August 2, 2014
Margaret A. Hamburg, MD
Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993-0002
Re: Food Labeling: Revision of the Nutrition and Supplement Facts Labels (Docket No. FDA—2012--N--1210; RIN 0910-AF22) and Serving Sizes of Foods That Can Reasonably Be Consumed at One-Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments (Docket No. FDA-2004-N-0258; RIN 0910-AF23)
Dear Dr. Hamburg:
The Academy of Nutrition and Dietetics appreciates the opportunity to submit comments to the Food and Drug Administration (FDA) related to its March 3, 2014 proposed food labeling rules: Revision of the Nutrition and Supplement Facts Labels (Docket No. FDA-2012-N-1210; RIN 0910- AF22)1 and Serving Sizes of Foods That Can Reasonably Be Consumed at One-Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments (Docket No. FDA-2004-N-0258; RIN 0910-AF23).2 With over 75,000 members comprised of registered dietitian nutritionists (RDNs),3 dietetic technicians, registered (DTRs), and advanced-degree nutritionists, the Academy is the largest association of food and nutrition professionals in the United States committed to improving the nation’s health through food and nutrition across the lifecycle. The Academy’s member RDNs independently provide expert nutrition care services, including nutrition education and Medical Nutrition Therapy4 to individuals as prevention and treatment for a wide variety of disease states and chronic conditions.
I. SUMMARY OF ACADEMY RECOMMENDATIONS
The Academy generally supports FDA’s proposal to revise the Nutrition Facts label. It is appropriate to consider the significant revision in the label since 1995 given that, as the agency notes, the public health profile of the U.S. population has changed, new information has become available about nutrient definitions, reference intake values, analytical methods, and new dietary recommendations have been published. The Academy’s detailed comments below can be summarized by the following recommendations:
A. Well-designed, adequately funded, and sustained nutrition education efforts are critical to effecting the purpose of Nutrition Facts label to provide consumers with tools at the point of purchase to help them readily observe and comprehend the label information and understand its relative significance in the context of a total daily diet.
B. More significant changes to the Nutrition Facts label should be considered in relation to consumer comprehension and the larger context of a healthy diet, including dietary guidance based on the Dietary Guidelines for Americans (DGA) and the use of the MyPlate icon and MyPlate food groups and eating plans.
C. FDA appropriately established new or revised reference values for nutrients of concern and definitions for dietary fiber.
D. The Academy supports FDA’s proposed mandatory declaration of added sugars and potassium and of absolute amounts for all declared nutrients, and further strongly encourages FDA to mandate declaration of phosphorous on the label.
E. The Academy generally supports the formatting changes and supports the alternative format of the Nutrition Facts label and encourages FDA to take further important steps on labeling such as front-of-package labeling consistent with the DGA and MyPlate recommendations, which may be beyond the scope of this particular rulemaking.
F. While recognizing the statutory requirement to base serving sizes on amounts customarily consumed, FDA should ensure that (1) serving sizes accurately reflect current consumption patterns and (2) consumers comprehend that listed serving sizes are not recommendations but are provided with recommended amounts consistent with the DGA to help consumers choose an overall healthy diet.
II. NUTRITION EDUCATION IS CRITICAL FOR SUCCESS
The Nutrition Labeling and Education Act of 1990 (NLEA) tasks the Secretary of Health and Human Services with the responsibility to educate consumers about two topics: (1) the availability of nutrition information in the label or labeling of food, and (2) the importance of that information in maintaining healthy dietary practices.5 Information on the Nutrition Facts label should be meaningful, relevant, and useful to consumers. The label should optimally not just be a mechanism for providing information to consumers, but should be a tool to help them make healthier food choices for themselves and their families. Beyond merely presenting data, the Nutrition Facts label should be used to normatively educate the public about establishing healthy eating behaviors.
Academy members are recognized for their expertise in translating scientific information that consumers can understand and apply to self-directed goals to improve their overall health. Our members use the label in client education and counseling in the community, in the media, and one- on-one with consumers. Research indicates that an individual’s socio-economic status, educational attainment, numeracy, English literacy, and health status impact what elements of the Nutrition Facts label are used and the extent to which an individual is able to more broadly incorporate a variety of nutrient content data into the context of a healthy daily diet.6
The Academy has deep reservations about nutrition information initiatives that are not matched with well-designed, adequately funded, and sustained nutrition education efforts. Information and education are not synonymous—they are complementary and synergistic. The educational effort will determine how successfully consumers can understand and utilize the information to enhance and maintain healthy dietary practices.
The consumer education campaign should be coordinated among federal government agencies, including FDA, the Centers for Disease Control and Prevention, other divisions within the U.S. Department of Health and Human Services (HHS) and the U.S. Department of Agriculture (USDA), and non-government entities, including food manufacturers, retailers, and non-profit organizations with an interest in nutrition and health. The campaign should begin when the final or interim final Nutrition Facts label and serving size regulations are finalized. While it would be important for all consumers to know about, understand, and use the revised Nutrition Facts label, the consumer education campaign should primarily target consumers who are least likely to understand and use the label, including low-income and low-education consumers, who are more likely to suffer from many obesity- and nutrition-related chronic diseases.
The consumer education campaign should integrate with existing consumer education programs and initiatives, including SNAP-Ed, school-based nutrition education programs, and grocery store and restaurant menu labeling and education initiatives. The education campaign should emphasize calories, since knowledge of calories is important for ameliorating the obesity epidemic; sodium, because of its contribution to cardiovascular disease; and nutrients that will be on the Nutrition Facts label for the first time, such as added sugars and also potassium (because of its role in “blunting the adverse effects of sodium”).7
Unfortunately, the Nutrition Facts label relies almost exclusively upon the %Daily Value (DV) to effectuate the intent of the NLEA to help consumers understand their chosen food product’s relative significance in the context of a total daily diet. Percent DVs, however, are inherently nutrient- specific rather than food-specific, in contrast to other federal dietary guidance in the DGA and MyPlate. The Academy would be grateful for an opportunity to work with FDA to enhance the Nutrition Facts label’s ability to improve consumers’ understanding to make overall healthy dietary choices.
III. REVISION OF REFERENCE VALUES AND MANDATORY NUTRIENTS
The Academy appreciates the multitude of factors that must be considered in establishing new reference values for the DVs that not only reflect current scientific consensus but also are conveyed to consumers in a manner enabling them “to readily observe and comprehend such information and to understand its relative significance in the context of a total daily diet.”8 The Nutrition Facts label successfully fulfills its statutory obligation to provide specific nutrition information about food products to consumers. Too often and for a variety of reasons, however, many consumers do not fully comprehend the information and are unable to effectively translate this information into healthy dietary practices.9
Given that the Nutrition Facts label has not been uniformly successful in providing context for consumers’ total daily diets, FDA should consider more aggressive options, including redoubling nutrition education efforts, fundamentally questioning whether the existing Nutrition Facts label is the best designed tool for helping all consumers contextualize the food product, and placing specifically explanatory language on the label that clarifies the information and minimizes confusion.
