Strategies to Reduce Sodium Intake in the United States (2010) / Chapter Skim
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7 The Regulatory Framework: A Powerful and Adaptable Tool for Sodium Intake Reduction
7 The Regulatory Framework: A Powerful and Adaptable Tool for Sodium Intake Reduction
Pages 213-234
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From page 213... ...
However, once the framework is understood, it becomes evident that regulatory approaches can offer a powerful and adaptable tool for reduction of sodium intake. The options in the current regulatory framework are diverse and could be used in creative ways to facilitate a meaningful reduction of sodium intake.
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From page 214... ...
In addition, the application of federal regulations to restaurant/foodservice operations is discussed. REGULATION TO ENSURE SAFETY OF SUBSTANCES ADDED TO FOODS BY MANUFACTURERS Protecting, enhancing, and preserving food by using "food additives" began in ancient times, undoubtedly long before documented history.
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From page 215... ...
revised Figure 7-1.eps stances intentionally added to food are defined as "food additives" and, in turn, that food additives must be approved by FDA before they are added to foods. The process of approval requires scientific evidence gathered by the petitioner to demonstrate that the substance -- under the conditions of its intended use -- meets the safety standard of a reasonable certainty of no harm.6 This standard recognizes both that safety cannot be proven with absolute scientific certainty and that a substance may be safe for one use or under certain conditions, yet possibly unsafe for other uses or under other conditions.
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From page 216... ...
To be GRAS, the intended uses of a substance must satisfy the same "reasonable certainty of no harm" safety standard that is applicable to food additives, based on the same quantity and quality of data ("scientific procedures") required for FDA approval of a food additive, except that for substances used in food prior to 1958, the safety can be satisfied on the basis of such data or "experience based on common use in food."7 While a substance that is GRAS is exempted from the food additive requirement of pre-approval by FDA, it must still be safe and, with reasonable certainty, cause no harm.
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From page 217... ...
FDA further stated: "The agency wishes to emphasize that if there is no substantial reduction in the sodium content of processed foods and if information [sic] sodium labeling is not adopted after a reasonable period, FDA will consider additional regulatory actions, including proposing a change in salt's GRAS status" (HHS/FDA, 1982, p.
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From page 218... ...
This study found that FDA does not systematically reconsider the safety of GRAS substances as new information becomes available and that the agency has acted slowly on petitions regarding GRAS status of substances including salt due to resource constraints and other priorities. As a result, one of the recommendations of the GAO report was that FDA "develop a strategy to conduct reconsiderations of the safety of GRAS substances in a more systematic manner, including taking steps such as allocating sufficient resources to respond to citizen petitions in a timely manner, [and]
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From page 219... ...
In carrying out activities to alter or revoke salt's GRAS status, FDA would have to address both scientific and policy questions, including the following: • The central question, which is predominantly scientific, is whether the current levels and uses of added salt satisfy the safety standard of "reasonable certainty of no harm" based on today's science. In addressing this question, FDA would be expected to take into account, among other sources of information and scientific find ings, the recommendations of and scientific advisory documents related to the Dietary Guidelines for Americans, which in 2005 established a recommendation of less than 2,300 mg/d of sodium for the general population and no more than 1,500 mg/d for those with hypertension, African Americans, and people middle-aged or older as appropriate upper limits to reduce the risk of elevated blood pressure.
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From page 220... ...
While FDA is charged with administering the food additives safety provisions that are applicable to meat and poultry products that are under USDA jurisdiction, USDA has its own regulatory authorities that would allow it to implement other suitable and appropriate provisions for meat and poultry products including labeling and the prohibition of deceptive uses of substances and solutions added to meat and poultry. These provisions may have sizeable impact given that USDA is responsible for food products that contain 2 percent or more by weight of meat and poultry which, in turn, constitute about 20 percent of the U.S.
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From page 221... ...
Other feasibility and related constraints may be considered in implementing new standards, including possible phase-in reductions to acceptable levels. In considering implementing salt GRAS standards in a stepwise fashion, FDA will benefit from the experience gleaned from the effort to reduce, in a sequential manner over time, the allowable levels of sodium in foods bearing the implied nutrient content claim "healthy." That experience demonstrates the considerable importance of gathering information and carefully weighing options before making final decisions about an implementation process relative to sodium.
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From page 222... ...
Some of these uses are currently GRAS, and some have been approved as food additives. Because sodium per se and not just sodium chloride is the concern relative to reducing the risk of elevated blood pressure, the presence of all these 14 Further, another section of the Federal Food, Drug, and Cosmetic Act [Section 403(a)
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From page 223... ...
In 1981, in response to the increasing national concern about sodium intake and elevated blood pressure, FDA began to urge the food industry to voluntarily identify the sodium content of foods on the label. In 1984, FDA issued a sodium labeling regulation (HHS/FDA, 1984)
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From page 224... ...
