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Congressional Research Service 7-5700 www.crs.gov R43733 Summary High rates of obesity and chronic diseases have prompted federal, state, and local initiatives such as exercise promotion, nutrition education, and food labeling. Nearly two-thirds of U.S. adults are overweight or obese, suggesting that consumers need to be more aware of their calorie intake. Labeling of the nutritional content of foods has been recommended by researchers and policymakers as a tool to address the obesity epidemic. National survey data indicate that the frequency of food label use among consumers has increased in the past decade; however, despite widespread use, certain elements of the Nutrition Facts label are outdated and confusing to consumers. Consumer research highlights the importance of salient and easy-to-understand nutrition information. The purpose of the Nutrition Facts label as a public health tool is to provide consumers with nutrition information that may help them make more informed food choices. Mandating declaration of certain nutrition information on the label may also prompt food manufacturers to reformulate products to make them healthier and more attractive to consumers. Increasing awareness about the nutritional content of various foods may promote healthier eating behaviors among consumers, resulting in lower calorie intake and, over time, decreasing rates of overweight and obesity. The Federal Food, Drug, and Cosmetic Act (FFDCA) of 1938 authorizes the Food and Drug Administration (FDA) to regulate labeling of most food products other than meat and poultry. The Nutrition Labeling and Education Act (NLEA) of 1990 amended the FFDCA to require that most foods, with the exception of meat and poultry, bear nutrition content labels. Since its introduction in 1993, the Nutrition Facts label has undergone few changes, while nutrition science and public health research have changed significantly. To ensure that the Nutrition Facts label remains scientifically valid and helpful to consumers, the FDA is proposing to update the label. In March 2014, FDA published two proposed rules that would amend previous labeling regulations. The first rule addresses which nutrients must be included on the label, the recommended intake of these nutrients, and the format in which the information is to be displayed. More specifically, the proposed changes include but are not limited to required information about "added sugars," removal of "Calories from Fat," required declaration of potassium and vitamin D, updated Daily Values for certain nutrients, and changed label design. The second rule proposes to change serving sizes to more accurately reflect actual food consumption behavior in the United States. The comment period on the proposed rules ended on August 2, 2014, and the FDA is currently finalizing the rules. In July 2015, FDA issued a proposed supplemental rule that would, among other things (1) require declaration of the percent daily value (%DV) for added sugars; and (2) change the current footnote on the Nutrition Facts label, reopening a comment period for 60 days. The estimated annual health care costs of obesity-related illness are $190.2 billion, or almost 21% of annual medical spending in the United States. Congress and the Obama Administration have shown a strong interest in developing policies to reverse the trend of rising obesity rates. The Healthy, Hunger-Free Kids Act (P.L. 111-296) addresses several nutrition-related concerns, and Section 4205 of the Patient Protection and Affordable Care Act (ACA, P.L. 111-148, as amended) required FDA to promulgate regulations for labeling of foods sold in some chain restaurants and vending machines (see CRS Report R42825, Nutrition Labeling of Restaurant Menus). Congress, consumers, food industry representatives, and federal regulators all have a stake in nutrition labeling. This report provides a brief overview of the proposed changes to the Nutrition Facts label, as well as the public health significance of these changes. Contents Introduction 1 Background on Nutrient Intake and Dietary Guidance 3 FDA Authority to Regulate Nutrition Labeling 5 Proposed Rules 6 Selected Aspects of Proposed Rule 1 6 Require Information About "Added Sugars" 6 Remove "Calories from Fat" 8 Require Declaration of Potassium and Vitamin D, Permit Vitamins A and C 9 Update Reference Values for Certain Nutrients 10 Update Units of Measure 13 Update Labeling of Foods for Infants, Young Children, and Pregnant or Lactating Women 14 Changes to Label Design 16 Selected Aspects of Proposed Rule 2 18 Changes to the RACCs 18 Changes to Single-Serving Sizes 19 Use of Dual Column Labeling 19 Compliance, Costs, and Considerations 21 Compliance Timeframes 21 Costs and Benefits 21 Considerations 22 Figures Figure 1. Basic Format of the Nutrition Label 2 Figure 2. Label Format 17 Figure 3. Dual Column Format 20 Contacts Author Contact Information 23 Introduction Nutrition labeling of foods first became a topic of discussion at the 1969 White House Conference on Food, Nutrition and Health. Various recommendations intended to combat hunger in America were proposed, including providing nutrition information on food labels to inform consumers about the nutrient content of the food they were eating. In the 1970s, a voluntary nutrition labeling