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

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:

Final rule.

SUMMARY:

The Food and Drug Administration (FDA or we) is issuing a final rule to define a single-serving container; require dual-column labeling for certain containers; update, modify, and establish several reference amounts customarily consumed (RACCs); amend the label serving size for breath mints; and make technical amendments to various aspects of the serving size regulations. We are taking this action to provide consumers with more accurate and up-to-date information on serving sizes.

DATES:

Effective date:

The final rule becomes effective on July 26, 2016.

Compliance date:

The compliance date of this final rule is July 26, 2018, for manufacturers with $10 million or more in annual food sales, and July 26, 2019, for manufacturers with less than $10 million in annual food sales. See Section IV, Effective and Compliance Dates, for more detail.

FOR FURTHER INFORMATION CONTACT:

With regard to the final rule:

Cherisa Henderson, Center for Food Safety and Applied Nutrition (HFS-830), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-1450,

NutritionProgramStaff@fda.hhs.gov.

With regard to the information collection:

Domini Bean, Office of Information Management, Food and Drug Administration, 8455 Colesville Rd., Rm. 14537G, Silver Spring, MD 20903,

domini.bean@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary

A. Purpose of the Final Rule

B. Summary of the Legal Authority

C. Summary of the Major Provisions of the Final Rule

D. Technical Amendments

E. Effective and Compliance Dates

F. Costs and Benefits

II. Background

A. Serving Size Proposed Rule

B. Legal Authority

III. Comments and FDA's Responses

A. General Comments

B. Single-Serving Containers

C. Dual-Column Labeling

D. Reference Amounts Customarily Consumed

E. Impact of Changes in RACCs on the Eligibility To Make Nutrient Content Claims and Health Claims

F. Establishing a New Serving Size for Breath Mints

G. Technical Amendments

IV. Effective and Compliance Dates

V. Analysis of Environmental Impact

VI. Economic Analysis of Impacts

VII. Paperwork Reduction Act of 1995

VIII. Federalism

IX. References

I. Executive Summary

A. Purpose of the Final 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 reevaluate 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 providing consumers information to assist them in maintaining 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 amends our regulations in §§ 101.9 and 101.12. Resulting from our evaluation of the new consumption data, this rule amends the 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 amends some of the required procedures used to determine serving sizes, amends the definition of a single-serving container, and requires 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 changes finalized in this rule are designed to ensure that serving sizes are based on current consumption data and to provide consumers with information on the Nutrition Facts label related to the serving size that will assist them in maintaining healthy dietary practices.

B. 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 we regulate. 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 final rule. Section 2(b)(1)(B) of the NLEA further requires the Secretary of Health and Human Services to issue regulations “which establish standards . . . to define serving size.” Additionally, we are relying on section 2(b)(1)(A) of the 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 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 final 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 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 the authorities listed in this paragraph

give us the authority to issue this final rule related to serving size labeling.

C. Summary of the Major Provisions of the Final Rule

1. Single-Serving Containers and Dual-Column Labeling

Over the last 20 years, evidence has accumulated demonstrating that container and unit sizes can influence the amount of food consumed. For containers and units of certain sizes, consumers are likely to eat the entire container or unit in one sitting. For other container and unit sizes, consumers may consume the container or unit in one sitting or may consume the container or unit over multiple sittings or share the container or unit contents with other consumers. To address containers that may be consumed in a single-eating occasion, we are requiring 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 and units that may be consumed in one or more sittings, or shared, we are requiring that containers and units that contain at least 200 percent and up to and including 300 percent of the RACC be labeled with a column of nutrition information within the Nutrition Facts label that lists the quantitative amounts and percent DVs for the entire container, in addition to the 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).

2. Changing the RACCs

We 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, we analyzed recent food consumption data from the 2003-2008 National Health and Nutrition Examination Surveys (NHANES) (hereinafter referred to as the NHANES 2003-2008 surveys or NHANES 2003-2008 consumption data, as applicable). Generally, this rule amends RACCs 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 have considered other factors, such as designating the same RACCs for products with similar consumption data and similar dietary usage or product characteristics.

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 final rule.

D. 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 final rule includes a number of technical amendments to help clarify the serving size requirements in these regulations.

E. Effective and Compliance Dates

We are establishing a compliance date of 2 years after the final rule's effective date for manufacturers with $10 million or more in annual food sales, and 3 years after the final rule's effective date for manufacturers with less than $10 million in annual food sales. (For more details, see Section IV, Effective and Compliance Dates.)

F. Costs and Benefits

We have developed one final regulatory impact analysis (FRIA) for this final rule as well as the final rule entitled “Food Labeling: Revision of the Nutrition and Supplement Facts Labels” (the Nutrition Facts final rule). The FRIA discusses key inputs in the estimation of costs and benefits of the changes finalized by the rules and assesses the sensitivity of cost and benefit totals to those inputs. The two nutrition labeling rules—which have a compliance date of 2 years after the final rule's effective date for manufacturers with $10 million or more in annual food sales, and 3 years after the final rule's effective date for manufacturers with less than $10 million in annual food sales—have impacts, including the sign on net benefits, that are characterized by substantial uncertainty. The primary sensitivity analysis shows benefits having the potential to range between $0.2 and $2 or $5 billion, and costs ranging between $0.2,

$0.5 and $0.8 billion (annualized over the next 20 years, in 2014 dollars, at seven percent interest).

1

1

There is substantial uncertainty regarding the impacts of the two nutrition labeling rules. For a full discussion of the uncertainty, please see the Welfare Estimates—Primary Sensitivity Analysis section of the Regulatory Impact Analysis.

Table 1—Summary of the Primary Sensitivity Analysis of the Costs and Benefits of the Final Rules

[in billions of 2014$]

Benefits

(low)

Benefits

(mean)

Benefits

(high)

Costs

(low)

Costs

(mean)

Costs

(high)

Present Value:

3%

$2.8

$33.1

$77.7

$2.3

$4.8

$8.6

7%

1.9

22.3

52.5

2.2

4.5

8.3

Annualized Amount:

3%

0.2

2.2

5.2

0.2

0.3

0.6

7%

0.2

2.1

5.0

0.2

0.4

0.8

Notes:

Costs estimates reflect an assumption that the rules have the same compliance date. Compliance period is 36 months for small businesses and 24 months for large businesses. For purposes of this analysis, we consider a small business to be a business with annual food sales of less than $10 million, and a large business to be a business with annual food sales of $10 million or more. Costs include relabeling, recordkeeping, fiber study, additional labeling, future UPC growth labeling, and reformulation costs. Annualized Amount = Amount/Annualizing Factor. Three percent annualizing factor = 14.88. Seven percent annualizing factor = 10.59. The annualizing factors are calculated by summing the inverse of 1 plus the discount rate to the power of the year (t = 1 through t = 20).

II. Background

A. Serving Size Proposed Rule

In the

Federal Register

of March 3, 2014 (79 FR 11989), we published a proposed rule (the serving size proposed rule or the proposed rule) to amend our serving size regulations, in part, in response to recommendations of the Report of the Working Group on Obesity, “Calories Count,” March 12, 2004 (Ref. 1), and our recognition that portion sizes have changed since we first published serving size regulations in 1993 (1993 serving size final rule, 58 FR 2229, January 6, 1993). We also published technical amendments to the 1993 serving size final rule on August 18, 1993 (58 FR 44039). The proposed rule also discussed six citizen petitions. The intended effect of the proposed rule, when finalized, was to provide consumers with more accurate and up-to-date information on serving sizes. In brief, the proposed rule would:

• Amend the definition of a single-serving container to remove the exception for products with large RACCs. Preexisting § 101.9(b)(6), which this rule will replace upon the effective date, required that a product that is packaged and sold individually 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, unless the product contains more than 150 but less than 200 percent of the RACC and has an RACC of 100 g or 100 mL or larger. Under the preexisting regulation, manufacturers of products that contain more than 150 but less than 200 percent of the RACC and have an RACC of 100 g or 100 mL or larger (large-RACC products) are permitted to label the product as containing 1 or 2 servings, at the manufacturer's discretion (§ 101.9(b)(6)). The proposed rule would remove the exception for large-RACC products being labeled as one or two servings so that all products packaged and sold individually and that contain less than 200 percent of the RACC would be required to be labeled as a single-serving container.

• 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.

• Update the RACCs when there is a significant change between the median amount consumed from 2003-2008 NHANES consumption data and the RACCs established in the 1993 serving size final rule.

• Modify and establish RACCs for certain product categories based on manufacturer requests and our initiative.

• Amend the serving size for breath mints.

• Make technical amendments to various aspects of the serving size regulations.

We provided an opportunity to comment on the serving size proposed rule until June 2, 2014. On May 27, 2014, we extended the comment period until August 1, 2014 (79 FR 30056). We received more than 500 comments in response to the proposed rule. Most submissions came from individuals. We also received comments from industry and trade associations, consumer and advocacy groups, academic organizations, State governments, and foreign government agencies.

B. Legal Authority

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 we have determined that amendments to those regulations are needed. We have analyzed consumption data for various food products and have determined that the data warrant amending many of the RACCs established in 1993. Additionally, both on our own initiative and in response to various requests, we have analyzed data for products that are not listed in the tables in § 101.12(b), and are establishing additional RACCs. Thus, in accordance with section 403(q)(1)(A)(i) of the FD&C Act, we are amending the RACCs in § 101.12(b) to reflect the current amounts customarily consumed for products already listed in § 101.12(b), as well as products not listed in § 101.12(b). Additionally, under the same authority we are amending related regulations in §§ 101.9 and 101.12 that set forth procedures for determining serving sizes for use on product labels based on the reference amounts. Included among these 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 the 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 amending § 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 column listing the quantitative amounts and percent DVs for a serving of food that is less than the entire container or unit. Section 2(b)(1)(A) of the NLEA provides authority for this 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 discussed further in section III.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 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 amendments in this rule include sections 701(a), 403(a)(1), and 201(n) of the FD&C Act. 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, 213 (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 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 final rule related to serving size labeling.

III. Comments and FDA's Responses

This section discusses the issues raised in the comments on the proposed rule and describes the final rule. For ease of reading, we preface each comment discussion with a numbered “Comment” and each response by a corresponding numbered “Response.” We have numbered each comment to help distinguish among different topics. The number assigned is for organizational purposes only and does not signify the comment's value, importance, or the order in which it was received.

A. General Comments

(Comment 1) Many comments stated that the labeled serving size represents a recommended amount of food to consume. Other comments stated that we were changing the RACCs from a recommended amount of food to eat to the amount of food that people actually eat. Some comments that thought we were changing the serving size from a recommended amount of food to eat to an amount of food that is customarily consumed supported the change. Some of these comments stated that basing the serving size on the actual amount eaten would make it easier for consumers to understand how many calories and other nutrients they are consuming.

In contrast, other comments asserting that we were changing the serving size from a recommended amount to an amount of food that is customarily consumed opposed the perceived change because, according to those comments, such changes would make it more difficult to use the labeled serving size for diet planning or other dietary practices. Further comments stated that updating the serving size portion of the Nutrition Facts label would increase consumer confusion and encourage excess consumption among those who think that the serving size is based on a recommended amount.

(Response 1) Some of these comments reflect a misunderstanding of the definition of serving size. Under section 403(q)(1)(A)(i) of the FD&C Act, serving size is an amount of food customarily consumed and which is expressed in a common household measure appropriate to the food. Thus, the serving size is not a recommended amount of food to eat and was not described as such in the 1993 serving size final rule.