A. Setting the Daily Value (DV)
The Academy supports FDA’s use of a population coverage approach in setting reference values. In a survey of Academy members in advance of our comment to the Advanced Notice of Proposed Rulemaking (ANPRM), the Academy members overwhelmingly supported (62.4%) using the higher value of the population-coverage approach over the population-weighted approach (26.2%) for setting a DV for vitamins and minerals (excluding values for pregnant and lactating women).10 However, the Academy encourages FDA to ascertain whether use of the highest Recommended Daily Allowances (RDA) or Adequate Intake (AI) risks exceeding the tolerable upper intake level (UL) for any specific subpopulation group, particularly young children consuming food products intended for the general population. In that event, FDA should consult with experts who can assess the potential risk and severity of the adverse effect of concern, and determine whether
an alternative value is required.
The Academy agrees that DVs should be based on the RDA for those nutrients for which there is an RDA, not their Estimated Average Requirements (EAR). The RDA is the reference value that is most familiar to the broad nutrition community and framed as the recommended amount that individuals should consume because it meets the needs of nearly all healthy individuals.11 If the EAR were the basis, it would also be confusing to the consumer to have some nutrients based on the AI, which should cover the needs of the broadest range of consumers, and other nutrients based on EARs, which could not be said to provide the same type of coverage. As one author explained, “these are two very different reference values defined and derived from completely different perspectives and with different meanings.”12
The Academy further recommends that the AIs used for nutrition labeling should be consistent with the other dietary guidance developed and distributed to the public by the Institute of Medicine (IOM), the DGA, and MyPlate, and that conflicts between guidance be resolved with consistently applied rationales. It can be assumed that while there are AIs for substances such as sodium, the issue related to sodium is due to a concern about overconsumption, and thus the AI would not be the appropriate basis for the DV for this or other nutrients where the critical need is to provide guidance related to limits on intake.
B. Comparative Use and Effectiveness of %DV and Absolute Amounts of Nutrients
Because the DVs and its associated %DV figure are typically set at a level appropriate for the “general population,” millions of Americans with various health conditions rely upon the absolute amounts of nutrients, because the %DV may not be appropriate for their individual circumstances. A survey of patients with chronic kidney disease by the Academy and the National Kidney Foundation found that the patients believed the %DV by itself is insufficient to identify appropriate foods and help them choose the foods they need to consume.13
Research indicates that many consumers do not understand %DV or know how to accurately compute the data or integrate it into useful dietary plans.14 In the above-referenced survey of patients with chronic kidney disease, 80% of respondents stated that they read the Nutrition Facts label for amounts of nutrients in a food (Table 5), which is critical for patients who must closely monitor their calcium intake. However, only approximately one in four (24%) individuals could correctly calculate the actual amount of calcium in a serving of food providing 10%DV for calcium (Table 6). Further, almost two-thirds of respondents (63.2%) indicated that they did not know that 25% DV for calcium was 250 mg.15
The survey of Academy members conducted in advance of the Academy’s comments to the ANPRM revealed that a majority of RDNs prefer to use absolute amounts over %DV when counseling patients and clients on how to use the Nutrition Facts label to build a healthy diet (67.1%), compare food products (81.8%), and set a dietary goal (80.5%). Absolute amounts are easier for consumers, particularly those with lower numeracy skills, to comprehend and are useful for patients with certain medical conditions requiring nutrient intake differing from the general population.
The %DV is intended to provide consumers with a context for the absolute amount of nutrients in a product to help them understand how a particular food product fits into either a diet prescription or an overall healthy diet, but significant work remains before that goal will be achieved. The Academy strongly encourages FDA to consider additional strategies for tying the Nutrition Facts label to a healthy diet beyond %DV, particularly the use of graphics and the incorporation of the totality of government food and nutrition recommendations, such as the DGA and MyPlate. One possible approach might resemble the successful, understandable diabetic exchange list, whereby a serving of a food is described as a proportion of a grain, fruit, vegetable, low-fat dairy, or meat and beans.
C. Declarations and Reference Amounts of Particular Nutrients
(1) Calories from Fat
The Academy supports the proposal to remove “calories from fat” from the Nutrition Facts label and supports replacing it with the %DV from calories to enable consumers to gauge the nutrient density and nutritional value of a food and how it contributes to an individual’s daily caloric target of 2,000 calories. The type of fat consumed is more important than the total amount of fat consumed. Removing the “calories from fat” statement would be consistent with current recommendations to limit saturated and trans fat while replacing them with food sources of monounsaturated and polyunsaturated fatty acids.16
(2) Added Sugars
(a) Mandatory Declaration of Added Sugars
The Academy strongly supports the mandatory declaration of “added sugars” on the Nutrition Facts label. Added sugars, especially in combination with solid fats and excess energy intake, have been linked to health concerns, including overweight and obesity, type 2 diabetes, prediabetes, and cardiovascular disease.17 Between 2003 and 2006, added sugars (sugar, high- fructose corn syrup, etc.) provided about 14% of total calories for the average American, and 25% or more of calories for more than 36 million Americans.18
Registered dietitian nutritionists educating consumers regularly focus on the need to differentiate between added sugars and sugars that are naturally occurring in foods, such as lactose and fructose. However, added sugars in processed foods can presently be identified only by reading the list of ingredients on the food label, made more difficult given the large number of varied names for sugars in the ingredient list (which would become even more difficult if certain manufacturers are successful in their efforts to change the names of nutritive sweeteners to which Americans have become accustomed).19
It is the position of the Academy that consumers can safely enjoy a range of nutritive sweeteners and nonnutritive sweeteners (NNS) when consumed within an eating plan that is guided by current federal nutrition recommendations, such as the DGA and the DRIs, as well as individual health goals and personal preference.20 The difficulty, of course, is striking a balance by making sure one only consumes added sugars within recommended calorie limits (e.g., 2000 calories/day) while still making sure one consumes the recommended intake of nutrients. The DGA advisory committee recognized the need to obtain adequate nutrients without overconsumption of energy to reduce risk of common chronic diseases such as obesity, cardiovascular disease, and some cancers.21 The IOM recommends that the intake of added sugars not exceed 25% of energy to ensure adequate intake of essential micronutrients that are typically not present in foods high in added sugars.22
The 2010 DGA acknowledge that the body metabolizes added sugars and natural sugars found in fruits and dairy foods the same way, but typically foods high in added sugars are higher in energy and lower in essential nutrients or dietary fiber.23 For example, if a food contains 10% of the recommended daily caloric intake and more than 10% of the recommended intakes for indicator nutrients, the food would be considered a smart, healthful choice for building a healthy diet. The proposed rule (discussed below) sets a new, different Reference Amount Customarily Consumed (RACC) for carbonated beverages (such as soft drinks) from the RACC for milk, fruit juice, and vegetable juice that recognizes the inherent value of nutrient-dense foods and beverages from those containing empty calories. Listing added sugars will also help consumers differentiate between products that may appear similar but have vastly different nutrient profiles, such as fruit drinks and fruit juices.
