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Appendix B
History of Nutrition Labeling1
Up to the late 1960s, there was little information on food labels to identify the nutrient content of the food.
From 1941 to 1966, when information on the calorie or sodium content was included on some food labels, those
foods were considered by the Food and Drug Administration (FDA) to be for “special dietary uses,” that is, intended
to meet particular dietary needs caused by physical, pathological, or other conditions. 2,3,4 At that time meals were
generally prepared at home from basic ingredients and there was little demand for nutritional information (Kessler,
1989). However, as increasing numbers of processed foods came into the marketplace, consumers requested infor-
mation that would help them understand the products they purchased (WHC, 1970). In response to this dilemma,
a recommendation of the 1969 White House Conference on Food, Nutrition, and Health was that FDA consider
developing a system for identifying the nutritional qualities of food:
Every manufacturer should be encouraged to provide truthful nutritional information about his products to enable
consumers to follow recommended dietary regimens. (WHC, 1970)
This chapter provides a history of the milestones in nutrition labeling since 1969. These events are also detailed
in the annex to this chapter.
VOLUNTARY NUTRITION LABELING
In response to the White House Conference, FDA developed a working draft of various approaches to nutrition
labeling and asked for comment by nutritionists, consumer groups, and the food industry. Then in 1972 the agency
proposed regulations that specified a format to provide nutrition information on packaged food labels. Inclusion
of such information was to be voluntary, except when nutrition claims were made on the label, in labeling, or in
advertising, or when nutrients were added to the food. In those cases, nutrition labeling would be mandatory. 5 This
1This Appendix contains material excerpted from: IOM. 2010. Front-of-Package Nutrition Rating Systems and Symbols: Phase I Report.
Washington, DC: The National Academies Press.
2 Federal Food, Drug, and Cosmetic Act, Sec. 411(c)(3) (21 U.S.C. Part 350).
3 6 FR 5921.
4 31 FR 8521.
5 37 FR 6493.
115
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116 FRONT-OF-PACKAGE NUTRITION RATING SYSTEMS AND SYMBOLS
action was based on Section 201(n) of the Federal Food, Drug, and Cosmetic Act of 1938 (FD&C Act) 6 that stated
that a food was misbranded if it “fails to reveal facts material in the light of such representation.” FDA argued that
when a manufacturer added a nutrient to a food or made claims about its nutrient content, nutrition labeling was
necessary to present all of the material facts, both positive and negative, about that food (Hutt, 1995) .
When finalized in 1973, these regulations specified that when nutrition labeling was present on labels of
FDA-regulated foods, it was to include the number of calories; the grams of protein, carbohydrate, and fat; and the
percent of the U.S. Recommended Daily Allowances (U.S. RDA) of protein, vitamins A and C, thiamin, riboflavin,
niacin, calcium, and iron.7 Sodium, saturated fatty acids, and polyunsaturated fatty acids could also be included
at the manufacturer’s discretion. All were to be reported on the basis of an average or usual serving size. The
U.S. RDAs were based on the Recommended Dietary Allowances (RDA) set forth by the National Academy of
Sciences (NAS) in 1968 (NRC, 1968). Because of the need for a single set of standard nutrient requirements for
nutrition labeling purposes, the values selected for the U.S. RDA were generally the highest value for each nutri -
ent given in the RDA table for adult males and non-pregnant, non-lactating females. However, values for calcium
and phosphorus were limited to 1 g because of their physical bulk and solubility. The Food Safety and Inspection
Service (FSIS) of the U.S. Department of Agriculture (USDA) provided for nutrition labeling of meat and poultry
products in a similar manner through policy memoranda.8
As can be seen in the annex to this chapter, few changes were made in nutrition labeling regulations over the
next decade (Hutt, 1995; Scarbrough, 1995). FDA, USDA, and the Federal Trade Commission (FTC) held hearings
in 1978 to gather information on food labeling issues and suggestions on how to make improvements. 9 The vast
majority of comments from the hearing favored mandatory nutrition labeling but also suggested making changes
to the format to make it more useful.10
The Rise in Use of Undefined Nutrient Content and Health Claims on Labels
After 1973, scientific knowledge about the relationship between diet and health grew rapidly, and, as a result,
consumers wanted to have more information on food labels, particularly on the labels of processed and packaged
foods. Food manufacturers were eager to respond to the consumer interest and did so in a variety of ways, often
through the use of an assortment of new, undefined claims on product labels that attempted to state or imply some -
thing about the special value of the food, such as “extremely low in saturated fat,” in order to catch consumers’
attention (Taylor and Wilkening, 2008a). The proliferation of ambiguous claims on labels and in advertising led
to charges that the government was tolerating claims that were “at best confusing and at worst deceptive economi -
cally and potentially harmful” (IOM, 1990).
In addition to making claims about the nutritional content of foods, some food manufacturers were also inter-
ested in making label claims about the health benefits of their food products. FDA’s regulations had prohibited the
explicit discussion of disease or health on food labels since passage of the FD&C Act in 1938. 11 The implement-
ing regulations for that act stated that a food was deemed to be misbranded if its labeling “represents, suggests,
or implies: That the food because of the presence or absence of certain dietary properties is adequate or effective
in the prevention, cure, mitigation, or treatment of any disease or symptom.” 12 A food making such claims was
considered to be misbranded or an illegal drug (Shank, 1989). This policy began when many of the links between
diet and disease had yet to be established or substantiated. It helped prevent misleading and potentially harmful
claims, but it also prevented useful and truthful claims from being made (Kessler, 1989). The agency’s policy was
challenged in 1984 when the Kellogg Company, in cooperation with the National Cancer Institute, began a labeling
campaign using the back panel of a high-fiber breakfast cereal to link fiber consumption to a possible reduction in
6 Federal Food, Drug, and Cosmetic Act, Sec. 201(n).
7 38 FR 6493.
8 56 FR 60302 at 60303.
9 43 FR 25296.
10 44 FR 75990.
11 Federal Food, Drug, and Cosmetic Act, Sec. 403.
12 38 FR 6950 at 6961, paragraph (i) and (i)(1).
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117
APPENDIX B
the risk of certain cancers. That campaign changed food labeling and marketing dramatically, as other companies,
in the absence of regulatory action, began making similar claims (Geiger, 1998).
The Initiation of Rulemaking for Nutritional Claims
In August 1987, FDA published a proposed rule to change its policy by permitting health claims on food
labeling if certain criteria were met.13 The proposal generated a large number of thoughtful and often conflicting
comments and was followed by a series of meetings between the agency and the food industry, consumer groups,
academia, and health professionals (Shank, 1989). A congressional hearing was also held in December 1987.
Subsequently, in February 1990, FDA withdrew its original proposal and published a new proposal that defined
appropriate health claims more narrowly and set new criteria to be met before allowing a claim. 14 During the late
1970s and throughout the 1980s FDA also was acting to increase the availability of nutrition information and to
provide for more truthful nutritional claims on all foods. In an effort to respond to consumers and the food industry,
FDA initiated rulemaking to provide more flexibility in making claims on foods that could be useful in reducing or
maintaining body weight or calorie intake,15 to establish policies concerning the fortification of foods,16 to include
sodium content in nutrition labeling and provide for claims about sodium17 and cholesterol content,18 and to allow
for food labeling experiments, such as experiments on supermarket shelf labeling. 19
The surge in consumer interest in nutrition that was fueling the food industry’s desire to highlight the posi -
tive nutritional attributes of food products was due, in part, to the publication in the late 1980s of two landmark
consensus reports on nutrition and health.20 The Surgeon General’s Report on Nutrition and Health (HHS, 1988)
and the National Research Council’s (NRC’s) report Diet and Health: Implications for Reducing Chronic Disease
Risk (NRC, 1989a) emphasized the relationship between diet and the leading causes of death among Americans
(e.g., heart disease, cancers, strokes, and diabetes). They suggested that changes in current dietary patterns—in
particular, reduced consumption of fat, saturated fatty acids, cholesterol, and sodium and increased amounts of
complex carbohydrates and fiber—could lead to a reduced incidence of many chronic diseases. The Surgeon
General’s report also called on the food industry to reform products to reduce total fat and to carry nutrition labels
on all foods. These reports made useful suggestions for planning healthy diets. However, without specific nutri -
tion information on food labels, consumers were unable to determine how certain individual foods fit into dietary
regimens that followed the recommendations of these reports. Major changes in nutrition labeling were necessary
if food labels were to be useful to consumers interested in adhering to these recommendations.
