the quantitative nutrient intake recommendations from recent
reports as standards for expressing amounts of macronutrients. Many groups
have also expressed concern about consumers' understanding of the U.S. RDA.
Some evidence suggests that consumers have difficulty understanding and using
percentages. It appears that many consumers do not understand that the U.S.
RDA percentages for different nutrients on food labels cannot collectively be
added up to reach a total of 100 percent for their U.S. RDA for the day. Other
critics question whether the concept of the U.S. RDA is sound in principle.
They suggest that there should be a different system for presenting nutrition
infonnation to consumers and, at the very least, some beer way to educate
consumers about the nutrition information on food packages.
Nutrition Label Format
Although there seems to be widespread support for changing the content
of nutrition labeling, opinions diverge on the best format for depicting nutrition
information on food labels. Current research provides little guidance about the
best nutrition label format for consumers. Advocates of label change, however,
have proposed a variety of untested new label formats. Other label expression
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CURRENT FOOD lABELING
69
issues include weight versus percentages, "and/or" labeling, and the listing of
the ingredients discussed above.
Critics of the current numeric labeling system have urged federal agencies to
use market research techniques, including focus groups, to demmim consumers'
ability to use different presentations of nutrition information on food labels. They
argue that education, media, and marketing experts should be included in the
development and analysis of new potential label formats. A variety of groups
have also supported the need for strong efforts to educate consumers about the
use of a new label once a new label format is developed and approved for
implementation.
Nutrition Information Pane!
The expression of fat content by weight (grams or household measures), as
calories from fat, or as a percentage of total calories has been widely discussed.
Although many supporters of additional fat information do not support use of
the percentage of calories from fat, they acknowledge that it may be useful when
comparing similar foods.
Numeric Displays
The current label format presents nutrition information as numbers in col-
umns. Many critics believe that the current format is confusing, complicated, and
difficult for consumers to understand. When FDA established nutrition labeling
regulations in 1973, it prescribed text and numbers rather than text alone or
text with graphics because results of the limited amount of consumer research
available suggested that consumers preferred numbers to indicate the amounts
of nutrients in a food.
The nutrient content of a food can be expressed as absolute amounts,
such as grams and milligrams, or as a percentage of a daily intake standard.
Currently, only protein, vitamins, and minerals are expressed in terms of a daily
intake standard. Some have suggested that other food components such as fat,
carbohydrates, and fiber should be expressed in a similar fashion.
Descriptive (Adjectival) Display
Descriptors are already widely used to describe He nutrient content of foods
on the principal display panel, and some argue that their use should be expanded
to describe nutrient content on Be nutrition panel. It is argued, for example, that
terms such as excellent, good, and fair, or high, medium, and low are more
easily understood by most consumers than are the metric weights (grams and
milligrams) currently used. Others note, however, the difficulty of defining
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NUTRITION LABELING
such terms and point to the lack of consistency in their use among agencies.
Some also argue that descriptive terms alone may not provide sufficiently precise
information on the nutrient content of a food, and numeric ranges would need
to be defined for the use of each term.
Graphic Display
There have been several innovative suggestions for the use of visual
representations to convey nutritional value. Pie charts have been proposed to
present information on the protein, fat, and carbohydrate contents of a food,
with the information being presented either on a weight basis or as a percentage
of calories. Critics of such approaches note that vitamins and minerals cannot
be presented in this manner since they make no caloric contribution to the food.
The bar graph is another graphic option that }has been proposed to express
nutritional values as a percentage of a daily intake standard. It has been noted,
however, that bar graphs confront problems in expressing nutrient values that
exceed 100 percent of the standard (e.g., over 100 percent of the U.S. RDA),
and some worry that consumers would perceive that only long bars are good.
Symbolic Display
Another approach to providing consumers with nutrient information is
the use of symbols. Various types of symbols (colors) have been suggested,
including the use of stoplight colors (e.g., red is bad or high, yellow is caution
or moderate, and green is good or low) and icons for low-fat, low-cholesterol,
low-sodium, high-fiber, and low-sugar. Symbols of this type currently appear
on some restaurant menus.
Groupings and Sequences
Some commentors have suggested the grouping of nutrients in positive and
negative clusters. Protein, fiber, vitamins, and minerals would appear in a group,
possibly at the top of the label, whereas fat, cholesterol, sugar, and sodium
would be clustered, perhaps, at the bottom of the label. Another variation would
be to provide groupings according to nutrient type; that is, all carbohydrates,
all fats, and all micronutrients would appear in separate blocks on the nutrition
panel.
Typography and Color
The type sizes of words on labels are frequently criticized as being too small
and, therefore, illegible to many consumers. Individuals with sight problems,
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CURRENT FOOD L4BE~NG
71
especially Me elderly, are thought to find labels difficult to use. Better
use of color has also been recommended to make information more Wily
distinguishable. Some industry representatives argue, however, that Be use
of multiple colors on labels may add significant costs and present additional
comprehension problems.
Nutrient Content Claims
The growing practice of labeling packaged foods win descriptors that
characterize a food's nutrient content has led FDA and USDA to establish or
propose definitions for certain descriptive teens, such as low catone (21 Can
§ 105.66), sodium free, low sodium (21 CAR §101.13), no cholesterol, and
low cholesterol (55 Fed. Reg. 29,45~29,473, July 19, 1990~. Other widely
used terms, however, such as natwal, organic, and fresh, have never been
defined by either agency or have been defined by only one. As a result, some
descriptors are used to refer to several different product characteristics, creating
confusion among consumers. For example, the term lite has been used by various
manufacturers to describe color, ~caste, texture, fat, sugar, calories, salt or sodium,
weight, and even breading. Furthermore, other descriptors are used in different
ways to describe Be same nutrient.
Most groups urge Rat regulations be established to define terms such as
high, reduced, low, no, lite, and others as they are nee - . Most groups have
requested formal definitions of descriptors for all nutrients that appear on Be
nutrition information label. There is disagreement whether certain claims should
be allowed only when a food meets over charactenstics (e.g., not allowing a
n~cholestero1 claim when a food is high in saturated fat).
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Representative terms from entire chapter:
nutrition information
