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Appendix B: History of Nutrition Labeling
Pages 115-134

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From page 115...
... 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.
From page 116...
... 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.
From page 117...
... . 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.
From page 118...
... . 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.
From page 119...
... 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.
From page 120...
... . 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)
From page 121...
... 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.
From page 122...
... , 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)
From page 123...
... . 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")
From page 124...
... , 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)
From page 125...
... 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 relationship 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.
From page 126...
... , 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.
From page 127...
... 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.
From page 128...
... 1989. Health claims on food labels: The direction in which we're headed.
From page 129...
... , 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)
From page 130...
... 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
From page 131...
... 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)
From page 132...
... 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)
From page 133...
... 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
From page 134...
... 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)


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