INITIATIVES TO STANDARDIZE AND REQUIRE NUTRITION LABELING
In the summer of 1989, concerned that food labeling did not allow Americans to take advantage of the latest
advances in nutrition, Dr. Louis W. Sullivan, then Secretary of the U.S. Department of Health and Human Services
(HHS), directed FDA to undertake a comprehensive initiative to revise the food label (FDA, 1990). 21 He later
stated that, “As consumers shop for healthier food, they encounter confusion and frustration. The grocery store
has become a Tower of Babel and consumers need to be linguists, scientists, and mind readers to understand the
many labels they see” (HHS, 1990). This new food labeling initiative began with the publication of an advance
notice of proposed rulemaking in August 1989 asking for public comment22 and a notice of public hearings to
13 52 FR 28843.
14 55 FR 5176.
15 43 FR 43248 and 43261.
16 45 FR 6314.
17 47 FR 26580 and 49 FR 15510.
18 51 FR 42584.
19 69 FR 15236.
20 54 FR 32610.
21 55 FR29487.
22 54 FR 32610.
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118 FRONT-OF-PACKAGE NUTRITION RATING SYSTEMS AND SYMBOLS
be held across the country to address the content and format of the nutrition label, ingredient labeling, and both
nutrient content and health claims.23 Unlike the situation surrounding the follow-up to the 1978 public hearings
when few regulatory changes were made, in 1989 a number of forces, such as advances in science, recommenda -
tions for dietary change, food industry use of the label, and the entry of state governments into the food labeling
arena, coalesced to propel important changes in the regulatory framework for food labeling (Scarbrough, 1995).
Developing Reference Values
By July 1990, FDA had published proposed rules for the mandatory nutrition labeling of almost all packaged
foods.24 FDA acknowledged that there was some question as to whether the agency had the legal authority under
the FD&C Act to mandate nutrition labeling on all foods that were meaningful sources of calories or nutrients,
so comments were requested on that issue as well as on the proposed nutrient requirements. Simultaneously,
proposals were also published to replace the U.S. RDAs25 and to establish regulations for determining serving
sizes to be used in nutrition labeling.26 In replacing the U.S. RDAs, FDA sought to base new values for vitamins
and minerals, to be known as Reference Daily Intakes (RDIs), on the most recent RDAs (NRC, 1989b). In addi -
tion, FDA proposed to establish new values to be known as Daily Reference Values (DRVs) for food components
considered important for good health (fat, saturated fatty acids, unsaturated fatty acids, cholesterol, carbohydrate,
fiber, sodium, and potassium) for which RDAs had not been established by the NAS (also see pp. 6-15). While
it was necessary to establish two separate categories of nutrients (RDIs and DRVs) for regulatory purposes, FDA
proposed to group the nutrients into a single set of reference values known as “Daily Values” for use in presenting
nutrition information on the food label.
Establishing Required Nutrients for Food Labels
In determining which nutrients and food components to require on the label, FDA looked to The Surgeon
General’s Report on Nutrition and Health (HHS, 1988) and the NRC’s report Diet and Health: Implications for
Reducing Chronic Disease Risk (NRC, 1989a). FDA proposed that calories and nutrients would be required to
be listed on nutrition labels if (1) they were of public health significance as defined in these two documents, and
(2) specific quantitative recommendations were set by NAS or other scientific organizations. Accordingly, FDA
proposed the mandatory listing of calories, fat, saturated fat, cholesterol, sodium, carbohydrate, fiber, protein,
vitamins A and C, calcium, and iron. Additional nutrients were required to be listed when added to a food or when
claims were made about them.
FDA considered the addition of total sugars to the list of required food components to declare on the label; but
total sugars did not meet the criterion of having specific quantitative recommendations for intake by a scientific
organization. Accordingly, the inclusion of total sugars on the nutrition label was made voluntary unless a claim
was made about the sugars content of the food. Some of the comments received suggested that nutrition labeling
of added sugars content also be required, but FDA did not propose to do so. The agency based its decision on (1)
the fact that there was no scientific evidence that the body makes any physiological distinction between added
and naturally occurring sugars; (2) a concern that the declaration of added sugars only would under-represent
the sugars content of foods high in naturally occurring sugars, thus misleading consumers who may need to be
aware of total sugars; and (3) an expectation that with mandatory nutrition labeling, consumers could differentiate
between sugar-containing foods with high versus low nutrient content and could therefore determine which foods
had the highest nutrient density.27
23 54 FR 38806.
24 55 FR 29487.
25 55 FR 29478.
26 55 FR 29517.
27 55 FR 29487.
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119
APPENDIX B
Moving Toward a Mandatory and Uniform Nutrition Labeling Policy
At the same time that FDA was developing its July 1990 proposal, a committee was formed at the Institute
of Medicine (IOM), the health arm of NAS to consider how food labels could be improved to help consumers
adopt or adhere to healthy diets. FDA and FSIS/USDA sponsored the study based on the belief that changes in
eating habits could improve the health of Americans and that food labeling could aid consumers in making wise
dietary choices. The committee’s report, Nutrition Labeling: Issues and Directions for the 1990s, was issued in
September 1990 (IOM, 1990). It recommended that FDA and FSIS adopt regulations to institute mandatory and
uniform nutrition labeling for almost all packaged foods, and it made recommendations concerning various facets
of nutrition labeling, including the content and presentation of information, in order to support findings and rec -
ommendations of The Surgeon General’s Report on Nutrition and Health (HHS, 1988) and the NRC’s report Diet
and Health: Implications for Reducing Chronic Disease Risk (NRC, 1989a). It also recommended that FDA and
USDA should define descriptors (e.g., “high,” “good source of”) for the content of nutrients such as fat, cholesterol,
sodium, and micronutrients.
PASSAGE OF THE NUTRITION LABELING AND EDUCATION ACT (NLEA) OF 1990
Congressional concerns about food labeling had been building for some. Members of Congress were aware
of consumer and industry interest in the subject and had responded by asking the General Accounting Office to
investigate labeling issues and by introducing a variety of bills on the subject (Scarbrough, 1995). This culminated
in November 1990 with passage of the NLEA,28 the most significant food labeling legislation in 50 years. The
NLEA amended the Federal Food, Drug, and Cosmetic Act29 to give FDA explicit authority to require nutrition
labeling on most food packages and specified the nutrients to be listed in the nutrition label. It also required that
nutrients be presented in the context of the daily diet; specified that serving sizes should represent “an amount
customarily consumed and which is expressed in a common household measure that is appropriate to the food”;
and provided for a voluntary nutrition labeling program for raw fruits, vegetables, and fish . It also required standard
definitions to be developed that characterized the level of nutrients and required that FDA provide for approved
health claims. The NLEA’s requirements for the content of the nutrition label were very similar to those in FDA’s
1990 proposal except that the NLEA included complex carbohydrates and sugars in the list of required nutrients.
It also permitted the agency to add or delete nutrients based on a determination that such a change would “assist
consumers in maintaining healthy dietary practices.” On November 27, 1991, FDA proposed 26 new food label
regulations to implement the NLEA. These included a new proposal on nutrition labeling and the establishment
of RDIs and DRVs30 and a proposal on serving sizes.31 General principles for nutrient content claims and the
definition of terms for claims to be allowed were also proposed,32 as were general principles for health claims,33
followed by individual proposals pertaining to ten possible topic areas for health claims, such as dietary fiber and
cancer, which were identified in the NLEA. While the format of the nutrition label was discussed in its November
27, 1991, proposal, FDA published a more detailed proposal for the format on July 20, 1992. 34 The purpose of
FDA’s proposals was threefold: to clear up confusion that had surrounded nutrition labeling for years, to help
consumers choose healthier diets, and to give food companies an incentive to improve the nutritional qualities of
their products (Kessler, 1995).