We acknowledge that some consumers may misconstrue the meaning of the serving size set forth in the FD&C Act. Since the publication of the proposed rule, several studies have been conducted that indicate that some consumers believe serving size specifies a recommended amount of food to eat (Refs. 2, 3, and 4), and we recognize that that such an understanding could lead to increased levels of consumption. In order to help consumers understand issues relating to this final rule, as discussed further in response to comment 2, we intend to conduct nutrition education to help clarify the meaning of the serving size and RACCs.

With regard to the comments that stated that updates to serving sizes would make it difficult to use the serving size for diet planning or other dietary practices, we disagree. Providing the nutrition content of the food based on current consumption amounts informs consumers of the amount of nutrients they are likely to ingest.

(Comment 2) Several comments recommended that we conduct extensive consumer education on the changes in this final rule. Some comments requested that we conduct consumer education in conjunction with the USDA regarding all proposed changes to the Nutrition Facts label and the underlying calculations used to determine the quantities presented on the labels. Several comments asserted that without public education, consumers may not fully understand how to use the Nutrition Facts label so that they can maintain healthy dietary practices.

(Response 2) We agree that an extensive consumer education campaign will serve an important role in continuing to provide information to assist consumers in maintaining healthy dietary practices. Currently, we have available a collection of various educational materials (

e.g.,

videos and an array of other education materials (in English and other languages)) on numerous nutrition topics, including materials on the Nutrition Facts label (

e.g.,

Read the Label, Make Your Calories Count, Using the Nutrition Facts Label) (Ref. 5). These materials are intended for educators, teachers, health professionals (

e.g.,

dietitians, nutritionists), as well as for consumers. Our intent is to update our existing educational materials and create new educational opportunities to explain the overall role of using the label to assist consumers in maintaining healthy dietary practices, with an emphasis on each of the new changes of the label.

We intend to continue to work in collaboration, and create new partnership opportunities, with other Federal government agencies including other parts of the Department of Health and Human Services, USDA, State health departments, health professional organizations, food manufacturers, retailers, and non-profit organizations that have an interest and responsibilities in nutrition education and health promotion. These partnerships will help us to develop and disseminate our educational materials, which will ease the transition to the revised nutrition label and help consumers to use the label to make informed dietary choices. Through our collaboration with both government and non-government entities, our continued goal is to increase consumers' knowledge and effective use of the new food label, and to ensure that consumers have accurate and adequate resource materials and information to assist them in maintaining healthy dietary practices. Furthermore, we intend to continue with a variety of activities, such as conducting and reporting on existing and planned food labeling research, developing education initiatives at the national and local level, holding regularly scheduled meetings to build labeling education exchanges, and integrating food labeling education into the existing programs (

e.g.,

USDA school-based nutrition education programs). We plan to continue to build partnerships capable of developing and evaluating labeling education targeted to the dietary needs of diverse populations, such as low-literacy consumers, those with lower incomes, minorities and various specific subpopulations (

e.g.,

children, older adults, women of childbearing age), as well as to the public at large.

(Comment 3) Several comments requested we require that a footnote be added to the Nutrition Facts label to indicate that the serving size is based on typically consumed, not recommended, servings. The comments stated that the purpose of adding this footnote would be to serve as nutrition education to

make consumers aware of the true meaning of the labeled serving size.

(Response 3) We recognize the importance of providing consumers with more in-depth information about the meaning of the serving size and, as explained in response to comment 2, intend to make this a key component of our future nutrition education efforts for consumers. At this time, however, we decline to establish as part of this rulemaking a requirement to add a footnote to the Nutrition Facts label that would indicate that the serving size is based on what is typically consumed, rather than what is recommended. We would like to consider this issue further before finalizing a provision that would mandate or voluntarily permit the addition of such a footnote to the Nutrition Facts label. We also note that, while no such footnote as requested in this comment can be added to the Nutrition Facts label voluntarily, manufacturers can voluntarily include a truthful and not misleading statement explaining the meaning of serving size elsewhere on the product label.

(Comment 4) Some comments requested that we change the term “serving size” to prevent consumers from assuming that the serving sizes are recommended servings. Some terms that the comments suggested we use instead were “typical serving,” “unit,” or “quantity.” Another suggestion was to remove the two lines that mention “serving” and add, next to the words “Amount per ___,” the fraction of the container that the RACC represents (for example, “Amount per

2/3

cup (

1/8

of container)”).

(Response 4) We decline to revise or remove the terms “serving” and “serving size” as suggested by the comments. Section 403(q)(1)(A) of the FD&C Act deems food, unless subject to an exception, to be misbranded unless its label or labeling bears the “serving size.” Therefore, we will continue to require that the terms “serving” and “serving size” be used on product labels.

(Comment 5) Some comments stated that the “serving size” should be expressed in household measurements or that serving size of similar food products should be based off of the same amount of food.

(Response 5) We agree. Section 403(q)(1)(A) of the FD&C Act requires that the serving size be expressed in a common household measure that is appropriate to the food or, if the use of the food is not typically expressed in a serving size, the common household unit of measure that expresses the serving size of the food. In addition, § 101.12(a)(9) states that products that have similar dietary usage, product characteristics, and customarily consumed amounts should have a uniform reference amount. Section 101.12(a)(9) is not being changed in this final rule and was used as part of the decision making when determining what RACCs to update, modify, and establish in the proposed rule and this final rule.

(Comment 6) Several comments indicated that we should consider a uniform serving size for all food products as is done in some other countries, such as 1 cup or 100 g. The comments stated that having a uniform serving size would allow consumers to be able to make side-by-side comparisons of all products in the grocery store.

(Response 6) We do not agree that a uniform serving size should be used for all foods. Under section 403(q)(1)(A) of the FD&C Act, serving size is defined as the amount of food customarily consumed. As all foods are not customarily consumed in the same amount, establishing a uniform serving size for all foods would not meet this statutory requirement.

B. Single-Serving Containers

Preexisting § 101.9(b)(6) requires that a product that is packaged and sold individually and that contains less than 200 percent of the applicable RACC be labeled as a single serving. 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). Under preexisting § 101.9(b)(6), manufacturers of large-RACC products could decide whether a package that contains more than 150 percent but less than 200 percent of the applicable RACC is 1 or 2 servings (§ 101.9(b)(6)). We provided the exception for large-RACC products based on consumption data available at the time the 1993 rule was issued that showed that “[i]t was much less likely that a person will 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 twice the reference amount of a food with a smaller reference amount” (79 FR 11989 at 12000).

In the preamble to the proposed rule (79 FR 11989 at 12001), we discussed the correlation between the consumption variation and the RACCs for all products containing less than 200 percent of the applicable RACC, including products with large RACCs and products that have RACCs that are less than 100 g (or mL), using combined consumption data from the NHANES 2003-2008 surveys (Refs. 6, 7, and 8). 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 to express the figure as the percent variation from the median consumption amount (Ref. 9). The result shows that the correlation coefficient is 0.13, which means that there is a low correlation between the RACCs and the consumption variation for all products containing less than 200 percent of the RACC, regardless of whether the RACC is large. 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, in the preamble to the proposed rule we proposed to remove the exemption from the requirement to label a product with a large RACC containing between 150 percent and 200 percent of the applicable RACC as a single-serving container because the exemption is no longer supported by consumption data (79 FR 11889 at 12001).

Additionally, as noted in the preamble to the proposed rule, 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 (79 FR 11889 at 12001). Research shows that package and portion sizes tend to have a considerable impact on the amount of food consumed (Refs. 10 and 11). Taking into account this research, we stated in the proposed rule that 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 food that they are consuming (79 FR 11989 at 12001). In light of this research and the previously discussed analysis on consumption variation, we proposed to remove the large-RACC exemption for single-serving containers.

We also proposed to remove the text in preexisting § 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 III.C.).

1. Definition of a Single-Serving Container

(Comment 7) Some comments supported our proposed changes to the definition of a single-serving container. The comments said that labeling foods that are less than 200 percent of the RACC as a single serving would increase consumer understanding of the nutritional content of foods. Some comments also stated that the proposed changes would provide consistency across all food products on the amount that constitutes a single serving. Other comments provided research in support of our proposed changes to the definition of a single-serving container.

(Response 7) The research provided in the comments is the same as the research discussed in the preamble of the proposed rule (79 FR 11989 at 11998). Lando & Labiner-Wolfe (2007) found that many focus group study participants believed that products like a large muffin or a 20 ounce (oz) soda that contain more than one serving, but are often eaten at a single eating occasion, should be labeled as a single serving (Ref. 12). Other studies have 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. 13).

(Comment 8) One comment asked that we raise the cutoff for a single-serving container to include containers with up to 300 percent of the RACC. The comment stated that our proposed amendment for single-serving containers to include anything less than 200 percent of the RACC excludes many foods that can reasonably be consumed by one person in a single eating occasion and that food companies could avoid “per package” labeling by simply increasing the container size to slightly more than 200 percent of the RACC.

(Response 8) While we understand the concern that keeping the cutoff for single-serving containers at less than 200 percent may exclude some food products that can reasonably be consumed by one person in a single eating occasion, we decline to increase the definition of a single-serving container to include products containing up to 300 percent of the RACC. Under section 403(q)(1)(A)(i) of the FD&C Act, serving size means the 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 because that would be at least twice the amount we have determined is customarily consumed. However, we agree with these comments that such products may reasonably be consumed by one person in a single eating occasion, and as discussed in section III.B., full-package nutrition information, or per-unit nutrition information, as applicable, for products containing at least 200 percent and up to and including 300 percent of the RACC will be required for certain products through dual-column labeling.

(Comment 9) One comment requested clarification on the meaning of the phrase “products that are packaged and sold individually.” The comment noted that it understood the phrase “products that are packaged and sold individually” to mean products that consist of a single unit and to exclude products that are divided into discrete units. The comment stated that if the phrase “products that are packaged and sold individually” does include products that are divided in discrete units, every product would be a product that is “packaged and sold individually.” Accordingly, the comment questioned whether the proposed single-serving and dual-column labeling requirements would apply only to products that consist of a single unit, or whether the requirements would also apply to non-discrete bulk products and products divided into discrete units. The comment also requested clarification on whether a product that is “packaged and sold individually” must be considered a single-serving container if it contains less than 200 percent of the RACC, and whether it must provide dual-column labeling if it contains 200 percent to 400 percent of the RACC.

(Response 9) In proposed § 101.9(b)(6) we use the phrase “products that are packaged and sold individually” and weighing less than 200 percent of the RACC to describe products for which single-serving container labeling requirements would apply. The phrase “products that are packaged and sold individually” was also used in the serving size proposed rule to describe products for which the proposed dual-column labeling requirements would apply, provided that they contained at least 200 and up to and including 400 percent of the RACC. In both of these cases we are using the phrase “products that are packaged and sold individually” to describe any package bearing a Nutrition Facts label.

