scope of this article to cover all the issues necessary to
make this a ‘‘how to’’ reference. In order to apply the
regulatory requirements to specific packaging issues, it is
necessary to consult with regulatory source documents,
regulatory guidebooks, and/or legal or regulatory advisors.
HISTORY OF NUTRITION LABELING
Although the history of food labeling laws reach back as
far as 1906 with the Pure Food and Drug Act, it was not
until after World War II that consumer interest in and
need for nutrition information became evident (1). During
the war, food preparation shifted from the household to
large-scale food processing. The extended shipping times
for delivery of goods needed in war encouraged the devel-
opment of additives to extend shelf life. Wartime health
problems led to the recognition of the relationship be-
tween nutrition and diseases, spawning interest in nutri-
tion research and food labeling. Scientists recognized the
need for vitamins and minerals to prevent certain diseases
such as beriberi and pellagra.
By 1969, there was significant public interest in the
relationship between diet and health. As a response to this
interest, President Nixon convened the White House
Conference on Food, Nutrition, and Health, addressing
malnutrition in America (2). He told Congress of the need
to ensure that the private food industry serves all Amer-
icans well and that people are educated in choosing proper
foods. As an outcome of this conference, along with Con-
gress’ effort to mandate nutrition labeling, the Food and
Drug Administration adopted a voluntary nutrition label-
ing program in 1973 that required the labeling of nutrition
information whenever a nutrient claim was made or a
product was fortified (3). At this time, the voluntary
nutrition label focused on key vitamins or minerals known
to cause deficiency disease.
Proponents of mandatory nutrition labeling were not
satisfied with the limitations of the voluntary program—
typically, only products with a good nutrition story
included nutrition labeling. Throughout the 1970s, man-
datory nutrition labeling continued to be addressed by
legislators—in particular, Senator George McGovern, who
chaired the Senate Select Committee on Nutrition and
Human Needs. This Committee investigated a number of
nutrition issues affecting Americans and was responsible
for issuing the U.S. Dietary Goals, the first government
report setting prudent dietary guidelines for Americans
(4). In 1978, McGovern initiated a series of hearings to
explore nutrition labeling and information, where he is
quoted: ‘‘It appears from all I have heard and read to date
that the present labeling system is not useful or appro-
priate. Therefore we must determine what nutrition in-
formation the public wants and needs, and how best to
convey that information’’ (5). Although the hearing dis-
played the bipartisan nature of the issue, it took Congress
another 13 years before the Nutrition Labeling and Edu-
cation Act of 1990 (NLEA) was passed.
With the election of President Reagan in 1980, the
thrust to adopt mandatory nutrition-labeling legislation
came to an abrupt halt (1). Deregulation limited available
resources, causing FDA to focus on food-safety issues
and to deemphasize economic issues such as food labeling.
Despite this shift in legislative priorities, there were
major advances in science that documented the link
between nutrition and health. Several reports issued by
the federal government (6–8), in addition to reports re-
leased by nonprofit agencies, such as the American Cancer
Society (9) and the American Heart Association (10),
clearly showed the growing consensus about the relation-
ship between dietary imbalances and chronic diseases,
specifically the overconsumption of calories, fat, saturated
fat, cholesterol, and sodium and the underconsumption
of dietary fiber. As a result of extensive media coverage
of these findings, consumers began to demand healthier
food products and more information about the fat, choles-
terol, and fiber content of foods. Food manufacturers
responded by introducing nutrient-focused products—pro-
ducts lower in fat, cholesterol, and sodium and high in
fiber proliferated. Unfortunately, there were no guidelines
for defining ‘‘low’’ or ‘‘high’’ or for labeling nutrients such
as dietary fiber, saturated fat, or cholesterol. As a result,
manufacturers’ efforts to produce and market such pro-
ducts without consistent rules led to incidence of abuse,
and consumer groups complained of food-labeling decep-
tions. By the end of the 1980s, the food industry, as well as
regulators and consumers, were frustrated by the contra-
dictions that prevailed on grocery-store shelves.
It was not until President Bush took office in the late
1980s that legislative and regulatory efforts again focused
on nutrition labeling. Senators Metzenbaum, Kennedy,
and Hatch and Representatives Waxman and Madigan
renewed the spirit of the 1970s with nutrition labeling
regulations that ultimately resulted in mandatory label-
ing, nutrient content and health claim definitions, and
federal preemption, now known as NLEA. While these
legislators were lobbying for mandatory nutrition labeling
laws, the National Academy of Sciences’ Institute of
Medicine (IOM) issued a report entitled Nutrition Label-
ing: Issues and Directions for the 1990s (11). The IOM
report recommended changes in food labeling to assist
consumers in implementing the recommendations of the
Surgeon General (7) and the National Research Council
(8). The FDA responded by working with all concerned
parties, including industry, consumer groups, and the
states, to define regulations that would meet the goals
set out by the IOM report.
On November 8, 1990, President George Bush signed
into law the Nutrition Labeling and Education Act
(NLEA) of 1990 (12), which dramatically changed the
way that food products were labeled in the United States.
The
NLEA represents a
comprehensive mandatory nutri-
tion-labeling system, designed to help consumers meet the
U.S. Dietary Guidelines (6) and reduce their risk of chronic
diseases. The intent of these regulations was to the
provide guidance to food manufacturers and package
designers needed to ensure consistent presentation of
nutrition information and to prevent erroneous nutrient
content and health claims.
The only significant change that has been made to the
Nutrition Facts panel since the implementation of NLEA
in the early 1990s was on July 9, 2003, when FDA issued a
NUTRITION LABELING 825