The NLEA pertains only to those labels of food products regulated by FDA, which has label authority over
the majority of foods. However, meat and poultry product labels are under the authority of FSIS in the USDA, and
alcoholic beverage product labels are under the authority of the Alcohol and Tobacco Tax and Trade Bureau of the
28 Nutrition Labeling and Education Act of 1990. Public Law 101-535, 104 Stat 2353.
29 Federal Food, Drug, and Cosmetic Act, sec. 403(q) and (r).
30 56 FR 60366.
31 56 FR 60394.
32 56 FR 60421 and 60478.
33 56 FR 60537.
34 57 FR 32058.
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120 FRONT-OF-PACKAGE NUTRITION RATING SYSTEMS AND SYMBOLS
Department of the Treasury, formerly the Bureau of Alcohol, Tobacco and Firearms. Leadership at USDA strongly
supported the claim that consumers need help to adopt and adhere to healthy diets. For this reason and to provide
consistent regulation for all foods, the decision was made to have FSIS coordinate efforts with FDA to implement
the requirements of NLEA for meat and poultry product labels (McCutcheon, 1995). To accomplish this, FSIS
first published an advance notice of proposed rulemaking to solicit comments to assist in developing regulations
for the nutrition labeling of meat and poultry products.35 Then, on November 27, 1991, in conjunction with FDA,
FSIS published proposed rules to establish a voluntary nutrition labeling program for single-ingredient raw meat
and poultry (consistent with NLEA’s provision for raw fruits, vegetables, and fish) and mandatory nutrition label -
ing for all other meat and poultry products.36 It also proposed the adoption of most of FDA’s proposals in regard
to nutrient content claims and proposed additional definitions for “lean” and “extra lean” as unique descriptors
for meat and poultry products.
The NLEA established very tight timeframes for implementing the provisions of the act. It required FDA to
publish proposed regulations within 12 months and final regulations within 24 months of enactment of the act. 37
If the agency failed to publish final regulations as specified, the proposed rules were to become final rules. With
those time constraints and over 40,000 written comments on the proposed rules to respond to, FDA and FSIS
mobilized their staffs to accomplish the task.
Declaration of Nutrient Content
Final regulations for both agencies were published on January 6, 1993, that mandated nutrition labeling in
the form of a Nutrition Facts panel on most packaged foods.38 Exemptions were allowed for foods that were
insignificant sources of calories or nutrients, foods shipped in bulk for further processing, restaurant foods, foods
manufactured by some small businesses, medical foods, and infant formula (the latter having other specific rules
for labeling). Nutrients to be listed on nutrition labels included calories, calories from fat, total fat, saturated fat,
cholesterol, sodium, total carbohydrate, dietary fiber, sugars, protein, vitamins A and C, calcium, and iron. By way
of exception when present at insignificant amounts and when no claims were made about them, regulations allowed
the declaration of calories from fat, saturated fat, cholesterol, dietary fiber, sugars, vitamins A and C, calcium or
iron to be omitted if a footnote was added at the bottom of the list of nutrients stating “Not a significant source of
____” with the blank filled in by the name of the nutrients(s) omitted. If they chose to do so, manufacturers were
permitted to list calories from saturated fat, polyunsaturated and monounsaturated fatty acids, potassium, soluble
and insoluble fiber, sugar alcohols, other carbohydrates, and any vitamins and minerals for which RDIs were
established; labeling for these nutrients became required, however, if they were added to the product or if claims
related to their content were made. In order to reduce consumer confusion and avoid the potential for misleading
labels, no other nutrients were allowed in the Nutrition Facts panel.
Despite being specified in the NLEA, complex carbohydrates were not included in the allowed list of nutrients.
Comments had convinced FDA that there was no consensus on a definition for the term “complex carbohydrates” as
it related to physiological effects, health benefits, or dietary guidance. Instead, the rules allowed for the voluntary
listing of “other carbohydrates” to be calculated as that amount of carbohydrate remaining after subtraction of the
amount of dietary fiber, sugars, and sugar alcohols from total carbohydrate.
Just as with the FDA proposals in 1990, the declaration of sugars also generated discussion in comments to
the 1991 proposals to implement the NLEA. Based on comments received, the proposed definition of sugars as
the sum of all free mono- and oligosaccharides through four saccharide units was changed to the sum of all free
mono- and disaccharides. Other comments had recommended that added sugars should be listed rather than total
sugars since there was both a dietary recommendation to use sugars in moderation and a dietary recommendation
for increased consumption of fruits, which are sources of naturally occurring sugars (HHS/USDA, 1990). Oppos -
35 56 FR 13564.
36 56 FR 60302.
37 Nutrition Labeling and Education Act of 1990. Public Law 101-535, 104 Stat 2353, Sec. 2(b).
38 58 FR 2079 (FDA) and 58 FR 632 (USDA).
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121
APPENDIX B
ing comments reiterated concerns expressed in the proposed rule that the body makes no physiological distinction
between the two types of sugars and that under-representing total sugars content could be misleading to consumers
concerned about total intake of sugars. The determinative issue, however, was that there were no analytical meth -
ods for distinguishing between the two types of sugars. Product labels are checked for accuracy and compliance
by FDA through laboratory analysis of the food product as packaged. That analysis yields only a value for total
sugars. FDA policy is that it should not promulgate regulations that it cannot enforce. Accordingly, the decision
was made to list only total sugars in the Nutrition Facts panel.
Several comments on the 1991 proposed rule suggested that trans fatty acids (trans fat) should be included in
the nutrition label, either with saturated fat or as a separate category. FDA disagreed at the time because reports
were inconsistent regarding the effects of trans unsaturated fats on blood cholesterol levels in humans (LSRO/
FASEB, 1985; Grundy and Denke, 1990). However, soon afterwards, new data emerged indicating that trans fats
raise LDL-cholesterol concentrations nearly as much as cholesterol-raising saturated fats (NIH, 1994). Based on
its own independent evaluation of studies on the effects of trans fat on blood cholesterol levels, FDA concluded
that under conditions of use in the United States, trans fats did contribute to increased serum LDL-cholesterol,
which increases the risk of coronary heart disease. As a result, a proposed rule was published in 1999 to modify
the Nutrition Facts panel to include trans fats on food products regulated by FDA.39 In 2003, FDA issued a final
rule requiring trans fats to be listed on a separate line immediately under saturated fat whenever present in amounts
of 0.5 g or more per serving, except that it must always be listed if claims are made on the label about it. 40 USDA
regulations permit, but do not require, trans fat to be listed on nutrition labels of meat and poultry products pro -
vided the declaration and definitions of trans fat adhere to the FDA regulations.41
Determination of Reference Values
As discussed above, for declaring amounts of vitamins and minerals FDA had proposed replacing U.S. RDAs
with RDIs based on the most current scientific knowledge as incorporated in the 1989 RDAs from the NAS (NRC,
1989b). It also proposed to use a population-adjusted mean of the RDA values for the various age–sex groups for
each nutrient rather than the highest value for each nutrient.42 However, on October 6, 1992, Congress passed the
Dietary Supplement Act of 1992 that, in section 203, instructed FDA not to promulgate for at least 1 year any
regulations that required the use of, or were based upon, RDAs other than those in effect at that time. 43 Inasmuch
as the NLEA required that final rules be promulgated by November 6, 1992, FDA was unable to wait long enough
to utilize the 1989 RDAs. Instead, FDA proceeded to change the name of the U.S. RDAs to RDIs to reduce confu -
sion with the RDAs developed by the NAS while maintaining the values based on the NAS 1968 RDAs. 44 Once
the moratorium on using newer RDA values was over, FDA decided to wait until revisions then in progress at the
NAS were finalized. It did, however, proceed to establish RDIs for those nutrients for which RDA values had not
been established in 1968: vitamin K, selenium, manganese, chromium, molybdenum, and chloride. 45 The agency
also asked the NAS to convene a committee to provide scientific guidance about how to use the new Dietary Ref -
erence Intakes from the NAS to update the nutrient reference values used in the Nutrition Facts panel. The com -
mittee’s report became available in 2003 (IOM, 2003). Then, in 2007, FDA issued an advance notice of proposed
rulemaking asking for comment on which reference values the agency should use to calculate the percent of daily
value in the Nutrition Facts panel and whether certain nutrients should be added or removed from the labels. 46
39 64 FR 62746.
40 68 FR 41434.
