# 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 > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A2014-04385 ## Record - **Collection:** Federal Register - **Document type:** Proposed Rule - **Published:** March 3, 2014 - **Citation:** 79 FR 11990 ## Text DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 101 [Docket No. FDA-2004-N-0258 (Formerly Docket No. 2004N-0456)] RIN 0910-AF23 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 AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. SUMMARY: The Food and Drug Administration (FDA or we) is proposing to amend the definition of a single-serving container; require dual-column labeling for certain containers; update and modify several reference amounts customarily consumed (RACCs or reference amounts); add several food products and food product categories to the reference amounts customarily consumed per eating occasion for the general food supply; amend the label serving size for breath mints; and make technical amendments to various aspects of the serving size regulations. These actions are being taken, in part, in response to recommendations of the 2003 FDA Obesity Working Group and FDA's recognition that portion sizes have changed since the original serving size regulations were published in 1993. This proposal also discusses six citizen petitions. The intended effect of this rulemaking is to provide consumers with more accurate and up-to-date information on serving sizes. DATES: Submit either electronic or written comments on the proposed rule by June 2, 2014. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by April 2, 2014, (see the “Paperwork Reduction Act of 1995” section of this document). ADDRESSES: You may submit comments, identified by Docket No. FDA-2004-N-0258 and/or RIN 0910-AF23, by any of the following methods, except that comments on information collection issues under the Paperwork Reduction Act of 1995 must be submitted to the Office of Information and Regulatory Affairs, Office of Management and Budget (OMB) (see the “Paperwork Reduction Act of 1995” section of this document). Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: http://www.regulations.gov . Follow the instructions for submitting comments. Written Submissions Submit written submissions in the following ways: • Mail/Hand delivery/Courier (for paper or CD-ROM submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Instructions: All submissions received must include the Agency name and Docket No. FDA-2004-N-0258 and Regulatory Information Number 0910-AF23 for this rulemaking. All comments received may be posted without change to http://www.regulations.gov, including any personal information provided. For additional information on submitting comments, see the “Comments” heading of the SUPPLEMENTARY INFORMATION section of this proposed rule. Docket: For access to the docket to read background documents or comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this proposed rule, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: With regard to the proposed rule: Cherisa Henderson, Center for Food Safety and Applied Nutrition (HFS-830), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-5429, NutritionProgramStaff@fda.hhs.gov . With regard to the information collection: Domini Bean, Office of Information Management, Food and Drug Administration, 1350 Picard Dr., PI50-400T, Rockville, MD 20850, domini.bean@fda.hhs.gov . SUPPLEMENTARY INFORMATION: Table of Contents Executive Summary Proposed Rule I. Background A. The Serving Size Regulations B. The Obesity Working Group C. The Advance Notice of Proposed Rulemaking 1. Single-Serving Containers 2. Updating the RACCs 3. Comparison of Calories in Foods of Different Portion Sizes 4. Overview of Comments on the Advance Notice of Proposed Rulemaking D. Requests for Changes to Serving Size Requirements 1. Requests To Modify and Establish Certain RACCs and Add Products to Product Categories 2. Adding Products to the List of Products for Each Product Category 3. Citizen Petitions a. Petition for Food and Beverages Sold in Single-Serving Containers b. Petition for a New RACC for Fruitcake c. Petition for a New RACC for Yogurt d. Petition for a New RACC for Mint Wafers and Similar Candy Products e. Petition for a New RACC for Certain Candies Weighing 20 g or Less per Piece f. Petition for a New Product Category and New RACC for Small Breath Mints Weighing 0.5 g or Less E. Technical Issues II. The Proposed Rule A. Legal Authority/Statutory Directive B. Need for This Regulation C. Single-Serving Containers and Dual-Column Labeling 1. Research Related to Single-Serving Containers and Dual-Column Labeling a. Research on the Impact of Package and Portion Sizes on Consumption b. Research on Consumer Use and Understanding of the Serving Size Labeling c. Research on Dual-Column Labeling 2. Single-Serving Containers a. Comments on the ANPRM Regarding Single-Serving Containers b. Proposed Amendments for Single-Serving Containers 3. Dual-Column Labeling—Mandatory Listing of a Second Column of Nutrient Values on the Nutrition Facts Label Based on the Entire Container or Unit a. Comments on the ANPRM Regarding Dual-Column Labeling b. Proposed Amendments for Dual-Column Labeling D. Reference Amounts Customarily Consumed 1. Research and Data Related to Updating, Modifying, and Establishing RACCs 2. Updating Existing RACCs a. Comments on the ANPRM Regarding Updating the Existing RACCs b. Methods Used To Update the Existing RACCs c. Proposed Amendments To Update the Existing RACCs 3. Modifying and Establishing RACCs a. Methods Used To Modify Existing RACCs and Establish New RACCs b. Proposed Amendments To Modify Existing RACCS and Establish New RACCs 4. Products of Concern Listed in Consumer Comments—Agency Request for Information 5. Impact of Changes in RACCs on the Eligibility of Nutrient Content Claims and Health Claims 6. Request To Establish a New 25 g RACC for Candies Weighing 20 g or Less E. Establishing a New Serving Size for Breath Mints F. Comparison of Calories in Foods of Different Portion Sizes G. Technical Amendments 1. Rounding Rules for Products That Have More Than Five Servings and the Number of Servings Falls Exactly Between Two Values 2. Options for When the Number of Servings per Container Varies 3. Minor Corrections to General and Product Category Names 4. Minor Changes to Footnotes 5. Minor Changes to Table 1 in 21 CFR 101.12(b) 6. Minor Changes to Table 2 in 21 CFR 101.12(b) 7. Reference Amounts for Products That Require Further Preparation 8. Reference Amount for Combined Products Consisting of Two or More Separate Foods That Are Packaged Together and Are Intended To Be Eaten Together and That Have No Reference Amount for the Combined Product 9. Reference Amounts for Varieties or Assortments of Foods in Gift Packages That Have No Appropriate Reference Amount III. Proposed Effective and Compliance Dates IV. Environmental Impact V. Analysis of Impacts VI. Paperwork Reduction Act of 1995 VII. Federalism VIII. Comments IX. References Executive Summary Purpose of the Proposed Rule Need for the Proposed Rule Following the passage of the Nutrition Labeling and Education Act (NLEA) of 1990 (Pub. L. 101-535), which added section 403(q) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 343(q)) we issued various regulations related to serving size requirements (see 21 CFR 101.9 and 101.12). Since we established those regulations, there have been developments that have compelled us to re-evaluate our regulations on serving sizes and determine whether and what, if any, revisions are needed to ensure that the Nutrition Facts label meets its intended goal of helping consumers maintain healthy dietary practices. Specifically, such developments include the availability of newer consumption data; research showing that amounts of food consumed by the American public have changed; and the availability of recent consumer research on the use and understanding of the Nutrition Facts label. In consideration of these new developments, this rule proposes a number of changes to our regulations in §§ 101.9 and 101.12. In consideration of the new consumption data, this rule proposes to amend the reference amounts customarily consumed (RACCs) that are used to determine serving sizes consistent with section 403(q)(1)(A)(i) of the FD&C Act, which states that a serving size is an amount of food customarily consumed. Additionally, in consideration of recent consumption data, research on consumption, and research on consumer understanding of the Nutrition Facts label, this rule proposes to amend some of the required procedures used to determine serving sizes, proposes to amend the definition of a single serving container, and also proposes to require that certain containers of foods bear an additional column of nutrition information to help consumers understand the nutritional significance of consuming an entire container of certain foods containing multiple servings. Overall, the proposals in this rule are designed to ensure that serving sizes are based on current consumption data, as well as to provide consumers with information on the nutrition facts label, related to the serving size, that will help them maintain healthy dietary practices. Summary of the Legal Authority The NLEA amended the FD&C Act to provide FDA with the authority to require nutrition labeling on most packaged foods regulated by the Agency. Specifically, section 403(q)(1)(A)(i) of the FD&C Act requires, with certain exceptions, that food that is intended for human consumption and offered for sale bear nutrition information that provides a serving size that reflects the amount of food customarily consumed and is expressed in a common household measure that is appropriate to the food, and is our primary legal authority to issue the regulations in this proposed rule. Additionally, we are relying on section 2(b)(1)(A) of NLEA, which states that requirements in regulations issued under the authority of the NLEA, including serving size requirements, shall be “conveyed to the public in a manner which enables the public to readily observe and comprehend such information and to understand its relative significance in the context of a total daily diet.” Finally, we are also relying on the authorities in sections 701(a), 403(a)(1), and 201(n) of the FD&C Act (21 U.S.C. 371(a), 343(a)(1), and 321(n)) for amendments in this proposed rule. Under section 701(a) of the FD&C Act, we have authority to issue regulations for the efficient enforcement of the FD&C Act. Under section 403(a) of the FD&C Act, a food is deemed misbranded if its labeling is deemed false or misleading in any particular. Additionally, under section 201(n) of the FD&C Act, in determining whether or not a food is misbranded because its labeling is misleading, we must take into account not only representations made or suggested, but also the extent to which the labeling fails to reveal facts that are material in light of such representations or material with respect to consequences that may result from the use of the food. All of these authorities listed in this paragraph give us the authority to issue this proposed rule related to serving size labeling. Summary of the Major Provisions of the Proposed Rule Single-Serving Containers and Dual-Column Labeling Over the last 20 years, evidence has accumulated demonstrating that container sizes can influence the amount of food consumed. For containers of certain sizes, consumers are likely to eat the entire container in one sitting. For other container sizes, consumers may consume the container in one sitting or may consume the container over multiple sittings or share the container contents with other consumers. To address containers that may be consumed in a single-eating occasion, FDA is proposing that all containers, including containers of products with large RACCs (i.e., products with RACCs of at least 100 grams (g) or 100 milliliters (mL)), containing less than 200 percent of the RACC be labeled as a single-serving container. To address containers that may be consumed in one or more sittings, or shared, FDA is proposing that containers that contain at least 200 percent and up to and including 400 percent of the RACC be labeled with dual-column labels that include a column of nutrition information within the Nutrition Facts label that lists the quantitative amounts and percent Daily Values (percent DVs) for the entire container, as well as the preexisting required column listing the quantitative amounts and percent DVs for a serving that is less than the entire container (i.e., the serving size derived from the RACC). Changing the Reference Amounts Customarily Consumed (RACCs) FDA established RACCs in 1993 based, in part, on data from Nationwide Food Consumption Surveys (1977-1978 and 1987-1988) conducted by the U.S. Department of Agriculture (USDA). Over the last decade, there has been general recognition that consumption patterns have changed. To determine changes in serving sizes and whether the RACCs should be updated, FDA has analyzed recent food consumption data from the National Health and Nutrition Examination Surveys (NHANES) (2003-2008 surveys). 1 Generally, changes to the RACCs are proposed in this rule if the NHANES median consumption data have increased or decreased by at least 25 percent compared to the 1993 RACCs. However, consistent with our regulations in § 101.12(a), we are also considering other factors, such as designating the same RACCs for products with similar consumption data and similar dietary usage or product characteristics. 