In short, many Americans are not striking the right balance in their overall diet and are consuming too much added sugar even though the 2010 DGA recommends that Americans limit their intake of added sugars. FDA’s proposal to require the declaration of the added sugars will provide consumers with one tool to assist them in meeting the DGA added sugars recommendations and the Academy wholeheartedly supports it.
(b) Nutrition Education for Added Sugars
In addition to arming consumers with information on the amount of added sugars in food products, public education on the food sources and health consequences of excessive added sugars intake is needed. Today, consumers are exposed to an abundance of nutrition information, including information on added sugars that may be hard to interpret. FDA should develop materials to explain that consuming foods high in added sugars makes it difficult to meet nutritional needs and stay within calorie requirements. Such an education program should emphasize that naturally- occurring sugars in fruits, vegetables, and dairy products do not pose any health problem, and, indeed, people should consume more fruits, vegetables, and low-fat dairy products.
(c) Dietary Reference Value (DRV) for Added Sugars
The Academy reluctantly agrees with FDA’s analysis that it is premature to establish a DRV for added sugars without a sound scientific basis for establishing an intake recommendation upon which a DRV could be derived. Although the DGA and IOM have suggested maximal intake as a percentage of energy, there has not yet been a consensus report setting a DRI. Without a DV for added sugars, consumers will be able to compare only the relative amounts of added sugars between products, but will generally not be able to consider the amount of added sugars in a product in the context of their overall daily diets. The average consumer will simply see a number next to a metric unit they do not fully understand,24 such as 20 g, next to added sugars and have no idea whether that is a lot or a little. In a 2012 survey of 712 readers by Consumer World, an Internet-based publisher of a consumer resource guide, those surveyed online were exposed to Nutrition Facts information in which the amount of sugars in a product was expressed in grams rather than in common household measurements. Up to 80% of survey participants could not accurately say how much sugar was contained in a product, and many respondents significantly underestimated the actual amount of sugar in the product.25
Including a DV as soon as a DRI is available is essential to ensuring that consumers are successful in reducing their consumption of added sugars and the potential adverse health effects of excessive sugars intake. Accordingly, the Academy encourages FDA to work with IOM to convene a committee at the earliest possible time to review and recommend a UL for added sugars, and then conduct a subsequent limited rulemaking to obtain public comment.
(d) Added Sugars in the Ingredient List
The Academy notes that many consumers may not recognize the many names for various added sugars on food labels, such as corn syrup, dextrose, fructose, high-fructose corn syrup (HFCS), honey, lactose, maltose, molasses, raw sugar, and sucrose.26 Therefore, although potentially outside the scope of this particular proposed rule, if permitted under existing law we recommend that the FDA revise regulations to require grouping of sugar sources in the ingredient list—with individual sugars in parentheses—so consumers could get a better idea of relative amount of total sugars in a product.
(3) Fiber; Dietary Fiber
The Academy supports continuing to require dietary fiber to be declared on the label and further supports FDA’s proposed new definition of dietary fiber, which would allow declaration of only those forms of dietary fiber that the agency has determined to have a physiological effect that is beneficial to human health. This definition would exclude soluble and insoluble non-digestible carbohydrates that have not shown a demonstrated physiological benefit. We note the possibility that some manufacturers have fortified foods with processed fiber without physiological health benefits and thus could otherwise make less healthful foods appear to be a healthier choice. Given this, the FDA’s proposed inclusion of a test for added fiber that measures its physiological benefits represents a considerable advance.
The DGA emphasize unprocessed forms of dietary fiber, which is often present as part of whole, healthy foods, such as vegetables and legumes, and note that “[f]iber is sometimes added to foods and it is unclear if added fiber provides the same health benefits as naturally occurring sources.”27 The Academy also supports discontinuance of the terms ‘soluble’ and ‘insoluble’ fibers, since those terms alone do not clearly identify physiological or nutritional functions.
The Academy recommends that FDA further define “physiological benefit” as science evolves, with consideration given to other authoritative regulatory bodies, such as Health Canada. Defining “physiological benefit” provides clarity and helps support meaningful food product development and innovation, especially in specialized foods designed to meet medical needs as a part of medical nutrition therapy recommended by RDNs.
(4) Other Carbohydrates
The Academy supports currently established daily values for carbohydrates, relative to a 2,000 kcal diet, which falls in the range of the Acceptable Macronutrient Distribution Range (AMDR) for carbohydrate. Although there is an EAR and RDA for total carbohydrate, neither is appropriate or needed to serve as the basis for the %DV, because relevant public health concerns are the ratio of carbohydrate to total fat and the source and type of carbohydrates in the diet.
Given the recommendations of consensus reports, the Academy presently agrees that the DRV for sodium should be based on the DRI Tolerable Upper Intake Level (UL) for sodium of 2,300 mg. This is consistent with the recommendations of the 2010 DGA to “[r]educe daily sodium intake to less than 2,300 milligrams (mg) and further reduce intake to 1,500 mg among persons who are 51 and older and those of any age who are African American or have hypertension, diabetes, or chronic kidney disease,” although the DGA did note that the 1,500 mg recommendation applies to about half of the U.S. population, including the majority of adults.28 The Academy believes the 2,300 mg DV is a reasonable immediate target for improvement relative to the current food supply and current palatability, and would support a lower DV over time consistent with a lower DRI adopted in future consensus reports.
(a) Impact of Sodium Reduction
Numerous studies show a direct relationship between sodium intake and blood pressure; as dietary salt intake rises, so does blood pressure. For many Americans, excess sodium consumption is strongly associated with the development and worsening of high blood pressure and an increased risk for stroke, heart failure, kidney failure, gastric cancer and osteoporosis.29,30
Studies have concluded that reducing sodium consumption would have significant health benefits and reduce medical costs. Reduced sodium intake could help prevent hypertension in non- hypertensive individuals and facilitate hypertension control. Reduced sodium intake is also associated with a blunted age-related rise in systolic blood pressure and a reduced risk of atherosclerotic cardiovascular events, congestive heart failure, and stroke.31
Simply achieving a target of 2,300 mg DV would be a public health achievement. Americans consume on average 3,400 mg of sodium, one-third more than the maximum recommended level.32 Although it is well understood that consuming less salt and sodium would improve public health, strategies for doing within the existing regulatory framework are complex and would likely require a shift in food consumption patterns.
(b) Need for Nutrition Education About Sodium Declaration
If FDA sets the DV at 2,300 mg, it is critical that FDA help consumers understand that unlike other DVs, the DV for sodium is not a recommended amount; it is instead a UL. The Academy strongly encourages FDA to develop some readily comprehendible system to enable consumers to differentiate between DVs that are minimum recommendations and DVs that represent intakes that are ULs. Consumers should not be expected to know that the same term (DV) has multiple meanings when trying to interpret the data and utilize it to plan an overall healthy diet. In the past, the footnote on the Nutrition Facts label has attempted to serve that purpose, but the Academy notes that the use of the Alternate Format of the Nutrition Facts label and the “Avoid Too Much” category could help convey that the DV for sodium is a UL.