A product that is packaged and sold individually,

i.e.,

a container that bears a Nutrition Facts panel, is considered a single-serving container if it contains less than 200 percent of the RACC. A product that is packaged and sold individually would be required to provide dual-column labeling if it contains at least 200 percent and up to and including 300 percent of the RACC, unless an exception from the requirement applies. The change from 400 percent of the RACC as the upper limit for the dual-column labeling requirements to 300 percent of the RACC as the upper limit for the dual-column labeling requirements is discussed in section III.B. While § 101.9(b)(2)(i) provides requirements for the serving size declaration for multiserving products in discrete units, products that satisfy the requirements of § 101.9(b)(6) (

i.e.,

products that are packaged and sold individually and that contain less than 200 percent of the applicable reference amount) are excepted from § 101.9(b)(2) (see 58 FR 2229 at 2234). There was no proposal to change this provision in the proposed rule, and it has not been amended in this final rule. Therefore, products in discrete units that are packaged and sold individually and that contain less than 200 percent of the applicable reference amount are required to be labeled as a single serving under § 101.9(b)(6). Products that contain discrete units and in which each discrete unit weighs at least 200 percent and up to and including 300 percent of the reference amount are required under § 101.9(b)(2)(i)(D) to bear two columns listing the quantitative amounts and percent DVs: One providing nutrition information for a serving that is less than the unit (

i.e.,

the serving size derived from the reference amount) and one providing nutrition information for the entire unit. Further, products in discrete units that are packaged and sold individually and contain at least 200 percent and up to and including 300 percent of the reference amount are required to comply with the dual-column labeling requirements in § 101.9(b)(12)(i). Similarly, products not in discrete units that are packaged and sold individually and contain at least 200 percent and up to and including 300 percent of the reference amount are required to satisfy the dual-column labeling requirements in § 101.9(b)(12)(i).

(Comment 10) Several comments pertained to multiple individually wrapped units in a single container, for which the combined weight of the units in the larger package is less than 200 percent of the RACC. The comments stated that products containing individual units in a container where the entire container weighs less than

200 percent of the RACC are unlikely to be consumed in a single eating occasion. One comment requested an exemption from the single-serving container requirement in a scenario in which a package weighing less than 200 percent of the RACC contains two discrete stuffed sandwiches, and requested that each sandwich, rather than the entire package, be considered one serving. The comment stated that under the proposed amendments to the definition of a single-serving container, the entire package containing the two stuffed sandwiches would need to be labeled as one serving. The comment stated that labeling each discrete stuffed sandwich as a single serving would be consistent with how consumers use and eat these types of products and asserted that consumers typically eat one individually wrapped unit in a single eating occasion, rather than opening a second unit. Another comment requested that we provide an exemption generally from the definition of single-serving container where a package contains multiple individually wrapped units, and each individual unit is labeled as a serving.

(Response 10) We disagree with comments suggesting that products containing discrete units in a container that weighs less than 200 percent of the RACC should be exempt from the single-serving container requirements, regardless of whether the individual units in the container are wrapped. Products containing discrete units in a container weighing less than 200 percent of the RACC were required to be labeled as a single-serving container under the 1993 requirements, unless the product qualified for the large-RACC exception discussed in section III.B. We did not propose to change this requirement in the proposed rule and are not changing it in the final rule. Other provisions of our regulations permit additional flexibility with respect to how products in discrete units are labeled. As explained in response to comment 12 and as reflected in § 101.9(b)(6), for products that are packaged and sold individually (

i.e.,

products bearing a Nutrition Facts panel) that contain more than 150 percent and less than 200 percent of the applicable reference amount, manufacturers may voluntarily add a second column of nutrition information to the left of the column that provides nutrition information per container that will provide nutrition information per common household measure that most closely approximates the reference amount. This would allow manufacturers of products that are packaged and sold individually and that contain two discrete units weighing more than 75 percent and less than 100 percent of the reference amount to voluntarily provide a second column that provides nutrition information per unit. Additionally, for packages that weigh less than 200 percent of the RACC each and that are contained within a larger outer container, manufacturers have the option of labeling each individual package with a Nutrition Facts panel that states that the individual package or container is one serving, and then labeling the outer container to state the number of servings as the number of individual packages within the outer container (§ 101.9(b)(8)(iv)). Finally, in order to provide additional flexibility to manufacturers that want to list nutrition information per unit of food, this final rule amends § 101.9(b)(10)(ii), which allows manufacturers to provide an additional column of nutrition information “[p]er one unit if the serving size of a product in discrete units in a multiserving container is more than 1 unit.” This final rule removes language in § 101.9(b)(10)(ii) limiting the provision to use only with multiserving containers. These amendments will allow single-serving products to voluntarily provide an additional column of nutrition information per unit of a product that is in discrete units.

2. Single-Serving Container Option for Large-RACC Products

(Comment 11) Several comments said that our analysis of the correlation between the consumption variation and the RACCs for all products containing less than 200 percent of the applicable RACC is flawed. The comments stated that we defined the average variability in the analysis as the standard deviation as a percent of the mean and that this represents the standard deviation of individual intakes from one person to the next. The comments stated that the standard deviations of the medians in all tables in our analysis are actually the standard errors of the medians and not the standard deviations of individual intakes as previously described (Ref. 9). The comments stated that because we did not actually conduct the appropriate analysis, no conclusion should be drawn from these reported summaries.

(Response 11) After carefully reexamining the data described in the Memorandum-to-file dated February 11, 2014 (Ref. 9), we agree that the standard deviations of the median are, in fact, the standard errors of the medians. Therefore, we have revised the correlation between the consumption variation and the RACCs for all products.

We disagree, however, that no conclusion should be drawn because of the error. The revised correlation coefficient, after adjusting the standard errors to standard deviations by multiplying with square roots of the sample size, is reduced to 0.13 from 0.18. This means that there is an even lower 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.” In other words, the correct calculation reinforces the conclusion that 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.

(Comment 12) One comment expressed concern about the impact that removing the exception for large-RACC products in § 101.9(b)(6) would have on products with varying densities. According to the comment, some varieties of the same type of product have serving sizes that are less than 200 percent of the RACC, while other varieties of the same type of product have serving sizes that are 200 percent of the RACC or greater. The comment noted as an example canned soups of different varieties that are often packaged in the same size and type of container, for which the different varieties may have different densities (

e.g.,

a cream-based soup may be heavier than a broth-based soup). According to the comment, under the proposed rule soups containing less than 200 percent of the RACC, or less than 490 g, would be required to be labeled as a single serving, while soups containing 200 to 400 percent of the RACC, or 490 to 980 g, would be labeled with dual-column labeling.

Another comment noted that inconsistencies in nutrition label formats could result from the use of single- and dual-column labeling for similar products which could lead to consumer confusion and make it difficult for consumers to compare identical products that may contain 200 percent or more of the RACC and use a dual-column label with single-serving container products that use a single-column label (

e.g.,

19 oz, 24 oz, and 40 oz products of identical formulation). The comment said that these products are often merchandised side-by-side in supermarkets and asserted that the

presence of two different serving sizes and two different formats (dual-column labeling for the 19 and 24 oz product versus single-column labeling for 13 and 15 oz products) would confuse the consumer.

We also received a comment requesting that we allow voluntary dual-column labeling for products that contain more than 150 and less than 200 percent of the RACC to present nutrition information per serving and per common household measure closest to the RACC. The comment noted that under the proposed rule, such products would be single-serving containers and would be required to declare nutrition information on a “per container” basis (proposed § 101.9(b)(6)). The comment asserted that it would be appropriate to provide nutrition information on a “per container” basis for these products but noted that some consumers may not eat the entire container in one sitting. The comment suggested that some consumers would find it helpful to have nutrition information on the label for an amount of food that approximates or is closest to the RACC.

One comment noted that it is a common practice for retailers to create a private label product with a “slightly lower” net content. In these instances, consumers would compare a brand name product to a private label product with a slightly lower net content and think the private label brand has a better nutritional profile than the brand name. The comment stated that this is because consumers would fail to understand that the nutritional difference is a result of the difference in net contents between the two products, not the actual nutritional value.

(Response 12) We recognize that certain differences will appear on product labels between the amounts of nutrients per serving listed on products that contain close to, but less than, 200 percent of the RACC, and products that contain 200 percent of the RACC or more. Allowing products that contain less than 200 percent of the RACC to voluntarily display an additional column with nutrition information per common household measure that most closely approximates the reference amount will allow consumers to easily compare the nutrition information of products containing more than 150 percent but less than 200 percent of the RACC with products that contain 200 percent of the RACC or more. Therefore, we are amending § 101.9(b)(6) to add a provision that allows manufacturers of products that contain more than 150 percent and less than 200 percent of the applicable reference amount to voluntarily add a second column of nutrition information to the left of the column that provides nutrition information per container (

i.e.,

per serving) that will provide nutrition information per common household measure that most closely approximates the reference amount. This provision will allow consumers to compare more easily the nutrition information amongst similar products that are packaged in containers that are near 200 percent of the RACC by allowing manufacturers to use a similar dual-column label format. This voluntary labeling provision is not limited to large-RACC products, but is permitted for all products that are packaged and sold individually in containers that are more than 150 percent and less than 200 percent of the RACC.

With regard to the concern that products of nearly identical size could appear to have significantly different amounts of nutrients per serving due to the fact that some products could be required to be labeled as a single serving while similar products could be labeled as having two servings, we note that the dual-column labeling requirements (see section III.C.) will help ensure that consumers have the opportunity to compare the nutritional information for the package as a whole for products containing at least 200 percent and up to and including 300 percent of the RACC with the serving size for those products containing just under 200 percent of the RACC.

To address the comment that stated that a lower net content in some product manufacturing would cause consumers to think that a certain product has a better nutritional profile than another, we note that the nutrition information that is provided on these products would still be accurate. If the net content is lower, the amount of product a person is likely to consume is also lower, which is reflected in the nutrition information on the label.

(Comment 13) We received numerous comments that supported the removal of the exemption for large-RACC products from the definition of a single-serving container. These comments stated that products containing less than 200 percent of the RACC are likely to be consumed in a single eating occasion and should be labeled as a single serving.

Several comments opposed the removal of language from § 101.9(b)(6), which gives manufactures the flexibility to label large-RACC products that contain more than 150 percent but less than 200 percent of the RACC as 1 or 2 servings, or to label packages that contain 200 percent or more of the applicable RACC as a single serving if the contents of the entire package can reasonably be consumed at a single eating occasion. The comments stated that eliminating this option takes away a manufacturer's flexibility and asserted that manufacturers are in the best position to determine if a product should be labeled as one or two servings. Other comments stated that labeling products with less than 200 percent of the RACC as one serving may not be appropriate for all foods. For example, several comments stated that some side dishes, such as frozen potato products, frozen vegetables, and macaroni and cheese kits, are consumed in smaller quantities than entrée items, and a consumer could not reasonably consume an amount close to 200 percent of the RACC.

A few comments objected to requiring products that were previously labeled as two servings to be labeled as one serving and asserted there was no change in consumption data. Other comments did not like the “one size fits all” approach and suggested that we look at actual usage of each product category before requiring that a product be labeled as a single serving. One comment noted that labeling products that are regulated by FDA and the USDA, such as chili, soup, stews, and several mixed dishes that often come in 15 oz cans (425 g), as a single serving would be a shift from the industry standard of labeling cans of this size as containing “about 2 servings.”

(Response 13) We disagree with the comments opposing the removal of the option of large-RACC products (

i.e.,

those products with an RACC of 100 g or 100 mL or larger) that contain more than 150 percent but less than 200 percent of the RACC to be labeled as one or two servings. We also disagree with the assertion that there has been no change in consumption data since 1993. 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, in 1993, 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 large RACCs, 150 percent may be a reasonable cutoff for a single-serving container (58 FR 2229 at 2233).

However, as discussed previously in this document, in developing the 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 and products that have RACCs that are less than 100 g (or mL), using combined consumption data from the NHANES 2003-2008 surveys (Ref. 9). The result shows that the correlation coefficient is 0.13, 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.” In other words, it is not less likely that a person would consume approximately twice the reference amount of a food with a large RACC than it is that he or she would consume approximately twice the reference amount of a food with a smaller reference amount. Therefore, we determined that the exemption from the requirement to label a product with a large RACC that contains more than 150 percent but less than 200 percent of the applicable RACC as a single-serving container is no longer warranted. We are also working with USDA to harmonize our regulations.