1 Hereinafter referred to as the NHANES 2003-2008 surveys or NHANES 2003-2008 consumption data, as applicable. In addition, since the final rule on serving sizes published in 1993, we have received requests from manufacturers to modify, establish and identify appropriate product categories within the tables in § 101.12(b), and change the serving size for various food products. Using the data currently available to us, we are also addressing these requests in this proposed rule. Technical Amendments We have been alerted to a number of technical amendments that should be made to the serving size regulations in §§ 101.9 and 101.12. This rule proposes a number of technical amendments to help clarify the serving size requirements in these regulations. Effective Date We are proposing an effective date of 60 days after the date of the final rule's publication in the Federal Register with a compliance date 2 years after the effective date. Costs and Benefits We have developed one comprehensive preliminary regulatory impact analysis (PRIA) that presents the benefits and costs of this proposed rule as well as the proposed rule entitled “Food Labeling: Revision of the Nutrition and Supplement Facts Labels”. The PRIA analyzes the costs and benefits of both the major changes proposed by the rules (i.e., those proposals that would require the manufacturer to undertake a re-design of their label), as well as the minor changes proposed by the rules (i.e., those proposals that would not require a label re-design). The cumulative impact of these two nutrition labeling proposals, assuming a two-year compliance period and taken as a whole, is shown in the following table. Summary of Costs and Benefits Over 20 Years [In billions of 2011 $] Benefits Costs Net benefits Present Value (PV): 3% $31.4 $2.3 $29.1 7% 21.1 2.3 18.8 Annualized (3% PV Amount): 3% 2.0 0.2 1.8 Annualized (7% PV Amount): 7% 1.9 0.2 1.7 Notes: Compliance period is 24 months. Costs include relabeling and reformulation costs, which are one-time costs, as well as recordkeeping costs, which recur. Present values of relabeling and reformulation costs are equivalent at 3 or 7 percent because we conservatively assume that these one-time costs are incurred upon publication of the rule instead of at the end of the compliance period. Recordkeeping costs, because of their recurring nature, differ by discount rate; however, such costs comprise a very small percentage of total costs. I. Background A. The Serving Size Regulations On November 8, 1990, the Nutrition Labeling and Education Act (the NLEA) was signed into law (Pub. L. 101-535). The NLEA amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act), and together with FDA's implementing regulations, established mandatory nutrition labeling for packaged foods to enable consumers to make more informed and healthier food product choices in the context of their daily diet. Section 403(q)(1)(A)(i) of the FD&C Act (21 U.S.C. 343(q)(1)(A)(i)) requires that most foods under FDA's jurisdiction bear nutrition information that provides a serving size that reflects the amount of food customarily consumed per eating occasion and is expressed in a common household measure appropriate to the food. Section 2(b)(1)(B) of the NLEA also required that we issue regulations that establish standards to define serving size. To implement the serving size requirements of the NLEA, FDA conducted notice-and-comment rulemaking (56 FR 60394, November 27, 1991 (the 1991 serving size proposed rule), and 58 FR 2229, January 6, 1993 (the 1993 serving size final rule)). FDA also published technical amendments to the 1993 serving size final rule on August 18, 1993 (58 FR 44039) (the 1993 technical amendments). Consistent with the FD&C Act, the serving size regulations established standards to define “serving size” that are composed of two basic elements: (1) Reference amounts customarily consumed (RACCs or reference amounts) per eating occasion for specific food product categories; and (2) procedures for determining serving sizes for use on product labels derived from the RACCs. The second element was necessary because the RACCs are provided primarily in metric units (based on data from national food consumption surveys that are expressed in grams); however, the FD&C Act requires that serving sizes be expressed in common household measures that are appropriate to the particular food. Section 101.9(b)(1) (§ 101.9(b)(1)) defines the term “serving or serving size” to mean an amount of food customarily consumed per eating occasion by persons 4 years of age or older, which is expressed in a common household measure that is appropriate to the food. When the food is specially formulated or processed for use by infants or by toddlers, a serving or serving size means an amount of food customarily consumed per eating occasion by infants up to 12 months of age or by children 1 through 3 years of age, respectively. Section 101.12(a) (§ 101.12(a)) describes the general principles and factors that we considered in arriving at the RACCs. Among these principles, we sought to ensure that foods that have similar dietary usage, product characteristics, and customarily consumed amounts have a uniform reference amount customarily consumed (RACC or reference amount) so that consumers could make nutritional comparisons of similar products in the marketplace. In § 101.12(b), we established RACCs (upon which label serving sizes are to be determined) for 129 product categories representing the general food supply and 11 product categories of foods for infants and children 1 through 3 years of age. The current RACCs represent the amount of food customarily consumed per eating occasion for each product category, and were derived primarily from data obtained from the 1977-1978 and 1987-1988 Nationwide Food Consumption Surveys (NFCS) conducted by the U.S. Department of Agriculture (USDA) (58 FR 2229 at 2236-2237). We reviewed food consumption data for the foods in each product category and considered three statistical estimates: The mean (average), the median (50th percentile), and the mode (the most frequent value). For the 1993 serving size final rule we followed the procedures discussed in the 1991 serving size proposed rule (56 FR 60394 at 60403-60406) and the general principles discussed in § 101.12, and determined the RACC that was most likely to represent the amount customarily consumed for each product category. Section 101.9(b) establishes procedures for converting RACCs into appropriate label serving sizes. Section 101.9(b)(6) defines the criteria for products to be labeled as single-serving containers. Generally, products packaged and sold individually that contain less than 200 percent of the applicable RACC must currently be labeled as one serving. An exception to this rule occurs for products that contain more than 150 but less than 200 percent of the RACC and that have a RACC of 100 grams (g) or 100 milliliters (mL) or larger. In this case, the product may be labeled as one or two servings, at the manufacturer's discretion. For example, the RACC for carbonated beverages is 240 mL (i.e., 8 fluid (fl) ounces (oz)). Containers of carbonated beverages that are 360 mL (i.e., 12 fl oz, 150 percent of 240 mL) or less must be labeled as a single serving. Containers of carbonated beverages weighing more than 360 mL and less than 480 mL (i.e., more than 12 fl oz, 150 percent of 240 mL, and less than 16 fl oz, 200 percent of 240 mL) may be labeled as “1 serving” or as “2 servings” per container. For products packaged and sold individually that contain 200 percent or more of the RACC, the manufacturer may currently label the product as a single-serving if the entire content of the container can reasonably be consumed at a single-eating occasion (§ 101.9(b)(6)). Under § 101.9(b)(11), manufacturers must provide a second column of nutrition information for products that are promoted on the label, labeling, or advertising for a use that differs in quantity from the RACC by 200 percent or greater from the use upon which the reference amount was based (e.g., liquid cream substitutes promoted for use with breakfast cereals). The second column of nutrition information is based on the amount customarily consumed in the promoted use. Manufacturers may also voluntarily provide a second column of nutrition information per 100g or 100 mL, or per 1 oz or 1 fl oz of the food as “packaged” or “purchased” (§ 101.9(b)(10)(i)) and per cup popped for popcorn in a multi-serving container (§ 101.9(b)(10)(iii)). Additionally, manufacturers may voluntarily provide a second column of nutrition information on the Nutrition Facts label per one unit if the serving size of a product in discrete units in a multi-serving container is more than one unit (§ 101.9(b)(10)(ii)). For example, the RACC for muffins is currently 55 g. Under § 101.9(b)(10)(ii), if three muffins in a multi-serving container of six muffins weigh 18 g each, there are two options for the serving size declaration: (1) A label showing the serving size as “3 muffins (55 g),” with the Nutrition Facts label listing nutrition information per serving (i.e., 3 muffins); or (2) a label with the Nutrition Facts label listing again the nutrition information per serving (i.e., 3 muffins), but also with an additional column listing the nutrition information per “1 muffin (18 g),” which would be less than one serving. Dual-column labeling may also be used to present nutrition information for two or more forms of the same food (e.g., both “as purchased” and “as prepared”) under § 101.9(e). Additionally, if a food is commonly combined with other ingredients or is cooked or otherwise prepared before eating, under certain circumstances an additional column may be used to declare nutrition information on the basis of the food as “consumed” (§ 101.9(h)(4)). For example a dry ready-to-eat cereal may be described with one set of Percent Daily Values for the cereal as sold per ounce, and may use another for the cereal with milk (e.g., per ounce of cereal plus 1/2 cup of vitamin D fortified skim milk). B. The Obesity Working Group In August 2003, the Commissioner of Food and Drugs created the Obesity Working Group (OWG) and charged it to develop an action plan covering the critical dimensions of the obesity problem in America to help consumers lead healthier lives through better nutrition. The OWG was composed of professionals across FDA who provided a range of expertise in areas such as food labels, communication and education efforts, the role of industry and restaurants, and therapeutic interventions for obesity. A docket was established in July of 2003 (Docket No. FDA-2003-N-0161 (formerly Docket No. 2003N-0338)) (the “Obesity docket”) to accept comments on obesity-related issues. The OWG's final report entitled “Calories Count” (the “Calories Count” report) centered on the scientific fact that weight control is primarily a function of the balance of calories eaten and calories expended; and therefore, focused on a calories count emphasis for FDA actions (Ref. 1). A principal aspect of the Commissioner's charge was for the OWG to develop an approach for enhancing and improving the food label to help consumers prevent weight gain and reduce obesity. To address this issue, among other actions, the OWG recommended that we reexamine our serving size regulations by inviting comment on: (1) Whether to require food packages that can reasonably be consumed at one-eating occasion to declare the whole package as a single serving; (2) which, if any, RACCs of food categories need to be updated; and (3) whether to provide for comparative calorie claims for smaller portions of identical foods. C. The Advance Notice of Proposed Rulemaking On April 4, 2005, we published an advance notice of proposed rulemaking (ANPRM) (70 FR 17010) entitled “Food Labeling: Serving Sizes of Products That Can Reasonably Be Consumed At One Eating Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes.” The ANPRM was published in response to the “Calories Count” report. The ANPRM focused on the following topics, which are also discussed in this proposed rule: (1) Single-serving containers and dual-column labeling; (2) updating the RACCs; and (3) calorie comparison claims. We used the three topics of the ANPRM to structure this proposed rule. 1. Single-Serving Containers The ANPRM invited comment on topics that originated, in large part, from the OWG's activities. Several comments submitted to the Obesity docket strongly opposed the practice of individually packaged foods that appear to be single-serving containers, declaring two or more servings on the label—such as certain sodas and snack packages. In 2003, we initiated eight focus groups around the country and showed them examples of labels of a 20 fl oz soda and an individually packaged large muffin. Focus group participants thought these products should be labeled as single-serving products (Ref. 1). Many participants (though not all) did understand that if the entire package of food is eaten, the number of servings should be multiplied by the amount of the nutrient of interest; though some participants made mistakes when trying to calculate the total amount of nutrients (Ref. 2) To address problems identified from focus groups, the ANPRM discussed amending the definition of a single-serving container in § 101.9(b)(6) and providing an additional column in the Nutrition Facts label that would list the nutrition information for the entire package in addition to a column listing multiple servings for the package (70 FR 17010 at 17012). In the 1993 serving size final rule, we used the mean, median, and mode from food consumption surveys to determine the RACCs. In addition to these three statistical estimates (i.e., the mean, median, and mode), food consumption surveys allow calculation of intake estimates for individuals who eat a greater amount of food than average (e.g., those in the 90th and 95th percentiles). Because estimates can be calculated for individuals that eat a greater amount of food than average, in the ANPRM, we invited comment on whether the 90th and 95th percentiles could be used to determine the cutoff points at or below which nutrition information should be provided for the entire package (70 FR 17010 at 17013). We also sought comment in the ANPRM on the potential effects of requiring that manufacturers list the nutrient content for the entire package for certain package sizes (70 FR 17010 at 17013). 2. Updating the RACCs Because there is evidence that the U.S. population is eating larger portion sizes than it did in the 1970s and 1980s (Refs. 3, 4, 5, and 6), the OWG recommended that FDA determine whether to update the RACCs, and, if so, how to update the RACCs. The ANPRM recognized that changes to the RACCs, in most instances, would require changes to the serving size on products, which in turn would require changes to the nutrient values listed on the Nutrition Facts label (70 FR 17010 at 17012). Even if consumers are consuming larger amounts, we do not want consumers to confuse the serving size on the food label (which the FD&C Act requires to be based on the amount customarily consumed) with an amount that dietary guidance documents, such as the Dietary Guidelines for Americans (Ref. 7), recommend for consumption. For example, if data show that consumers are drinking larger amounts of carbonated beverages, and we increase the RACC for such beverages, which will likely increase the amount of the serving size on the label, additional educational efforts may be needed to reinforce to consumers that a larger serving size on the container is not a “recommended” serving size. The ANPRM invited comment on how recent consumption data should factor into the determination of which, if any, RACCs should be updated 2 and what criteria should be used as the basis for change (70 FR 17010 at 17012). We also invited comment on how we could make serving size information on the Nutrition Facts label easier for consumers to use when deciding what foods and how much of these foods to eat (70 FR 17010 at 17012). 