program was established by the Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA) under their respective statutes; however, the nutrition label formats slightly differed between the two agencies, making comparisons among food products difficult. Despite some interagency consideration of whether the nutrition labels needed to be updated, actions on any food labeling reform stalled. In 1988, the Surgeon General's report on Nutrition and Health was published, citing mounting evidence that dietary changes could reduce the incidence of certain chronic diseases such as heart disease, cancer, and diabetes. In 1989, the launch of an Institute of Medicine (IOM) study provided an assessment of the implications of nutrition and health knowledge for food labeling, and laid out a roadmap for modifying ingredient and nutrition labeling policy. That same year, the Nutrition Labeling and Education Act (NLEA) was introduced, and then signed into law on November 8, 1990 (P.L. 105-535). The Act granted FDA explicit authority to require nutrition labeling on most food packages and included provisions addressing nutrition labeling regulations, nutrient content and health claims, and uniform nutrition labeling. In 1992, FDA proposed a format for nutrition labeling, which is still being used today (see Figure 1). Figure 1. Basic Format of the Nutrition Label Source: 21 C.F.R. 101.9(d)(12). Since the implementation of the NLEA, consumers have become increasingly more aware of the Nutrition Facts label. National survey data indicates that the frequency of food label use among consumers has increased in the past decade. The FDA's Health and Diet Surveys found that the percentage of consumers reporting that they "often" read a food label the first time they purchase a food product rose from 44% in 2002 to 54% in 2008., , The National Health and Nutrition Examination Survey (NHANES) reported a similar increase, with the percentage of working age adults that reported using the Nutrition Facts label "always" or "most of the time" when shopping for food increased to 42% in 2009-2010 from 34% in 2007-2008. Among older adults the percentage increased to 57% from 51%. However, consumer research data also suggests that despite reported widespread use of food labels, certain elements of the Nutrition Facts label may need improvement. Among these elements causing confusion is the percent daily value (%DV) declaration, with the majority of consumers being unable to identify what that number means. The FDA is proposing to revise the Nutrition Facts label to both provide updated nutrition information and improve how that nutrition information is presented to consumers. The proposed changes reflect current public health concerns in the United States (i.e., growing rates of obesity and chronic disease) and correspond to new information on consumer behavior and consumption patterns. This report describes the FDA's two proposed rules to update the Nutrition Facts label in order to provide consumers with more up-to-date nutrition information. The first rule reflects the changes in nutrition science and public health research, specifically addressing modifications to which nutrients must be listed on the label, as well as an updated design to display the new information. The second rule addresses updates to serving size and labeling requirements for specific package sizes. In July 2015, FDA issued a proposed supplemental rule that would, among other things (1) require declaration of the percent daily value (%DV) for added sugars, and (2) change the current footnote on the Nutrition Facts label. This report also discusses some of the concerns raised by industry, policymakers, and the public. Background on Nutrient Intake and Dietary Guidance The prevalence of obesity in the United States remains high and although there have been no significant changes in obesity between 2003-2004 and 2011-2012, one-third of adults and 17% of children are still obese. Chronic diseases such as heart disease, cancer, and stroke, which are associated with obesity, are the leading causes of death and disability in the United States. The 2010 Dietary Guidelines for Americans (DGA) cite the role of physical inactivity and calorie overconsumption as the primary factors contributing to the increased prevalence of overweight and obesity. The DGA are evidence-based recommendations issued jointly by the USDA and Department of Health and Human Services (HHS) every five years. These recommendations are created by a committee of nationally recognized experts in the field of human nutrition and chronic disease prevention, and they provide the basis for federal food and nutrition policy, as well as nutrition education initiatives. In February 2015, the 2015 Dietary Guidelines Advisory Committee (DGAC) submitted its recommendations for the 8th edition of the DGA to the Secretaries of HHS and USDA. The Secretaries are to consider the DGAC's scientific recommendations, as well as comments from federal agencies and the public in the development of the final policy document. The nature and number of recommendations issued in the final DGA policy documents have changed since the first edition of the guidelines was published in 1980. The 2010 report, for example, was different from previous reports because for the first time, it addressed an American public of