In response to the comments that stated that we are reducing the flexibility of our regulations, although we work to increase the flexibility of our regulations when appropriate, the purpose of this option was not to allow manufacturers the ability to make a choice, but to allow for foods to be labeled in a way that reflects how much a person is consuming a certain product. Our decision to remove this option is based on the data indicating that consumers are consuming the same amount of large-RACC products in proportion to the RACC as they are of smaller-RACC products in proportion to the RACC.

To address the comments that stated that not all foods that are less than 200 percent of the RACC should be considered a single serving, we reiterate that research demonstrates that package and portion sizes tend to have a considerable impact on the amount of food consumed (Refs. 10 and 11). We also note that we did not propose to change the upper limit for the definition of a single serving container in the serving size proposed rule. Additionally, as explained in comment 12, we are amending § 101.9(b)(6) to allow manufacturers of products that contain more than 150 percent and less than 200 percent of the applicable reference amount to voluntarily add a second column of nutrition information to the left of the column that provides nutrition information per container, which will provide nutrition information per common household measure that most closely approximates the reference amount.

(Comment 14) Some comments stated that requiring products that were previously labeled as two servings to be labeled as one serving would encourage consumers to eat more. One comment asserted that the information on the label of a single-serving container could discourage consumption of a particular food product due to the quantity of a specific nutrient in the container or other information about the product, while on the whole that product could provide valuable nutrients in the diet. The comment gave an example of a frozen entrée that may be high in saturated fat, yet be a good source of protein, dietary fiber, and potassium. The comment stated that, if consumers were to focus only on the saturated fat content of the product, they may choose not to eat the frozen entrée, even though it is a good source of other essential nutrients.

(Response 14) As noted previously, research demonstrates that package and portion sizes tend to have a considerable impact on the amount of food consumed (Refs. 10 and 11). We acknowledge that certain consumers may pay attention to specific, individual nutrients, but one of the main goals of nutrition labeling is to provide consumers with accurate nutrition information to assist them in maintaining healthy dietary practices. If a product is high or low in a specific nutrient for which an individual consumer is looking to either increase or decrease intake, this information is useful to consumers who are interested in the specific nutrient. Consumer education on understanding the Nutrition Facts label and the diet can be used to help explain the benefits and risks associated with the intake of nutrients. Additionally, for products that satisfy the requirements to make a nutrient content claim such as a “good source” claim (see 21 CFR 101.54), the product may include such a claim to draw attention to the positive attributes of the product.

C. Dual-Column Labeling

Preexisting § 101.9 provides various provisions for types of voluntary dual-column labeling (

e.g.,

paragraphs (b)(10), (e), and (h)(4)) and one provision for mandatory dual-column labeling under certain circumstances (paragraph (b)(11)). In comment 10 we discuss a revision in this final rule to the voluntary dual-column labeling provision in § 101.9(b)(10)(ii), which broadens the scope of the provision to allow dual-column labeling per unit for single-serving products. Also, in comment 12 we discuss a new voluntary provision for dual-column labeling for products that are packaged in containers that include more than 150 percent but less than 200 percent of the RACC, in § 101.9(b)(6).

In the preamble of the proposed rule (79 FR 11989 at 11998 to 11999), we cited research that shows 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 (Refs. 14 and 15). In the preamble of the proposed rule (79 FR 11989 at 11999), we also discussed consumer research that we conducted to help increase our understanding of whether modifications to the label format may help consumers use the label. Our 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. The main findings from this study are that the availability of 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 single-column labels that listed two servings per container.

The proposed rule would require, under certain circumstances, the use of dual-column labeling to provide nutrition information per serving and per container (proposed § 101.9(b)(12)(i)), or per serving and per unit of food (proposed § 101.9(b)(2)(i)(D)). As noted in the preamble of the proposed rule, such dual-column labeling 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 (79 FR 11989 at 12003).

In the preamble of the proposed rule we stated that to determine an upper limit for the range of package sizes for which dual-column labeling would be required, we looked at food consumption data from NHANES 2003-2008 surveys (Ref. 16) (79 FR 11989 at 12003). The 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. Therefore, we determined that dual-column labeling for packages containing at least 200 percent of and up to and including 400 percent of the RACC would capture the most frequent consumption habits for almost all product categories. Conversely, the data show that products that contain more than 400 percent of the current RACC are less likely to be consumed in one eating occasion compared to products that contain 400 percent or less of the current RACC. Therefore, we proposed dual-column labeling to be required for all packages that contain at least 200 percent of and up to and including 400 percent of the applicable RACC (proposed § 101.9(b)(12)(i)).

In the preamble of the proposed rule (79 FR 11989 at 12004) we requested comment on exemptions from dual-column labeling for products that require further preparation, such as macaroni and cheese kits, pancake mixes, pasta products, and for products that are commonly consumed in combination with other foods (

e.g.,

cereal and milk), and that contain at least 200 percent and up to and including 400 percent of the applicable RACC. 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)). Some of these products voluntarily contain two columns of nutrition information on the “as purchased” and “as prepared” forms of the food. Therefore, we tentatively concluded in the proposed rule 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, and for products that are commonly consumed in combination with other foods (

e.g.,

cereal and skim milk) (§ 101.9(h)(4)) should be exempt from the dual-column labeling requirements.

In § 101.9(b)(12)(ii) we proposed to require that if a health or nutrient content claim is made on the label of a product that uses dual-column labeling, as would be required under proposed § 101.9(b)(12)(i) and (b)(2)(i)(D), the claim would be required to be followed by a statement that sets forth the basis on which the claim is made if the product qualifies for the claim based on the amount of the nutrient per RACC and not the amount in the entire container or unit of food (

e.g.,

for nutrient content claims, “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”).

As noted previously in the introduction to section III.B., we also proposed to remove the text in preexisting § 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. Proposed § 101.9(b)(2)(i)(D) states that if a unit weighs at least 200 percent and up to and including 400 percent of the applicable reference amount, the manufacturer must provide an additional column within the Nutrition Facts label that lists the quantitative amounts and percent DVs for the individual unit, as well as the preexisting columns listing the quantitative amounts and percent DVs for a serving that is less than the unit (

i.e.,

the serving size derived from the RACC).

1. General Comments on Dual-Column Labeling

(Comment 15) We received several comments in support of the dual-column labeling requirements as proposed. The comments stated that because consumers may eat a full package of food regardless of its serving size, those consumers must be able to easily understand the nutrition content of the full package of food as consumed. A few comments stated that consumers who might otherwise simply assume that the Nutrition Facts label applies to the entire package would see, at a glance, that the nutrition information for the entire package is considerably greater than the serving size. These comments stated that seeing two sets of nutrition information per serving and per container could prompt people to think about the portion size they are consuming.

Some comments mentioned specific food product categories that they thought would be ideal for dual-column labeling because they are sometimes consumed by a single person in one eating occasion and sometimes eaten over multiple meals or by multiple people. The products mentioned in the comments included pints of ice cream, frozen pizzas, main entrées, side dishes, frozen vegetables, bags of chips, large candy bars, snack foods, cookies, and 20 oz sodas.

(Response 15) We agree that dual-column labeling will help consumers more easily understand the contents of a particular package both on a per-serving and per-container basis. As discussed in the introduction to section III.C., research suggests that dual-column labeling helps consumers understand the amount of nutrients in an entire container of food. The foods that were listed in the comments as being appropriate for dual-column labeling are similar to the foods that were mentioned in the April 4, 2005, Advance Notice of Proposed Rulemaking (ANPRM) 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” as foods that consumers thought were single servings, but were really multiple servings (70 FR 17010 at 17013). To the extent these comments suggest that the requirements relating to dual-column labeling should apply only to certain types of products, we disagree. This issue is addressed in our response to comment 19.

(Comment 16) We received several comments that opposed the additional wording that we proposed to require in § 101.9(b)(12)(ii) if a health or nutrient content claim is made on a product containing a dual-column label. The comments asserted that the proposed statements are too lengthy and unnecessary, would clutter the label and take focus away from information in the claim, and would create inconsistency across package sizes. The comments asserted that there is no consumer research to establish that nutrient content claims on dual-column labels present the potential for consumer confusion (

i.e.,

without the “basis” language), that consumers would believe that the claims are based on an entire container in the event dual-column labeling were used, or that the proposed language would assist consumers in understanding the basis for the claim. The comments further questioned whether we had an adequate legal basis for requiring the proposed explanatory statement and noted that there is a current regulation that allows for indicating the basis of a claim if the claim is not based on the RACC. A few comments indicated that if some type of

statement becomes necessary, then it should be very simple and short, such as the addition of “per serving” or “per

X

oz. serving.” We received one comment in support of the statement as proposed. We received one comment that requested we limit the qualifying statement to nutrient content claims about the absence of a nutrient (

e.g.,

low fat), as when these type of claims are made on products that include a dual-column label, the product would only meet the criteria for the claim on the basis of the RACC and per labeled serving, but not the entire container.

(Response 16) We do not agree that a statement explaining the basis of a nutrient content claim or health claim, as described in proposed § 101.9(b)(12)(ii), is always unnecessary. Because the use of dual-column labeling per serving and per container will become more prevalent on food labels, consumers will more often encounter nutrition claims on foods with dual-column labeling. When consumers encounter a nutrient content claim or health claim (

e.g.,

low fat) and are also presented with two sets of nutrition information (

i.e.,

per serving information and per container information), and the criteria for the claim would only be met based on the set of nutrition information that does not apply to the entire container or unit, as applicable, explanation is needed to avoid consumer deception and clarify which set of nutrition information the claim applies to. When the claim relates to the nutritional information presented in one column, but not the other, the possibility for consumer deception is self-evident. Due to the expected use of nutrient content claims and health claims on products using dual-column labeling, we want to ensure that consumers understand the basis on which the claim is made. We are authorized to prohibit claims that are false or misleading under sections 403(a) and 201(n) of the FD&C Act.

See also Cent. Hudson Gas & Elec. Corp.

v.

Public Serv. Comm'n,

447 U.S. 557, 593 (1980) (explaining that “false and misleading commercial speech is not entitled to any First Amendment protection”). Current provisions for claims require a manufacturer to communicate if a product meets the criteria for a nutrient content claim or health claim only on the basis of the reference amount (

e.g.,

a product with a serving size of 2 cookies weighing 35g, but that only meets the criteria for a nutrient content claim based on the 30 g RACC for cookies) (§ 101.12(g)), but there are currently no provisions which require a claim to explain which set of nutrition information it is based on in the context of dual-column labeling. When a nutrient content claim or health claim is made on a package that does not use dual-column nutrition labeling, consumers are provided with only one set of nutrition information (based on the serving size) in the Nutrition Facts label to associate with the claim. In the case of dual-column labeling, however, consumers are presented with two sets of nutrition information and would not be able to determine which set of data to associate with the claim. Therefore, in order to help consumers understand the context of the claim, there is a need for a provision requiring a statement that sets forth the basis on which the claim is made under certain circumstances when dual-column labeling is presented on the product label.