2 We note that in this proposed rule, when we speak of “updates to” or “updating” the RACCs established in 1993, we are referring to amendments to RACCs for products that are currently listed in the tables in § 101.12(b), and for which the NHANES 2003-2008 consumption data showed a significant change in consumption (as discussed in the proposed amendments section, we have determined that an increase or decrease in consumption by at least 25 percent from the amount listed in the tables in § 101.12(b) would be considered a significant change). 3. Comparison of Calories in Foods of Different Portion Sizes As noted in the “Calories Count” report, the Federal Trade Commission had suggested that we consider “allowing food marketers to make truthful, non-misleading label claims comparing foods of different portion sizes (Ref. 1).” Our regulations discuss requirements to use certain characterizing terms to make comparative nutrient content claims (called “relative claims”) that compare the level of nutrients in two foods, including calorie comparisons, and require that all such comparisons be based on a uniform amount of food, i.e., per RACC for individual foods or per 100 g for meals and main dishes (see 21 CFR Part 101, Subpart D, and § 101.13(j)). Section 101.13(j) also requires that such comparisons made in “relative claims” reflect actual nutrient differences in the same quantity of similar foods (e.g., “Reduced calorie chocolate ice cream, 25 percent fewer calories than the leading brand of chocolate ice cream. The leading brand contains 150 calories per 1/2 cup serving. Our ice cream contains 100 calories per 1/2 cup serving”) or dissimilar foods within a product category that can be substituted for one another (e.g., “Reduced sodium pretzels, 33 percent less sodium than the leading brand of potato chips. Our pretzels contain 105 mg of sodium per serving. The leading brand of potato chips contains 320 mg of sodium per serving). The nutrient content claim regulations do not specifically discuss claims that compare the amount of calories based on different sized portions of the same food product. However, FDA's regulations do allow certain statements in the label or labeling of a food product about the amount or percentage of a nutrient in the food (see § 101.13(i)). As noted in the “Calories Count” report, “using the food label to promote consumption of smaller portions may have merit, particularly if consumers understand that: (1) The calorie reduction is solely a function of the reduction in portion size and, (2) the smaller portion size is actually less than what they usually consume.” Thus, the ANPRM invited comment regarding the appropriateness of label claims based on the amount of calories in a specified portion of a product (i.e., the amount of food specified by the claim, e.g., one 15 g cookie) versus claims based on the RACC and specified in the labeled serving size of a product (i.e., the amount specified on the Nutrition Facts label (e.g., two 15 g cookies)) (70 FR 17010 at 17013). 4. Overview of Comments on the Advance Notice of Proposed Rulemaking The ANPRM resulted in approximately 850 comments from health advocacy groups, industry, trade associations, consumer groups, individual consumers, government, health professionals, and academia. Not all of the comments received addressed the questions posed in the ANPRM, and many comments were outside the scope of the rulemaking. We discuss the comments within the scope of the ANPRM later in this proposed rule. D. Requests for Changes to Serving Size Requirements This section describes the six citizen petitions, as well as other documentation related to requests for changes to serving size requirements and requests for dual column labeling that will be addressed, in part, in this proposed rule. 1. Requests To Modify and Establish Certain RACCs and Add Products to Product Categories We have received several requests (Ref. 8), and six citizen petitions that are discussed in this document, to modify 3 the current RACCs for specific products that are already listed in the tables in § 101.12(b). We have also received several requests to establish 4 “new” RACCs for food products that are not listed in the tables in § 101.12(b) by adding “new” product categories to a general category or “new” products to a product category (Refs. 8, 9, and 10). We discuss these requests in sections II.D.3.b., II.D.6 and II.E. 3 We note that in this rule, when we speak of “modify” or “modifying” RACCs, we are referring to changes to existing RACCs in the tables in § 101.12(b) for which the NHANES 2003-2008 consumption data did not show an increase or decrease in consumption by at least 25 percent. 4 We note that in this rule, when we speak of “establish” or “establishing” RACCs, we are referring to the addition of products (and assigning RACCs for such products) that are not already listed in the tables in § 101.12(b). 2. Adding Products to the List of Products for Each Product Category In the 1991 serving size proposed rule, we provided as a reference (Ref. 20 of the 1991 serving size proposed rule) an extensive list that manufacturers could use, which included examples of products for a given product category (Ref. 11). The List of Products for Each Product Category was updated in the 1993 serving size final rule and we stated that we would revise the list as necessary (58 FR 2229 at 2241) and that those who were not sure about which product category their specific products belong to should refer to the list or consult us (58 FR 2229 at 2291). Copies of the list are available from the Office of Nutrition, Labeling and Dietary Supplements, Food and Drug Administration 5100 Paint Branch Parkway, College Park, MD 20740. Separately from this rulemaking, we are planning to update the list and make it available as draft guidance after the publication of this proposed rule. If finalized, the guidance document would be made available on our Web site. 3. Citizen Petitions a. Petition for Food and Beverages Sold in Single-Serving Containers On October 29, 2004, the Center for Science in the Public Interest (CSPI) submitted a citizen petition (Docket No. FDA-2004-P-0210, formerly Docket No. 2004P-0483) (the CSPI petition) ( http://www.regulations.gov/#!docketDetail;D=FDA-2004-P-0210 ). The CSPI petition claimed that trends of increasing sizes of snack foods and beverages make the current Nutrition Facts label on some products misleading for the average consumer. The CSPI petition discussed three groups of products: Soft drinks, snack food products, and baked goods. The CSPI petition claimed that larger package sizes for snack food products and soft drinks have led to increased consumption of these items, which contributes to the obesity epidemic. The CSPI petition requested that we improve the nutrition labeling in three areas for foods and beverages. Specifically, the CSPI petition requested that we: (1) Amend the definition of a single-serving container by increasing the cutoff for single-serving containers to include 300 percent of the applicable RACC for soft drinks/beverages and muffins/pastries; (2) consider whether the cutoff level for the single-serving labeling of other food categories should be raised; (3) require dual columns on the Nutrition Facts label on a per serving and per package basis for snack packages that contain at least 200 percent and up to and including 400 percent of the applicable RACC, if the snack package can be consumed by one person, but is often consumed by multiple people; (4) require snack packages that contain at least 200 percent and up to and including 400 percent of the applicable RACC to be labeled as a single serving if the package is usually consumed by one person; and (5) require disclosure on the principal display panel (PDP) of food labels for products that contain at least 200 percent and up to and including 400 percent of the applicable RACC of the number of servings in the package. We discuss issues raised in the first four requests from the CSPI petition in sections II.C.2.b and II.C.3.b. The fifth request for requiring disclosure on the PDP of food labels on the number of servings in the package for certain size packages is outside the scope of this rulemaking. b. Petition for a New RACC for Fruitcake We received a citizen petition (the fruitcake petition) on September 15, 2008, from certain fruitcake manufacturing companies (Docket No. FDA-2008-P-0511) ( http://www.regulations.gov/#!docketDetail;D=FDA-2008-P-0511 ), requesting that we exercise administrative discretion to establish 43 g (~1 1/2 oz) as the RACC for fruitcake rather than the current RACC of 125 g. The fruitcake petition provided labels, order forms, and other documents establishing that the fruitcake industry has been using 1 1/2 oz as a serving size. The fruitcake petition did not provide any consumption data to establish a RACC. We will be discussing issues raised in this citizen petition in section II.D.3.b. c. Petition for a New RACC for Yogurt On June 2, 2011, the National Yogurt Association (NYA) submitted a citizen petition (Docket No. FDA-2011-P-0440) (the NYA petition) ( http://www.regulations.gov/#!docketDetail;D=FDA-2011-P-0440 ), requesting that we change the existing RACC for yogurt from 225 g (roughly 8 oz) to 170 g (6 oz). Nutrient content claims and health claims for yogurt are based on the 8-oz RACC (§ 101.12(g)). According to the petition, over half of the yogurt containers on the market today are sold in 6-oz containers. However, manufacturers cannot make nutrient content claims and health claims for yogurt based on a 6-oz amount, because the 8-oz RACC must be used to determine if the criteria for the claims has been met (see § 101.12(g)). The NYA petition used current consumption data to justify their request for a smaller RACC. We discuss the issues in the NYA petition in section II.D.3.b. d. Petition for a New RACC for Mint Wafers and Similar Candy Products On February 17, 1996, we filed a petition submitted by the Nutrition Research Group for Andes Candies, Inc., (the Andes petition) (Docket No. FDA-1996-P-0309, formerly Docket No. 96P-0023) http://www.regulations.gov/#!searchResults;rpp=25;po=0;s=FDA-1996-p-0309;fp=true;ns=true . The petition requests that we amend the RACC for Andes mint wafers and products that are similar to Andes mint wafers. Specifically, the Andes petition requested that we: (1) Change the RACC for Andes mint wafers and similar products from 40 g (the current RACC for “All other candies”) to 15 g; and (2) amend the “Sugars and Sweets” product category for “Hard candies, others” to read “Hard candies, mint wafers and others”. The Andes petition provided data from a 1995 consumer study conducted by Andes to support a RACC of 15 g for Andes mint wafers. The Andes petition also stated that the USDA national food consumption data available at the time (1995) also supported a RACC of 15 g for Andes mint wafers. These data included the 1987-1988 NFCS and 1989-1991 Continuing Survey of Food Intake by Individuals (CSFII). e. Petition for a New RACC for Certain Candies Weighing 20 g or Less per Piece On May 30, 1996, the Chocolate Manufacturers Association (CMA) and the National Confectioners Association (NCA), trade associations representing chocolate and confectionary companies, jointly submitted a citizen petition (the CMA/NCA petition) to FDA (Docket No. FDA-1996-P-0246, formerly Docket No. 96P-0179) http://www.regulations.gov/#!searchResults;rpp=25;po=0;s=FDA-1996-P-0246;fp=true;ns=true . The CMA/NCA petition requested that we amend the “Sugars and Sweets” general category by establishing a new 25 g RACC for candies (other than hard candies or baking candies) weighing 20 g or less per piece. The CMA/NCA petition pointed out that the current 40 g RACC for “All other candies” encompasses a large variety of candy products, ranging from very small pieces weighing only a few grams each, to king-size candy bars and novelty items that can weigh more than a pound. CMA/NCA submitted data from two consumer studies to support their request for a new 25 g RACC. The CMA/NCA petition concluded that a smaller RACC for chocolate and non-chocolate candies (other than hard candies or baking candies) weighing 20 g or less was warranted, and would result in labels that provide more useful nutrition information to consumers. We discussed the Andes petition and the CMA/NCA petition in a proposed rule entitled “Food Labeling; Serving Sizes; Reference Amounts for Candies” on January 8, 1998 (63 FR 1078) (Docket Nos. FDA-1996-P-0309 and FDA-1996-P-0246 (formerly Docket Nos. 96P-0023 and 96P-0179)). Later, we announced the withdrawal of that proposed rule in the Federal Register on November 26, 2004 (69 FR 68831). Because we are updating, modifying, or establishing RACCs for all product categories in this proposed rule, we discuss the issues raised in the Andes petition and the CMA/NCA petition in this proposed rule. These issues are discussed in sections II.D.3.b and II.D.6., respectively. f. Petition for a New Product Category and New RACC for Small Breath Mints Weighing 0.5 g or Less We received a petition (the breath mints petition) dated April 20, 1994 (Docket No. FDA-1994-P-0314, formerly Docket No. 94P-0168) ( http://www.regulations.gov/#!documentDetail;D=FDA-1994-P-0314-0001 ) from Ferrero USA, Inc. requesting that we amend the product category for “Sugars and Sweets: Hard candies, breath mints” to create a separate product category for small breath mints (weighing 0.5 g or less) having the same breath-freshening capacity as larger mints. The breath mints petition explained that small breath mints weigh about 0.4 g each, and therefore the current RACC of 2.0 g is unrealistic for this product category because it means the serving size would be 5 mints. The breath mints petition emphasized that because consumers typically eat one breath mint at a time, the serving size for small breath mints should be “1 mint” and that the RACC for this product category should be 0.5 g. The breath mints petition contained study data collected from two telephone interviews with a randomly selected, nationally representative sample of consumers who acknowledged using breath mints during the past three months. The results of these studies, which included data on both small and large breath mint products, indicated that one breath mint was the amount customarily consumed per eating occasion by the majority of breath mint users. We also received two letters from breath mints manufacturers suggesting that breath mint products should have a “one mint” serving size (Refs. 12 and 13). We discussed the breath mints petition in a proposed rule entitled “Food Labeling; Serving Sizes: Reference Amount and Serving Size Declaration for Hard Candies, Breath Mints” on December 30, 1997 (62 FR 