Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating

Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating

Contains Nonbinding Recommendations 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: Guidance for Industry Small Entity Compliance Guide Additional copies are available from: Office of Nutrition and Food Labeling Nutrition Programs Staff, HFS-830 Center for Food Safety and Applied Nutrition Food and Drug Administration 5001 Campus Drive College Park, MD 20740 (Tel) 240-402-1450 http://www.fda.gov/FoodGuidances You may submit electronic or written comments regarding this guidance at any time.

Submit electronic comments to https://www.regulations.gov. Submit written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.

For questions regarding this document contact the Center for Food Safety and Applied Nutrition (CFSAN) at 240-402-1450. U.S. Department of Health and Human Services Food and Drug Administration Center for Food Safety and Applied Nutrition February 2018

Contains Nonbinding Recommendations 2 Table of Contents I. Introduction II. Who Is Subject to the Rule? II.1 Does the Rule Apply to Food Manufacturers? II.2 How Does FDA Define “Serving Size”? II.3 How Does the Rule Define Single-Serving Container? II.4 What Are the Requirements for Dual-Column Labeling? II.5 What Products Are Not Required to Provide Dual-Column Labeling? II.6 What Food Product Categories Are Updated, Modified, and Established in the RACC Tables? II.7 How Does the Rule Amend the Label Serving Size for Breath Mints? III.

What Foods Are Covered by the Rule?

III.1 Does the Rule Cover Foods for Infants and Young Children 1 Through 3 Years of Age? III.2 Does the Rule Cover Foods for the General Food Supply? III.3 Does the Rule Cover Dietary Supplements? III.4 How Does the Rule Address Products that Require Further Preparation? IV. What Foods Are Not Covered by the Rule? V. How Do I Comply with the Label Serving Size Requirements? V.1 When Dual-Column Labeling Is Required, How Must I Label the Product? V.2 Do I Have Label Options for Single-Serving Containers that Contain More Than 150% and Less Than 200% of the RACC?

Contains Nonbinding Recommendations 3 V.3 Do I Have to Update Nutrient Content Claims and Health Claims Stated on Food Products Labels? VI.

How Do I Determine the Appropriate Serving Size for My Product? VI.1 How Do I Use the RACCs to Determine Serving Sizes? VI.2 Which Products Have Special RACC Rules to Determine Serving Sizes? VI.3 How Do I Determine Serving Sizes for Discrete Units, Large Discrete Units, and Bulk Products? VI.4 What Are Common Household Measures? VI.5 How Do I Determine the Number of Servings Per Container? VII. When Must I Comply with the Rule?

VIII. What Happens if I Do Not Comply with the Rule?

Contains Nonbinding Recommendations 4 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: Guidance for Industry1 Small Entity Compliance Guide This guidance represents the current thinking of the Food and Drug Administration (FDA or we) on this topic. It does not establish any rights for any person and is not binding on FDA or the public.

You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page.

I. Introduction In the Federal Register of May 27, 2016 (81 FR 34000), we published a final rule pertaining to serving sizes for food. The final rule amends the definition of a single-serving container, requires dual-column labeling for certain containers, updates the tables of Reference Amounts Customarily Consumed (reference amounts, or RACCs), and amends the serving size for breath 1 This guidance has been prepared by the Office of Nutrition and Food Labeling in the Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration.

Contains Nonbinding Recommendations 5 mints.

The rule became effective on July 26, 2016. We have prepared this Small Entity Compliance Guide in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121, as amended by Public Law 110-28). This guidance document restates in plain language the legal requirements set forth in the rule, and is intended to help small entities comply with the rule established in 21 CFR 101.9 and 101.12. FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.

The use of the word should in our guidances means that something is suggested or recommended, but not required.

In the remainder of this guidance, “you” and “I” refer to food manufacturers that are subject to the rule. Many answers in this guidance are followed by citations to show where a specific requirement can be found in either the Federal Food, Drug, and Cosmetic Act (FD&C Act) or Title 21 of the Code of Federal Regulations. II. Who Is Subject to the Rule? II.1 Does the Rule Apply to Food Manufacturers? You are subject to the rule if you manufacture food that is subject to our nutrition labeling requirements.

II.2 How Does FDA Define “Serving Size”? A serving size is the amount of food customarily consumed (i.e., typically eaten) in one sitting for that food (section 403(q)(1)(A)(i) of the FD&C Act).

Serving sizes are determined from the RACCs established in 21 CFR 101.12(b) and the procedures described in 21 CFR 101.9(b). A serving size should be written in a common household measure (e.g., cup, tablespoon, piece, slice, fraction (e.g., 1/4 pizza), ounce (oz), fluid ounce (fl oz), or other common household equipment used to package food products (e.g., jar, tray)) as defined under 21 CFR 101.9(b)(5).