41 A Guide to Federal Food Labeling Requirements for Meat and Poultry Products. Available online: http://www.fsis.usda.gov/pdf/labeling_
requirements_guide.pdf (accessed September 19, 2010).
42 55 FR 29476 and 56 FR 60366.
43 Dietary Supplement Act of 1992, Public Law 102-571.
44 58 FR 2206.
45 60 FR 67164.
46 72 FR 62149.
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122 FRONT-OF-PACKAGE NUTRITION RATING SYSTEMS AND SYMBOLS
Establishment of Daily Reference Values
A challenge presented by the NLEA was the requirement that the nutritional information “be conveyed to
the public in a manner which enables the public to readily observe and comprehend such information and to
understand its relative significance in the context of a total daily diet.”47 This requirement necessitated reporting
in relation to a daily reference value the amounts of all nutrients listed and not just the amounts of vitamins and
minerals, as had been done since voluntary nutrition labeling rules were put in place in 1973. In accordance with
its 1990 proposal, the final nutrition labeling rules established for the first time reference values, known as Daily
Reference Values (DRVs), that would be used in reporting values of total fat, saturated fatty acids, cholesterol, total
carbohydrate, dietary fiber, sodium, and potassium—for which RDAs had not been established in 1989—and for
protein.48 The DRVs were based largely on recommendations from The Surgeon General’s Report on Nutrition and
Health (HHS, 1988), the NRC’s report Diet and Health: Implications for Reducing Chronic Disease Risk (NRC,
1989a), and the National Cholesterol Education Program’s “Report of the Expert Panel on Population Strategies
for Blood Cholesterol Reduction” (NIH, 1990). The recommendations used for total fat were 30 percent of calories
or less; for saturated fat, less than 10 percent of calories; for cholesterol, less than 300 mg; for total carbohydrate,
60 percent of calories; for sodium, 2,400 mg; for potassium, 3,500 mg; and for protein, 10 percent of calories (so
that calorie-providing nutrients sum to 100 percent of calories). The DRV for fiber, for which the two consensus
documents had not provided a recommendation, was instead based on a recommendation in a report of the Life
Sciences Research Organization of the Federation of American Societies for Experimental Biology that fiber intake
be 10 to 13 g per 1,000 calories (LSRO, 1987). No recommendations existed for intake of sugars, so no DRV was
established. For those nutrients for which the recommendation was for a percent of calories, the DRVs were based
on a caloric intake of 2,000 calories. For example, the level for total fat was derived by calculating 30 percent of
2,000 calories and dividing by 9, which is the number of calories per gram of fat. The resulting value, 66.7 g, was
then rounded down to 65 g for ease of use. In an effort to show consumers how the values would differ with dif -
ferent caloric intakes, the regulations called for a footnote on larger food packages that would state, “Your daily
values may be higher or lower depending on your calorie needs,” followed by a table showing the daily values for
both a 2,000- and 2,500-calorie diet.
Basic Format of Nutrition Label
The format to be used for the nutrition label had been a topic of the 1989 advance notice of proposed rulemak -
ing49 and the public hearings50 on nutrition labeling. Many speakers at the public hearings supported a new label
format in order to simplify the label and make it more understandable (FDA, 1990). Prior to the 1991 proposals,
focus group sessions had been held (Lewis and Yetley, 1992) and experimental studies conducted (Levy et al., 1991,
1996) to determine the effectiveness of various label formats. The results were made available to the public, and
comments were requested.51 FDA also initiated a cooperative pilot program with industry to test alternative formats
which led to several industry sponsored studies,52 and it held a public meeting on the subject.53 The research showed
that graphic presentations, such as pie charts and bar graphs, were not well suited for conveying the diversity and
amount of information required on nutrition labels, so FDA looked to a format based more on consumers’ ability to
use and comprehend numeric values (Scarbrough, 1995). The format proposed in July 1992 was one that included
quantitative amounts of macronutrients but that gave particular emphasis to a column of nutrient values expressed
as a percent of the label reference value, the RDIs and DRVs, which was to allow consumers to quickly determine
if the food contained a little or a lot of a nutrient.54 At the end of the comment period, when a format had been
47 Nutrition Labeling and Education Act of 1990. Public Law 101-535, 104 Stat 2353, Sec. 2(b)(1)(A).
48 58 FR 2206.
49 54 FR 32610.
50 54 FR 38806.
51 56 FR 23072.
52 56 FR 29963.
53 57 FR 11277.
54 57 FR 32058.
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APPENDIX B
Nutrition Facts
Serving Size 1 cup (228g)
Servings Per Container 2
Amount Per Serving
Calories 260 Calories from Fat 120
% Daily Value*
Total Fat 13g 20%
25%
Saturated Fat 5g
Trans Fat 2g
Cholesterol 30mg 10%
Sodium 660mg 28%
Total Carbohydrate 31g 10%
0%
Dietary Fiber 0g
Sugars 5g
Protein 5g
•
Vitamin A 4% Vitamin C 2%
•
Calcium 15% Iron 4%
* Percent Daily Values are based on a 2,000 calorie diet.
Your Daily Values may be higher or lower depending on
your calorie needs:
Calories: 2,000 2,500
Total Fat Less than 65g 80g
Sat Fat Less than 20g 25g
Cholesterol Less than 300mg 300mg
Sodium Less than 2,400mg 2,400mg
Total Carbohydrate 300g 375g
Dietary Fiber 25g 30g
Calories per gram:
• •
Fat 9 Carbohydrate 4 Protein 4
FIGURE B-1 Nutrition Facts panel.
determined that provided the proper context and emphasis, FDA worked with graphic experts to design the label,
taking into account research on comprehension, legibility, and literacy (Kessler et al., 2003).
The format research and comments on the proposed rule had led FDA to conclude that in nutrition labeling
a consistent system of percentages makes it possible for virtually all the nutrients on the label to be provided in
equivalent units—as a percent of the appropriate RDI or DRV (to be known on the Nutrition Facts panel simply as
the “Percent of Daily Value”).55 That consistency is not possible when the list contains nutrients given in different
units (e.g., grams and milligrams). Thus, a low value on the list is likely to be a “true” low value within the context
of the daily diet, and a high value is likely to be a “true” high value. This consistency also allowed educational
programs to be built around the concept that 5 percent or less of any nutrient is a small amount, whereas 20 percent
or more is a large amount (Taylor and Wilkening, 2008a). Consumers had often been confused by earlier nutri -
tion label formats when comparing nutrient amounts, such as comparing fat in grams with sodium in milligrams,
so the actual quantities were moved adjacent to the name of the nutrient where they would get less attention. To
put emphasis on the amount of nutrients in a serving of food “in the context of a total daily diet,” the format for
the Nutrition Facts panel provided for a separate column for the listing of Percent of Daily Value (% Daily Value
or %DV) (see Figure B-1). Noticeably, a few nutrients are lacking a value in the %DV column. For trans fat and
55 58 FR 2079.
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124 FRONT-OF-PACKAGE NUTRITION RATING SYSTEMS AND SYMBOLS
sugars, scientific evidence was not sufficient to support the establishment of a RDI or DRV. In the case of protein,
a DRV had been established, but the %DV for protein required taking into account protein quality and not just
the quantity of protein present. Such a calculation requires the computation of the protein-digestibility-corrected
amino acid score for a food, a costly analysis. Because the typical American diet provides enough protein of suf -
ficiently high biological quality to meet the nutritional needs of most persons, protein intake is not a public health
concern. Therefore, listing the %DV for protein is voluntary for foods intended for adults and children 4 or more
years of age unless a protein claim is made for the product.