67775) (the 1997 breath mints proposed rule) (Docket No. FDA-1994-P-0314, formerly Docket No. 94P-0168). This proposed rule also discussed changing the rounding rules for calories to allow the nutrition label on any product with less than 5 calories per serving to optionally declare the exact amount of calories in lieu of zero calories. Because we are addressing issues related to the label serving size for breath mints, in conjunction with other serving size issues, in this proposed rule, we are withdrawing the 1997 breath mints proposed rule elsewhere in this issue of the Federal Register . E. Technical Issues Since the 1993 serving size final rule and the 1993 technical amendments were published, we have been alerted to several additional technical amendments that should be made. These technical amendments include: (1) Clarifying the rounding rules for products that have more than five servings when the number of servings fall exactly between two values; (2) clarifying options when the number of servings per container varies; (3) making minor corrections to the general and product category names; (4) making minor changes in the footnotes to the tables in § 101.12(b); (5) making minor changes to Table 2 in § 101.12(b); (6) making minor corrections and clarifications to the rules for reference amounts for products that require further preparation (e.g., mixes); and (7) clarifying the rules for reference amounts for products that consist of two or more separate foods that are packaged together and are intended to be eaten together (e.g., pancake and syrup). These amendments are discussed in section II.F. II. The Proposed Rule A. Legal Authority/Statutory Directive Our primary legal authority to issue regulations that establish requirements for serving size is derived from section 403(q) of the FD&C Act. Specifically, section 403(q)(1)(A)(i) of the FD&C Act requires, with certain exceptions, that food that is intended for human consumption and offered for sale bear nutrition information that provides a serving size that reflects the amount of food customarily consumed and is expressed in a common household measure that is appropriate to the food. The NLEA added section 403(q)(1)(A)(i) to the FD&C Act, and, under section 2(b)(1)(B) of NLEA, required that we issue regulations that establish standards to define serving size. We established those standards in the 1993 serving size final rule, and at this time we have determined that amendments to those regulations are needed. We have analyzed consumption data for various food products, and have determined that many of the RACCs established in 1993 have changed enough to warrant amending the current RACCs. Additionally, both on our own initiative and in response to various requests, we have analyzed data for products that are not currently listed in the tables in § 101.12(b), and are proposing to establish additional RACCs. Thus, in accordance with section 403(q)(1)(A)(i) of the FD&C Act, we are proposing to amend the RACCs in § 101.12(b) to reflect the current amounts customarily consumed for products that are already listed in § 101.12(b), as well as those not currently listed in § 101.12(b). Additionally, under the same authority we are proposing to amend related regulations in §§ 101.9 and 101.12 that set forth procedures for determining serving sizes for use on product labels from the reference amounts. Included among these proposed amendments are revisions to the procedures for determining what products must be labeled as a single serving. Further, in addition to requiring FDA to issue regulations that establish standards to define serving size, section 2(b)(1)(A) of NLEA states that the regulations shall require such information to be “conveyed to the public in a manner which enables the public to readily observe and comprehend such information and to understand its relative significance in the context of a total daily diet.” Under this authority, we are proposing to amend § 101.9 to require that certain products provide an additional column within the Nutrition Facts label that lists the quantitative amounts of the required nutrients and food components, and percent DVs for such nutrients and food components, for the entire container or unit of food as well as the preexisting columns listing the quantitative amounts and percent DVs for a serving of food that is less than the entire container. Section 2(b)(1)(A) of the NLEA provides authority for this proposed amendment because the additional column of information will help consumers to understand the nutritional significance of consuming an entire container or unit of certain foods containing multiple servings in the context of a total daily diet. As is discussed further in section II.C.1., research has shown that package and portion size play a role in influencing the amounts that consumers eat, and that consumers can be confused about the amount of nutrients they consume in packages containing more than one serving but that could be consumed in a single eating occasion. The proposed amendment is intended to help consumers understand the amounts of nutrients in certain containers and units of food, as well as the DVs for those nutrients, so that those amounts can be taken into consideration when evaluating a daily diet. Other relevant authorities that we are relying on for the proposed amendments in this rule include sections 701(a), 403(a)(1), and 201(n) of the FD&C Act (21 U.S.C. 371(a), 343(a)(1), and 321(n)). Under section 701(a) of the FD&C Act, we have authority to issue regulations for the efficient enforcement of the FD&C Act. We may issue regulations for the efficient enforcement of the FD&C Act in order to “effectuate a congressional objective expressed elsewhere in the Act” ( Association of American Physicians and Surgeons, Inc. v. FDA, 226 F. Supp. 2d 204 (D.D.C. 2002) (citing Pharm. Mfrs. Ass'n. v. FDA, 484 F. Sup. 1179, 1183 (D. Del. 1980). Under section 403(a) of the FD&C Act, a food is deemed misbranded if its labeling is deemed false or misleading in any particular. Additionally, under section 201(n) of the FD&C Act, in determining whether or not a food is misbranded because its labeling is misleading, we must take into account not only representations made or suggested, but also the extent to which the labeling fails to reveal facts that are material in light of such representations or material with respect to consequences that may result from the use of the food. These other authorities, in addition to the authorities described previously in this document, give us the authority to issue this proposed rule related to serving size labeling. B. Need for This Regulation Since we adopted the Nutrition Facts and Supplements Facts labels, there have been developments that have compelled us to re-evaluate our regulations on serving sizes and determine whether and what, if any, revisions are needed to ensure that the Nutrition Facts label meets its intended goal of helping consumers maintain healthy dietary practices. Specifically, such developments include the availability of newer consumption data; research showing that the amount of food consumed by the American public has changed; and the availability of recent findings of consumer research on the use and understanding of the Nutrition Facts label. In light of these factors, we propose to amend the serving size regulations to provide consumers with information, including the serving size, in order to help them maintain healthy dietary practices. These factors are discussed in sections II.C.1 and II.D.1. The proposed amendments are important because poor dietary practices have public health impacts (Refs. 14, 15, 16, 17, 18, and 19). Since 1993, there has been a shift in the population prevalence of being overweight or obese among the U.S. population. The U.S. Centers for Disease Control and Prevention (CDC) identifies as overweight an adult whose body-mass index, or BMI (defined as weight in kilograms divided by the height in meters squared), is between 25 and 29.9. CDC defines an obese adult as a person 20 years of age or older whose BMI is 30 or above (Ref. 16). CDC data indicate that 68 percent of the adult U.S. population is overweight or obese, including 34 percent who are considered obese (Ref. 14). The prevalence of obesity in the United States has increased dramatically in the past 30 years. In the 1976-1980 NHANES II data, 15 percent of participants were obese, while in the 2007-2008 NHANES data, 34 percent of people were obese (Refs. 14 and 15). The primary risk factors for overweight and obesity in the general population are overconsumption of calories (i.e., eating more calories than are needed to maintain body weight) and physical inactivity (i.e., getting an amount of exercise below the amount required to burn excess calories consumed over the amount needed to maintain body weight) (Ref. 7). For adults, being overweight or obese increases the risk for a number of chronic diseases, including coronary heart disease, type 2 diabetes, stroke, hypertension, arthritis, and certain types of cancer (Ref. 16). A BMI over 35 is associated with excess mortality, primarily from cardiovascular disease, diabetes, and certain types of cancer (Refs. 14, 17, and 19). Heart disease, cancer, and, stroke account for more than 50 percent of all deaths in the United States each year (Ref. 18). In 2005, 133 million Americans (almost one out of every two adults) had at least one chronic illness (Ref. 18). In addition, portion sizes of foods served at home and in restaurants have increased. The package or portion sizes of foods purchased at supermarkets, stores, fast food restaurants, and chain restaurants were two to eight times larger than serving size standards set by Federal Agencies, including the USDA's Food Guide Pyramid and FDA's serving size standards, based on RACCs (Ref. 4). This change has been especially true for portion sizes of salty snacks, soft drinks, fruit drinks, and some fast foods (Ref. 6). Studies have shown that increases in package size and portion size are related to higher calorie intake among individual consumers and overconsumption in American culture (Refs. 20, 21, 22, 23, and 24). In a study conducted by Rolls et al., participants were given afternoon snacks in prepackaged containers with varying portion sizes. They were given dinner later in the day to determine the effects of varying snack sizes on the subsequent meal. Study results showed that snack intake increased significantly as the package size increased. In most cases, participants did not significantly reduce intake at dinner to compensate for the increased calorie intake from the snack, and overall combined calorie intake from the dinner and snack increased when subjects were given larger snack packages (Ref. 21). The primary risk factors for overweight and obesity in the general population are overconsumption of calories and physical inactivity (Ref. 7). Therefore, it is significant that increased package and portion size may contribute to increase consumption of total calories. In consideration of all of the previously-mentioned factors, amendments to the serving size requirements are necessary to help consumers maintain healthy dietary practices. These amendments are described in sections II.C.2.b, II.C.3.b, II.D.2.c, II.D.3.b, and II.F. We invite comments on all aspects of this proposed rule, including the amendments described in these sections. C. Single-Serving Containers and Dual-Column Labeling FDA regulations require that a product that is packaged and sold individually and that contains less than 200 percent of the applicable RACC be considered to be a single-serving container, and that the entire content of the product be labeled as one serving, except that, for products that have RACCs of 100 g or 100 mL or larger, manufacturers may decide whether a package that contains more than 150 percent, but less than 200 percent of the RACC, will be labeled as 1 or 2 servings (§ 101.9(b)(6)). In the 1991 serving size proposed rule, we proposed to set the upper limit of a single-serving container at “less than 200 percent,” in part, because products that contain 200 percent of the reference amount are, by definition, two servings. Thus, they are not single servings (56 FR 60394 at 60398). A reference amount is an amount customarily consumed (section 403(q)(1)(A)(i) of the FD&C Act). The RACCs we established are based primarily on nationally representative food consumption data and represent the amount of a food that a U.S. individual customarily consumes per eating occasion. Thus, if a product contains 200 percent or more of the applicable RACC, this amount would be twice as much as the customarily consumed amount per eating occasion. Section 101.9 provides various provisions for types of voluntary dual-column labeling (e.g., § 101.9(b)(10)(i)) and one provision for mandatory dual-column labeling under certain circumstances (§ 101.9(b)(11)). As explained in detail in this document, we are amending § 101.9(b) to change the criteria for when a food product must be labeled as a single serving, and to require the use of dual-column labeling that provides nutrition information per serving and per container, or per serving and per unit of food under certain circumstances. 