The Academy cannot overemphasize that education is a key element to helping Americans learn to make informed food choices. According to FDA’s 2002 Health and Diet Survey, 46% of respondents indicated that they did not think they personally had any need to worry about their sodium consumption, and another 23% think they probably should reduce it, but have not really tried.33 Perhaps most surprisingly, in FDA’s 2008 Health and Diet Survey, only 20% of respondents thought that salt, salty foods, or sodium “might be related to heart disease or heart attacks.”34
(6) Nutrients of Concern
With regard to nutrients not discussed in more detail below, for which AI values are available (vitamin K, pantothenic acid, and biotin), voluntary labeling for these nutrients based on their AIs is consistent with the Academy’s belief that the DVs should be established on a population-coverage approach and should be consistent with the two other components of federal consumer nutrition education: MyPlate and the DGA.
The Academy supports the mandatory declaration of Vitamin D on the Nutrition Facts label. The Academy also supports changing the DVs for vitamins A, D, and E to micrograms RAE (retinol activity equivalents), micrograms D3cholecalciferol, and mg alpha tocopherol, respectively. We also support changing the current DV units for folate (micrograms), copper (milligrams), chloride (milligrams), potassium (milligrams), and sodium (milligrams) to be consistent with the units in the IOM DRI reports: folate (micrograms DFE [dietary folate equivalents]), copper (micrograms), chloride (grams), potassium (grams), and sodium (milligrams). Expressing nutrients in multiple units requires considerable expense and time to maintain multiple databases while creating confusion for both nutrition professionals and consumers. Moving ahead with a single expression of units should alleviate some of these issues, and would update the Nutrition Facts and Supplements Facts labels with currently accepted scientific terminology.
(7) Nutrient Issues in Subpopulations with Unique Needs Related to Hypertension and
Chronic Kidney Disease: Ca; K; and P
More than 72 million American adults—one in three—have high blood pressure, or hypertension, according to the National High Blood Pressure Education Program. 35 Similarly, chronic kidney disease (CKD), which often develops in individuals with long-term hypertension, is a significant and growing public health problem. Kidney disease, the ninth leading cause of death in the United States is a costly disease associated with severe morbidity and premature death. According to the National Kidney and Urologic Diseases Information Clearinghouse at the National Institutes of Health, one in 10 American adults—more than 20 million citizens—have some level of CKD.36 Patients with hypertension or CKD must acutely monitor their intake of certain minerals, such as calcium, potassium, and phosphorous. By 2020, with the aging of the population and the increasing prevalence of diabetes, nearly 150,000 persons in the United States are projected to begin therapy for end-stage renal disease (ESRD), nearly 800,000 persons will be living on dialysis or with a kidney transplant, and costs for ESRD are projected to reach approximately $54 billion.37 It is projected that 67% of the near 800,000 will be treated with dialysis. Kidney disease, like obesity, is a public health problem that leads to increased morbidity and mortality. However, patients with kidney disease who follow a special diet have improved outcomes. Nutritional recommendations for patients with kidney disease are markedly different from the general public and nutrition education efforts need to be supported by more transparent, informative and clearer food labeling.
The Academy applauds FDA for proposing to require the declaration of potassium on the Nutrition Facts label, which is an important step in helping to prevent and treat these conditions and diseases. However, in addition to this important advancement, the Academy urges FDA to give due consideration to the 20 million Americans with CKD needing to monitor or restrict their intake of phosphorous by requiring its declaration on the Nutrition Facts label, thereby providing the necessary information to enable these patients to do so.
FDA’s current nutrition labeling regulations mandate the declaration of sodium and calcium on the Nutrition Facts label. The declaration of potassium, however, is merely voluntary at present. Moreover, the absolute amount of calcium need not even be included on the Nutrition or Supplement Facts labels, in direct conflict to IOM’s Guiding Principles for Nutrition Labeling and Fortification recommendation that absolute amounts be declared for all nutrients on the Nutrition Facts and Supplement Facts label.38
Individuals with CKD, including those who need dialysis to cleanse the blood of impurities that accumulate because of kidney failure, must carefully select foods to maintain appropriate blood levels of specific nutrients to manage life threatening and debilitating CKD complications such as heart failure, hypertension, and bone and mineral metabolism problems. Among the nutrients that may need to be restricted in this patient population are the minerals calcium, sodium, phosphorus, and potassium. Registered dietitian nutritionists specializing in renal nutrition and their patients are particularly challenged to follow these restrictions, because of the difficulty ascertaining the nutrient content of potassium and phosphorous or the absolute amount of calcium in the absence of a mandatory declaration. Sadly, the Academy’s and National Kidney Foundation’s survey of patients with CKD reveals their frustrating “solution”: between 50% and 60% of respondents indicated they simply would not buy a food product or beverage if potassium, calcium or phosphorus amounts are not listed on the label because of the attendant potential risks.39
The Academy supports FDA’s proposal to list the absolute amount of calcium on the Nutrition Facts label. Adequate calcium intake recommendations have been set at levels associated with desirable retention of body calcium since high bone density is known to be less susceptible to bone fractures. Many Americans—particularly men, ethnic minorities, and the socially disadvantaged—are not meeting the current recommendations for adequate calcium intake though diet alone or with supplements.9 Data from the Continuing Survey of Food Intakes by Individuals 1994-1996, 1998, and National Health and Nutrition and Examination Survey (NHANES) 1999-2000 show that African Americans in all age groups consume fewer mean servings per day of total dairy, milk, cheese, and yogurt than non-African Americans, and have lower mean intakes of calcium.40
The DGA recognizes that most Americans would benefit from increased consumption of dietary calcium, even as certain subpopulations have different needs. Clinical practice guidelines developed by the National Kidney Foundation recommend a limited total elemental calcium intake (resulting from both dietary calcium intake and consumption of calcium-based phosphate binders) for individuals with Stage 3-5 CKD that does not exceed 2,000 mg/day.41. Because CKD affects bone and mineral metabolism, kidney patients are at increased risk for bone fractures and vascular calcification.
The Academy enthusiastically supports FDA’s proposal to require the declaration of potassium on the Nutrition Facts label using the AI of 4700 mg of potassium as the DV for a 2,000 kcal diet, which appropriately embodies a population-coverage approach. Less than 2% of American adults currently get the recommended amount of potassium (4,700 mg a day).42
Potassium has been recognized as having a valuable protective role against the development of hypertension and reducing risk of kidney stones and reduced bone loss. The 2010 DGA specifically addressed increasing potassium intake as a lifestyle change that can prevent or delay the onset of high blood pressure and can lower elevated blood pressure by “blunting the adverse effects of sodium.”43 The Committee on the Dietary Reference Intakes recommended an Adequate Intake (AI) for potassium at 4,700 mg/day for all adults and noted that, at present, dietary intake of potassium by all groups in the United States and Canada is approximately half of the AI.44 The National Institutes of Health notes that eating plans such as the DASH diet “emphasize potassium from food, especially fruits and vegetables, to help keep blood pressure levels healthy.”45
However, for the subpopulation of people with CKD, too much potassium increases the risk of cardiovascular events. Significant loss of kidney function impairs the ability to excrete potassium. Relatively small deviations in potassium concentrations can be life threatening for patients with advanced CKD.