Determination of Serving Size
The serving size of a food product affects virtually every number in the Nutrition Facts panel other than those
in the footnote. As a result, the development of regulations prescribing the manner in which it is to be calculated for
the wide diversity of foods available in the market was of major importance. The NLEA required that serving sizes
be based on amounts customarily consumed56 rather than on recommended portion sizes, as some comments had
suggested, or on a 100-g basis, as is done in some other countries. To determine the amount customarily consumed,
FDA utilized food consumption data from USDA’s nationwide food consumption and intake surveys, augmented
by other sources of information where available.57 In order to facilitate consumer comparisons, categories of foods
that are generally used interchangeably in the diet and that have similar product characteristics were developed
so that those foods would have uniform serving sizes. Statistical analyses of consumption data, using the mean,
median, and modal values, were then utilized to develop Reference Amounts Customarily Consumed (RACC)
for each category.58 Procedures for converting the RACC values to serving sizes expressed in common household
measures were specified in the regulations.59
Single-Serving Containers
Single–serving-size containers proved to be particularly troublesome (Taylor and Wilkening, 2008a). The regu-
lations require that most packages that are less than 200 percent of the applicable RACC must declare the entire
package as one serving. If the package is 200 percent or more of the RACC and the whole unit can reasonably
be consumed at one time, the manufacturer may, but need not, declare the package as one serving. Additionally,
for products that have a RACC of 100 g or more and are individual units within a multi-serving package, if the
unit contains more than 150 percent but less than 200 percent of the RACC, the manufacturer may declare the
individual unit as one or two servings. For products that are more than 200 percent of the RACC yet intended to
be consumed by one individual at one time, FDA has encouraged manufacturers to base the nutrition information
on the entire contents of food in the container (CFSAN/FDA, 2004; FDA, 2004). Because there is little evidence
that this is widely practiced (Taylor and Wilkening, 2008a), FDA asked in a 2005 advance notice of proposed
rulemaking for comment on whether its regulations should be changed to require packages that can reasonably
be consumed at one eating occasion to provide the nutrition information for the entire package, either alone or
in conjunction with a listing of the serving size derived from the RACC. 60 Also, because there is evidence that
Americans are eating larger portion sizes than in the 1970s and 1980s, when the food consumption surveys upon
which RACCS are based were conducted (Nielsen and Popkin, 2003; Smiciklas-Wright et al., 2003), comments
were requested on which RACCs may need to be updated.
56 Nutrition Labeling and Education Act of 1990. Public Law 101-535, 104 Stat 2353, Sec. 2(a)(q)(1)(A)(i).
57 58 FR 2229.
58 58 FR 2229.
59 58 FR 2229.
60 70 FR 17010.
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APPENDIX B
Serving Size and Health Outcomes
The increase in portion sizes consumed is considered to be one of many factors leading to increased obesity in
the United States (Young and Nestle, 2002). To address the issue of obesity, Mark McClellan, then FDA Commis -
sioner, created a committee in 2003 to outline an action plan to cover critical dimensions of the obesity problem
from FDA’s perspective and within its regulatory authorities. Among other topics, the committee’s report, entitled
Calories Count: Report of the Working Group on Obesity (FDA, 2004), addressed food labeling issues pertaining
to serving sizes and the design of the Nutrition Facts panel. The advance notice of proposed rulemaking mentioned
above was an outcome of that report, as was another advance notice asking for comment on ways to increase the
prominence of calorie information on the label.61 At the time of this report, action on those issues is still awaited.
Specification of Nutrient Content Claims
In addition to requiring food labels to contain information on the amounts of certain nutrients, the NLEA also
specified that claims characterizing the level of a nutrient may be made on food labels only if the characterization
uses terms that have been defined in regulations.62 The NLEA further specified that claims characterizing the rela-
tionship of any nutrient to a disease or health-related condition only be made only in accordance with regulations
promulgated under the act; however, such claims, known as “health claims,” are not the subject of this report and
will not be discussed further here. The intent of this section of the NLEA was to allow meaningful comparisons of
foods and to encourage the consumption of foods with the potential to improve dietary intake and reduce chronic
disease (Taylor and Wilkening, 2008b).
Defining Descriptive Nutrient Content Claims
The act specifically required that definitions for the terms “free,” “low,” “light,” “reduced,” “less,” and “high”
in relation to nutrients required to be listed in the Nutrition Facts panel. 63 In addition, to allow for the use of claims
that were being used on labels of conventional foods in the marketplace, FDA and USDA also defined the terms
“good source,” “more,” “fewer,” “lean,” and “extra lean”64 when implementing the NLEA and provided for the
use of synonyms for many of the terms. Subsequently, both agencies also defined the implied claim “healthy.” 65
The current definitions for all these claims on FDA-regulated food items can be found here in this report. A full
discussion of the rationale behind the definition of each claim can be found in the preambles to the proposed (1991)
and final (1993) rules (see Annex). It should be noted that the definitions for claims on individual food products
differ in some respects from those for meal and main dish items. Meal and main dish items are combinations of
foods intended to contribute a larger portion of the total daily diet, which necessitates separate criteria, often based
on an amount per 100 g, in order to provide for appropriate claims .66
Briefly, in developing the criteria for claims, FDA took into account the dietary recommendations for each
nutrient and generally considered the amounts of the nutrient present per RACC, per serving size, and per 100 g
(or per 50 g if the serving size is small); the distribution and abundance of the nutrient in the food supply; ana -
lytical methods; and the presence of other nutrients that could possibly cause a particular claim to be misleading.
61 70 FR 17008.
62 Nutrition Labeling and Education Act of 1990. Public Law 101-535, 104 Stat 2353, Sec. 3(a)(r)(1).
63 Nutrition Labeling and Education Act of 1990. Public Law 101-535, 104 Stat 2353, Sec. 3(b)(1)(A)(iii).
64 58 FR 2302 (FDA) and 58 FR 632 (USDA).
65 59 FR 24232 (FDA) and 59 FR 24220 (USDA).
66 58 FR 2302.
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126 FRONT-OF-PACKAGE NUTRITION RATING SYSTEMS AND SYMBOLS
Defining Levels of Nutrients to Limit
In the case of “free” claims, levels of each nutrient were selected that were at or near the reliable limit of detec -
tion for the nutrient in food and that were considered to be dietetically trivial or physiologically inconsequential. 67
In the case of foods that are inherently free of a nutrient, regulations require that the claim must refer to all foods
of that type rather than to a particular brand to which the labeling is attached (e.g., “broccoli, a fat-free food”). 68
Claims for “low” levels of nutrients presented a bigger challenge and needed to be considered individually.
The goal was “that the selection of a food bearing the term should assist consumers in assembling a prudent daily
diet and in meeting overall dietary recommendations to limit the intake of certain nutrients.” 69 For nutrients that
are ubiquitous in the food supply, the definition of a “low” level was set at 2 percent of the DRV for the nutri -
ent. If the nutrient was not ubiquitous, the amount defined to be “low” was adjusted to account for the nutrient’s
uneven distribution in the food supply. In that way, if a person was to consume a reasonable number of servings of
food labeled as “low,” balanced with a number of servings of foods that do not contain the nutrient and a number
of servings of foods that contain the nutrient at levels above the “low” level, he or she would still be able to stay
within dietary recommendations. For example, the DRV for total fat was set at 65 g. Two percent of 65 g is 1.3 g,
which was rounded up to 1.5 g. Since fat is not inherent in many foods (e.g., fruits, vegetables, non-dairy bever-
ages, fat-free dairy products, jams, etc.), yet is found in more than a few foods, FDA concluded that an appropriate
upper limit for a “low fat” claim should be set at two times 2 percent of the DRV, or 3 g. Balancing the number of
foods that do not contain fat with those that contain more than “low” levels would allow a person consuming up to
20 foods a day to stay within the DRV of 65 g. An exception to this method of calculation was made for sodium
inasmuch as the term “low sodium” had been defined 8 years earlier as 140 mg or less per serving (rather than
96 mg if following the new procedure) with no apparent concerns about that level. Also, unique to sodium, there
was a regulatory definition for “very low sodium” at 35 mg or less per serving. Responding to comments, FDA
maintained these definitions for use by individuals wishing to reduce total sodium intake and those on medically
restricted diets.70 Again, in the case of foods inherently free of a nutrient, claims for “low” levels of a nutrient must
refer to all foods of that type rather than to a particular brand to which the labeling is attached.
Defining Levels of Nutrients to Encourage
Claims for “positive” nutrients (e.g., vitamins and minerals) are used to emphasize the presence of a nutrient.