We agree, however, that the proposed statements could be lengthy. The comments provided examples of concise language that could accompany nutrient content claims and still meet the objective of indicating the basis of the claim. We agree that, when possible, shorter clarifying statements on the food label are preferable and that more concise language than that in proposed § 101.9(b)(12)(ii) is available for nutrient content claims. Therefore, for nutrient content claims, § 101.9(b)(12)(ii) requires manufacturers to state that the claim refers to the amount of a nutrient per serving or per reference amount but allows the use of simpler language to explain the basis on which nutrient content claims are made per serving (

e.g.,

“good source of calcium per serving” or “per X [insert unit]__serving”) or per reference amount (

e.g.,

“good source of calcium per [insert reference amount (

e.g.,

per 8 ounces)]”), as required based on § 101.12(g). For health claims, no examples of more concise language were provided in comments to the proposed rule, and upon further evaluation of the explanatory statement provided in the proposed rule (

i.e.,

“A serving of __ounces of this product conforms to such a diet”), we believe that the statement is as concise as possible to convey the intended message. Health claims, as opposed to nutrient content claims, already frequently require informational statements related to the substance of the claim, the disease condition, and/or the target populations. Therefore, we conclude that the statement related to the basis of the claim, as proposed, is an appropriate statement to include with health claims, is consistent with other types of accompanying statements to health claims, and is as concise as needed for the intended message.

With regard to the assertion that the additional wording that we proposed to require in § 101.9(b)(12)(ii) if a health or nutrient content claim is made on a dual-column label would create inconsistency across package sizes, we note that distinctions already may arise among products of different sizes with regard to which package sizes are eligible to bear a nutrient content or health claim. Claims are typically based on the RACC, but in some cases they are based on both an RACC and a per label serving size. Existing requirements may already result in differences in the eligibility of a food packaged in different forms (

e.g.,

bulk package versus individual serving packages) to bear a specific claim. Likewise, differences exist with regard to the ability of products to make nutrient content or health claims because of the variety of possible size options (

e.g.,

one very large cookie versus an individual serving container of small cookies).

With regard to the comment that suggested the requirement to include the qualifying statement should be limited to nutrient content claims about the absence of a nutrient, we disagree with establishing a limitation based on the specific claim at issue (

e.g.,

low fat) but agree with the comment to the extent that it suggests that the qualifying statement should not be required on product labels when the product would meet the criteria to make the claim at issue based on both columns of nutritional information. We agree, for example, that if a product for which dual-column labeling would be required under § 101.9(b)(12)(i) were to contain sufficient vitamin C per serving to make a “high” claim regarding vitamin C content, and the container as a whole were to meet the criteria for a “high” in vitamin C claim, consumers are not likely to be misled by the presence of such a claim in the absence of a qualifying statement. The language in proposed § 101.9(b)(12)(ii) already provides an exception from the requirement for products when the nutrient that is the subject of the claim meets the criteria based on the entire container or unit amount. We have modified that language in the final rule to explain that a clarifying statement is not required for products when the nutrient that is the subject of the claim meets the criteria for the claim based on the reference amount for the product and the entire container or the unit amount.

(Comment 17) One comment questioned our legal authority to require dual-column labeling. The comment

stated that section 403(q)(1)(A)(i) of the FD&C Act requires nutrition information to be provided on the basis of an amount customarily consumed and which is expressed in a common household measure that is appropriate to the food. The comment stated that the quantity of nutrients in a package or unit that contains at least 200 percent and up to and including 400 percent of the RACC is not an amount customarily consumed and that none of the exemptions stated in the NLEA give us the authority to require nutrition information to be declared on the basis of an amount other than the serving size.

(Response 17) We disagree with the suggestion that we lack the legal authority to require dual-column labeling. The mandatory dual-column label will continue to provide nutrition information based on the labeled serving size, which is the amount that is customarily consumed. As explained previously in section II.B., the primary legal authority for requirements pertaining to the labeled serving size is derived from section 403(q)(1)(A) of the FD&C Act, with additional authority coming from section 2(b)(1)(B) of the NLEA. Additionally, the legal authority for the second column in a dual-column label is derived from section 2(b)(1)(A) of NLEA, which states that requirements in regulations issued under the authority of the NLEA 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” (79 FR 11989 at 11991). As explained previously in section III.C. and in the preamble to the proposed rule (79 FR 11989 at 11999), consumer research shows that the availability of dual-column labels results in more participants correctly identifying the number of calories per container and the amount of other nutrients per container compared to single-column labels that listed two servings per container. Additional authority for the dual-column labeling requirements includes section 701(a) of the FD&C Act, which provides us with authority to issue regulations for the efficient enforcement of the FD&C Act.

(Comment 18) One comment asserted that we failed to consider certain First Amendment concerns associated with the proposed dual-column labeling requirements. The comment asserted that the purpose of dual-column labeling is to shape consumer behavior rather than to provide purely factual information, and that we justified our proposal to require dual-column labeling based on a study that concluded that dual-column labeling reduces snack food consumption when compared to single-column labeling for people who are not currently dieting. The comment stated that by explaining that we would continue to conduct consumer research throughout the rulemaking process to help enhance our understanding of whether and how much any modifications to the label format may help consumers use the label, we impliedly conceded the insufficiency of our reliance on this study in the proposed rule.

The comment further questioned our asserted reliance on statutory authority granted in section 2(b)(1)(A) of the NLEA in light of our mandate to implement regulations in accordance with the First Amendment. The comment asserted that because dual-column labeling “is unnecessarily duplicative,” the dual-column labeling requirement would be subject to analysis under the standard set forth in

Central Hudson Gas & Elec. Corp.

v.

Public Serv. Comm'n,

447 U.S. 557 (1980), rather than

Zauderer

v.

Office of Disciplinary Counsel of Supreme Court,

471 U.S. 626 (1985). The comment asserted that the Supreme Court's decision in

Zauderer

and its progeny supports the proposition that the government may require a clarifying disclosure “to dissipate the possibility of consumer confusion or deception” after finding that the possibility of deception is “self-evident,”

id.

at 652, and that mandatory disclosures are not permitted unless the state demonstrates an actual likelihood that consumers will be misled absent the disclosure.

The comment asserted that we admitted that the dual-column labeling requirement attempts to influence consumer behavior by discouraging consumers from consuming food that is packaged between 200 percent and 400 percent of the RACC. The comment stated that we failed to establish that dual-column labeling would serve a substantial government interest in discouraging consumption of food that is packaged between 200 percent and 400 percent of the RACC. The comment further asserted that we failed to establish in the proposed rule that dual-column labeling would have a discernable effect on consumer behavior and, therefore, that the proposed rule cannot satisfy the third prong of

Central Hudson

in that it did not present evidence that dual-column labeling would directly advance the interest in promoting consumer health and preventing overconsumption of certain foods. The comment stated that we rely in part on study results suggesting that dual-column labeling reduces snack food consumption but asserted that we failed to consider the effect of dual-column labeling on consumption of other categories of food besides snacks. According to the comment, we inexplicably concluded, based on studies of “junk foods”, that consumption of all foods packaged as RACCs between 200 percent and 400 percent should be discouraged.

The comment asserted that the dual-column labeling requirement as proposed is “vastly overbroad” and fails to satisfy

Central Hudson's

reasonable fit test, in part because we acknowledged in the proposed rule that modifying the Nutrition Facts label would require some reeducation on how to read the Nutrition Facts label. The comment asserted that we failed to adequately consider comments that suggested that the dual-column format may be confusing and that we erroneously suggested that the burden is on opponents of the regulation to provide evidence that dual-column labeling may be confusing.

(Response 18) We recognize the importance of the First Amendment protections raised in this comment, and we disagree with the assertion that we neglected to consider such protections in proposing the dual-column labeling requirements. In

Zauderer,

the Supreme Court explained that “[b]ecause the extension of First Amendment protection to commercial speech is justified principally by the value to consumers of the information such speech provides, [a speaker's] constitutionally protected interest in

not

providing any particular factual information in his advertising is minimal.” 471 U.S. at 651 (emphasis in original) (internal citations omitted). Requirements “to make purely factual disclosures related to . . . business affairs, whether to prevent deception or simply to promote informational transparency, have a `purpose . . . consistent with the reasons for according constitutional protection to commercial speech' . . . [and] facilitate rather than impede the `free flow of commercial information.' ”

Beeman

v.

Anthem Prescription Mgmt.,

58 Cal. 4th 329, 356 (Cal. 2013) (quoting

44 Liquormart, Inc.

v.

Rhode Island,

517 U.S. 484, 501 (1996) and

Va. Pharmacy Bd.

v.

Va. Consumer Council,

425 U.S. 748, 765 (1976), respectively). As a result, government requirements to disclose factual commercial information are subject to a more lenient constitutional standard than that set forth under the

Central Hudson

framework.

Zauderer,

471 U.S. at 651. Under

Zauderer,

the government can

require disclosure of factual information in the realm of commercial speech as long as the disclosure provides accurate, factual information; is not unjustified or unduly burdensome; and is “reasonably relate[d]” to an adequate interest.

Id.

Contrary to the comment's assertion, the validity of the dual-column labeling requirements under the First Amendment is properly evaluated under

Zauderer,

471 U.S. 626, rather than

Central Hudson,

447 U.S. 557. Courts generally apply

Zauderer'

s rational relationship test, as opposed to intermediate scrutiny under

Central Hudson,

“in compelled commercial disclosure cases” because “mandated disclosure of accurate, factual, commercial information does not offend the core First Amendment values of promoting efficient exchange of information or protecting individual liberty interests.”

Nat'l Elec. Mfrs. Ass'n

v.

Sorrell,

272 F.3d 104, 114-15 (2d Cir. 2001) (explaining that the disclosure of accurate, factual commercial information “furthers, rather than hinders, the First Amendment goal of the discovery of truth”). Case law interpreting

Zauderer

clarifies that the government need not establish that compelled disclosure will prevent consumer deception for the

Zauderer

standard to apply. In

American Meat Institute

v.

USDA,

the court held that “[t]he language with which Zauderer justified its approach. . .sweeps far more broadly than the interest in remedying deception.” 760 F.3d 18, 22 (D.C. Cir. 2014) (en banc). In reaching the conclusion that the applicability of

Zauderer

extends beyond regulations in which the government is attempting to mandate a disclosure to remedy deception, the court focused on the “material differences between disclosure requirements and outright prohibitions on speech,”

id.

(quoting

Zauderer,

471 U.S. at 650), the fact that “the First Amendment interests implicated by disclosure requirements are substantially weaker than those at stake when speech is actually suppressed,”

id.

(quoting

Zauderer,

471 U.S. at 652 n.14), and the fact that “[b]ecause the extension of First Amendment protection to commercial speech is justified principally by the value to consumers of the information such speech provides, [a] constitutionally protected interest in not providing any particular factual information in his advertising is minimal,”

id.

(citing

Zauderer,

471 U.S. at 651). The court found that, “[a]ll told, Zauderer's characterization of the speaker's interest in opposing forced disclosure of such information as `minimal' seems inherently applicable beyond the problem of deception.”

Id.

Several other circuits concur.

See Pharm. Care Mgmt. Ass'n

v.

Rowe,

429 F.3d 294, 297-98, 310, 316 (1st Cir. 2005);

N.Y. State Rest. Ass'n

v.

N.Y. City Bd. of Health,

556 F.3d 114, 133 (2d Cir. 2009);

Nat'l Elec. Mfrs. Ass'n

v.

Sorrell,

272 F.3d 104, 115 (2d Cir. 2001) (affirming use of the “reasonable-relationship”

Zauderer

standard when “the compelled disclosure at issue . . . was not intended to prevent `consumer confusion or deception'”);

Discount Tobacco City & Lottery, Inc.

v.

United States,

674 F.3d 509, 556 (6th Cir. 2012) (holding that “

Zauderer'

s framework can apply even if the required disclosure's purpose is something other than or in addition to preventing consumer deception”);

CTIA—The Wireless Ass'n®

v.

