KESSLER ET AL.:  DEVELOPING THE FOOD LABEL
               Developing the “Nutrition Facts” 
               Food Label
               David A. Kessler, MD, JD; Jerold R. Mande, MPH; F. Edward 
               Scarbrough, PhD; Renie Schapiro, MPH; and Karyn Feiden
                        he  development  of  the  “Nutri-        rules were issued in 1993, the FDA esti-
                        tion Facts” label, which is required     mated that the label might save as much 
               Ton virtually every processed food  as $26 billion in healthcare costs over the 
                                                                                2
               item sold anywhere in the United States,          next 20 years.
               is,  from the perspective of both industry           This year marks the tenth anniversary 
               and the American consumer, one of the  of the Nutrition Facts label. Over the past 
               most  ambitious  public  health  initiatives      decade, nutrition and the role of diet in 
               ever  undertaken  by  the  Food  and  Drug        disease  have  assumed a more prominent 
               Administration (FDA).  By providing con-          place in public health discussions. At the 
               sumers with information to make health-           same time, obesity has become increasing-
               ier  food  choices,  the  label  was  designed    ly widespread and is projected to surpass 
               to  help  Americans  reduce  their  risk  of      tobacco as the leading cause of preventable 
               health problems associated with diet.  An         death.3    These  and  other  developments 
               estimated 300,000 preventable deaths per          have  generated  interest  in  updating  the 
                                          1
               year are related to diet.   In a regulatory       existing Nutrition Facts label.  While de-
               impact analysis conducted when the final          bate about the need for and the nature of 
               David A. Kessler, MD, JD, served as Commissioner of the United States 
               Food and Drug Administration from 1990 to 1996, and is now Dean 
               of the University of California, San Francisco School of Medicine.  He 
               received his law degree from the University of Chicago.  Jerold R. Mande, 
               MPH, was senior adviser to the FDA commissioner.  He is a member of 
               the Institute of Medicine committee on food labeling, and is Associate 
               Director for Policy at the Yale Cancer Center.  F. Edward Scarbrough, PhD, 
               served as Director, Office of Food Labeling, FDA, and is currently U.S. 
               Manager for the Codex Alimentarius Commission.  Renie Schapiro, MPH, 
               was the speechwriter and a policy advisor for the FDA commissioner, 
               and is now consulting in Madison, Wisconsin.  Karyn Feiden is a New 
               York City-based writer who specializes in health and public health.
                                                                                    Vol. 4, No. 2, Fall 2003   13
                FEATURES: NUTRITION AND PUBLIC HEALTH
                possible revisions has only begun, this is            Food manufacturers also  found  other 
                a useful time to review the history of the         faults  with  the  existing  label,  protesting 
                food label initiative and the reasoning be-        that competitors were able to include mis-
                hind some of the scientific and technical          leading information on it and expressing 
                decisions the Agency made, often in the            concern that differing state laws were cre-
                face of uncertain knowledge.  This article         ating a patchwork of food label standards.  
                is intended as a record of this public health      The need for action at the national level 
                policy initiative.                                 was clear.
                                                                      In the spring of 1989, Department of 
                The Nutrition Labeling and  Health  and  Human  Services  (DHHS) 
                                                                   Secretary  Louis  Sullivan  announced  that 
                Education Act                                      the FDA would undertake a major food 
                                                                   labeling reform initiative.  The FDA deter-
                Nutrition policy in the United States after        mined that existing statutes gave it a base 
                World War II focused primarily on pre-             from which to update the label, and over a 
                venting vitamin-deficiency diseases.  Over         period of several months, the Agency held 
                time, largely as a result of nutrient fortifi-     hearings and other meetings in many parts 
                cation programs, those ailments declined           of the country to solicit comments from 
                dramatically in this country, and research-        consumers, industry, and scientists.  After 
                ers increasingly turned their attention to         hearing from more than 3,500 people, it 
                the  relationship  between  nutrition  and         published proposed labeling rules in July 
                chronic disease.  New studies documented           1990.8
                the  role  of  diet  in  heart  disease,  cancer,     The possibility of a new food label was 
                obesity,  and other chronic ailments, and          already  being  discussed  in  Congress  at 
                in the 1980s, the Surgeon General and the          the time and shortly after the FDA took 
                Institute of Medicine published pivotal re-        its action, the federal Nutrition Labeling 
                                       4,5
                ports on the subject.                              and Education Act (NLEA) became law.  