Regulations provide for claims at two levels, “high” and “good source.”71 The definition for “high” was set at 20
percent or more of the appropriate RDI or DRV per serving. The IOM Committee had suggested a criterion of
greater than 20 percent for “high” claims (IOM, 1990), and in a review of its food consumption database FDA found
that the 20-percent cut would permit a sufficient number of foods to make the claim. This in turn would enable
consumers using the claim to select a diet from a wide variety of foods rather than from a few highly fortified
foods.72 “Good source” claims, defined as 10 to 19 percent of the DRV, were intended to emphasize the presence
of a nutrient at a mid-range of nutrient content, drawing consumers’ attention to foods that contain a significant
amount of a nutrient and that are likely to help meet dietary recommendations. 73
Implied Claims
As opposed to claims about the specific amount of a nutrient present in a food, “implied claims” are claims
that describe a food or an ingredient in such a manner that the consumer is led to assume that a nutrient is absent
67 58 FR 2302.
68 58 FR 2302.
69 58 FR 2302.
70 58 FR 2302.
71 58 FR 2302.
72 56 FR 60421.
73 56 FR 60421.
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APPENDIX B
or present in a certain amount (e.g., “high in wheat bran” implies that the food is high in fiber). 74 Implied claims
can also suggest that the food may be useful in maintaining healthy dietary practices. To that end, following pub -
lication of the final rules implementing NLEA, FDA and USDA issued proposed 75 and final rules76 to define the
implied claim implicit in “healthy.” The term “healthy” was considered a unique nutrient content claim because it
not only characterized the level of the nutrients in a food but also implied a judgment about the food. Comments
on the proposed rule suggested that consumers had varying ideas of what the term meant, leading FDA to find
that the “fundamental purpose of a ‘healthy’ claim is to highlight those foods that, based on their nutrient levels,
are particularly useful in constructing a diet that conforms to current dietary guidelines.” 77 This led the FDA and
USDA to set criteria that limited use of the term to foods that had “low” levels of fat and saturated fat and slightly
more moderate levels of cholesterol and sodium. In addition, the food, (other than raw fruits or vegetables, a single
ingredient or a mixture of canned or frozen fruits or vegetables or enriched cereal grain products that conform to
a standard identity) had to contain at least 10 percent of the RDI or DRV of vitamin A, vitamin C, calcium, iron,
protein, or fiber. As for sodium, FDA was persuaded that levels of it should be restricted so that foods bearing the
“healthy” claim would be helpful in reaching dietary goals. Yet the agency found that the majority of products
bearing the claim would be disqualified from doing so if sodium levels were set at a level as low as 360 mg per
serving. Therefore, to provide time for the industry to reformulate their products and for consumers to become
accustomed to lower levels of sodium, final regulations issued on May 10, 1994, provided a two-tier approach to
sodium levels, specifying a maximum level for individual foods at 480 mg per serving, with a requirement that the
level drop to 360 mg per serving by January 1, 1998. Prior to the 1998 date, FDA and USDA received petitions
from a food manufacturer asking that the more restrictive second tier be eliminated or at least delayed until there
were advances in food technology that allowed for the development of acceptable products with reduced sodium
content. The agencies found that issues raised relative to technological and safety concerns of reduced-sodium
foods merited further consideration, so it extended the effective date.78 This process continued until final rules were
issued which abandoned the more restrictive sodium requirements altogether because of the documented technical
difficulties in finding suitable alternatives for sodium that would be acceptable to consumers. 79
NUTRITION LABELING AS AN EVOLVING PROCESS
Nutrition labeling is a tool for consumers to use in selecting healthy diets that meet dietary recommendations.
To accomplish this, it must be flexible enough to accommodate continuing advances in science and nutrition as
well as changes in consumer behavior. The need for these changes is evidenced by the current advance notices of
proposed rulemaking pertaining to modifications to give more prominence to calories, 80 amendments to serving
size regulations,81 and the establishment of new reference values.82 Current activities regarding front-of-package
labeling are another example of innovative approaches to nutrition labeling designed to help consumers select
foods that may lead to more healthful diets.
REFERENCES
CFSAN/FDA (Center for Food Safety and Applied Nutrition). 2004. Letter to food manufacturers about accurate serving size
declaration on food products. College Park, MD: FDA.
FDA (Food and Drug Administration). 1990. Food Labeling Reform. Washington, DC: FDA. Pp. 1-23
FDA. 2004. Calories Count: Report of the Working Group on Obesity. Washington, DC: Food and Drug Administration.
74 56 FR 60421.
75 58 FR 2944 (FDA) and 58 FR 688 (USDA).
76 59 FR 24232 (FDA) and 59 FR 24220 (USDA).
77 59 FR 24232.
78 62 FR 15390 (FDA) and 63 FR 7279 (USDA).
79 70 FR 56828 (FDA) and 71 FR 1683 (USDA).
80 70 FR 17008.
81 70 FR 17101.
82 72 FR 62149.
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Geiger, C. 1998. Health claims: History, current regulatory status, and consumer research. Journal of the American Dietetic
Association 98:1312-1322.
Grundy, S., and M. Denke. 1990. Dietary influences on serum lipids and lipoproteins. Journal of Lipid Research 31:1149-1172.
HHS (Department of Health and Human Services). 1988. The Surgeon General’s Report on Nutrition and Health. DHHS
Publication No. 88-50210. Washington, DC: U.S. Government Printing Office.
HHS. 1990. Remarks by Louis W. Sullivan, M.D., Secretary of Health and Human Services at the National Food Policy Con -
ference. Washington, DC: HHS. Pp. 1-12.
HHS/USDA (U.S. Department of Agriculture). 1990. Dietary Guidelines for Americans. Washington, DC: U.S. Government
Printing Office.
Hutt, P. 1995. A brief history of FDA regulation relating to the nutrient content of food. In Nutrition Labeling Handbook, edited
by R. Shapiro, New York City: Marcel Dekker. Pp. 1-27.
IOM (Institute of Medicine). 1990. Nutrition Labeling, Issues and Directions for the 1990s. Washington, DC: National Acad-
emy Press.
IOM. 2003. Dietary Reference Intakes: Guiding Principles for Nutrition Labeling and Fortification. Washington, DC: The
National Academies Press.
IOM. 2010. Front-of-Package Nutrition Rating Systems and Symbols: Phase I Report. Washington, DC: The National Acad-
emies Press.
Kessler, D. A. 1989. The federal regulation of food labeling, promoting foods to prevent disease. New England Journal of
Medicine 321:717-725.
Kessler, D. A. 1995. The evolution of national nutrition policy. In Annual Review of Nutrition, Vol. 15, ed. D. B. McCormick.
Palo Alto, CA: Annual Reviews.
Kessler, D. A., J. R. Mande, F. E. Scarbrough, R. Schapiro, and K. Feiden. 2003. Developing the “Nutrition Facts” food label.
Harvard Health Policy Review 4:13-24.
Levy, A., S. Fein, and R. Schucker. 1991. Nutrition labeling formats: Performance and preference. Food Technology 45:116-121.
Levy, A., S. Fein, and R. Schucker. 1996. Performance characteristics of seven nutrition label formats. Journal of Public Policy
& Marketing 15:1-15.
Lewis, C., and E. Yetley. 1992. Focus group sessions on formats of nutrition labels. Journal of the American Dietetic Associa-
tion 92:62-66.
LSRO (Life Sciences Research Office). 1987. Physiological Effects and Health Consequences of Dietary Fiber. Bethesda, MD:
Federation of American Societies for Experimental Biology.
LSRO/FASEB (Federation of American Societies for Experimental Biology). 1985. Health Effects of Dietary Trans Fatty Acids.
Bethesda, MD: FASEB.
McCutcheon, J. 1995. Nutrition labeling of meat and poultry products-An overview of regulations from the U.S. Department
of Agriculture. In Nutrition Labeling Handbook, edited by R. Shapiro. New York City: Marcel Dekker. Pp. 53-63.
Nielsen, S., and B. Popkin. 2003. Patterns and trends in food portion sizes, 1977-1998. Journal of the American Medical
Association 289:450-453.
NIH (National Institutes of Health). 1990. National Cholesterol Education program: Report of the Expert Panel on Population
Strategies for Blood Cholesterol Reduction. Wasington, DC: U.S. Government Printing Office.
NIH. 1994. Expert panel on detection, evaluation, and treatment of high blood cholesterol in adults National Cholesterol Edu -
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adults (Adult Treatment Panel II). Circulation 89:1329-1445.
NRC (National Research Council). 1968. Recommended Dietary Allowances. Washington, DC: National Research Council.