The Academy is disappointed that FDA failed to mention dietary phosphorus intake in the proposed rule, and did not propose to add phosphorus content to the nutrition label. This omission is a significant missed opportunity. Phosphorus can occur naturally in various forms of food, or as a component in commonly used food additives. Widespread practices of processing of meat and fish products increases the phosphorus content above the naturally occurring levels in the protein itself.46 The proposed rule states that when FDA is determining if mandatory or voluntary labeling is indicated: “First we consider whether there is evidence of a relationship between the nutrient and a chronic disease, health-related condition, or health-related physiological endpoint. Second, we consider whether there is evidence of a problem related to health in the general U.S. population.” Under that rubric, the Academy believes FDA should require the mandatory declaration of phosphorous on the Nutrition Facts label.
The kidney is responsible for the homeostasis of phosphorus through the effect of several hormones that increase the excretion of phosphorus in the urine. While these mechanisms of enhancing urinary phosphorus excretion are effective in maintaining normal blood phosphorus levels until very late in the course of progressive kidney disease, the persistent elevation of these hormones causes bone disease, heart disease, and are associated with mortality in patients with CKD. Furthermore, recent studies also indicate that higher levels of phosphorus can increase mortality in patients without kidney disease, even if those levels are within the normal range.47 For individuals with obesity, reducing phosphorus intake has also been associated with less urine albumin excretion (UAE). UAE is one of the first signs of kidney disease.48
The Academy contends that restricting dietary phosphorus intake is an important therapeutic strategy in patients with kidney disease. However, the increasing use of additives and the lack of mandatory labeling of phosphorus content pose significant—and often insurmountable— challenges to patients and their families from adhering to these important recommendations. Two recent scientific meetings highlighted the importance of patients with kidney disease phosphorus regulation: A scientific consensus symposium sponsored by the National Kidney Foundation in 201249 and a symposium at the Annual Meeting in Experimental Biology in 2013 at a session entitled “Dietary Phosphorus Excess: A risk factor in chronic bone, kidney and cardiovascular disease” sponsored by the American Society of Nutrition and American Society of Nephrology.50
Studies of patients with kidney disease demonstrate that high phosphorus intake, whether in the form of additives or meat, leads to changes in hormones that are shown to be associated with mortality.51 52 53 54 In particular, individuals that consume processed foods with phosphorus additives (most commonly in the form of sodium phosphate and its derivatives) have increased urinary sodium and phosphorus compared to similar foods without additives, indicating significant absorption of these nutrients from the additives.55 In one study of patients on dialysis, simply instructing patients to avoid processed foods (where most additives are found) led to a reduction in blood phosphorus levels that allowed reduction in phosphate binder prescriptions.56
Another study found that over 45% of the best-selling grocery items contained phosphorus additives,57 and these items typically cost less and are eaten more commonly in individuals of lower socioeconomic status.58 The use of phosphate-containing food additives has increased substantially over the last several years.59 Analyses of processed foods that contain phosphate additives indicate that these increase the food phosphorus content by 70%.60 Analyses of meat and poultry products demonstrate that additives increase both the phosphorus and potassium intake two- to three-fold, respectively,61 both leading to adverse consequences in patients with CKD.
In the Section II Proposed Rule, H. Essential Vitamins and Minerals of Public Health Significance, Essential Vitamins and Minerals that are Mandatory (p 11921) the rule discusses the role of ULs of safety on additives that are “[g]enerally regarded as safe.” We strongly recommend that FDA make labeling of phosphorus content a mandatory part of the label as opposed to a voluntary part of the label. This change would ideally be further subdivided into natural content of phosphorus versus added phosphates, similar to the proposed changes for distinguishing between sugar content of food versus added sugar as detailed in Section II Proposed Rule, D. Carbohydrates, 2. Sugars and 3. Added Sugars (p 11902).
The evidence described above supports the need for phosphate additives to also have a UL of safety on food labels. The proposed rule does not plan changes to micronutrients such as phosphorus. However, given the considerable evidence that phosphorus is associated with adverse outcomes in kidney disease—which affects more than 20 million Americans—and the fact that phosphorus is increasingly widely used in food production and is increasingly associated with risks to the general public as well—we believe that labeling the micronutrient be mandatory. Furthermore, we recommend, separately from the food labeling process, that FDA define ULs of tolerability and intake in special populations such as people with kidney disease.
IV. FORMAT CHANGES TO THE NUTRITION FACTS LABEL
The Academy supports well-considered formatting changes based on consumer research that increase the prominence of important declarations on the label, to the extent consumer research shows the format change does not detract from the overall effectiveness of Nutrition Facts label and the consumer’s ability to discern the overall nutritional value or nutrient density of the food product to the diet.
We strongly support FDA’s proposal requiring that total calories continue to be declared on the label and to increase the prominence of the calorie declaration. The 2010 DGA, in recognition of the nation’s high prevalence of overweight and obesity, made one of its primary recommendations to “maintain calorie balance over time to achieve and sustain a healthy weight.”62 Consumers selecting, preparing, and consuming foods and beverages with the appropriate number of calories to meet their needs for weight management must be able to easily see and use the number of calories in a serving of a particular food or beverage. Therefore, we strongly support the proposal to increase the type size for both the “Calories” heading and the numerical value and to require that the information be highlighted in bold or extra bold type. The Academy also supports enhancing information about the serving size and number of servings in the package.
We strongly prefer the alternative label format over the agency’s proposed label, because we think it will more effectively assist consumers in choosing (1) more foods high in nutrients the DGA recommends Americans consume more of and (2) fewer foods high in nutrients the DGA recommends Americans eat less of. Both the current label and FDA’s proposed label are plain lists of information with lots of numbers and include nutrients that may be unfamiliar to many consumers. For certain nutrients, we suspect that some consumers don’t even know whether they should consume more or less of them. Providing context and advice within the label would, in effect, constitute part of FDA’s education campaign.
The Academy believes that if the alternative label is adopted, FDA should require use of “Total Sugars” instead of “Sugars.” In addition, FDA should identify a way to place “Total Sugars” on the label in a way that simultaneously ensures a clear connection between “Total Sugars” and “Added Sugars” and does not impugn healthy products high in natural sugars by suggesting consumers should eat less of them.
Research has found that people who use nutrition labels are more likely to have a lower body mass index (BMI), a measure of obesity, than people who do not, though such studies cannot establish cause and effect. The difference in label usage is particularly striking for women, with women who do read nutrition labels having a BMI that is 1.49 points lower than women who do not63 (for a woman who is 5’5” tall, that represents a difference of about 9 pounds).64 Again, while such studies cannot establish cause and effect, that finding suggests that increasing the use of nutrition labels could be an important tool for helping people manage their weight. Making the Nutrition Facts label more understandable could help to encourage more people to use nutrition labels, as well as help them to understand it and use it effectively in their food purchase and consumption decisions.