Thus, the NLEA was directed to the labeling of foods, primarily packaged foods, regulated by FDA. In addition, FDA established a voluntary labeling program for raw fruits, vegetables, and fish.17 However, the NLEA exempted nutrition labeling for restaurant foods as well as packaged foods products sold only to restaurant/foodservice operations.18 Despite the exemption, and in light of the growing proportion of American meals consumed outside the home, FDA has sought to enlist the assistance and support of restaurants in addressing national obesity concerns by urging them to provide point-of-purchase nutrition information to consumers (HHS/FDA, 2004)
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From page 225... ...
Sodium is one of the required nutrients, and its declarations are expressed both as a milligram amount and as a percentage of the recommended DV, which currently is established as 2,400 mg.22 FDA regulations provide a procedure for food producers to analyze the sodium content and determine quantitative sodium levels in their products. To be in compliance with labeling requirements, the actual nutrient content must not differ from the amounts declared in the panel by more than 20 percent.23 For sodium, the actual amount can not be more than 20 percent above the declared value.24 Establishing the Daily Value for Sodium One of the goals of the NLEA was to allow consumers to quickly and easily view and understand the nutrition information on food labels.
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From page 226... ...
Moreover, the presence of this information on the packaged food label could incentivize the food industry overall to develop foods with better "nutrition profiles." At the time of NLEA implementation, FDA explored approaches to set the quantitative nutrition information within the context of a total daily diet (Levy et al., 1996; Lewis and Yetley, 1992)
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From page 227... ...
Currently, if there were 500 mg of sodium in a serving, the label would reflect that a serving of the food contains about 20 percent of the DV, while an updated DV of 1,500 mg would result in the label indicating that a serv 26 Unlike AIs for other nutrients intended to reflect observed intake, the AI for sodium was set at a value that ensures that the overall diet would provide an adequate intake of important nutrients (that is, setting the reference value closer to the body's functional requirement for sodium would be too restrictive given today's food supply and preclude meeting other nutritional needs) and also covers sodium sweat losses in unacclimated individuals who are exposed to high temperatures or who become physically active (IOM, 2005)
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From page 228... ...
Therefore, the expectation is that the DV declarations will be consistent with the best thinking about the desirable composition of a daily diet. Sodium Claims Sodium Content Claims As described above, the NLEA also directed FDA to establish the standards for which manufacturers could make claims on food labels.
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From page 229... ...
In 1997, FDA was persuaded to postpone the reduction in sodium requirements based on comments that indicated technical difficulties in finding suitable alternatives for sodium and claimed that consumers would reject certain so-called "healthy" products made with lower levels of sodium or salt substitutes. The comments also voiced technological concerns with reducing sodium in food products, such as impacts on microbial safety, changes in texture and water-binding capacities, and effects on flavor characteristics of other ingredients (HHS/FDA, 1997, 2005)
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From page 230... ...
APPLICATION OF FEDERAL REGULATIONS TO RESTAURANT/FOODSERVICE OPERATIONS Application of the Food Safety Provisions and GRAS Status to Restaurant/Foodservice Menu Items The food additive provisions of the Federal Food, Drug, and Cosmetic Act apply to substances the intended use of which results in their becoming a component of any food.30 Because the act applies to all foods that have moved in interstate commerce, FDA regulations limiting the amount of a substance in a food (in this case, salt or sodium) apply whether the substance has been added before or after the food has moved in interstate commerce.31 In essence, the thrust of the provisions are that it is unlawful to add an unapproved food additive to food before, during, or after the food's passage in interstate commerce.
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From page 231... ...
Application of the Nutrition Labeling and Education Act to Restaurant/Foodservice Operations Under the 1990 NLEA, the requirement for declarations about the nutritional content of a food product is limited to packaged foods, with some exceptions.32 Thus, the mandatory use of a Nutrition Facts panel type of declaration is not currently applicable to restaurant/foodservice menu items. However, the act did not limit nutrient content and health claims to packaged foods, and therefore FDA could, under its existing misbranding and enforcement authorities, regulate the voluntary use of such claims by restaurant/foodservice operators on foods at least some component of which has moved in interstate commerce.
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From page 232... ...
States and localities would not be able to require additional nutrient information on menus. STATE AND LOCAL MENU LABELING INITIATIVES The recognition of the contribution that menu items from restaurant/ foodservice operations make to the American diet, coupled with growing public health concerns about obesity and other chronic diseases, has increased the focus on point-of-purchase nutrition information within restaurant/foodservice operations.
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From page 233... ...
2005. Food labeling; nutrient content claims, definition of sodium levels for the term "healthy"; final rule.
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From page 234... ...
2001. Nutrition labeling of ground or chopped meat and poultry products and single-ingredient products; proposed rule.
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