1. Research Related to Single-Serving Containers and Dual-Column Labeling a. Research on the Impact of Package and Portion Sizes on Consumption Research has shown that package and portion sizes have a considerable impact on the amount of food consumed, and that the size of the unit of food or package can set a consumption norm for consumers (Refs. 25 and 26). In one study, moviegoers were given either medium or large containers of popcorn that were either fresh or stale (Ref. 25). Study results showed that moviegoers who were given fresh popcorn in larger containers ate 45.3 percent more popcorn than those given medium containers of fresh popcorn. Moviegoers who were given stale popcorn in large containers still ate 33.6 percent more popcorn than those given medium containers even though they reported that they disliked the popcorn (Ref. 25). In another study, subjects were given four different sizes of a deli sandwich, which were 4-inches, 6-inches, 8-inches and 12-inches. The results show that increasing the portion size of a food in a discrete unit, such as a sandwich had a significant effect on calorie intake (Ref. 26). These and other studies have demonstrated that the size of the package or unit may implicitly suggest what might be construed to be a “normal,” or “appropriate,” amount of food to consume (Refs. 20, 25, and 26). Using young adults enrolled at one university, another study found that participants experienced portion distortion (perceiving large portion sizes as appropriate amounts to eat at a single-eating occasion) and needed guidance in monitoring how much they ate (Ref. 27). Studies have also shown that some consumers may tend to experience a “unit bias,” and view intact units/packages of food as a marker of the appropriate amount of food to consume (Ref. 28). b. Research on Consumer Use and Understanding of the Serving Size Labeling Research also suggests that many consumers do not correctly calculate nutrient amounts in food products by multiplying the nutrient amount by the number of servings per container. A review article of studies on nutrition labels in the United States, Canada, and Northern Europe has found that although consumers could understand some information, they reported finding nutrition labeling confusing, especially the use of numerical information (Ref. 28). One study looked at participants of different socioeconomic backgrounds (Ref. 29). It found that only 32 percent of study participants could correctly calculate the amounts of carbohydrates in a 20 oz bottle of soda that had 2.5 servings in the bottle. Only 60 percent of participants could correctly calculate the amount of carbohydrates consumed if they ate half a bagel, when the serving size was a whole bagel (Ref. 29). Common errors found in the study were that participants: (1) Did not attempt to apply the serving size or servings per container information, or used it inappropriately; (2) were confused by complex information on the label; and (3) had calculation and other errors. Similar results were reported in the “Calories Count” report. Although some focus group participants knew how to correctly multiply by the number of servings to calculate nutrition information per package, others were confused or made mathematical mistakes (Ref. 2). Other research conducted suggests that individuals might not make the distinction between serving size labeling and total package nutrition information, which could result in consumers considering the entire package as one serving despite the declaration of multiple (e.g., 2) servings per container on the Nutrition Facts label. For example, in one study, participants were interviewed to determine whether they could calculate the total calories in sample snack food packages that contained two to three servings (Ref. 30). Ninety percent of the subjects correctly identified the number of calories per individual serving, but only 37 percent were able to recognize the number of calories per package (Ref. 30). Some subjects tended to think of the multiple-serving package as one serving, and they underestimated and under-reported caloric intake from snack food sources (Ref. 30). c. Research on Dual-Column Labeling Other research has shown that dual-column labeling with the nutrition information given per serving and per package may help certain consumers recognize nutrient amounts per package in certain types of packaged foods (Ref. 31). In one study, participants were given a snack food product and either a single-column nutrition label or dual-column nutrition label (i.e., labeling indicating the nutrition information per serving and per package). Participants were classified as either dieters or non-dieters based on self-reported dieting behavior. Study results found that a dual-column label reduces snack food consumption when compared to a single-column labeling for people who are not currently dieting. When the dual-column label was used, non-dieters in the study ate smaller portions that were closer to those portions consumed by dieters. The authors of this study speculated that a dual column label works as a contextual cue that raises awareness of the amount of food consumed in a package among certain consumers (Ref. 31). We will be conducting consumer research throughout this rulemaking. The overall goal of the consumer research is to help enhance our understanding of whether and how much modifications to the label format may help consumers use the label. The research conducted thus far has examined the effects of modifications to the Nutrition Facts label on foods that could reasonably be consumed at a single-eating occasion, but were sometimes listed as having more than one serving per container, such as a grab bag of chips or a frozen meal. Participants were randomly assigned to one of ten label formats that could be classified into three groups: Listing two servings per container with a single column (“two-serving single-column labels”), listing two servings per container with a dual-column that listed the nutrients in both “per serving” and “per container” columns (“dual-column labels”), and declaring the entire package as one serving and listing all of the nutrients as a single serving (“single serving per container labels”). The study compared participants' ability to perform various tasks, such as evaluating product healthfulness and calculating the number of calories and other nutrients per serving and per container, when using the current label versus modified versions of the current label, and compared participants' overall attitudes toward these labels. The main findings are that single serving per container labels and dual-column labels resulted in more participants correctly identifying the number of calories per container and the amount of other nutrients per container and per serving compared to two-serving single-column labels (such as the current label). Overall, participants reported more positive attitudes toward single-serving and dual-column labels in comparison to two- serving single-column formats (Ref. 32). 2. Single-Serving Containers a. Comments on the ANPRM Regarding Single-Serving Containers Amending the Definition for Single-Serving Containers The ANPRM invited comment on whether we should begin rulemaking to require packages that can reasonably be consumed at one-eating occasion to provide the nutrition information for the entire package (70 FR 17010 at 17013). Most comments indicated that we need to address the labeling of packages that appear to be single-serving packages, but are actually labeled as containing multiple servings, which they considered to be “fraudulent” and “deceitful.” Many comments stated that manufacturers should not be allowed to list multiple servings for items that an average person would consume at one-eating occasion. Examples of such items consumed at one-eating occasion that commenters thought to be misleading included 16 and 20 oz bottles of carbonated beverages, canned soup, snack size packages of potato chips, corn chips and pretzels, individual packs and cans of fruit juice, microwave popcorn, canned chili and ravioli, packages of shelled nuts, iced tea, frozen entrees and meals, energy drinks, 5-inch pizzas, dairy beverages, pre-packaged lunches, vending machine items, pre-packed breakfast cereals, cookies, and crackers. Many comments also objected to the use of fractional portions when declaring the numbers of servings for these products (i.e., 2.5 servings) and noted that we should require nutrition labeling for the entire package for products that could reasonably be consumed at one-eating occasion. One comment understood the listed serving sizes to be recommendations, rather than amounts customarily consumed, and stated that serving sizes such as a single sandwich divided into 2 servings, a single muffin divided into 3 servings, or a single bag of chips sold as a side to sandwiches divided into 2 servings were very confusing and unrealistic. We agree, in part, with comments that opposed individually packaged foods that appeared to be single-serving containers, but which declared two or more servings on their package labels. We agree that these types of packaged foods can be confusing to consumers; however, we do not agree that all of these products should be labeled as a single serving. As discussed in detail below, these types of products should provide nutrition information for the whole package, as the only column of nutrition information for some products, or with dual-column labeling for other products, which would provide nutrition information per serving and per container or per unit, as applicable. As discussed in section II.C.1.a., scientific evidence has shown that some consumers may tend to experience a “unit bias,” and view certain sizes of intact units/packages of food as a marker of the appropriate amount of food to consume, and thus consumers should be provided with nutrition information for the amount of calories and nutrients that they might reasonably consume in an individual package or unit (Refs. 25, 26, 30, and 33). Several comments noted that requiring larger products that could be eaten in a single serving to include nutrition information for the entire package could be problematic or confusing to consumers in that the labels may encourage overconsumption. We disagree with comments suggesting that providing nutrition information for the entire package would be problematic or confusing to consumers on the grounds that the labels may encourage consumers to eat more. In an FDA-commissioned study (Ref. 32), participants who viewed nutrition information for a food labeled as a single serving container tended to rate the products as less healthful on average than participants who viewed nutrition information for the same food declared as a two-serving product. As noted in a recent literature review (Ref. 34), people often expect that they can eat more of foods that they perceive as healthful. Research has shown that when smaller serving sizes were used to present nutrition information, participants were led to believe that they would experience less guilt after consuming the entire package and reported that they would be more likely to purchase these products than when nutrition information for the same products was declared using a larger serving size (Ref. 34). In light of the findings from FDA's research, which suggest that providing nutrition information for an entire package of a food that would be consumed in a single eating occasion could result in more discerning product judgments, and the conclusions by Chandon and Wansink (Ref. 34), the data to date suggest that providing nutrition information for the entire package would provide consumers with more accurate information about the nutritional significance of foods that are likely to be consumed in a single eating occasion. Therefore, FDA disagrees that providing nutrition information for the entire package would be problematic or confusing to consumers or encourage overconsumption. Finally, one comment indicated that the current nutrition labeling format and the criteria to define a single-serving container should be maintained because this would allow manufacturers flexibility to respond to their markets. We disagree with the comment that states that the current criteria used to define a single-serving container should be maintained because it adds more “flexibility to respond to their markets.” The comment did not explain what it meant by “flexibility to respond to their markets” or why changes to the criteria used to define a single-serving container would not provide such flexibility. As is discussed in detail in the following section, the current criteria for the labeling of certain products as single-serving containers in § 101.9(b)(6) are not consistent with the current consumption data. Criteria for Determining When a Product Is a Single-Serving Container The ANPRM invited comment on the criteria we should use to determine which multi-serving products would require nutrition information for the entire package (70 FR 17010 at 17013). We also asked whether the criteria should be based on the total amount in the container, the types of food, or something else, and whether the current criteria to define single-serving containers should be changed (70 FR 17010 at 17013). Most comments stated that single-serving labeling should be used even if a serving size is 200 percent or more of the applicable RACC when evidence indicates the product rarely is eaten by more than one person or at more than one time. Several other comments pointed out that factors such as whether a product is ready to eat, how the product is packaged (e.g., packaged in a re-sealable container), and how the food is presented by the media are relevant to determining whether a package is truly a single serving. Another comment stated that single-wrapped items, such as muffins or pastries, where the item is not divided should not be labeled as multiple servings. Several comments stated that foods containing one to three servings or less, regardless of the food, should list the nutrient information for the entire package (alone or with another column listing the nutrient information per serving). Another comment stated that sodas, chips, and candy bars should be labeled as single-serving containers if a package contained three servings under the current labeling requirements, and in instances when the package contains more than three servings, the product should be labeled as family sized. One comment indicated that products containing and including 3.5 servings under the current labeling requirements should be labeled as a single-serving container. Another comment recommended that products containing two to four servings per container be labeled as a single-serving container for products that potentially could be consumed at a single-eating occasion. A comment also stated that if the food contained fewer than five servings, it should also have nutrition information provided per package. Lastly, a comment noted that allowing anything less than 200 percent of the RACC to constitute one serving was too high of a cutoff, which could cause confusion about the amount of a serving size and potentially encouraging overeating. The comment suggested that the cutoff for a single-serving container should be lowered to between 75 to 150 percent of the applicable RACC. We do not agree that single-wrapped items such as muffins and pastries, which are not divided for consumption, should always be labeled as single-serving containers. As explained previously in this document, products that contain 200 percent or more of the RACC by definition contain more than one serving, because they contain at least two times the amount that is customarily consumed. We also disagree with the comments that suggested the criteria for determining a single-serving container should be 200 percent or more of the RACC if the product is rarely eaten by more than one person, comments that suggested that the criteria should be 300 percent or less of the RACC, and with comments that suggested that the criteria should be 350 percent or less of the RACC. Products that contain 200, 300, or 350 percent of the RACC, by definition, contain 2, 3, or 3.5 servings, respectively, and thus are not single-serving containers. We also disagree that, in order to