II.3 How Does the Rule Define Single-Serving Container? A single-serving container is a product that is packaged and sold individually and contains less than 200 percent of the applicable reference amount for that product (21 CFR 101.9(b)(6)). The entire content of a single-serving container must be labeled as one serving (21 CFR 101.9(b)(6)). The final rule removed a preexisting exception from this labeling requirement that applied to

Contains Nonbinding Recommendations 6 certain products for which the RACC was 100 g or mL or larger. Under the final rule, regardless of the size of the RACC, all products that are packaged and sold individually and contain less than 200 percent of the applicable reference amount for that product must be labeled as a single- serving container (21 CFR 101.9(b)(6)).

However, if the product is more than 150 percent and less than 200 percent of the applicable RACC, the manufacturer may voluntarily provide an additional on the Nutrition Facts label, to the left of the column that provides nutrition information per container (i.e., per serving). The voluntary column would list the quantitative amounts and the percent Daily Value (DV) per common household measure that most closely approximates the RACC (21 CFR 101.9(b)(6)).

II.4 What Are the Requirements for Dual-Column Labeling? FDA regulations, at 21 CFR 101.9(a)(1), require that the labeling of packaged foods provide certain nutrition information in a specified format (i.e., the Nutrition Facts label). While most packaged foods provided a single column of nutrition information under preexisting regulations, the final rule requires that a second column of nutrition information be placed on products that are packaged and sold individually and that contain at least 200 percent and up to and including 300 percent of the applicable reference amount for that product, unless an exemption applies (21 CFR 101.9(b)(12)(i)).

The second column is part of the Nutrition Facts label and must list the nutrition information for the entire package (21 CFR 101.9(b)(12)(i)). The first nutrition column must list the nutrition information per serving (21 CFR 101.9(b)(12)(i)). See Figure 1. Unless an exemption applies, dual-column labeling requirements also apply for products in discrete units— regardless of whether they are packaged and sold individually—where the discrete unit contains at least 200 percent and up to and including 300 percent of the reference amount (21 CFR 101.9(b)(2)(i)(D)). For these products, the second column that is part of the Nutrition Facts label must list the nutrition information for the discrete unit (21 CFR 101.9(b)(2)(i)(D)).

Contains Nonbinding Recommendations 7 Figure 1: Example of a "Dual-Column" Label II.5 What Products Are Not Required to Provide Dual-Column Labeling? Dual-column labeling is not mandatory for the following products, regardless of whether they contain at least 200 percent and up to and including 300 percent of the applicable reference amount: (1) products that meet the requirements to use the tabular format (see 21 CFR 101.9(j)(13)(ii)(A)(1) and Figure 2, below) or to products that meet the requirements to use the linear format (see 21 CFR 101.9(j)(13)(ii)(A)(2) and Figure 3, below) (21 CFR 101.9(b)(12)(i)(A)); (2) raw fruits, vegetables, and seafood that provide voluntary labeling or advertising or when claims are made about the product (see 21 CFR 101.9(b)(12)(i)(B)); (3) products that require further preparation (e.g.

pancake mix) and voluntarily provide an additional column of nutrition “as prepared” (see 21 CFR 101.9(b)(12)(i)(C) and 21 CFR 101.9(e)); (4) products that are commonly consumed in combination with another food (e.g. cereal and milk) and provide an additional column of nutrition information for the combination (see 21 CFR 101.9(b)(12)(i)(C) and 21 CFR 101.9(e)); (5) products that provide an additional column of nutrition information for two or more groups for which Reference Daily Intakes are established

Contains Nonbinding Recommendations 8 (e.g., both infants and children less than 4 years of age) (see 21 CFR 101.9(b)(12)(i)(C) and 21 CFR 101.9(e)); (6) popcorn products that provide an additional column of information per 1 cup popped popcorn (see 21 CFR 101.9(b)(12)(i)(C)); or (7) varied-weight products (see 21 CFR 101.9(b)(8)(iii)). Figure 2: Example of a "Tabular Format" Label Figure 3: Example of a “Linear Format” Label II.6 What Food Product Categories Are Updated, Modified, and Established in the RACC Tables?

The final rule updates, modifies, or establishes RACCs for several food categories in the tables in 21 CFR 101.12(b).

The RACC updates and modifications, as well as the newly established RACCs, are based, in part, on consumption information from the 2003 – 2008 National Health and Nutrition Examination Surveys (NHANES). Generally, the rule “updates” the RACC if the NHANES consumption data showed an increase or decrease in consumption of at least 25 percent from the preexisting RACC. The rule “modifies” the RACC for certain product categories for which the data did not show an increase or decrease of at least 25 percent from the preexisting RACC, but other criteria led us to determine that a modification was necessary.

The rule “establishes” a RACC if it adds a product category to the RACC tables.