A label that takes a step towards providing interpretive data is consistent with the need to make information clearer for consumers with lower levels of health literacy and numeracy. Interpreting the data on the current and proposed label requires a high degree of background understanding about healthful and less-healthful nutrients. Grouping nutrients into categories that clearly indicate, in comprehensible language, which nutrients are more or less healthful would help to achieve the purposes underlying most of FDA’s proposed changes to the label, as it would make clear that consumers should consume less sodium and added sugars, among other items. Normative labeling suggesting what consumers should do about particular nutrients would effectuate a massive step forward in popular understanding of basic principles of nutrition, and would embed this essential education on every package.
A. Serving Sizes
V. SERVING SIZES AND DUAL COLUMN LABELING
The Academy, as a matter of nutrition policy, does not support increasing the RACCs when consumption practices increase over time, because ideally serving sizes should reflect the recommended serving sizes for a particular food product. Increasing the RACCs as portion sizes grow is contrary to the intended use of the label as an educational tool that consumers can use to adopt healthier dietary practices.
However, we recognize that the NLEA specifically requires that food products’ serving sizes must be descriptively set as the “amount customarily consumed,” despite evidence that consumers mistakenly perceive these serving sizes as recommended portions.65 Consumers are accustomed to the DGA’s and MyPlate’s specific recommendations and may reasonably assume FDA’s approach to setting serving sizes would be similar. These approaches are fundamentally similar; FDA’s statutory responsibility to “enable consumers to make more informed and healthier food product choices in the context of their daily diet” can be harmonized with the DGA and MyPlate by minimizing consumer confusion in choosing a healthy diet.
The Academy encourages FDA to consider ways to integrate the label with recommended dietary guidance for appropriate servings, whether by clarifying that the serving sizes on the label are not recommended or by tying the label back to the recommended guidance. Such clarification would be appropriate under FDA’s authority under the NLEA to “carry out activities which educate consumers about (1) the availability of nutrition information in the label or labeling of food, and (2) the importance of that information in maintaining healthy dietary practices.”66 Therefore, to be consistent, it would be appropriate for the label to reflect the portion recommendations consistent with MyPlate and the DGA in addition to serving sizes commonly (and increasingly) consumed by Americans.
Using consumption data from the most recent NHANES, 2003-2008, the agency proposes to modify an existing RACC if the median consumption increased or decreased by at least 25%, compared to the RACC established in 1993.6768 The FDA states that it also took into account other factors when deciding to modify an existing RACC, including information from citizen petitions, industry comments, and market trends. We urge the FDA to consider:
• The change in consumption of some food categories exceeds 25%, and yet FDA did not propose new RACCs.
Pegging the proposal to set new RACCs only for changes of 25% or greater neglects some categories that deserve re-evaluation due to their impact on public health. Under the law, FDA is required to define the reference amounts for foods based on the amount of food customarily consumed. See Pub. L. 101.9(b)(1); 58 F.R. 44039 et seq. We urge FDA to consider whether additional foods with a smaller percentage change warrant new RACCs.
B. Dual Column Labeling
The Academy supports the proposal that dual columns be the standard on the Nutrition Facts label to enable consumers to compare the total nutrient contribution of a package that is intended as a single serving to the RACC. This same standard should also apply if the entire contents of the package could reasonably be consumed at one eating occasion. Research indicates that some consumers do not understand that “calories per serving of a food” does not represent the total calorie contribution of an entire multi-serving package.
Research with consumers indicates, however, that most consumers are able to identify on the label the number of calories per individual serving of a food or beverage product. One study found, however, that nearly two-thirds of consumers were not able to recognize that some of the prototype food packages contained multiple servings. The study also reported that most consumers underestimated and underreported calorie intake from snack food sources, suggesting that a good number of consumers are unaware of the energy value of foods commonly consumed.69 Combined with the increasing portion sizes of foods commonly consumed today (e.g., muffins, bagels, and sodas), consumers appear to be becoming accustomed to larger portion sizes.70 71 Research has also found that people tend to eat more when the portion size or serving container is larger, indicating a need for increased consumer education and awareness about what the labeled serving size means and appropriate portion sizes.72 Well-controlled clinical studies suggest that providing children and adults with larger food portions can lead to significant increases in energy intake.73
The Academy does not support claims comparing the calories of two packages of differing sizes. Comparisons should only be made among the RACCs as done currently, by other federal serving size recommendations as may exist, and the amount in that package. The term “reduced? should not be used to compare calorie claims for the same food simply in a smaller package. For bulk food items, only the calories for the RACC or other federal serving size recommendations as may exist should be permitted.
The Academy encourages FDA to consider the merits of clarifying through labeling when a serving of a food is a “good source” of a nutrient of concern ‘naturally’ as opposed to when the food has been ‘fortified.’ One possible way to address concerns about the possible over-fortification of the food supply would be to require a positive declaration on the label that the food is “a source of added nutrients” or “a fortified food.” The Academy notes that FDA set a precedent in its regulations defining “healthy” single item foods as providing at least 10% of one or more of six specified nutrients.74
We encourage FDA to conduct research and publish its findings concerning the impact of nutrition labeling requirements on fortification of foods and beverages and the impact of that fortification on consumer intake of certain vitamins and minerals commonly added to foods and beverages through fortification. We also encourage FDA to assess the impact of nutrition labeling requirements making mandatory declarations of particular vitamins or nutrients on supplement consumption.
VII. NEXT STEPS
FDA should continue an iterative effort defined by a comprehensive, integrated approach to revising the food label that is supported by studies detailing the impact of specific label changes on consumer behavior. Additional improvements to the Nutrition Facts label would be an important contribution towards making the existing point-of-purchase environment more conducive to the selection of healthy choices.
FDA notes in the proposal that it plans to conduct consumer research on several items prior to the publication of a final rule. In addition to the research agenda identified therein, we urge the agency to conduct additional research on several proposed changes and items on which comment has been requested. Needed research could be completed within the expected time, and should not delay publication of a final rule if the agency moves forward expeditiously in commissioning the research. Topics raised in the proposed rule on which we believe additional research is warranted include:
o Moving the DV to the left-hand column: Does this distract from or discourage consumers who are trying to obtain information from the label?
o Changing “% Daily Value” to “%DV:” Does this facilitate consumer understanding of the significance of daily values?
o Is consumer understanding assisted by measuring sugar in teaspoons in addition to grams?
o How does the relative size of information and the order of information on serving size, number of servings, and calories impact consumer use and understanding?
o What is the impact of replacing the term “carbohydrates” with the term “carbs”?
o What is the impact of modifications to the footnote on consumer understanding of how the nutrition information on the label fits their daily nutrient needs?
While we applaud FDA’s important proposed updates to the Nutrition Facts label, next steps include addressing the great need for easily understood, federally regulated, front-of-package nutrition labels. In an era in which diet-related health problems, such as obesity and heart disease, are far too common and consumers’ time is frequently constrained, front-of-package labels would greatly facilitate healthy consumer choices by presenting relevant information as quickly as possible.
As noted above, the population that is least likely to read and understand the information on the NFP is the same population that, for health reasons, needs clear, interpretive health information most. Lower health literacy and numeracy skills as well as restricted attention spans will, despite FDA’s best efforts, impact consumers’ ability to take full advantage of the proposed revisions to the Nutrition Facts label.