avoid encouraging overeating, the cutoff for a single-serving container should be lowered to between 75 to 150 percent of the RACC. Prior research has demonstrated that using smaller serving sizes to declare nutrition information may lead consumers to form more positive impressions of the nutritional attributes of foods than are warranted (Refs. 32 and 35). Therefore, we believe that lowering the cutoff for a single-serving container could increase the likelihood that the product would be perceived more positively, which in turn may encourage overeating. Further, as noted previously in section II.C.1.b., research shows that giving consumers nutrition information for the entire package will help them to more easily comprehend the nutrient amounts in the food. b. Proposed Amendments for Single-Serving Containers We are proposing to revise, in part, the definition of a single-serving container so that a product that is packaged and sold individually and contains less than 200 percent of the applicable RACC must be considered a single-serving container, and the entire content of the product must be labeled as one serving (proposed § 101.9(b)(6)) regardless of the size of the RACC of the product. Currently the definition of a single-serving container is a product that is packaged and sold individually and that contains less than 200 percent of the RACC. This provision, however, does not apply to products that have “large” RACCs (i.e., products that have reference amounts of 100 g (or mL) or larger). Manufacturers of these products may decide whether a package that contains more than 150 but less than 200 percent of the applicable RACC can be labeled as having one or two servings. See § 101.9(b)(6). We provided this qualification for products with large RACCs based in part on comments to the 1991 serving size proposed rule. We stated in the 1993 serving size final rule that we agreed with the comments that the 200 percent cutoff level may be too high for some products with large RACCs. Further, we stated that the reference amounts of these products are very large compared to many other products, and examination of food consumption data showed that the average variability (defined as the standard deviation as a percent of the mean) in the amount customarily consumed for foods having a reference amount of 100 g (or mL) or larger is about two-thirds of the variability for foods having a reference amount less than 100 g (58 FR 2229 at 2233). In other words, at that time, we concluded that it was much less likely that a person would consume approximately twice the reference amount of a food with a reference amount of 100 g (or mL) or more, than it was that he or she would consume approximately twice the reference amount of a food with a smaller reference amount. Therefore, in the 1993 serving size final rule, we concluded that, for those products that have reference amounts of 100 g (or mL) or larger, 150 percent is a more reasonable cutoff for a single-serving container. As a result of this, we revised § 101.9(b)(6) to allow manufacturers to choose whether to declare 1 or 2 servings in packages that contain more than 150 percent but less than 200 percent of the reference amount if the food in the package has a reference amount of 100 g (or mL) or larger. For this proposed rule, we examined the correlation between the consumption variation and the RACCs for all products containing less than 200 percent of the applicable RACC, including the products with large RACCs (i.e., those products with RACCs of at least 100 g or 100 mL) and products that have RACCs that are less than 100 g (or mL), using combined consumption data from the NHANES 2003-2008 surveys (Ref. 36). The consumption variation is calculated as the standard deviation of the median consumption amount divided by the median consumption amount and then multiplied by 100 and is expressed as the percent of the median consumption amount (Ref. 36). The result shows that the correlation coefficient is 0.18, which means that there is a low correlation between the RACCs (whether the reference amount is more than or less than 100 g or mL) and the consumption variation for all products containing less than 200 percent of the RACC, regardless of whether the RACC is “large” or not. In other words, it is not less likely that a person would consume approximately twice the reference amount of a food with a reference amount of 100 g (or mL) or more, than it is that he or she would consume approximately twice the reference amount of a food with a smaller reference amount. Therefore, the exemption from the requirement to label a product with a large RACC, and containing between 150 percent and 200 percent of the applicable RACC, as a single-serving container is no longer warranted. Additionally, raising the required cutoff for labeling a product with a large RACC as a single serving may help consumers to more accurately interpret the nutrient amounts in these products. As discussed in section II.C.1., research shows that consumers have trouble accurately calculating the nutrient amounts in the entire package of a food that is labeled as containing multiple servings, and research also shows that package size tends to have a considerable impact on the amount of food consumed. Therefore, removing the exemption from the requirement to label a product with a large RACC as a single-serving container may help consumers to correctly interpret the nutrient amounts in the amount of food that they are consuming. We are not proposing to change the current cutoff of less than 200 percent of the applicable RACC as the criterion for labeling a product as a single-serving container. Additionally, we are not proposing to increase the cutoff of less than 200 percent of the applicable RACC because, by definition, a product that contains 200 percent or more of the RACC means that it contains at least twice as much as the RACC and it is not a “single” serving container. Under section 403(q)(1)(A)(i) of the FD&C Act, a serving size is an amount customarily consumed. The RACCs we have established are reference amounts of food that are customarily consumed per eating occasion. As such, we do not consider it appropriate to label foods containing 200 percent or more of the applicable RACC as single-serving containers. Therefore, proposed § 101.9(b)(6) would remove the provision that products packaged and sold individually and containing 200 percent or more of the applicable RACC may be labeled as a single serving if the entire contents of the container can reasonably be consumed at a single- eating occasion. For consistency with the proposed changes to the definition of a single-serving container, we propose to remove § 101.9(b)(2)(i)(E), which provides that if a discrete unit of food contains more than 150 percent but less than 200 percent of the RACC, the manufacturer may decide whether to declare the individual unit as 1 or 2 servings, for units that have large RACCs of 100 g (or 100 ml) or larger and are individual units within a multi-serving container. Also consistent with the changes in proposed § 101.9(b)(6), we are proposing to remove the text in current § 101.9(b)(2)(i)(D), which states that if a unit weighs 200 percent or more of the RACC the manufacturer may declare one unit as the serving size if the entire unit can reasonably be consumed in one-eating occasion, and replace the text with the text in proposed § 101.9(b)(2)(i)(D) (which is discussed in section II.C.3.b). Finally, we also propose to redesignate § 101.9(b)(2)(i)(F) as § 101.9(b)(2)(i)(E), redesignate § 101.9(b)(2)(i)(G) as § 101.9(b)(2)(i)(F), redesignate § 101.9(b)(2)(i)(H) as § 101.9(b)(2)(i)(G), and redesignate § 101.9(b)(2)(i)(I) as § 101.9(b)(2)(i)(H), because the proposed rule would remove current § 101.9(b)(2)(i)(E). 3. Dual-Column Labeling—Mandatory Listing of a Second Column of Nutrient Values on the Nutrition Facts Label Based on the Entire Container or Unit a. Comments on the ANPRM Regarding Dual-Column Labeling Dual-Column Labeling Requirements The ANPRM invited comment on whether to require certain products to include an additional column within the Nutrition Facts label to list the quantitative amounts and percent DVs for the entire package, as well as the required columns listing the quantitative amounts and percent DVs for a serving that is less than the entire package (i.e., the serving size derived from the RACC) (70 FR 17010-17013). Some comments supported the use of dual-column labeling. One comment suggested dual-column labeling for products that may be consumed in their entirety at a single occasion, but often are shared or eaten over time. Several comments requested that we not require dual-column labeling on the packaging of all food products. These comments stated that any discussion of disclosing information per package should address only packages that potentially could be consumed by one person at a single-eating occasion or possibly shared between one or more persons. Other comments suggested that we provide dual-column labeling on all packages with multiple servings such as a family sized package of frozen lasagna. We agree with comments supporting a requirement for the use of an additional column of nutrition labeling (i.e., dual-column labeling) under certain conditions. As discussed in section II.C.1.c., research suggests that dual-column labeling helps consumers understand what the nutrient amounts are in an entire container of food. We also agree that dual-column labeling should be used for products that may be eaten by one individual in one-eating occasion or over several-eating occasions, but may also be eaten by multiple individuals. Information on the nutrient amounts in an entire container of food would not be as relevant to consumers if the food could not reasonably be consumed by one individual in a single-eating occasion. For this reason, we agree that it is unreasonable to require dual-column labeling on the containers of all food products. As discussed in this section, data show that products that contain more than 400 percent of the RACC are less likely to be consumed in one-eating occasion when compared to products that contain 400 percent or less of the RACC (Ref. 37). For this reason, we do not believe it is appropriate to require a second column of nutrient values on containers that contain more than 400 percent of the applicable RACC. Additionally, the proposed rule would not require dual-column labeling for bulk products that are used primarily as ingredients (e.g., flour, sweeteners, shortenings, oils); bulk products traditionally used for multi-purposes (e.g., eggs, butter, margarine); and multipurpose baking mixes, because labeling these products with nutrition information based on the entire container would not be consistent with how these products are typically consumed. We also do not agree with the comment that stated that dual-column labeling should be required for all multi-serving products, such as a family-sized package of lasagna. Products that contain more than 400 percent of the RACC are less likely to be consumed in one-eating occasion compared to products that contain 400 percent or less of the RACC (Ref. 37). Some comments opposed mandatory dual-column labeling. A few comments opposed dual-column labeling noting that it would require changes that could cost a significant amount of money for companies and would use up valuable package space that is often used for other types of nutrition education messages. These comments noted that dual-column labels would be difficult for products with small label space. Some comments suggested that dual-column labeling be voluntary and not mandatory. We agree that it may be difficult to fit an extra column of nutrition information on the labels of some products. However, many food packages, such as grab-size bags of chips, cookies, crackers, and frozen entrees that would be affected by the proposed dual-column labeling requirements provide enough space to accommodate a second column of nutrition information based on the entire container. We address the concern about providing dual-column labels for small products with a limited amount of space on the Nutrition Facts label in section II.C.3.b. We also agree that a dual-column labeling requirement would have some costs for industry. The costs of the proposed dual-column labeling requirement are addressed in section IV. Dual-Column Labeling and Consumer Understanding The ANPRM invited comment on how listing the nutrient amount per serving size and per package side-by-side in separate columns would affect consumers' ability to understand the Nutrition Facts label (70 FR 17010-17013). A few comments that objected to the use of dual-column labeling stated that the second column of values would be confusing to consumers or provide too much information, and would thus contribute to label clutter. Several comments noted that dual-column labeling may confuse the consumer in that it could imply to consumers that larger serving sizes were a recommended amount to consume and would have the opposite effect from what was intended and result in overconsumption. These comments also stated that consumers may not need, want, or understand why this information is on the label and how this quantity differs from a typical serving size. One comment noted that a problem with dual-column labeling was that consumers were unlikely to be interested in information provided in the second set of nutrition values and that the nutrition label format would become more complicated, potentially making the Nutrition Facts labels less friendly and manageable. None of these comments, however, provided data or information to support the possible consumer reactions identified. We are not convinced that dual-column labeling may be confusing to consumers and that dual-column labeling would imply that consumers should eat more of an item. In fact, as discussed in section II.C.1.c., research findings from a study suggest that dual-column labeling would lead consumers who are not dieting to reduce rather than increase the amount of food they consume as suggested by comments (Ref. 31). We also conducted a study (Ref. 32) to help enhance our understanding of whether and what types of modifications to the label format may help consumers use the label. The main finding was that single serving per container labels and dual-column labels resulted in more participants correctly identifying the number of calories per container and the number of other nutrients per container and per serving compared to two-serving single-column labels (such as the current label) (Ref. 32). One comment suggested that an appropriate and informative approach may be to have products that can be consumed in one-eating occasion provide both “Servings Per Package” and “Calories Per