                   As  consumers  became  more  aware  of          The NLEA gave the Agency more explicit 
                these findings, they wanted more compre-           authority to require nutrition labeling on 
                hensive, readable, and useful information          most  food  packages  and  set  demanding 
                                 6,7 
                on food labels.     Since 1973, a label had        deadlines for completing the task, requir-
                been required on foods if the manufacturer         ing the FDA to issue final rules within two 
                added certain nutrients to them, or made           years.  As a result, the FDA redirected its 
                claims about a food’s nutritional properties       efforts somewhat to focus on implement-
                or its usefulness in the daily diet.  Yet while    ing the new legislation.
                the food label was required to list the type          In the NLEA, Congress made clear that 
                and amount of nutrients in a food, it did          the new label should become a more effec-
                not put that information in the context of         tive public health tool, and that it should 
                a daily diet, nor did it present the informa-      be used to reduce the incidence of diet-
                                                                                    9
                tion in a uniform format.  Decisions about         related disease.   The legislation required 
                the label’s design, typeface, type size, and       that some additional nutrients be listed on 
                location on the package were left to the           the label, including calories from fat, satu-
                discretion of the manufacturer.                    rated fat, cholesterol, sugars, and dietary 
                14   Harvard Health Policy Review
                                                           KESSLER ET AL.:  DEVELOPING THE FOOD LABEL
                fiber,  but  more  significantly,  it  required    dietary  fiber,  sugars,  protein,  vitamin  A, 
                that nutrients be presented in the context         vitamin C, calcium, and iron – were con-
                of a daily diet.  The NLEA also mandated           tained in the food.  The label also had to 
                standard definitions for nutrient content          allow consumers to tell at a glance whether 
                claims (e.g., “low in fat”) and required that      the amounts present represented a large or 
                the FDA approve health claims (e.g., “diets        small portion of the daily recommended 
                low in fat may reduce your risk of heart           levels.  
                disease and cancer”).                                 This requirement was intended to re-
                   In November 1991, one year after the            move some of the confusion from the old 
                NLEA was signed into law, the FDA pro-             label, which listed many nutrient amounts 
                posed  26  new  food  label  regulations  to       in measures such as grams.  That approach 
                                          10
                implement the statute.   Those propos-             was  misleading  because  some  relatively 
                als  generated  40,000  written  comments          large  numbers actually represented small 
                –  one  of  the  largest  responses  ever  to  a   intakes, while some relatively small num-
                set of FDA-proposed rules.  The Agency  bers represented large quantities.  Research 
                reviewed every comment and issued final            had  shown,  for  example,  that  because 
                                          11
                rules  in  January  1993.    The  Nutrition        the recommended daily intake of sodium 
                Facts label began appearing on food pack-          (2,400 mg or less) is a relatively large num-
                ages over the next 18 months.                      ber, consumers often mistakenly identified 
                                                                   low-sodium food (e.g., 140 mg of sodium 
                Agency Decisions Under                             per serving) as containing a lot of sodium.  
                                                                   Similarly,  consumers  often  mistakenly 
                NLEA                                               identified foods that were relatively high 
                                                                   in saturated fat (e.g., 5 grams per serving) 
                                                                                            12
                In developing the label, the FDA sought to         as low in that nutrient.   
                incorporate the best available research and           A useful approach was found on the old 
                thinking about nutrition and dietary goals.        food label, which used a concept known 
                However,  knowledge  was  sometimes  in-           as  “Percentage  of  U.S.  Recommended 
                complete, and in some cases, there was no          Daily Allowances (U.S. RDA).”  The FDA 
                consensus within the scientific communi-           had  required  manufacturers  to  present 
                ty.  To achieve the goal of communicating          information about protein, vitamin, and 
                key information to a wide range of con-            certain  mineral  content  as  a  percentage 
                sumers in the small space of a food label,         of  the  amount recommended to prevent 
                the Agency had to consider many possible           nutritional deficiencies.  The use of per-
                approaches and make many difficult deci-           centages on the label had enabled consum-
                sions.                                             ers to quickly determine whether a food 
                                                                   contained a small or large portion of the 
                Percent daily value                                recommended  amount.    It  also  simpli-
                                                                   fied the label; consumers did not have to 
                The NLEA required that the label indicate          understand measures such as grams, mil-
                how much of at least a dozen different nu-         ligrams,  international  units,  and  retinol 
                trients – including total fat, saturated fat,      equivalents.