which the majority was overweight or obese, yet deficient in several key nutrients. According to NHANES data, the number of calories consumed by individuals in the United States increased from an average of 1,875 calories per day in 1977-1978 to 2,067 per day in 2005-2008, an increase of 10.2%. But despite growing obesity rates and caloric overconsumption, nutrient deficiencies are still prevalent in many subpopulations. According to the 2010 DGA, dietary intakes of nutrients such as potassium, dietary fiber, calcium, and vitamin D are low enough to be of public health concern for children and adults. Less than 2% of American adults get the recommended amount of potassium, and the rate of nutrient deficiencies in the general U.S. population ranges from less than 1% for folate, vitamin A, and vitamin E to about 10% for vitamin B6, iron, and vitamin D. The highest rates of vitamin D deficiency (31%) occur in non-Hispanic blacks. The CDC also reports higher rates of iron deficiency in Mexican-American children aged one to five years (11%) and in non-Hispanic black (16%) and Mexican-American women (13%) of childbearing age when compared to other race/ethnic groups. The Scientific Report of the 2015 Dietary Guidelines Advisory Committee reflects a slightly different public health environment. For example, more recent NHANES data show that obesity rates seem to have stabilized since 2003-2004, and daily caloric intake has declined by 118 calories (about 5%), on average, between 2005-2006 and 2009-2010. It has been suggested that these changes may be, in part, attributed to various local, state, and federal policy initiatives. With the passage of the Affordable Care Act in 2010, chain restaurants and fast food establishments have started to post calorie counts on menus. The federal government has changed school lunch requirements, limiting calories, sodium, and saturated fat content in school meals. And individual cities have taken their own actions (e.g., soda taxes in Berkley, CA). In the 2015 scientific report, the DGAC determined that Americans are overconsuming two nutrients—sodium and saturated fat—and two food components—refined grains and added sugars. The DGAC concluded that independent of where food is obtained or prepared, the diet quality of the U.S. population does not meet recommendations for fruit, vegetables, dairy, or whole grains, and exceeds recommendations for sodium and saturated fat, as well as refined grains, solid fats, and added sugars. Although most of the proposed changes to the Nutrition Facts label are based on the 2010 DGA policy document, FDA published a supplemental notice of proposed rulemaking with additional proposed revisions, based on the scientific rationale included in the 2015 DGAC report. FDA Authority to Regulate Nutrition Labeling The 1938 Federal Food, Drug, and Cosmetic Act (FFDCA) authorized the Food and Drug Administration to regulate food products and their ingredients. In 1990, Congress passed the Nutrition Labeling and Education Act, which amended the FFDCA to require that all foods, with certain exceptions, bear nutritional content labels. The NLEA gave FDA explicit authority to require nutrition labeling and control health claims on food labels. In 1991, FDA issued more than 20 proposals to implement the NLEA and in 1992, FDA issued several final regulations which became effective in 1993. The published regulations addressed (1) the declaration of nutrients on food labeling, mandatory and voluntary, as well as the format for declaration; (2) label reference values for declaring the nutrient content of a food; (3) two types of reference values, Reference Daily Intakes (RDIs) and Daily Reference Values (DRVs), which are used to declare nutrient contents as percent Daily Values (DVs) on the Nutrition Facts label; (4) exemptions for specified products; and (5) circumstances for a simplified form of nutrition labeling. The NLEA also authorized the FDA to "establish regulations defining serving size or other unit of measure." To establish serving sizes, FDA consulted the Nationwide Food Consumption Surveys (1977-1978 and 1987-1988) and considered three statistical estimates (i.e., mean, median, and mode) for each food product category. Using this methodology, the FDA established reference amounts customarily consumed (RACCs) and provided a process for manufacturers to derive serving sizes from the RACCs., Since FDA's issuance of the 1992 regulations, the Nutrition Facts label has undergone few changes. The recommended daily values (DVs) were last updated in 1995 (60 FR 67164; December 28, 1995) and the label itself was modified in 2003 when the FDA amended the labeling regulations to require the declaration of trans-fatty acids. (68 FR 41434; July 11, 2003). Proposed Rules In response to new scientific information and a public health profile characterized by high rates of obesity and chronic disease, the FDA is proposing two rules to revise the 1993 labeling regulations. The Nutrition Facts label as a public health tool serves to provide consumers with nutrition information that may help them make more informed food choices. Mandating declaration of certain nutrition information on the label may also prompt food manufacturers to reformulate products to make them healthier and more attractive to consumers. For the purpose of this report, the rule "Food Labeling: Revision of the Nutrition and Supplement Facts Label" will be referred to as the first rule or rule 1. The rule "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" will be referred to as the second rule or rule 2. Selected Aspects of Proposed Rule 1 The following sections present the changes proposed as part of the first rule. These updates specifically address changes to the label's required nutrients and the label's design. While some changes seem relatively non-controversial, others have generated debate. This section discusses major changes and flags stakeholder concerns. Require Information About "Added Sugars" The first proposed rule includes a provision mandating an "added sugars" line on the Nutrition Facts label. "Sugars" are defined as the number of grams of sugar in a serving of a food item. This includes the sum of all monosaccharides (i.e., glucose, fructose, galactose) and disaccharides (i.e., sucrose, lactose, and maltose). This designation includes both those sugars naturally occurring in foods such as fruit (fructose) or milk products (lactose), as well as those added during the production process to items such as soda or other sweetened beverages, cereals, and candy. Under current regulations, manufacturers are required to declare on the label the amount of sugar in a food item. However, manufacturers do not have to differentiate between naturally occurring sugar and added sugar. Artificial sweeteners and sugar alcohols that are added to a food are not included in the "Sugars" designation; they are required to be labeled in the ingredients statement but not on the Nutrition Facts label itself. A key recommendation of the 2010 DGA is to reduce the intake of calories from added sugars, as studies show that diets high in added sugars can decrease the intake of nutrient-rich foods and increase overall calorie intake. The American Heart Association estimates that Americans consumed an average of more than 22 teaspoons of added sugar per day from 2001 to 2004. The average American consumes 16% of their total daily calories from added sugars, and added sugars contribute extra calories to a diet, which may lead to weight gain and obesity. A declaration of added sugars on the Nutrition Facts label would let consumers know how much sugar has been added to the product beyond the naturally occurring sweetener, and requiring manufacturers to disclose the amount of added sugar in a food item may also change how much sweetener they add to their products. The inclusion of the added sugars label on the Nutrition Facts panel has received support from several public health and nutrition stakeholders. However, some groups have also asked that FDA establish a recommended daily value for sugar (see "Update Reference Values for Certain Nutrients"), which would give consumers a daily target or upper limit. Groups have also suggested that it may be appropriate to use a more common metric of sugar such as the number of teaspoons as opposed to grams. In July 2015, FDA issued a proposed supplemental rule that would require a mandatory percent daily value (%DV) declaration for added sugars. In the initial iteration of the proposed rule, FDA proposed mandatory declaration of the amount of added sugars in a food item but not a percent DV, citing lack of scientific evidence to substantiate such a recommendation. However, the Scientific Report of the 2015 Dietary Guidelines Advisory Committee (2015 DGAC) published in February 2015 provided new scientific evidence to support establishing a reference amount for added sugar intake. Specifically, the DGAC's report concluded that there is a moderate relationship between added sugar intake and cardiovascular disease, and a strong association between added sugar consumption and type 2 diabetes in adults. Cohort studies comparing groups with varying levels of added sugar consumption support the recommendation to keep added sugars intake below 10% of total calories, which is consistent with the World Health Organization's recommendation to keep added sugar intake to less than 10% of total energy intake. In light of this new evidence, FDA determined that it has the scientific basis to establish a percent DV for added sugars, proposing that the percent DV be based on the recommendation that the daily intake of calories from added sugars not exceed 10% of total calories. The DV, which is used to calculate the percent DV that consumers see on the Nutrition Facts label, would be 50 grams of added sugars for adults and children four years of age and older and 25 grams for children one through three years of age. There has been some controversy surrounding the mandatory labeling of added sugars. Some food industry groups are questioning the FDA's statutory authority under the FFDCA, stating that the agency may only require the labeling of sugar if it will help consumers maintain healthy dietary practices. Members of certain food industry groups have also argued that there is a lack of evidence to justify a label that distinguishes between naturally occurring and added sugars because sugar is sugar. Others have said that FDA's added sugars proposal may be preemptive, as the Secretaries of HHS and USDA have not yet released the final policy document that is the 8th edition of the DGA. Remove "Calories from Fat" The second provision of the first