Package” near the top of the Nutrition Facts label. Finally, multiple comments noted that modifying the Nutrition Facts label would require consumer re-education on how to read an amended Nutrition Facts label. We tested a format similar to the one suggested in the comment, in which “Servings Per Package” and “Calories Per Serving” were in close proximity, in our consumer study (Ref. 32). The test format included a listing of “Calories in 1 cup serving” followed by the declaration of servings per container (i.e., “2 Servings per container”) near the top of the Nutrition Facts label (Label 4). Results from this study showed that dual-column labels were read with somewhat better accuracy when compared against labels that were similar to the one suggested in the comment. Based on these results, we do not agree with the comment. We agree with the comment that modifying the Nutrition Facts label would require some re-education on how to read the Nutrition Facts label. We consider it important to provide consumers with education and outreach on nutrition labeling. We will consider appropriate education methods after the publication of this proposed rule. Criteria for Determining Dual-Column Labeling The ANPRM did not address the criteria to be used to determine what types of products should require dual-column labeling. However, some comments provided criteria for the use of dual-column labeling on Nutrition Facts labels based on the quantity of food in the container. One comment suggested that dual-column labeling on the Nutrition Facts label could be required for products that contained 200 to 300 percent of the RACC, unless the Nutrition Facts label for the product provided a single column for the entire packaged amount. The comment further suggested that for products with RACCs of 100 g or 100 mL or greater, and that contain more than 150 percent but less than 200 percent of the RACC, dual-column labeling could be optional, similar to the existing requirement for the Nutrition Facts label declaration for single-serving containers. Finally, the comment suggested that dual-column labeling should not be required for products that: (1) Contain up to 150 percent of the RACC or (2) contained 5 calories or less per RACC and were not fortified. Another comment suggested that products with 2, 3, or 4 servings per container that are likely to be consumed at a single-eating occasion be required to add an additional column with a disclosure for calories per container at the top of Nutrition Facts label, just below the servings per container. Other comments requested that information based on the entire package be listed for products with up to five servings and that this information be provided in a second column of the label. In consideration of an upper limit for dual-column labeling, we looked at food consumption data from the NHANES 2003-2008 surveys. Dual-column labeling can, in part, provide information for products that may be consumed by one person in a single-eating occasion, but are oftentimes consumed by more than one person or in more than one-eating occasion. To determine an upper limit for these products, we looked at NHANES 2003-2008 consumption data (Ref. 37). Intake distribution per eating occasion for each product showed that for almost all products, regardless of the amount of the RACC, the ratio of the intake at the 90th percentile level to the RACC was 400 percent or less. Thus, the data suggest that 90 percent of the reported consumption amount is 400 percent of the RACC or less for almost all product categories, meaning that dual-column labeling for products with 400 percent or less of the RACC would capture the most frequent consumption habits for all product categories. Conversely, the data show that products that contain more than 400 percent of the RACC are less likely to be consumed in one-eating occasion compared to products that contain 400 percent or less of the RACC. An upper limit of 400 percent of the RACC for dual-column labeling would be consistent with the upper limit suggested in the CSPI citizen petition, which requested that we consider dual-column labeling for snack packages containing between 200 percent and up to and including 400 percent of the RACC. Given the consumption data, we do not agree with the comments that suggested thresholds for requiring dual-column labeling for products that contain 200 to 300 percent of the RACC or the comments that suggested that dual-column labeling be provided for up to five servings. As noted in the preceding paragraph, the data suggest that 90 percent of the reported consumption amount is 400 percent or less of the RACC for almost all product categories. Therefore, based on the consumption data, 300 percent of the RACC appears to be too low of a cutoff level for dual-column labeling and 500 percent is too high. We disagree with the comment that suggested that for products with RACCs of 100 g or 100 mL or greater, and that contain more than 150 percent but less than 200 percent of the RACC, dual-column labeling could be optional, similar to the existing requirement for the Nutrition Facts label declaration for single-serving containers. As noted previously in section II.C.2.b, current consumption data indicate that there is no difference in intake of large RACC products containing 100 g or 100 mL or greater and smaller RACC products. Therefore, there is no need to make a distinction for large RACC products. Additionally, we are proposing to require that all products that contain less than 200 percent of the RACC be labeled as a single serving. Therefore, a proposal for dual-column labeling for these packages is unnecessary, because the products would already contain nutrition information based on the amounts in the entire container under the proposed revisions to the single-serving requirements. We agree with the comment that suggested that dual-column labeling should not be required for products that contain up to 150 percent of the RACC. As noted previously in section II.C.2.b, we are proposing that all products packaged in containers with less than 200 percent of the RACC must be labeled as a single serving and have a Nutrition Facts label per container only. However, we disagree with the second part of the comment that suggested that dual-column labeling should not be required for products that contained 5 calories or less per RACC and were not fortified. If we were to adopt this provision, then this would allow for products, such as diet soft drinks, to be exempt from dual-column labeling. We believe that, for consistency purposes, dual-column labeling should apply to these products as well. This will allow consumers to view the same type of label and make an easy comparison when looking at different soft drinks. b. Proposed Amendments for Dual-Column Labeling We have carefully considered all available data, information, and comments for and against a second column of nutrient values based on the entire container and have concluded that mandatory labeling of a second column of nutrient values based on the entire container for containers that contain 200 percent and up to and including 400 percent of the applicable RACC is warranted. This will provide nutrition information for those who consume the entire container in one-eating occasion as well as those who consume the container over multiple-eating occasions or share the container with others. We base our conclusion, in part, on results of a consumer study we conducted that suggested that dual-column labels resulted in more participants correctly identifying the number of calories per container and the number of other nutrients per container and per serving compared to two-serving single-column labels (such as the current label) (Ref. 32). In addition, we are basing our conclusion, in part, on another study that suggested that dual-column labeling would lead consumers who are not dieting to reduce rather than increase the amount of food they consume (Ref. 31). This additional awareness is important in light of studies that indicate that package sizes influence the amount consumers consume (Refs. 21 and 25). We are proposing the cutoff of 400 percent for dual-column labeling based on our analysis of the intake distribution per eating occasion for all products. Based on this analysis, we concluded that for each product the ratio of the intake at the 90th percentile level to the RACC was 400 percent or less. As such, dual-column labeling for products 400 percent or less of the RACC would capture the most frequent consumption habits for all product categories. We propose a threshold of 200 percent of the applicable RACC to trigger the requirement for dual-column labeling, because under the proposed requirements discussed in section II.C.2.b., all products containing less than 200 percent of the RACC would be labeled as a single-serving container (proposed § 101.9(b)(6)). Therefore, products containing less than 200 percent of the RACC will already contain nutrient information based on the contents of the entire container. Consequently, we are proposing to add a new § 101.9(b)(12) which would require an additional column within the Nutrition Facts label to list the quantitative amounts and percent DVs for the entire container, to the right of the preexisting column listing the quantitative amounts and percent DVs for a serving that is less than the entire container (i.e., the serving size derived from the RACC), for products that are packaged and sold individually and contain at least 200 percent and up to and including 400 percent of the applicable RACC. For example, under the proposed amendment, a manufacturer would have to use dual-column labeling on a bag of chips that contained 3 oz (90 g) (about 300 percent of the RACC). A major advantage of the proposed approach of dual-column labeling is that it will not require math to determine nutrition information for consumers who consume the entire container in a single-eating occasion and will continue to provide nutrient information per RACC for consumers who do not consume the entire container in a single-eating occasion, and for consumers who share the product. Thus, easily understandable information will be provided for all types of consumers of these products. For an example of a dual-column label as described in this section, see the proposed codified of the “Food Labeling; Revision of the Nutrition and Supplement Facts Labels” proposed rule published elsewhere in this issue of the Federal Register . In addition to proposing dual-column labeling per serving and per container (or unit, as applicable) for all nutrition information on the label, we are considering two additional options that would require nutrition information per serving and per container for only certain declarations but not all label declarations for containers of food or units of food, as applicable, containing at least 200 percent and up to and including 400 percent of the applicable RACC. The first option is for a label that includes calorie information per serving and per container (or unit, as applicable) following the serving size information in the Nutrition Facts label. With this option, the remaining nutrition information would be listed on a per serving basis only and in a single column below the calorie information per serving and per container. The second option is to provide nutrition information per serving and per container (or unit, as applicable) for calories, saturated fat and sodium following the serving size information in the Nutrition Facts label and the remaining nutrition information would be listed on a per serving basis in a single column below the dual column provided for calories, saturated fat and sodium declarations. These options may specifically highlight the calorie content alone, and the calorie content, saturated fat content, and sodium content, respectively, for both the serving size and the entire container of food (or unit, as applicable). These options would focus on a smaller number of nutrients presented per serving and per container of food (or unit, applicable) that the U.S. population should limit for those foods with at least 200 percent and up to and including 400 percent of the RACC. We question whether consumers would be more inclined to use dual column labeling for a smaller set of nutrients. We invite comment and data on dual column-labeling as proposed in this rule as well as the options presented for providing nutrition information per serving and per container (or unit, as applicable) for only certain declarations. For consistency with proposed § 101.9(b)(12), the proposed rule would change § 101.9(b)(2)(i)(D). Section 101.9(b)(2)(i)(D), which applies to products in discrete units within a multi-serving container, provides that if a unit weighs 200 percent or more of the RACC, the manufacturer may declare the whole unit as the serving size if the whole unit can reasonably be consumed at a single-eating occasion. As noted previously, we are proposing to delete the current text in § 101.9(b)(2)(i)(D) and to replace it with text requiring that products that are discrete units within any size of a multi-serving container, and contain at least 200 percent and up to and including 400 percent of the applicable RACC (e.g., a container of six muffins where each muffin contains 200 percent of the RACC), have an additional column within the Nutrition Facts label that lists the quantitative amounts and percent DVs for each discrete unit, as well as the preexisting columns listing the quantitative amounts and percentage DVs for a serving that is not based on the discrete unit (i.e., the serving size derived from the RACC). We are also proposing in § 101.9(b)(12)(i)(B) that the provisions for dual-column labeling would not be required for bulk products that are used primarily as ingredients (e.g., flour, sweeteners, shortenings, oils), or bulk products traditionally used for multi-purposes (e.g., eggs, butter, margarine), and multipurpose baking mixes because labeling these products with nutrition information based on the entire container would not be consistent with how these products are typically consumed. Finally, due to limitations in labeling space, proposed § 101.9(b)(12)(i)(A) would state that products that meet the requirements to present the Nutrition Facts label using the tabular format under current § 101.9(j)(13)(ii)(A)(1) or the linear format under current § 101.9(j)(13)(ii)(A)(2) are exempt from dual-column labeling. We are aware of several food products that require further preparation, and contain at least 200 and up to and including 400 percent of the applicable RACC, such as macaroni and cheese kits, pancake mixes, pasta products, and rice products. Under our regulations, nutrition information for these types of products may be presented for