City of Berkeley,

No. C-15-2529, 2015 U.S. Dist. LEXIS 126071, at *46 (N.D. Cal. 2015) (holding that

Zauderer

is not “limited to preventing consumer deception” and explaining that “it would make little sense to conclude that the government has greater power to regulate commercial speech in order to prevent deception than to protect public health and safety”).

The dual-column labeling requirements readily satisfy the

Zauderer

test. First, the proposed dual-column labeling provisions, which are being finalized in this rule, require accurate disclosures of factual commercial information. The required disclosure will help facilitate the free flow of commercial information and does not “prescribe what shall be orthodox in politics, nationalism, religion, or other matters of opinion.”

Zauderer,

471 U.S. at 651 (quoting

W. Va. State Bd. of Educ.

v.

Barnette,

319 U.S. 624, 642 (1943)). The comment did not dispute the accuracy of the information at issue.

Second, the dual-column labeling requirements would not be unduly burdensome. Factual nutrition information is currently required to be provided on packaged foods. While dual-column labeling will require more space on certain packages for factual nutrition information, the majority of the label space on products subject to the dual-column labeling requirements will still be available for product messaging by the manufacturer. We also note that, as discussed in our economic analysis (Ref. 17), the cost to manufacturers is relatively low under the compliance timelines in the final rule which will allow most manufacturers to add dual-column labeling during regularly scheduled label changes for their products. Additionally, this final rule reduces from the proposed rule the amount of products for which dual-column labeling will be required, as we are lowering the upper limit for which dual-column labeling is required from those containers weighing up to 400 percent of the RACC to those containers weighing up to 300 percent of the RACC. Furthermore, certain packages for which dual-column labeling would require a greater proportion of the label space are exempt from these requirements. For example, under § 101.9(b)(12)(i)(A), the dual-column labeling requirements in § 101.9(b)(12) do not apply to 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

).

Third, the requirement to provide dual-column labeling is reasonably related to the Government's interests in promoting the public health and providing consumers access to factual information that will help them understand the nutrient content on certain packages that contain more than one serving of food. The factual information could be used to assist consumers in maintaining healthy dietary practices. Recent NHANES data shows that products containing up to and including 300 percent of the RACC could reasonably be consumed in a single eating occasion. Additionally, our research demonstrates that some consumers may have difficulties determining nutrition information per container when a label declares that the package contains more than one serving and is reasonably consumed in a single eating occasion. Our recent format experimental study, however, showed that, in the case of a proposed label with percent DVs listed on the left of the label, dual-column labeling improved the percentage of participants that were able to identify correctly the amount of nutrients in the entire container. In addition, our recent eye-tracking study showed participants both the current and proposed format of the Nutrition Facts labels, with one label showing one serving and the other two servings. Only about half of the participants noticed the number of servings on the label, and less than one third of the participants were able to identify which product contained fewer calories per container (Refs. 18 and 19). These results suggest that some consumers may not correctly recognize the accurate nutrient contents of packages containing more than one serving, including packages that may be consumed in a single eating occasion,

and therefore may not be able to use the label information to assist them in maintaining healthy dietary practices.

The dual-column labeling requirement is reasonably related to the Government's interest in enhancing consumer understanding of nutrient packaging and promoting the public health because it presents nutrition information in a manner that is easy to understand, giving consumers helpful tools to assist them in maintaining healthy dietary practices. As noted previously, our research shows that some consumers have difficulty determining the nutrient amounts in packages that contain more than one serving of food and that do not display the nutrient content of the entire package on the product label. Dual-column labeling helps to ensure that consumers have access to nutrient information for containers of certain sizes that could reasonably be consumed in a single eating occasion and therefore could assist consumers in maintaining healthy dietary practices.

The comment incorrectly asserts that the purpose of the proposed dual-column labeling requirements is to shape consumer behavior by discouraging consumption of food in containers that weigh between 200 percent and 400 percent of the reference amount. As explained in the proposed rule (see 79 FR 11989 at 12003), and as reiterated in this final rule, the purpose of dual-column labeling is not to discourage the consumption of certain foods but rather to increase consumer understanding of the quantity of nutrients in packages and containers of certain sizes that may be reasonably consumed in a single eating occasion. The reference provided in the proposed rule to a study that showed a reduction in snack food consumption amounts was included for the purpose of demonstrating that dual-column labeling could raise contextual awareness of the quantity of nutrients in a given container. While the reduction in the consumption amounts for certain products could potentially be associated with dual-column labeling, such changes in consumption are not the purpose of the requirement. Our findings, both as reported in the proposed rule and as explained previously in this final rule, demonstrate that the presence of dual-column labeling could help consumers understand the quantity of nutrients they are actually consuming if they consume the entire package in one eating occasion. Consumption data further shows that it is reasonably likely that some consumers will consume, in a single eating occasion, the entire container of products containing at least 200 percent and up to and including 300 percent of the RACC. We therefore disagree with the assertion that the dual-column labeling requirement “is unnecessarily duplicative” or that our reliance on the statutory authority granted in section 2(b)(1)(A) of NLEA conflicts with our obligation to promulgate regulations consistent with the protections granted by the First Amendment. Additionally, as discussed in the preamble to the proposed rule (79 FR 11989 at 11998), there is evidence that consumers do not correctly calculate nutrient amounts in food products by multiplying the nutrient amount by the number of servings per container, and research shows that dual-column labeling can help consumers more accurately determine the number of calories and nutrients in a food product compared to single-column labeling (Ref. 15). In short, dual-column labeling provides consumers with information that can assist them in maintaining healthy dietary practices.

While we disagree that the

Central Hudson

standard would be applicable to the requirement to provide a second column of nutrition information, the requirement to provide dual-column labeling would nonetheless be Constitutional under the standard set forth in

Central Hudson,

447 U.S. 557. If the

Central Hudson

standard were applicable to the evaluation of the dual-column labeling requirement, we would be required to identify a “government interest [that] is substantial,” establish that “the regulation directly advances the government interest asserted,” and show that the regulation “is not more extensive than is necessary to serve that interest.”

Id.

at 566. Under the

Central Hudson

test, we have the discretion to “judge what manner of regulation may best be employed” to serve the substantial government interest.

See City of Cincinnati

v.

Discovery Network, Inc.,

507 U.S. 410, 416 n.12 (1993) (citing

Bd. of Trs.

v.

Fox,

492 U.S. 469, 480 (1989)).

There can be no question that the government has a substantial interest in promoting the health of its citizens.

E.g., Rubin

v.

Coors Brewing Co.,

514 U.S. 476, 485 (1995). Our asserted interests are in promoting the public health and ensuring consumer access to information that could assist in maintaining healthy dietary practices. These interests are substantial because the consumption of excess and limited amounts of certain nutrients is linked to risk of chronic disease.

Dual-column labeling directly advances our asserted interests in promoting the public health and ensuring that consumers have access to information that could assist in maintaining healthy dietary practices. Our research shows that providing a second column of nutrition information on containers of certain sizes provides consumers information that allows them to understand the nutrient content of packaged foods. We disagree that our decision is based on “mere speculation or conjecture.”

See Rubin,

514 U.S. at 487. Our conclusion that dual-column labeling helps consumers understand the nutrient content of packaged foods when a label declares the package contains more than one serving and is reasonably consumed in a single eating occasion is supported by the consumer research cited throughout this document (Refs. 13 and 17).

Finally, the requirement to provide a second column of nutrition information is no more extensive than necessary to serve its purpose.

See Central Hudson,

447 U.S. at 566. The standard is not a “least restrictive means” test, and instead requires a reasonable fit between the ends and the narrowly tailored means chosen to accomplish those ends.

Lorillard Tobacco Co.

v.

Reilly,

533 U.S. 525, 556 (2001). The dual-column labeling requirement requires only factual disclosures of information about the nutrient content of products, and the required disclosure is limited to the information that we have determined is necessary to assist consumers in maintaining healthy dietary practices. The required disclosure is confined to one area of the food label and will enable consumers to understand the information in the Nutrition Facts label. Overall, this additional factual disclosure is limited in scope, and there are not “numerous and obvious less-burdensome alternatives” to this requirement.

See Discovery Network,

507 U.S. at 418 n. 13. In our research we looked at labels that provided a second column only for calories. Our research showed that this type of label was not as effective as providing a full second column of information about all nutrients listed on the Nutrition Facts label because different consumers are mindful of distinct nutrients and because the nutritional benefits of a product does not depend on a limited number of nutrients only. For example, some consumers need to ensure adequate consumption of specific vitamins or minerals, while others are concerned about protein intake. Full, dual-column nutritional information is more helpful to consumers and does not suggest that consumers should place greater emphasis only on selected nutrients. We therefore disagree with

the implication that this requirement is more burdensome than necessary because it requires the full set of nutritional information in the second column. Requiring that a second column of nutrition information appear on the label is a limited requirement that would serve the purpose of ensuring that consumers have access to information about the nutrient contents of packages and containers of certain sizes that could assist consumers in maintaining healthy dietary practices.

We disagree with the comment's assertion that the dual-column labeling requirement is “vastly overbroad,” which the comment asserts is demonstrated by our intent to conduct consumer education once the rule is finalized. Such education efforts are beneficial any time such a significant change in our regulations is made, and the addition of a second column of nutrition information is not the sole basis for our plan to continue to educate consumers. Additionally, as noted previously, certain packages for which dual-column labeling would require a greater proportion of the label space are exempt from these requirements (see § 101.9(b)(12)(i)(A)).

Because the dual-column labeling requirement supports a government interest that is substantial, directly advances that government interest, and is no more extensive than is necessary to serve that interest, the requirement would pass Constitutional scrutiny under

Central Hudson.

However, as noted previously in this section, case law makes clear that

Zauderer

applies to cases in which the government mandates the disclosure of factual and accurate disclosures of commercial information,

Zauderer,

471 U.S. at 651, as is the case here.

With regard to other specific issues raised in this comment, we disagree with the assertion that by explaining that we would continue to conduct consumer research throughout the rulemaking process we impliedly conceded the insufficiency of our consumer research cited in the proposed rule. The consumption data and research cited in the proposed rule provides sound justification for dual-column labeling. Additionally, since the publication of the proposed rule, we have conducted an additional study that corroborates the results discussed in the proposed rule,

i.e.,

that consumers were more likely to accurately determine the amount of nutrients shown on a label when dual-column labeling was used (Ref. 19). We continued to conduct research throughout the rulemaking process because the Lando and Lo study used the current format and we wanted to explore whether findings derived from that study would replicate on a different label format as outlined in our proposed rule. The subsequent study did, in fact, replicate the original finding that more consumers were able to accurately identify the amount of total nutrients shown on a product label when using the dual-column label, as compared to a single-column label with multiple servings per container (Ref. 15).

We further disagree with the assertions that we justified our proposal for dual-column labeling based on one study or that our conclusions for dual-column labeling are based solely on a study of snack foods. In addition to the studies discussed in the previous paragraph, we received a citizen petition and many comments to the ANPRM from consumers that said that labeling products that were considered to be single servings as having two or more servings is “confusing” and “misleading.” We also note that the labels tested in the Lando and Lo study (Ref. 15), which were also cited in the proposed rule, included sample Nutrition Facts labels for frozen meals, which are not considered “snack foods.” Dual-column labeling would require certain containers to display easy-to-understand nutrition information for the primary ways in which people consume these products. The studies that were cited in the proposed rule were used as part of the support for the need for dual-column labeling, not as our sole justification for dual-column labeling.