rule proposes to remove "Calories from Fat" from the Nutrition Facts label. Currently, manufacturers are required to declare the amounts of "Total Fat," "Calories from Fat, "Saturated Fat," and "Trans fat." However, evidence suggests that the type of fat is more important than total fat intake in regard to chronic disease risk. Dietary fats are categorized as saturated, trans, monounsaturated, and polyunsaturated fatty acids, with most American consuming too much saturated and trans fat and not enough unsaturated fat. In general, animal sources tend to provide a greater proportion of saturated fat, and plant sources tend to provide more of the mono- and polyunsaturated fats. Over the years, evidence has suggested that a higher intake of saturated fat is associated with greater risk of cardiovascular disease, and recommendations have been to reduce intake of saturated fats and replace them with monounsaturated and polyunsaturated fatty acids. Specifically, the DGA recommend that Americans consume less than 10% of calories from saturated fat, and lowering that number to 7% of calories may further reduce the risk of cardiovascular disease. However, it is worth noting that some recent studies have found evidence against the association between saturated fat intake and cardiovascular disease risk. Meanwhile, the evidence against trans fat intake remains strong, with studies reporting an strong association between trans fatty acid intake and cardiovascular disease risk. Furthermore, an IOM review suggests there is insufficient evidence to set a level of intake that would pose no adverse health effects and at this time, the recommendation is for Americans to keep their intake of trans fatty acids as low as possible. FDA consumer research also indicates that removal of the declaration of "Calories from Fat" has no effect on consumers' ability to judge the healthfulness of a product. Thus, FDA would continue to require "Total Fat," "Saturated Fat," and "Trans Fat" on the label, but not "Calories from Fat." No substantive comments for or against this proposal have been identified. Require Declaration of Potassium and Vitamin D, Permit Vitamins A and C As part of the first rule, FDA is also proposing to update the nutrients that are required to be listed on the Nutrition Facts label. The current Nutrition Facts label regulations mandate the declaration of vitamins A and C, as well as calcium and iron. FDA states that these four nutrients were considered to be "of public health significance" based on their inadequate intakes among specific segments of the U.S. population at the time the regulations were established. However, more recent data has informed the FDA proposal to update the list of vitamins and minerals that must be included on the Nutrition Facts label., To determine whether a non-statutory nutrient should be a mandatory or voluntary declaration, two factors are considered: existence of quantitative intake recommendations and public health significance. Based on consideration of these factors, the FDA is proposing to require the declaration of potassium and vitamin D, and to permit, rather than require, the declaration of vitamins A and C. Calcium and iron continue to be considered nutrients of public health significance so there will be no change to their mandatory labeling. FDA analysis demonstrates that while American consumers get adequate amounts of vitamins A and C, potassium and vitamin D have been identified as nutrients of concern for certain subpopulations. Vitamin D plays an important role in bone health and NHANES biomarker data, as well as the high prevalence of osteoporosis and osteopenia among the U.S. population, suggest inadequate dietary intake. Potassium is also considered a nutrient of public health significance as it plays an important role in blood pressure regulation, and data indicates both a low likelihood of potassium adequacy and a high prevalence of hypertension in the U.S. population. The FDA proposal to include vitamin D on the list of mandatory nutrients has generated some debate. Vitamin D is a hormone synthesized by the body in response to sunlight exposure, and some experts question the efficacy of orally consumed vitamin D. There is also concern that mandating vitamin D disclosure will encourage mass fortification, as vitamin D is naturally found in few foods. This also raises questions about the potential for overconsumption and toxicity, as vitamin D is a fat-soluble hormone that can be stored in fat tissue long-term. In addition, there is also concern about the proposal to permit rather than require declaration of vitamins A and C. Although overt deficiency of these two nutrients is not common among the U.S. population, inadequate intake of these nutrients remains a concern. Update Reference Values for Certain Nutrients The FDA is also proposing to update the recommended Daily Values (DVs) for certain nutrients to help consumers understand how these nutrients fit into the context of a daily diet. The DV or %DV indicates to consumers how much of the recommended intake of a nutrient is provided by a certain food. The text box below explains how DVs are determined. Reference Values There are two sets of reference values for reporting nutrients on the Nutrition Facts label: Daily Reference Values (DRVs) and Reference Daily Intakes (RDIs). To limit