Contains Nonbinding Recommendations 9 See Figure 6 for all changes in “Table 1—Reference Amounts Customarily Consumed Per Eating Occasion: Foods for Infants and Young Children 1 Through 3 Years of Age.” See Figure 7 for all changes in “Table 2—Reference Amounts Customarily Consumed Per Eating Occasion: General Food Supply.” II.7 How Does the Rule Amend the Label Serving Size for Breath Mints? The final rule changes the label serving size for breath mints to “1 unit.” The rule continues to use two grams (2 g) as the RACC for the “hard candies, breath mints” product category (21 CFR 101.12(b)).

III.

What Foods Are Covered by the Rule? III.1 Does the Rule Cover Foods for Infants and Young Children 1 Through 3 Years of Age? Yes. When the food is intended for infants or children 1 through 3 years of age, a serving size means the amount customarily consumed by either (1) infants up to 12 months of age or (2) children 1 through 3 years of age (21 CFR 101.9(b)(1)). The RACC changes for foods for infants and young children 1 through 3 years of age are 21 CFR 101.12(b), Table 1. See Figure 6. III.2 Does the Rule Cover Foods for the General Food Supply? Yes. Foods for the general food supply are foods eaten by persons 4 years of age or older.

A serving size for the general food supply means the amount of food customarily consumed by this age group (21 CFR 101.9(b)(1)).

The RACC changes for foods in the general food supply are found in 21 CFR 101.12(b), Table 2. See Figure 7. III.3 Does the Rule Cover Dietary Supplements? Yes. Section 201(f) of the FD&C Act defines “food” as: “(1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.” Further, section 201(ff) of the FD&C Act explains that dietary supplements are deemed to be foods within the meaning of the FD&C Act except for the purposes of sections 201(g) (definition of “drug”) and 417 (reportable food registry) of the FD&C Act.

The RACC for dietary supplements is found in 21 CFR 101.12(b), Table 2. See Figure 6.

Contains Nonbinding Recommendations 10 III.4 How Does the Rule Address Products that Require Further Preparation? Products that require further preparation are products that require steps, such as cooking or the addition of water or other ingredients, before they can be consumed (21 CFR 101.12(c)). The RACC tables listed in 21 CFR 101.12(b) primarily provide RACCs for food in the packaged or as-purchased form (21 CFR 101.9(b)(9)). However, for foods that require further preparation, the RACC tables may provide a reference amount for a product in both the prepared and unprepared form. If the tables do not provide a RACC for the unprepared form, then the RACC for the unprepared product must be the amount of the unprepared product required to make the RACC for the prepared product (21 CFR 101.12(c)).

IV. What Foods Are Not Covered by the Rule? Under 21 CFR 101.9(j), numerous foods are exempt from nutrition labeling requirements or are subject to special labeling requirements. Such products generally include: (1) Foods offered for sale by a retailer who has annual gross sales made or business done in sales to consumers that is not more than $500,000; (2) foods offered for sale by a retailer who has annual gross sales made or business done in sales of food to consumers of not more than $50,000; (3) foods served in restaurants; (4) foods served in other establishments in which food is served for immediate consumption (e.g.

schools, hospitals, trains, airplanes); and (5) foods that contain insignificant amounts of all nutrients (e.g. coffee beans, tea leaves). For more information on foods not covered by the rule and for further information about exemptions from these requirements, see 21 CFR 101.9(j).

V. How Do I Comply with the Label Serving Size Requirements? V.1 When Dual-Column Labeling Is Required, How Must I Label the Product? For products for which a dual-column label is required (i.e., products packaged and sold individually that contain at least 200 percent and up to and including 300 percent of the RACC, and products with discrete units that weigh at least 200 percent and up to 300 percent of the RACC), the product label must provide one column of nutrition information based on the serving size that is less than the entire package (i.e., the serving size derived from the reference amount) and a second column of nutrition information for the entire package (see 21 CFR 101.9(b)(12)(i) or discrete unit (see 21 CFR 101.9(b)(2)(i)(D)), as applicable.

See Figure 1.

Contains Nonbinding Recommendations 11 V.2 Do I Have Label Options for Single-Serving Containers that Contain More Than 150% and Less Than 200% of the RACC? Manufacturers of products that contain more than 150 percent and less than 200 percent of the applicable reference amount may voluntarily provide an additional column in the Nutrition Facts label. The additional column must be placed to the left of the column providing nutrition information per container (i.e., per serving) (21 CFR 101.9(b)(6)). The additional column (i.e., the left column) will display nutrition information per common household measurement (e.g., cups, ounces) that most closely approximates the reference amount for the product (21 CFR 101.9(b)(6)).

The nutrition information column for the serving size (i.e., the right column) must provide nutrition information for the entire container (i.e., the serving size) (21 CFR 101.9(b)(6)).

Figure 4: Multiple Examples of "Dual-Column" Labels Dual-Column Display

Contains Nonbinding Recommendations 12 Dual-Columns, Two Forms of the Same Food

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