Finally, we disagree that dual-column labeling may be confusing to consumers, that we failed to consider comments that suggested dual-column labeling may be confusing, and that we have suggested that those who are looking to challenge the dual-column labeling requirements have the burden to provide evidence that dual-column labeling may be confusing. As discussed previously in this document, our research has shown that single-serving-per-container labels and dual-column labels resulted in more participants correctly identifying the number of calories per container and the quantity of other nutrients per container and per serving compared to two-serving, single-column labels (such as the current label) (Ref. 19).

2. Dual-Column Labeling Requirements

(Comment 19) We received several comments from manufacturers objecting to 400 percent of the RACC as the upper limit for mandatory dual-column labeling.

Several comments suggested that we consider the type of product at issue in establishing an upper limit. Some of the comments stated that an upper limit of 400 percent of the RACC was not appropriate for all product categories. Other comments stated that dual-column labeling should only be required for certain types of products. A few comments objected to what they called a one-size-fits-all approach to applying the dual-column labeling requirements. One comment stated that we should take into account how people use and consume specific types of food in establishing an upper limit, such as whether the food is a snack, an ingredient, or a center-of-plate food in a main meal, and whether a person is likely to eat more than two servings of food at one time. Another comment suggested that we reanalyze the data to provide category-specific RACC upper thresholds for dual-column labeling.

A few comments stated that we should only require dual-column labeling for product categories of food for which we have data indicating that a consumer can reasonably consume the entire package of a product between 200 percent and up to and including 400 percent of the RACC in one eating occasion. Other comments argued that an upper limit of 400 percent of the RACC would require dual-column labeling on foods that are not likely to be consumed in one eating occasion.

Several other comments requested that we require a lower upper limit for dual-column labeling generally. Some comments stated that dual-column labeling should only be required for packages up to 250 percent of the RACC, while other comments requested that dual-column labeling be required for packages up to 300 percent of the RACC.

We received comments that stated that by setting 400 percent as the upper limit for dual-column labeling, we would create the unintended consequence of establishing a dual-column labeling requirement for some products for which a 90th percentile of intake is much lower than 400 percent of the RACC, meaning that such products would be required to have dual-column labeling on package sizes for which consumption data shows that people do not reasonably consume the entire amount in one eating occasion. One example given in comments was for 100 percent fruit juices such as orange juice. Comments stated that the amount of fruit juice equal to 400 percent of the RACC would be 32 fl ozs, which is inconsistent with data showing that the amount of 100 percent fruit juice consumed at the 90th percentile is 219 percent of the RACC. One comment

noted that, based on NHANES 2003-2006 data, the 75th percentile of 100 percent orange juice consumption by adults is 8.8 fl ozs per day (Ref. 20) and for children age 2 to 18 years is 12.5 fl ozs per day (Ref. 21). Comments argued that requiring a dual-column label on a 32-oz container of orange juice does not represent the amount consumed by the majority of individuals.

Other examples given in comments of products for which a 90th percentile of intake is lower than 400 percent of the RACC were fluid milk and cottage cheese. Comments noted that the intake at the 90th percentile is 205 percent of the RACC for cottage cheese (226 g or 1 cup) and 181 percent of the RACC for milk (444 g or 14.5 fl oz). Some comments stated that a quart of fluid milk and a 16-oz container of cottage cheese are both at 400 percent of the RACC and would be required to have a dual-column label. Comments stated that labeling these two product packaging sizes with dual-column labels is inconsistent with how they are consumed.

Yet another example given in a comment of a product for which the 90th percentile of intake is lower than 400 percent of the RACC was frozen waffles. The comment described a 12.3 oz 8-pack of waffles where two waffles equal a serving based on the 85 g RACC. The comment stated that an 8-pack of waffles would be required to have a dual-column label listing nutrition information per two-waffle serving and per container. The comment stated that the 90th percentile intake for waffles is 168 percent of the RACC (about 3 waffles) and that it is difficult to imagine a consumer eating 8 waffles on one eating occasion.

Other comments asserted the following additional types of foods have consumption amounts at the 90th percentile that are less than 400 percent of the RACC and therefore are not appropriate for dual-column labeling: Beverage product categories, frozen potato products, side dishes, natural cheese in 3.5 oz packages, sausage, nuts, frozen vegetables, frozen oatmeal, frozen pizza, frozen entrées, canned beans, canned vegetables, canned fruits, 100 percent fruit juices, veggie “burger” patties, and cereal bars.

A few comments stated that they reviewed our data used to support the decision to use an upper limit of up to and including 400 percent of the RACC and found that in 84 percent of the food categories reviewed, average consumption was 299 percent or less of the RACC, and in 68 percent of categories, average consumption was 250 percent or less of the RACC. These comments stated that only a small number of product categories had consumption greater than 300 percent of the RACC, and those categories, which included wine coolers, fluid cream, lemon and lime juice, horseradish, and mustard, are not commonly consumed categories that should drive labeling changes.

Several comments argued that the 90th percentile was too high of an upper limit to be considered as a reasonably consumed amount and that the basis for our picking this value was unclear. One comment further requested that we provide information about the statistical distribution of these ratios to justify our cutoff of 400 percent. Other comments asserted that our decision to establish 400 percent of the RACC as the cutoff for dual-column labeling is arbitrary, incongruous with most common eating patterns, and could result in consumer confusion and needless changes for food manufacturers. Another comment suggested that we use the proposed RACCs, instead of RACCs from 1993, as the basis to compare to 90th percentile of intake.

(Response 19) In the preamble of the proposed rule (79 FR 11989 at 12003), we stated that our review of the 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. Use of the 90th percentile of intake distribution allows us to capture the substantial majority of consumption amounts per eating occasion (

i.e.,

90 percent) for the U.S. population, but this level is not so high as to impose dual-column labeling requirements on most package sizes for which consumption data shows that people do not reasonably consume the entire amount in one sitting.

As noted previously, the purpose of dual-column labeling is to provide nutrition information for multiple ways in which people are likely to consume a product. Consumption data show that while some people eat certain products in a single eating occasion, others eat the product over time or share it. Dual-column labeling provides nutrition information for all of these scenarios. To the extent that comments suggested that dual-column labeling requirements generally would require needless changes to food labeling for manufacturers to comply with the dual-column labeling requirement and that the requirements may result in consumer confusion, we disagree. Dual-column labeling requirements are not intended to be limited to the single most common consumption pattern for a particular product. When determining the criteria for dual-column labeling, we therefore looked at data that shows how the product is consumed in 90 percent of eating occasions, to ensure that the requirements would encompass the distinct ways such products could reasonably be consumed. In the proposed rule we determined that dual-column labeling for products with 400 percent or less of the RACC would capture the most frequent consumption habits for almost all product categories.

We disagree with comments stating that the upper limit for dual-column labeling should be 250 percent. Eighteen percent of products have 90th percentile of consumption between 250 percent and 300 percent of the RACC based on the 1993 RACCs and the proposed RACCs, meaning that establishing an upper limit of 250 percent would eliminate from dual-column labeling requirements a significant proportion of products which data show are reasonably likely to be consumed in a single eating occasion.

In light of information provided in comments, we examined which food products have consumption levels at the 90th percentile between 300 percent and 400 percent of the 1993 RACCs and the proposed RACCs. Our analysis was consistent with those of comments that suggested that a substantial majority of food products (

i.e.,

more than 90 percent) have consumption levels that are 300 percent or less of the RACC at the 90th percentile (Ref.16). We agree with comments to the extent they state that in the substantial majority of the food categories the average consumption was 300 percent or less of the RACC at the 90th percentile and that only a small number of product categories had consumption greater than 300 percent of the RACC at the 90th percentile. We also agree with comments that stated that setting an upper limit for dual-column labeling at 400 percent of the RACC could have the unintended consequence of requiring dual-column labels on packages for which data shows people do not reasonably consume in a single eating occasion, such as a quart of milk, a 32 fl oz bottle of juice, or a 12.3 oz 8-pack of waffles where two waffles equal a serving based on the 85 g RACC.

In consideration of the information provided in comments and further evaluation of relevant consumption data compared with the proposed RACCs, we are lowering the upper limit of dual-column labeling from 400 percent to 300 percent of the RACC. Providing an upper limit at 300 percent of the RACC would ensure that dual-column labeling captures 90 percent of the consumption

habits for about 91 percent of food products and limit the possibility that dual-column labeling will be required for package sizes that are not likely to be consumed in a single eating occasion. As a result of our decision to lower the upper limit for dual-column labeling from 400 percent to 300 percent, certain products about which comments expressed specific concerns—such as a quart of milk, a 32 fl oz container of juice, a 16- oz container of cottage cheese, and a package of waffles containing 4 servings—would not be required to have a dual-column label.

In response to those comments that suggested that we consider the type of product at issue in establishing an upper limit, we decline to apply different upper thresholds for dual-column labeling or to require dual-column labeling only for specific product categories. The use of a uniform upper criterion for all product categories will ensure that consumers are able to compare nutrition information across various product types that are packaged in the sizes that we have determined are reasonably likely to be consumed at one eating occasion or shared with others. For the same reason, we disagree with those comments that suggested that dual-column labeling is not appropriate for certain types of foods and decline to limit the dual-column labeling requirement to certain types of foods.

In response to the comment that recommended that we use the proposed RACCs, instead of RACCs from 1993, as the basis to compare to the 90th percentile of intake, this final rule relies upon both 2003-2008 consumption data and the 1993 RACCs as a basis to determine the 90th percentile of intake when determining an upper threshold for dual-column labeling. While the proposed rule used the 1993 RACCs as the basis to compare to the 90th percentile of intake, we agree that comparison to the proposed RACCs provides useful information. We have now reviewed the 90th percentile of intake for the proposed RACCs that we are finalizing with this rule. A review of this information shows that almost all of the proposed product categories have a 90th percentile of consumption that is less than 300 percent of the RACC. This information is included as a reference to this rule (Ref. 22).

(Comment 20) We received a few comments that stated that dual-column labeling should be voluntary instead of mandatory. Other comments suggested that all packages containing 200 percent or more of the RACC that can be reasonably consumed in a single eating occasion should be labeled as a single serving instead of using dual-column labeling.

(Response 20) We disagree with comments that state that dual-column labeling under § 101.9(b)(12) should be voluntary. As discussed previously in section III.C., we consider the benefits of dual-column labeling to the consumer—in particular, ensuring greater consumer understanding of the package's contents—to be significant enough to require dual-column labeling for products in containers that meet the criteria for dual-column labeling. As discussed in response to comment 8, to address the comment that suggested that we require mandatory listing as a single serving for packages over 200 percent of the RACC that can be reasonably consumed in a single eating occasion in place of dual-column labeling, the purpose of dual-column labeling is to provide label information for products that may be consumed in a single eating occasion, but can also be shared or eaten in multiple eating occasions. If these products are labeled as single-serving containers, then they would not provide nutrition information for all three of these scenarios. Additionally, as explained in detail previously in section II.B., under section 403(q)(1)(A)(i) of the FD&C Act, “serving size” means the 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 because that would be twice the amount or more than we have determined is customarily consumed.

(Comment 21) Some comments asserted that a multiserving container would only require dual-column labeling if the individual units contained at least 200 percent and up to and including 400 percent of the RACC, and argued that the relevant factor in establishing whether dual-column labeling is required is not the size of the entire multiserving container, but the size of each individually packaged unit. Therefore, the comments concluded that the proposed dual-column labeling in § 101.9(b)(2)(i)(D) and (b)(12)(i) would be required if a unit in the multiserving container weighs at least 200 percent and up to and including 400 percent of the applicable reference amount. A few comments noted that for a multiserving container, the consumer must in some cases unwrap each unit, and thus would know how many units he or she has eaten. According to these comments, the number of those individual units should represent the number of servings in the multiserving container.

