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2 History of Nutrition Labeling
Pages 19-36

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From page 19...
... 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 20...
... 8 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.9 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)
From page 21...
... . This new food labeling initiative began with the publication of an advance notice of proposed rulemaking in August 1989 asking for public comment 21 and a notice of public hearings to be held across the country to address the content and format of the nutrition label, ingredient labeling, and both nutrient content and health claims.22 Unlike the situation surrounding the follow-up to the 1978 public hearings when few regula tory changes were made, in 1989 a number of forces, such as advances in science, recommendations for dietary 12 52 FR 28843.
From page 22...
... . Developing Reference Values By July 1990, FDA had published proposed rules for the mandatory nutrition labeling of almost all packaged foods.23 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 23...
... 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 DRVs29 and a proposal on serving sizes.30 General principles for nutrient content claims and the definition of terms for claims to be allowed were also proposed,31 as were general principles for health claims,32 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 24...
... 36 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.
From page 25...
... 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.38 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. 39 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.40 Determination of Reference Values As discussed above, for declaring amounts of vitamins and minerals, FDA had proposed replacing U.S.
From page 26...
... , 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.47 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 27...
... 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 V alues are based on a 2,000 calorie diet.
From page 28...
... , 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.59 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.
From page 29...
... Meal and main dish items are combina tions 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 .65 Briefly, in developing the criteria for claims, FDA took into account the dietary recommendations for each nutrient; the amounts of the nutrient present per RACC, per serving size, and per 100 g; the distribution and abundance of the nutrient in the food supply; analytical methods; and the presence of other nutrients that could possibly cause a particular claim to be misleading. Defining Leels 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.
From page 30...
... To that end, following pub lication of the final rules implementing NLEA, FDA and USDA issued proposed74 and final rules75 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." 76 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 (see Appendix B)
From page 31...
... The need for these changes is evidenced by the current advance notices of proposed rulemaking pertaining to modifications to give more prominence to calories, 79 amendments to servingsize regulations,80 and the establishment of new reference values.81 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/Food and Drug Administration)
From page 32...
... 1989. Health claims on food labels: The direction in which we're headed.
From page 33...
... ; and for use in regulating the intake of sodium White House Conference on Food, Nutrition, and Health recommends that FDA consider the 1969 development of a system for identifying the nutritional qualities of food 1971 Proposed rule on labeling of foods with information on cholesterol, fat, and fatty acid composition 36 FR 11521-11522; 21 CFR Part X 125.12 1972 Proposed rules for voluntary nutrition labeling of packaged foods (except mandatory when nutrient 37 FR 6493-6497; 21 CFR Part 1.16 X 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 regulate the intake of sodium 37 FR 9763-9764; 21 CFR Part 125.9 X 1973 Final rule establishing rules for voluntary nutrition labeling of packaged foods (except mandatory 38 FR 2125-2132; 21 CFR Part 1.17 X when nutrient claims are made or nutrients added)
From page 34...
... 101.108 49 FR 15510-15535; 21 CFR Parts 1984 Final rule establishing definitions for sodium claims and requiring inclusion of sodium in nutrition X X 101.9, 101.13, and 105.69 labeling information whenever nutrition labeling appears on food labels 1986 Proposed rule to establish definitions for cholesterol claims (e.g., "cholesterol free") and amend 51 FR 42584-42593; 21 CFR Parts X X nutrition labeling rules to require that the declaration of either fatty acid or cholesterol content 101.9, and 101.25 information will require that both be provided in nutrition labeling Proposed rule to exclude nondigestible dietary fiber when determining the calorie content of a food 1987 52 FR 28690-28691; 21 CFR Part X for nutrition labeling purposes 101.9 1987 Proposed rule to codify and clarify the agency's policy on the appropriate use of health messages on 52 FR 28843-28849; 21 CFR Part X food labeling 101.9 1989 Advance notice of proposed rulemaking to announce a major initiative of HHS to improve food 54 FR 32610-32615 X X labeling with request for public comment on labeling requirements, including nutrition labeling and claims 1989 Announcement of four public hearings to discuss food labeling issues, including nutrition labeling 54 FR 38806-38807 X X and claims 1990 Reproposed rule to provide for the use of health messages on food labeling and to withdraw the 55 FR 5176-5192; 21 CFR Part 101.9 X X August 4, 1987, proposal 1990 Tentative final rule establishing definitions for cholesterol claims and requiring that declaration of 55 FR 29456-29473; 21 CFR Parts X X either fatty acid or cholesterol content information triggers declaration of both in nutrition labeling 101.9 and 101.25 1990 Proposed rule to replace U.S.
From page 35...
... 58 FR 688-691; 9 CFR Parts 317.363 X and 381.463 1993 Final rule to permit voluntary nutrition labeling on single-ingredient raw meat and poultry products, 58 FR 632-685; 9 CFR Parts 317, X X to establish mandatory nutrition labeling for all other meat and poultry products, and to establish 320, and 381 nutrient content claims for use on meat and poultry product labels (USDA) 1994 Proposed rule to establish Reference Daily Intakes for vitamin K, selenium, manganese, fluoride, 59 FR 427-432; 21 CFR Part 101.9 X chromium, molybdenum, and chloride for use in nutrition labeling 1994 Final rule defining the term "healthy" for use on meat and poultry product labeling (USDA)
From page 36...
... 2009 Guidance for industry on evidence-based review for the scientific evaluation of health claims January 2009 X http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ FoodLabelingNutrition/ucm073332.htm 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.


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