NRC. 1989a. Diet and Health: Implications for Reducing Chronic Disease Risk . Washington, DC: National Academy Press.
NRC. 1989b. Recommended Dietary Allowances. 10th edition. Washington, DC: National Academy Press.
Scarbrough, F. 1995. Perspectives on Nutrition Labeling and Education Act. In Nutrition Labeling Handbook, edited by R.
Shapiro. New York City: Marcel Dekker. Pp. 29-52.
Shank, F. A. 1989. Health claims on food labels: The direction in which we’re headed. Journal of the Association of Food &
Drug Officials: 53:45-49.
Smiciklas-Wright, H., D. Mitchell, S. Mickle, and J. Goldman. 2003. Foods commonly eaten in the United States, 1989-1991
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of Public Health 92:246-249.
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APPENDIX B
ANNEX
MILESTONES IN NUTRITION LABELING
TABLE B-1 Milestones in Nutrition Labeling
Nutrition
Date Activity References Labeling Claims
1941 Proposed rule to prescribe label statements for 6 FR 3304-3310; 21 CFR X
dietary properties of foods represented as being for Part 125
special dietary use and to establish minimum daily
requirement values for vitamins and minerals
1941 Final rule prescribing label statements for dietary 6 FR 5921-5926; 21 CFR X
properties of foods represented as being for Part 125
special dietary use and establishing minimum daily
requirements for vitamins and minerals
1962 Proposed rules for food for special dietary uses that 27 FR 58155818; 21 CFR X
would define terms for label statements relating to Part 125
vitamins and minerals, for use in weight control
(e.g., “low calorie”), and for use in regulating the
intake of sodium
1966 Final rules for food for special dietary uses that 31 FR 8521-8524; 21 CFR X
defined terms for label statements relating to Part 125
vitamins, minerals, and protein; for use in weight
control (e.g., “low calorie”), and for use in
regulating the intake of sodium
1969 White House Conference on Food, Nutrition,
and Health recommends that FDA consider the
development of a system for identifying the
nutritional qualities of food
1971 Proposed rule on labeling of foods with information 36 FR 11521-11522; 21 CFR X
on cholesterol, fat, and fatty acid composition Part 125.12
1972 Proposed rules for voluntary nutrition labeling of 37 FR 6493-6497; 21 CFR X
packaged foods (except mandatory when nutrient Part 1.16
claims are made or nutrients added) and for
Recommended Daily Allowances to be used as a
reference standard for nutrition labeling
1972 Final rule on label statements for foods intended to 37 FR 9763-9764; 21 CFR X
regulate the intake of sodium Part 125.9
1973 Final rule establishing rules for voluntary nutrition 38 FR 2125-2132; 21 CFR X
labeling of packaged foods (except mandatory when Part 1.17
nutrient claims are made or nutrients added) and
U.S. Recommended Daily Allowances (U.S. RDAs)
to be used as a reference standard
1973 Final rule on labeling of foods with information 36 FR 2132-2137; 21 CFR X
on cholesterol, fat, and fatty acid composition Part 1.18
(separate from nutrition label)
1973 Amendments to final rules on nutrition labeling and 38 FR 6950-6964; 21 CFR X
labeling of information on cholesterol, fat, and fatty Parts 1.17 and 1.18
acid composition
1977 Tentative order on label statements for special 42 FR 37166-37176; 21 CFR X
dietary foods for use in reducing or maintaining Parts 105.66 and 105.67
weight or calorie intake (e.g., “low calorie”)
continued
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130 FRONT-OF-PACKAGE NUTRITION RATING SYSTEMS AND SYMBOLS
TABLE B-1 Continued
Nutrition
Date Activity References Labeling Claims
1978 Announcement of five public hearings to discuss 43 FR 25296-25307 X X
food labeling, including nutrition labeling and
claims
1978 Final rule on label statements for special dietary 43 FR 43248-43262; 21 CFR X
foods for use in reducing or maintaining weight or Parts 105.66 and 105.67
calorie intake (e.g., “low calorie”)
1978 Proposed rule to permit “reduced calorie” claim for 43 FR 43261-43262; 21 CFR X
bread with 25% reduction in calories Part 105.66
1979 Tentative positions of FDA, USDA, and FTC on 44 FR 75990-76020 X X
food labeling issues as a result of public hearings
1980 Final policy statement on the addition of nutrients 45 FR 6314-6324; 21 CFR
to food (i.e., fortification) Part 104.20
1982 Proposed rule to establish definitions for sodium 47 FR 26580-26595; 21 CFR X
claims (e.g., “sodium free,” “reduced sodium,” “no Part 105.69
salt added”) and safety review
1983 Temporary exemption from food labeling rules for 48 FR 15236-15241; 21 CFR X
conducting authorized food labeling experiments Part 101.108
aimed at providing consumers with more useful
food labeling information (e.g., shelf labeling)
1984 Final rule establishing definitions for sodium claims 49 FR 15510-15535; 21 CFR X X
and requiring inclusion of sodium in nutrition Parts 101.9, 101.13, and 105.69
labeling information whenever nutrition labeling
appears on food labels
1986 Proposed rule to establish definitions for cholesterol 51 FR 42584-42593; 21 CFR X X
claims (e.g., “cholesterol free”) and amend nutrition Parts 101.9 and 101.25
labeling rules to require that the declaration of
either fatty acid or cholesterol content information
will require that both be provided in nutrition
labeling
1987 Proposed rule to exclude nondigestible dietary fiber 52 FR 28690-28691; 21 CFR X
when determining the calorie content of a food for Part 101.9
nutrition labeling purposes
1987 Proposed rule to codify and clarify the agency’s 52 FR 28843-28849; 21 CFR X
policy on the appropriate use of health messages on Part 101.9
food labeling
1989 Advance notice of proposed rulemaking to 54 FR 32610-32615 X X
announce a major initiative of HHS to improve
food labeling with request for public comment on
labeling requirements, including nutrition labeling
and claims
1989 Announcement of four public hearings to discuss 54 FR 38806-38807 X X
food labeling issues, including nutrition labeling
and claims
1990 Reproposed rule to provide for the use of health 55 FR 5176-5192; 21 CFR X X
messages on food labeling and to withdraw the Part 101.9
August 4, 1987, proposal
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APPENDIX B
TABLE B-1 Continued
Nutrition
Date Activity References Labeling Claims
1990 Tentative final rule establishing definitions for 55 FR 29456-29473; 21 CFR X X
cholesterol claims and requiring that declaration of Parts 101.9 and 101.25
either fatty acid or cholesterol content information
triggers declaration of both in nutrition labeling
1990 Proposed rule to replace U.S. RDAs with Reference 55FR 29476-29486; 21 CFR X
Daily Intakes (RDIs) for protein and 26 vitamins Parts 101.3, 101.9, and 104.20
and minerals and to establish Daily Reference
Values (DRVs) for fat, saturated fatty acids,
unsaturated fatty acids, cholesterol, carbohydrate,
fiber, sodium, and potassium
1990 Proposed rule to require nutrition labeling on most 55 FR 29487-29517; 21 CFR X
packaged foods and to revise the list of required Part 101.9
nutrients and conditions as well as the format for
listing nutrients in nutrition labeling
1990 Proposed rule to define serving size on the basis on 55 FR 2951729533; 21 CFR X
the amount of food commonly consumed per eating Parts 101.8, 101.9, and 101.12
occasion and to establish standard serving sizes
for 159 food product categories to assure uniform
serving sizes upon which consumers can make
nutrition comparisons among food products
1990 Passage of the Nutrition Labeling and Education Public Law 101-585 (Sec. 403(q) & X X
Act of 1990 (NLEA) mandating nutrition labeling (r) of the Federal Food, Drug, and
on most packaged foods and providing for nutrient Cosmetic Act)
content claims and health claims on food labels
1991 Proposed rule with notice of FDA’s plans to 56 FR 1151-1152 X X
respond to passage of NLEA
1991 Notice of public meeting to discuss issues related 56 FR 8084-8092 X
to how serving size should be determined and
presented as a part of nutrition labeling
1991 Advance notice of proposed rulemaking to solicit 56 FR 13564-13573 X
comment on nutrition labeling of meat and poultry