When considering appearance the Academy asks that FDA keep in mind that simple, familiar front- of-package labels were the most successful in encouraging healthy eating choices.75 Front-of-package labels should also be tied into the MyPlate recommendations. For comparison purposes, it would also be ideal to also have front-of-package labels as signage or shelf tags on produce and other foods that are not packaged with individual wrapping or boxes. Finally, when such labeling goes into effect, FDA will need to mount a comprehensive education program that teaches consumers how to use the labels.
The Academy appreciates the opportunity to comment on this important initiative; please contact either Jeanne Blankenship at 202-775-8277 ext. 6004 or by email at [email protected] or Pepin Tuma at 202-775-8277 ext. 6001 or by email at [email protected] with any questions or requests for additional information.
Jeanne Blankenship, MS RDN
Vice President, Policy Initiatives and Advocacy
Academy of Nutrition and Dietetics
Pepin Andrew Tuma, Esq.
Director, Regulatory Affairs
Academy of Nutrition and Dietetics
1 Revision of the Nutrition and Supplement Facts Labels. Accessed July 30, 2014. Available at http://www.gpo.gov/fdsys/pkg/FR-2014-03-03/pdf/2014-04387.pdf
2 Serving Sizes of Foods That Can Reasonably Be Consumed at One-Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments. Accessed July 30, 2014. Available at http://www.gpo.gov/fdsys/pkg/FR-2014-03-03/pdf/2014-04385.pdf
3 The Academy recently approved the optional use of the credential “registered dietitian nutritionist (RDN)” by “registered dietitians (RDs)” to more accurately convey who they are and what they do as the nation’s food and nutrition experts. The RD and RDN credentials have identical meanings and legal trademark definitions.
4 “Medical Nutrition Therapy is an evidence-based application of the Nutrition Care Process. The provision of MNT (to a patient/client) may include one or more of the following: nutrition assessment/re-assessment, nutrition diagnosis, nutrition intervention, and nutrition monitoring and evaluation that typically results in the prevention, delay, or management of diseases and/or conditions.” Academy Definition of Terms List. Accessed July 30, 2014.
5 Nutrition Labeling and Education Act of 1990, Pub. L. No. 101-535, § 2, 104 Stat. 2353–57 (codified as amended at 21 U.S.C. § 343).
6 See, e.g., Rothman RL, Housam R, Weiss H, et al. Patient understanding of food labels: the role of literacy and numeracy. Am J Prev Med. 2006;31(5):391-8. See also, Speirs K et al, Health Literacy and Nutrition Behaviors among Low-Income Adults. Accessed July 30, 2014.
7 U.S. Department of Agriculture and U.S. Department of Health and Human Services. Dietary Guidelines for Americans, 2010. 7th Edition, Washington, DC: U.S. Government Printing Office, December 2010.
8 Food and Drug Administration. Part III. Food Labeling: Mandatory Status of Nutrition Labeling and Nutrient Content Revision: Format of Nutrition Label. Final Rule. Federal Register. January 6, 1993: 58 FR 2079-205
9 National Kidney Foundation and American Dietetic Association. Usefulness of the nutrition label for persons with kidney disease. Submitted to Docket No. 2006N-0169, April 29, 2008.
11 Institute of Medicine. Dietary Reference Intakes: Applications in Dietary Planning. Washington, DC: National Academies Press; 2003.
12 Yates AA. Which dietary reference intake is best suited to serve as the basis for nutrition labeling for daily values?. J Nutr. 2006;136(10):2457-62.
13 National Kidney Foundation and American Dietetic Association. Usefulness of the nutrition label for persons with kidney disease. Submitted to Docket No. 2006N-0169, April 29, 2008.
14 Yates AA. Which dietary reference intake is best suited to serve as the basis for nutrition labeling for daily values?. J Nutr. 2006;136(10):2457-62.
15 National Kidney Foundation and American Dietetic Association. Usefulness of the nutrition label for persons with kidney disease. Submitted to Docket No. 2006N-0169, April 29, 2008.
16 U.S. Department of Agriculture and U.S. Department of Health and Human Services. Dietary Guidelines for Americans, 2010. 7th Edition, Washington, DC: U.S. Government Printing Office, December 2010.
17 US Departments of Agriculture and Health and Human Services. Dietary Guidelines for Americans, 2010. 7th ed. Washington, DC: US Government Printing Office; 2010.
18 Marriott BP, Olsho L, Hadded L, et al. “Intake of added sugars and selected nutrients in the United States, National Health and Nutrition Examination Survey (NHANES) 2003–2006,” Crit Rev Food Sci Nutr 2010, vol. 50, pp. 228-58.
19 US Departments of Agriculture and Health and Human Services. Dietary Guidelines for Americans, 2010. 7th ed. Washington, DC: US Government Printing Office; 2010.
20 Fitch C, Keim KS. Position of the Academy of Nutrition and Dietetics: use of nutritive and nonnutritive sweeteners. J Acad Nutr Diet. 2012;112(5):739-58.
21 US Departments of Agriculture and Health and Human Services. Report of the Dietary Guidelines Advisory Committee on the Dietary Guidelines for Americans, 2010. http://www.cnpp.usda.gov/dgas2010-dgacreport.htm. Accessed February 7, 2011.
22 Institute of Medicine, Food and Nutrition Board. Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein and Amino Acids. Washington,DC: National Academies Press; 2002/2005
23 US Departments of Agriculture and Health and Human Services. Dietary Guidelines for Americans, 2010. 7th ed. Washington, DC: US Government Printing Office; 2010.
24 Metric Measurements On Nutrition Labels Mislead Many. Accessed July 30, 2014. Available at http://www.consumerworld.org/pages/nutritionlabelprs.htm.
26 United States Department of Agriculture (USDA). “What are added sugars?” Available at http://www.choosemyplate.gov/weight-management-calories/calories/added-sugars.html. Accessed April 11, 2014.
27 U.S. Department of Agriculture and U.S. Department of Health and Human Services. Dietary Guidelines for Americans, 2010. 7th Edition, Washington, DC: U.S. Government Printing Office, December 2010.
28 US Departments of Agriculture and Health and Human Services. Report of the Dietary Guidelines Advisory Committee on the Dietary Guidelines for Americans, 2010.
29 Appel LJ, Frohlich ED, Hall JE, et al. “The importance of population-wide sodium reduction as a means to prevent cardiovascular disease and stroke: a call to action from the American Heart Association,” Circulation 2011, vol. 123, pp. 1138-1143.
30 Whelton PK, Appel LJ, Sacco RL, et al. “Sodium, blood pressure, and cardiovascular disease: Further evidence supporting the American Heart Association sodium reduction recommendations,” Circulation 2012, vol. 126, pp. 2880-9.
31 Lichtenstein A, Appel LJ, Brands M, et al. “Diet and Lifestyle Recommendations Revision 2006: A Scientific Statement from the American Heart Association Nutrition Committee.,” Circulation 2006, vol. 114, pp. 82-96.