consumer confusion, a single term, Daily Value (DV), is used to designate both the DRVs and the RDIs. Daily Reference Values (DRVs) were developed to inform consumers about the maximum intake of a nutrient and are provided for total fat, saturated fat, cholesterol, total carbohydrates, dietary fiber, sodium, and protein; DRVs are established for adults and children four years and older. Reference Daily Intakes (RDIs) were developed to help consumers meet a nutrient requirement or daily minimum. RDIs are provided for vitamins and minerals, as well as for protein for children under the age of four and pregnant and lactating women. The DRVs and RDIs are determined using Dietary Reference Intakes (DRIs): The Recommended Daily Allowance (RDA) is the basis for the RDI. The RDAs are intake goals referring to the average daily nutrient intake level sufficient to meet the nutrient requirement of nearly all (97%-98%) individuals in a particular life stage and gender group. The RDA is set using the Estimated Average Requirement (EAR). The Estimated Average Requirement (EAR) is the average daily nutrient intake level that is estimated to meet the requirements of half of the healthy individuals in a particular life stage and gender group. An Adequate Intake (AI) is established when there is insufficient evidence to develop an RDA and is set at a level assumed to ensure nutritional adequacy. It is used to establish the RDI in the absence of an RDA. The Tolerable Upper Intake Level (UL) is the maximum daily intake that is unlikely to cause adverse health effects. The UL is not intended to be a recommended level of intake. Sources: C Lewis and L Meyers, "Chapter 106: Dietary Reference Intakes," in Modern Nutrition in Health and Disease, ed. A. Catharine Ross, Benjamin Caballero, Robert Cousins, Katherine Tucker, Thomas Ziegler, 11th ed. (Lippincott Williams & Wilkins, 2014), pp. 1480-1489. Food and Drug Administration, "Guidance for Industry: A Food Labeling Guide (14. Appendix F: Calculate the Percent Daily Value for the Appropriate Nutrients), January 2013. Since the implementation of the NLEA, new reports from the IOM and the 2010 DGA have updated the quantitative intake recommendations of certain nutrients. The FDA is proposing to update the reference values used in the declaration of %DV on the Nutrition Facts label so that it is consistent with the new data. These updated reference values have been proposed for several nutrients including sodium, dietary fiber, and potassium, which are required to be declared on the label, as well as vitamin K, chloride, choline, and vitamin B12, which are permitted but not required to be on the label. Reduce Sodium Limits The FDA is proposing to reduce the Daily Value (DV) for sodium. Regulations under the NLEA established the DRV for sodium as 2,400 mg; however, more recent scientific literature and recommendations from the 2005 and 2010 DGA highlight the need to reconsider this value., In accord with the 2005 and 2010 DGA recommendations, FDA is proposing to reduce the DRV to 2,300 mg. This value is consistent with a 2013 IOM report on sodium intake, which established the Tolerable Upper Intake Level (UL) of sodium to be 2,300 mg. The IOM report determined that there is insufficient evidence to conclude that lowering sodium intakes below 2,300 mg will increase or decrease the risk of cardiovascular disease outcomes or all-cause mortality in the general U.S. population. Meanwhile, some public health groups propose that 2,300 mg is still too high and that 1,500 mg would be a more appropriate target level for the general population., Increase Dietary Fiber Recommendations The FDA is also proposing to increase the DRV for dietary fiber intake. Currently, the DRV for dietary fiber is 25 grams. In 2002, an IOM report set an Adequate Intake (AI) for total fiber of 14 grams per 1,000 calories for total fiber. Based on this report, FDA is proposing to increase the DRV for dietary fiber to 28 grams per day, using a reference calorie intake of 2,000 calories per day. The declaration of dietary fiber will continue to be mandatory, but a new definition of dietary fiber would allow only those forms of dietary fiber that the FDA has determined to be of "physiological benefit" to human health to be included in the amount declared. In the past, food manufacturers have been permitted to fortify food products with processed fiber. However, it remains unclear whether processed added fiber confers the same health benefits as naturally occurring sources from fruits, vegetables, and whole grains. There is some industry concern regarding FDA's proposal to change the definition of dietary fiber, as manufacturers may be unclear as to what qualifies as a "physiological benefit." Furthermore, some argue that this requirement imposes a pre-authorization approach similar to that required for health claims. Increase Potassium Under current regulations, the DRV for potassium is 3,500 mg. In 2005, IOM established age- and gender-specific Adequate Intakes (AI s) for potassium based on its beneficial health and physiologic effects. Because potassium is an essential mineral with available age- and gender-specific AIs, FDA is proposing to establish an RDI of 4,700 mg based on the AI and in place of the DRV. Comments have arisen regarding the use of an AI to determine the RDI, particularly if