products (USDA)
1991 Notice of availability of a report on food label 56 FR 23072-23083 X
formats conducted by FDA and request for
comment on nutrition label format research
1991 In response to requirements of the NLEA, 56 FR 60366-60394; 21 CFR X
proposed rule to modify proposal of July 19, Part 101.9
1990, on mandatory nutrition labeling and the
establishment of RDIs and DRVs for use in
nutrition labeling
1991 In response to requirements of the NLEA and 56 FR 60394-60421; 21 CFR X
comments received, proposed rule to modify Parts 101.9 and 101.12
proposal of July 19, 1990, on serving sizes for use
in nutrition labeling
1991 Proposed rule to define nutrient content claims for 56 FR 60421-60478; 21 CFR X
calories, sugar, and sodium and for claims such Parts 101.13, 101.54, 101.60, 101.61,
as “source,” “high,” “more,” and “light,” and to 101.69, 101.95, and 105.66
provide for their use on food labels
continued
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132 FRONT-OF-PACKAGE NUTRITION RATING SYSTEMS AND SYMBOLS
TABLE B-1 Continued
Nutrition
Date Activity References Labeling Claims
1991 Proposed rule to define nutrient content claims for 56 FR 60478- 60512; 21 CFR X
fat, fatty acids, and cholesterol and to provide for Parts 101.25 and 101.62
their use on food labels
1991 Proposed rule to permit nutrient content claims to 56 FR 60512; 21 CFR
be made for butter Part 101.67
1991 Proposed rule to establish general requirements 56 FR 60537-60566; 21 CFR X
for health claims that characterize the relationship Parts 101.14, 101.70, and 101.71
of a food component to a disease or health-related
condition on the labels and in labeling of foods
1991 Proposed rule to permit voluntary nutrition labeling 56 FR 60302-60364; 9 CFR X X
of single-ingredient meat and poultry products, to Parts 317, 320, and 381
establish mandatory nutrition labeling of all other
meat and poultry products, and to establish nutrient
content claims for use on meat and poultry product
labels (USDA)
1992 Proposed rule on format for presenting nutrition 57 FR 32058-32089 X
information on food labels
1992 Passage of the Dietary Supplement Act of 1992, Public Law 102-571 X
which put a 1-year moratorium on regulations that
required the use of, or were based upon, RDAs
other than those in effect at that time
1993 Final rule requiring nutrition labeling on most 58 FR 2079-2205; 21 CFR X
packaged foods and specifying a new format for Part 101.9
declaring nutrition information
1993 Final rule establishing Reference Daily Intakes 58 FR 2206-2228; 21 CFR X
and Daily Reference Values, to be known as Daily Part 101.9
Values, for declaring the nutrient content of a food
1993 Final rule defining serving sizes based on amounts 58 FR 2229-2300; 21 CFR X
customarily consumed per eating occasion, provide Parts 101.8, 101.9, and 101.12
for their use, and establish reference amounts for
139 food categories
1993 Final rule establishing general principles for the 58 FR 2302-2426; 21 CFR X
use of nutrient content claims, define terms such Parts 101.13, 101.54, 101.56, 101.60,
as “free,” “low,” “lean,” ”high,” “reduced,” “light,” 101.61, 101.62, 101.65, 101.69, and
“less,” and “fresh,” and provide for the use of 101.95
implied nutrient content claims
1993 Final rule to establish general principles for the use 58 FR 2478-2536; 21 CFR X
of health claims Part 101.14
1993 Proposed rule to define the implied nutrient content 58 FR 2944-2949, 21 CFR X
claim “healthy” Part 101.65
1993 Proposed rule to permit the term “healthy” on meat 58 FR 688-691; 9 CFR X
and poultry products (USDA) Parts 317.363 and 381.463
1993 Final rule to permit voluntary nutrition labeling on 58 FR 632-685; 9 CFR X X
single-ingredient raw meat and poultry products, to Parts 317, 320, and 381
establish mandatory nutrition labeling for all other
meat and poultry products, and to establish nutrient
content claims for use on meat and poultry product
labels (USDA)
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133
APPENDIX B
TABLE B-1 Continued
Nutrition
Date Activity References Labeling Claims
1994 Proposed rule to establish Reference Daily Intakes 59 FR 427-432; 21 CFR X
for vitamin K, selenium, manganese, fluoride, Part 101.9
chromium, molybdenum, and chloride for use in
nutrition labeling
1994 Final rule defining the term “healthy” for use on 59 FR 24220 –24229; 9 CFR X
meat and poultry product labeling (USDA) Parts 317.363 and 381.463
1994 Final rule defining the term “healthy” for use on 59 FR 24232-24250; 21 CFR X
the food label Part 101.65
1995 Proposed rule to amend general principles for the 60 FR 66206-66227; 21 CFR X
use of nutrient content and health claims to provide Parts 101.13 and 101.14
additional flexibility and encourage their use in
order to assist consumers in maintaining a healthy
diet
1995 Final rule to provide codified language for nutrition 60 FR 174-216; 9 CFR X
labeling regulations that were previously cross- Parts 317 and 381
referenced to FDA regulations (USDA)
1995 Final rule establishing Reference Daily Intakes 60 FR 67164-67175; 21 CFR X
for vitamin K, selenium, manganese, chromium, Part 101.9
molybdenum, and chloride
1998 Notice of availability of a guidance document on 63 FR 32102 X
notifications for nutrient content or health claims
based on an authoritative statement of a scientific
body in response of FDA Modernization Act of
1997
1999 Proposed rule to require the addition of trans fatty 64 FR 62746-62825; 21 CFR X
acids to nutrition labeling and to define a nutrient Parts 101.9, 101.13, and 101.14
content claim for the “free” level of trans fatty
acids
1999 Notice of availability of guidance on significant 64 FR 17494 X
scientific agreement in the review of health claims
for conventional foods and dietary supplements
2003 Proposed rule to amend regulations that pertain to 68 FR 8163-8179; 21 CFR X
sodium levels in foods that use the term “healthy” Part 101.65
on product labels
2003 Final rule requiring the addition of trans fatty acids 68 FR 41434-41506; 21 CFR X
to nutrition labeling Part 101.9
2005 Advance notice of proposed rulemaking to request 70 FR 17008-17010 X
comment on amending nutrition labeling regulations
to give more prominence to calories of food labels
2005 Advance notice of proposed rulemaking to request 70 FR 17010; 21 CFR Part 101 X
comment on amending nutrition labeling regulations
concerning serving size
continued
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134 FRONT-OF-PACKAGE NUTRITION RATING SYSTEMS AND SYMBOLS
TABLE B-1 Continued
Nutrition
Date Activity References Labeling Claims
2005 Final rule amending regulations that pertain to 70 FR 56828-56849; 21 CFR X
sodium levels in foods that use the term “healthy” Part 101.65
on product labels
2006 Interim final rule concerning level of sodium in 71 FR 1683-1686; 9 CFR X
labels of meat and poultry products that bear the Parts 317.363 and 381.463
term “healthy” (USDA)
2006 Guidance for industry on FDA’s implementation of May 2006 X
“qualified health claims” http://www.fda.gov/Food/
GuidanceComplianceRegulatoryInformation/
GuidanceDocuments/FoodLabelingNutrition/
ucm053843.htm
2007 Advance notice of proposed rulemaking to request 72 FR 62149–62175; 21 CFR X
comments on establishing new reference values Part 101
(i.e., RDIs and DRVS)
2009 Guidance for industry on evidence-based review for January 2009 X
the scientific evaluation of health claims
http://www.fda.gov/Food/
GuidanceComplianceRegulatoryInformation/
GuidanceDocuments/FoodLabelingNutrition/
ucm073332.htm
2010 Final rule to require nutrition labeling of major cuts 75 FR 82148-82167; CFR X
of meat and poultry and on all ground or chopped Parts 317 and 318
meat and poultry products on labels or at point-of-
purchase (USDA)
NOTE: Table excludes foods for special dietary use (other than label statements about nutrient content), dietary supplements, foods for infants
less than 1 year of age, individual health claims, and the voluntary nutrition labeling program for raw fruits, vegetables, and fish. Unless other-
wise noted, regulations and notices have been issued by the Food and Drug Administration of the Department of Health and Human Services.