32 US Departments of Agriculture and Health and Human Services. Report of the Dietary Guidelines Advisory Committee on the Dietary Guidelines for Americans, 2010.
33 U.S. Food and Drug Administration. 2002 Health and Diet Survey. November 2007. Accessed July 30, 2014.
34 2008 Health and Diet Survey. Accessed July 30, 2014. Available at http://www.fda.gov/food/foodscienceresearch/consumerbehaviorresearch/ucm193895.htm.
35 National Institutes of Health, National High Blood Pressure Education Program. Accessed July 30, 2014.
36 National Kidney and Urologic Diseases Information Clearinghouse website. Kidney Disease Statistics for the United States. Accessed June 22, 2014 at http://kidney.niddk.nih.gov/kudiseases/pubs/kustats/
37 US Renal Data System. ESRD incidence and prevalence. In: US Renal Data System 2007 annual data report: atlas of chronic kidney disease and end-stage renal disease in the United States. Bethesda, MD: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases; 2007. Accessed July 30, 2014. Available at http://www.usrds.org/2007/pdf/02_incid_prev_07.pdf
38 Institute of Medicine. Guiding Principles for Nutrition Labeling and Fortification. Washington, DC: National Academy Press, 2003.
39 National Kidney Foundation and American Dietetic Association. Usefulness of the nutrition label for persons with kidney disease. Submitted to Docket No. 2006N-0169, April 29, 2008.
40 Fulgoni V, Nicholls J, Reed A, Buckley R, Kafer K, Huth P, Dirienzo D, Miller GD. Dairy consumption and related nutrient intake in African-American adults and children in the United States: Continuing Survey of Food Intakes by Individuals, 1994-1996, 1998, and the National Health and Nutrition Examination Survey, 1999, J Am Diet Assoc. 2007;107:256-264.
41 National Kidney Foundation. K/DOQI clinical practice guidelines for bone metabolism and disease in chronic kidney disease, American Journal of Kidney Diseases, 2003;42(Suppl 3):1-202.
42 Cogswell ME, Zhang Z, Carriquiry AL, et al, ”Sodium and potassium intakes among U.S. adults: NHANES 2003-2008.,” Am J Clin Nutr 2012, vol 96, pp. 647-57.
43US Departments of Agriculture and Health and Human Services. Report of the Dietary Guidelines Advisory Committee on the Dietary Guidelines for Americans, 2010.
44 Institute of Medicine. Dietary Reference Intakes for Water, Potassium, Sodium, Chloride, and Sulfate. Washington, DC: National Academy Press; 2005.
45 National Institutes of Health. Accessed July 30, 2014. Available at https://www.nhlbi.nih.gov/health/public/heart/hbp/dash/how_make_dash.html.
46 Lou-Arnal LM., et al. The impact of processing meat and fish products on phosphorus intake in chronic kidney disease patients. Nefrologia : publicacion oficial de la Sociedad Espanola Nefrologia 2013;33:797-807.
47 Nadkarni GN and Uribarri J. Phosphorus and the kidney: what is known and what is needed. Advances in nutrition 2014;5:98-103.
48 Chang, Alex, et al. Association of a Reduction in Central Obesity and Phosphorus Intake With Changes in Urinary Albumin Excretion: The PREMIER Study. American journal of kidney diseases: the official journal of the National Kidney Foundation 2013; 62:5: 900-907.
49 Block GA, Ix JH, Ketteler M, et al. Phosphate homeostasis in CKD: report of a scientific symposium sponsored by the National Kidney Foundation. American journal of kidney diseases: the official journal of the National Kidney Foundation 2013;62:457-473.
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53 Isakova T, Gutierrez, et al. Pilot study of dietary phosphorus restriction and phosphorus binders to target fibroblast growth factor 23 in patients with chronic kidney disease. Nephrology, dialysis, transplantation: official publication of the European Dialysis and Transplant Association - European Renal Association 2010.
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56 Sullivan C, et al. Effect of food additives on hyperphosphatemia among patients with end-stage renal disease: a randomized controlled trial. JAMA : the journal of the American Medical Association 2009;301:629-635.
57 Leon JB, et al. The prevalence of phosphorus-containing food additives in top-selling foods in grocery stores. Journal of renal nutrition : the official journal of the Council on Renal Nutrition of the National Kidney Foundation 2013;23:265-270
58 Gutierrez OM, et al. Associations of Socioeconomic Status and Processed Food Intake With Serum Phosphorus Concentration in Community-Living Adults: The Multi-Ethnic Study of Atherosclerosis (MESA). Journal of renal nutrition: the official journal of the Council on Renal Nutrition of the National Kidney Foundation 2012.
59 Calvo MS, et al. Assessing the health impact of phosphorus in the food supply: issues and considerations. Advances in nutrition 2014;5:104-113.
60 Benini O, et al. Extra-phosphate load from food additives in commonly eaten foods: a real and insidious danger for renal patients. Journal of renal nutrition: the official journal of the Council on Renal Nutrition of the National Kidney Foundation 2011;21:303-308.
61 Sherman RA, Mehta O. Phosphorus and potassium content of enhanced meat and poultry products: implications for patients who receive dialysis. Clinical journal of the American Society of Nephrology : CJASN 2009;4:1370-1373.
62 U.S. Department of Agriculture and U.S. Department of Health and Human Services. Dietary Guidelines for Americans, 2010. 7th Edition, Washington, DC: U.S. Government Printing Office, December 2010, p. 54.
63 Loureiro ML, Yen ST, Nayga RM. The Effects of Nutritional Labels on Obesity. Agricultural Economics 2012; 43:333-342.
64 Calculated based on BMI table available at https://www.nhlbi.nih.gov/guidelines/obesity/bmi_tbl.htm. Accessed April 21, 2014.
65 See, Watson E, Behavioral scientists: Changing serving sizes on Nutrition Facts label could have unintended consequences. July 21, 2014. Available at http://www.foodnavigator-usa.com/Regulation/Could-new-serving-sizes-on-Nutrition-Facts-label-backfire.
66 Nutrition Labeling and Education Act of 1990, Pub. L. No. 101-535, § 2, 104 Stat. 2353–57 (codified as amended at 21 U.S.C. § 343).
67 Food and Drug Administration, Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed at One-Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments, Mar. 3, 2014, 79 FR 11990, at 12008.
68 Juan W, “Memorandum to file: Consumption estimates for foods for infants and children 1 through 3 years of age and for the general food supply for individuals ages 4 years and older in the United States by general category and product category using data from the National Health and Nutrition Examination Survey, 2003–2008 (NHANES 2003–2008) compared to the 1993 RACCs, and Proposed Changes to RACCs.” Feb. 11, 2014.
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73 Ello-Martin JA, Ledikwe JH, Rolls BJ, “The influence of food portion size and energy density on energy intake: implications for weight management,” Am J Clin Nutr 2005, vol. 82, pp. 236S-241S.
74 21 CFR 101.65(d)(2).
75 Institute of Medicine. Front-of-Package Nutrition Rating Systems and Symbols: Promoting Healthier Choices, 106. Washington, DC: National Academies Press, 2012.