                cholesterol,  sodium,  total  carbohydrates,          In its proposed rules, the FDA decided 
                                                                                      Vol. 4, No. 2, Fall 2003   15
               FEATURES: NUTRITION AND PUBLIC HEALTH
               to extend this approach to the entire list of    Institute of Health’s National Cholesterol 
                                                                                      16
               nutrients required on the Nutrition Facts        Education Program,  and the 1988 Sur-
               label.  The new label was to present nutri-      geon  General’s  Report  on  Nutrition  and 
               ent amounts as a percentage of a standard        Health.4  Based on these documents, the 
               recommended intake, expressed on the la-         FDA established “Daily Reference Values” 
               bel as “% Daily Value.”                          (DRVs) for nutrients without RDAs.  
                  During the comment period, some nu-              While the use of two different names 
               trition groups expressed concern that not        – RDIs and DRVs – alerted nutrition pro-
               all consumers would be comfortable with          fessionals that the values had different ori-
               percentages.  The FDA responded to those         gins, the FDA decided to call them both 
               comments  by  reexamining  the  research         “Daily Values” on the Nutrition Facts label 
               on the use of percentages by consumers.          to avoid confusing consumers.
               While it found certain limitations to their 
               use, the Agency concluded they nonethe-          How many calories?
               less represented the best available format.
                  The FDA’s next task was to decide which       Percent Daily Values for nutrients such as 
               standards to draw on to determine the rec-       total fat, saturated fat, total carbohydrate, 
               ommended nutrient intakes on which the  and dietary fiber depend on an individual’s 
               % Daily Value would be based.  The FDA  daily caloric intake.  In the early 1990s, the 
               had already developed U.S. RDAs for the          NAS’s recommendations for total caloric 
               old label.  These were based on the Rec-         intake for adults ranged from 1,900 calo-
               ommended Dietary Allowances (RDAs),  ries per day for women age 51 and older to 
               figures published by the National Acade-         3,000 for males 15 to 18 years of age.  On 
                                       13
               my of Sciences (NAS).   Where they were          average, the recommended level for most 
               available, the FDA used the U.S. RDAs for        women was about 2,200 calories and for 
               the new label, renaming them “Reference          most men, was about 2,900 calories.  Since 
               Daily Intakes,” or RDIs.                         the size of the label limited the amount of 
                  However, the NAS had not developed  information it could contain, the Agency 
               RDAs for many of the nutrients being re-         had to make a critical choice about which 
               quired on the new label, so the FDA had          caloric intake level to use for its % Daily 
               to identify other sources on which to base       Value calculations.
               recommended quantities of total fat, satu-          The FDA initially proposed to use a 
               rated fat,  cholesterol,  total  carbohydrate,   population-weighted average of 2,350 cal-
               dietary fiber, and sodium.  Lacking a single     ories.  However, most health professional 
               consensus document, the FDA turned to  and consumer groups advocated basing the 
               the  recommendations  in  Dietary  Guide-        % Daily Values on 2,000 calories, arguing 
               lines  for  Americans,14 a report by DHHS        in  their  comments  that  a  higher  figure 
               and the U.S. Department of Agriculture,          would result in excessive intakes of fat and 
               and to the underlying research supporting        other nutrients for most women.  Industry 
               these  recommendations.    Three  reports        and the U.S. Department of Agriculture 
               proved extremely helpful: the Institute of       claimed that 2,000 calories would overly 
                                                     15
               Medicine’s 1989 Diet and Health,   the  restrict the nutrient intakes of many men 
               1990 expert panel report of the National         and very active women.  Some comments 
               16   Harvard Health Policy Review