two or more forms of the same food (e.g., both as “purchased” and “prepared”) (§ 101.9(e)). Most of these products voluntarily contain two columns of nutrition information on the “as purchased” and “as prepared” forms of the food. Therefore, we tentatively conclude that these types of products that require further preparation and voluntarily include two columns of nutrition information on the “as purchased” and “as prepared” forms of the food, should be exempt from the dual-column labeling requirement under proposed § 101.9(b)(12)(i). For products requiring further preparation for consumption, it is helpful to consumers to include nutrition information based on the prepared form of the product in addition to the “as purchased” form of the product. If these products were required to use dual-column labeling with nutrition information for the serving size based on the RACC and nutrition information for the entire container, they would have to include at least three columns if they also voluntarily included one column of nutrition information representing servings per container for the prepared form of the food. Manufacturers could opt to not include the voluntary column for the prepared form of the food if we were to require dual-column labeling under proposed § 101.9(b)(12)(i) for their product. However, nutrition information based on the entire container of the unprepared food may be less meaningful to consumers than information on a serving of the prepared form of the food, because these types of products are meant to be consumed after further preparation. Thus, the proposed rule would exempt food products that require further preparation and also include voluntary labeling of “as purchased” and “as prepared” forms of the food under § 101.9(e) from the provisions of dual-column labeling (proposed § 101.9(b)(12)(i)(C)). Likewise, the proposed rule would exempt products that are commonly consumed in combination with other foods (e.g., cereal and skim milk) and that include another column with information regarding that combination as specified in § 101.9(e) and (h)(4) (proposed § 101.9(b)(12)(i)(C)). As is the case with foods that require further preparation, nutrition information based on the entire container of an uncombined food (for a food that is commonly combined with another food) may be less meaningful to consumers than information on a serving of the combined food, because these types of products are commonly consumed in combination with another food. For consistency, FDA is also proposing that the exemptions under §§ 101.9(b)(12)(i)(A), (B), and (C) apply to the dual-column labeling requirement under proposed § 101.9(b)(2)(i)(D) as well. We invite comments on our tentative conclusion that products requiring further preparation and products that are commonly consumed in combination with other foods, and that voluntarily provide another column of nutrition information under § 101.9(e), should not be required to provide dual-column labeling under proposed § 101.9(b)(12)(i) or § 101.9(b)(2)(i)(D). Additionally, we invite comments regarding whether any other products that voluntarily include an additional column (or multiple columns) of nutrition information under our regulations (e.g., products for which RDI's are established for two or more groups, as discussed under § 101.9(e)) should be exempt from the proposed dual-column labeling requirements under § 101.9(b)(12)(i) or § 101.9(b)(2)(i)(D). Use of Nutrient Content Claims and Health Claims on Products With Dual-Column Labeling per Serving and per Container RACCs are used to determine whether individual foods are eligible to bear nutrient content and health claims (§ 101.12(g)). If dual-column labeling is finalized as proposed, nutrition information will be presented on a per serving basis and on a per container or per unit basis, as applicable. To clarify that the level of the nutrient that is the subject of the claim is based on the RACC and not the amount in the entire container or unit of food, proposed § 101.9(b)(12)(ii) would require that the claim be followed by a statement that sets forth the basis on which the claim is made. The statement must express the amount of the nutrient in a serving for a nutrient content claim (e.g., “good source of calcium” “a serving of __ oz of this product contains 150 mg of calcium” or for health claims “A serving of __ ounces of this product conforms to such a diet”). However, if the serving size declared on the product label differs from the RACC, and the amount of the nutrient contained in the labeled serving does not meet the maximum or minimum amount criterion in the definition for the descriptor for that nutrient, the claim must be followed by the criteria for the claim as required by § 101.12(g). We are also proposing that the statement that sets forth the basis on which the claim is made would not be required for products when the nutrient that is the subject of the claim meets the criteria based on the entire container amount or unit amount, as applicable. D. Reference Amounts Customarily Consumed The RACCs in the tables listed in § 101.12(b) are arranged by categories. The broadest category is the “general category.” There are 21 general categories, which separate the food products into broad groups, with similar types of products placed together. Examples of general categories are “Beverages” and “Desserts.” In each general category, there are product categories. As noted previously in this document, currently there are RACCs for 129 product categories for people 4 years of age or older in Table 2 of § 101.12(b) and 11 product categories for infants and children 1 through 3 years of age in Table 1 of § 101.12(b), for a total of 140 product categories. A product category is a group of products with similar dietary usage. The RACCs are assigned by product categories. In some cases, in the tables listed in § 101.12(b), examples of the types of products in the product category are listed. The current RACCs for the 140 product categories are derived primarily from food consumption data from the 1977-1978 ( http://www.ars.usda.gov/Services/docs.htm?docid=16184 ) and 1987-1988 ( http://www.ars.usda.gov/Services/docs.htm?docid=16185 ) NFCS conducted by the USDA. In light of newer consumption data, newer food products in the market place, comments received on the ANPRM, several written requests (Refs. 8, 9, and 10) and four citizen petitions (the fruitcake petition, the NYA petition, the CMA/NCA petition, and the Andes petition), we are proposing to update, modify or establish RACCs. Updating RACCs refers to proposed amendments to RACCs for products that are currently listed in the tables in § 101.12(b), and for which the NHANES 2003-2008 consumption data showed an increase or decrease in consumption by at least 25 percent. Modifying RACCs refers to changes to existing RACCs in the tables in § 101.12(b) for which the NHANES 2003-2008 consumption data did not show an increase or decrease in consumption by at least 25 percent. Establishing RACCs refers to the addition of products (and assigning RACCs for such products) that are not already listed in the tables in § 101.12(b). In Section II.D.2. we are proposing to update the RACCs for selected categories for products that are already in the tables in § 101.12(b). In section II.D.3., we are proposing to modify or establish new RACCs based, in part, on requests to establish new RACCs for products that are not in the tables in § 101.12(b), modify the RACCs for selected products that are already in the tables in § 101.12(b), or add products to an existing general category or product category in the tables in § 101.12(b) (Refs. 8, 9, and 10). In section II.D.3., we are also proposing to modify some product categories on our own initiative. We invite comment on whether the RACCs and labeled serving size for certain products identified as products of concern in comments to the ANPRM should be updated. We also invite comment on whether we should propose changes to other product categories not amended by this proposed rule. 1. Research and Data Related to Updating, Modifying, and Establishing RACCs We recognize that many consumers may consume substantially larger portions than the serving sizes presented on the Nutrition Facts label, and this could lead consumers to under-estimate the number of calories and other nutrients consumed. The current RACCs used to determine serving sizes are based primarily on data obtained through 1977-78 and 1987-88 NFCS conducted by USDA. More recent empirical evidence suggests, however, that for many types of food the amount of food that Americans customarily consume has changed significantly since these data were collected. For instance, a review of nationwide food intake surveys from 1977-78, 1989, and 1996 concluded that portion sizes for numerous types of foods grew substantially between 1977 and 1996 (Ref. 6). Another review of data likewise concluded that portion sizes have increased substantially since the current RACCs were established (Ref. 5). Additionally, a study has noted the supersizing of portion sizes in America in recent years (Ref. 38). Additionally, package sizes for many foods have increased, and the package size of a food product has been shown to have an impact on the amount of food that is consumed by a person. Package sizes in grocery stores, amounts served in restaurants, and dishware sizes at home could all influence how much people eat and their perceptions about portion sizes. In one study showing a link between larger portion sizes and increased calorie intake, participants were given all meals for two consecutive days each week for three weeks in a laboratory (Ref. 24). Each week the portion sizes of the meals varied from 100, 150, or 200 percent of the baseline amount. Results showed that a 50 percent increase in portion size led to a 16 percent increase in calorie intake and a 100 percent increase in portion size led to a 26 percent increase in calorie intake (Ref. 24). We recognize that increases in portion and/or package sizes may play a role in overeating because the growth in portion and package sizes have coincided with the surge of obesity rates in the United States (Refs. 5, 6, and 39). We also recognize that the serving size can provide a usable reference point for evaluating the nutritional content of a food and is a critical tool to those trying to achieve or maintain a healthy lifestyle and/or body weight. The serving size can also help consumers select among food products based upon calories and other nutrients per serving. However, to be an appropriate reference point, the serving size must be based upon a meaningful quantity of food, which is what the RACCs provide. We have analyzed current data and determined that, for some product categories listed in the tables in § 101.12(b), the RACCs have changed. Additionally, we recognize that, since 1993, information regarding the RACCs for certain products not currently listed in the tables in § 101.12(b) has become necessary. These factors, combined with findings from the “Calories Count” report, information regarding the rise in obesity, increase in package sizes, and requests to establish and modify the RACCs have led us to propose the amendments to the RACCs below. The proposed amendments would help convey clear and accurate information on serving sizes and the related nutritional profile of foods, which is important for consumers to be able to make choices that support a more healthful diet. Section II.D.2.c. discusses our proposals for updating existing RACCs and section II.D.3.b discusses our proposals for modifying and establishing new RACCs. 2. Updating Existing RACCs This section discusses public comments, methods used for updating existing RACCs, and the changes that we are proposing to update existing RACCs. a. Comments on the ANPRM Regarding Updating the Existing RACCs Selection of Food Consumption Data Sources and Criteria for Changing the RACCs Established in 1993 The ANPRM invited comment on how recent food consumption data, such as data from the 1999-2000 and 2001-2002 NHANES, should factor into the determination of which, if any, RACCs need to be updated and if there are other food consumption data sources that are available, or that could be provided for our consideration (70 FR 17010-17012). We also asked what criteria should be used as the basis for changing the RACCs, if the RACCs were revised. Most comments supported the use of national food consumption data to establish serving sizes. One comment suggested that we consider the USDA/Agriculture Research Service Automated Multiple Pass Method validation study (AMPM) which provides an overall picture of health and nutrition as a consumption survey tool. Some comments opposed the use of any data other than food consumption data, arguing that they do not fulfill the FD&C Act's requirement that the serving sizes reflect amounts customarily consumed. Some comments advised us against using current data to establish updated RACCs. These comments indicated that basing serving sizes on current consumption data was unsound from a policy perspective in that it could suggest to consumers they could or should eat larger amounts, which contradict current efforts to curb obesity as well as federal dietary recommendations. Some comments reasoned that food consumption data have many limitations, and therefore it is not possible to derive accurate estimates of the customarily consumed amounts from such data. Several comments indicated that nutrition survey data are not appropriate and there is no justification to base serving size on food consumption data because these data have known inaccuracies. Regarding the comments on how food consumption data should factor into updating the RACCs, we note that none of the comments opposing the use of consumption data to establish RACCs provided any alternative sources of data to use. Section 403(q)(1)(A)(i) of the FD&C Act states that a serving size is the amount customarily consumed, making food consumption data the best source for determining serving sizes. In addition to the variability among individuals, we are aware of the limitations of the available food consumption databases. However, these databases are still the best sources of food consumption data collected under actual conditions of use available to us. Thus, we conclude that the use of food consumption data as the primary source for the customarily consumed amounts of food for nutrition labeling purposes is appropriate. Regarding the comment suggesting that we consider the USDA/Agriculture Research Service Automated Multiple Pass Method validation study, this study as well as the food consumption data are used as part of [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2014-04385. Public record. Not legal advice.