Several comments requested that we clarify that the proposed changes in § 101.9(b)(2)(i)(D) and (12)(i) are not intended to require dual-column labeling on a multiserving retail container comprised of individual discrete units, when the multiserving retail container as a whole contains at least 200 percent and up to and including 400 percent of the RACC. Examples provided in comments of these types of packaging configurations were a four-pack of individually packaged 6 oz yogurt containers, individually wrapped cupcakes, muffins, and breakfast pastries. In the examples given, the multiserving retail container contained at least 200 percent and up to and including 400 percent of the RACC, but each of the individual discrete units contained less than 200 percent of the RACC.

One comment noted we typically do not use the phrase “packaged and sold individually” to describe multipack products and, citing to § 101.9(b)(2)(i), stated that we instead refer to the multipack containers as “packages containing several individual single-serving containers” and that we refer to units as “individually packaged products within a multiserving package.” The comment asked us to clarify that the proposed criteria for mandatory dual-column labeling applies only to those individual units that have between 200 and 400 percent of the RACC and not to the multipack container when the weight of the multipack is between 200 and 400 percent of the RACC. The comment stated that in the proposed rule we specifically identify a “grab-size bags of chips” as an example of a product that would be subject to dual-column labeling if it contains 200 percent to 400 percent of the applicable RACC, even though the comment considered chips to appear to be a non-discrete bulk product.

(Response 21) Dual-column labeling with nutrition information listed per serving and per unit is required for each product in discrete units in multiserving containers when the unit weighs at least 200 percent and up to and including 300 percent of the applicable RACC. Section 101.9(b)(2)(i) provides, in part, the requirements for serving sizes for products in discrete units (

e.g.,

muffins, sliced products, such as sliced bread, or individually packaged products within a multiserving package). Under proposed § 101.9(b)(2)(i)(D), if the individual unit within a multiserving container weighs at least 200 percent and up to and including 400 percent of

the applicable RACC, the manufacturer would need to provide an additional column that lists the quantitative amounts and percent DVs for the individual unit, as well as a column listing the quantitative amounts and percent DVs for a serving that is less than the unit (

i.e.,

the serving size derived from the RACC). The first column would be based on the serving size for the product, and the second column would be based on the individual unit. We are amending § 101.9(b)(2)(i)(D) in this final rule to apply to individual units within a multiserving container that weigh at least 200 percent and up to and including 300 percent of the applicable RACC. The reason for the change from 400 percent of the RACC as the upper limit to 300 percent of the RACC as the upper limit is discussed in section III.B. We have also modified the language for clarity.

Under the proposed rule, dual-column labeling would be required on a multiserving retail container comprised of individual discrete units, when the multiserving retail container as a whole contains at least 200 percent and up to and including 400 percent of the RACC. As explained in response to comment 9, a product that is packaged and sold individually (

i.e.,

a container that bears a Nutrition Facts panel) that is comprised of individual discrete units and that as a whole contains at least 200 percent and up to and including 300 percent of the RACC would be subject to the dual-column labeling requirements under § 101.9(b)(12)(i) in this final rule, unless an exemption applies. If, for example, the product at issue is a box containing two individually bottled, 16 oz sodas, and if the box, and not the bottles, were to display the Nutrition Facts label, the multipack container would be required to bear dual-column labeling because the multipack would be packaged and sold individually and would contain at least 200 percent and up to and including 300 percent of the RACC. In contrast, if the product at issue is encased in a clear plastic wrapper and includes two individually bottled, 16 oz sodas for which each bottle is labeled with a Nutrition Facts panel that is visible at the point of sale, the outside wrapper would not be required to bear dual-column labeling even though the combined weight of all bottles would be at least 200 percent and up to and including 300 percent of the RACC. We note that § 101.9(b)(12)(i) pertains to products that are packaged and sold individually and contain at least 200 and up to and including 300 percent of the RACC, regardless of whether the product is in discrete units.

With respect to the comment's request for clarification about whether a “grab bag” of chips would be subject to the dual-column labeling requirements, we note that if such a bag of chips were to bear a Nutrition Facts panel and contain at least 200 percent and up to and including 300 percent of the RACC, it would be subject to the dual-column labeling requirements unless an exemption applied. Whether a product contains discrete units or non-discrete bulk food, dual-column labeling is required if the criteria for such labeling is met, and if no exemptions apply. Section 101.9(b)(2)(i)(D) explains when a second column of nutrition information that describes the nutrient content per unit is required, and § 101.9(b)(12)(i) explains when a second column of nutrition information that describes the nutrient content per container is required.

(Comment 22) One comment noted that our rounding rule requirements may present inherent problems because the requirements may cause quantitative amounts and percent DVs to look inconsistent when displayed in a dual-column format per serving and per container. The comment suggested that this result may not satisfy the requirements of section 2(b)(1)(A) of the NLEA if dual-column labeling does not convey information in a manner that “enables the public to readily observe and comprehend such information and to understand its relative significance in the context of a total daily diet.” To demonstrate the potential inconsistency, the comment provided an example of a Nutrition Facts label of two different flavors of candy bars which presented nutrition information per two pieces and per one piece. The comment noted that the calories from fat for two pieces is 111.0 g (actual) but is rounded to 110 g using our rounding rules, while the calories from fat for 1 piece is 55.5 g (actual), but rounded to 60 g using our rounding rules. The comment noted that this discrepancy may cause consumer confusion since if the serving size were halved they would expect the declaration of “Calories from fat” to be 55 g. The example provided in the comment also demonstrated inconsistencies in the values provided for total fat, sodium, and protein due to our rounding rules. The comment suggested that we permit the use of a footnote such as “Columns may not add due to rounding” when such inconsistences exist.

(Response 22) We acknowledge that the use of dual-column labeling per serving and per container could, under certain conditions, cause apparent discrepancies in the nutrition values between the two columns. The discrepancies would result from mathematical rounding procedures and our requirements for the increments in which nutrition values are declared in the Nutrition Facts label under § 101.9(c). We recognize that consumers viewing nutrition information per serving and per container may expect the nutrition values per container to result from multiplying the number of nutrients per serving by the number of servings per container, and that the numbers that may result under existing regulations may not reflect this expectation in all cases. However, under the preexisting nutrition labeling regulations, consumers may have already seen such rounding issues in the labeling of products in discrete units in a multiserving container that are more than 1 unit (§ 101.9(b)(10)(ii)).

While we acknowledge that in some instances apparent discrepancies may occur, we are not proposing to change our requirements for the increments in which nutrition values are declared in the Nutrition Facts label (§ 101.9(c)). Changes to this regulation, such as a requirement that the per-container information be provided by multiplying the nutrients per serving by the number of servings, would likely result in the need to round the information twice. This could result in a requirement to provide nutrition information per container in a way that does not accurately reflect the amount of nutrients in the product. We consider this result to be more problematic than any apparent discrepancies that may result from existing rounding requirements. However, we will monitor this situation as more products are introduced into the marketplace with dual-column labeling per serving and per container.

We disagree with the comment suggesting the need for a footnote such as “Columns may not add due to rounding.” The presence of a footnote will require additional space, and we do not believe at this time that any apparent rounding discrepancies are significant enough as to warrant a requirement to include such a footnote or to permit the use of such a footnote voluntarily. We do, however, plan to include information about potential rounding discrepancies as part of our planned nutrition education efforts to clarify why the per-serving and per-container nutrition values appearing on dual-column labels may not appear consistent. We also note that, while no such footnote as requested in this comment can be added to the Nutrition

Facts label, manufacturers can voluntarily include a truthful and not misleading statement explaining how rounding effects dual-column labeling elsewhere on the product label.

3. Exemptions From Dual-Column Labeling

(Comment 23) One comment asserted that we acted arbitrarily in proposing to exempt the following types of products from the dual-column labeling requirement because we determined that labeling of such products with nutrition information based on the entire container would not be consistent with how these products are typically consumed: Bulk products that are used primarily as ingredients (

e.g.,

flour, sweeteners, shortenings, oils), bulk products traditionally used for multipurposes (

e.g.,

eggs, butter, margarine), and multipurpose baking mixes.

(Response 24) After further consideration of this exemption, and as explained in response to comment 19, the use of a uniform upper criterion for all product categories will ensure that consumers are able to compare nutrition information across various product types that are packaged in the sizes that we have determined are reasonably likely to be consumed at one eating occasion or shared with others. We have no consumption data showing that it is reasonably likely that bulk products are consumed differently from non-bulk products. Therefore, we are not finalizing the exemption for bulk products that are used primarily as ingredients, bulk products traditionally used for multipurposes, and multipurpose baking mixes as proposed in § 101.9(b)(12)(i)(B).

(Comment 24) We received comments relating to proposed exemptions from dual-column labeling requirements for products that require further preparation, such as macaroni and cheese kits, pancake mixes, pasta products, and common combinations of food (

e.g.,

cereal and milk) that contain at least 200 percent and up to and including 400 percent of the applicable RACC. Comments we received regarding this exemption were generally supportive of the exemption. A few comments, however, stated that instead of allowing products to be exempt from dual-column labeling, we should instead require dual-column labeling per serving and per container for the as-prepared form of the product and eliminate the as-purchased information altogether.

We received a few comments requesting that we allow an exemption for any product that provides voluntary dual-column labeling as allowed under the preexisting regulations in § 101.9(b)(10)(i) to (iii). Another comment requested that we provide exemptions from dual-column labeling under § 101.9(e) not only for products that provide an additional column of information for two or more forms of the same food “as purchased” and “as prepared” and for common combinations of food, but also when nutrition information is provided for two or more groups for which Reference Daily Intakes (RDI's) are established (

e.g.,

both infants and children less than 4 years of age) or when nutrition information is provided in different units (

e.g.,

slices of bread or per 100 g).

(Response 24) We agree, in part, with comments that support allowing an exemption to the dual-column labeling requirements if the voluntary provisions provided for in § 101.9(b)(10) are used. The exemptions under § 101.9(b)(10) are for products that provide another column of figures that may be used to declare the nutrient and food component information per 100 g or 100 mL, or per 1 oz or 1 fl oz of the food as packaged or purchased (§ 101.9(b)(10)(i)); per one unit if the serving size of a product in discrete units in a multiserving container is more than 1 unit (§ 101.9(b)(10)(ii)); and per cup popped for popcorn in a multiserving container (§ 101.9(b)(10)(iii)). We agree that providing voluntary dual-column labeling per unit if the serving size of a product in discrete units in a multiserving container is more than 1 unit would provide useful information to those that consume one unit, and therefore are permitting the use of such a second column of information in lieu of a second column that provides per-container information. We also agree that providing voluntary nutrition information per cup of popped popcorn per serving in a multiserving container (§ 101.9(b)(10)(iii)) in an as-consumed form will be more beneficial to consumers than having nutrition information for the “as purchased” form on both a per-serving and per-container basis. As explained further in comment 25, while we recognize that popcorn is not consumed in the as-purchased form, the as-purchased nutrition information is still needed. Therefore, we are permitting the label of such products to contain a second column of information for the popped form, in lieu of a second column that provides per-container information.

As noted in the serving size proposed rule, we tentatively concluded that it would be helpful to consumers to have access to nutrition information based on the prepared form of the product in addition to the “as purchased” form of the product (79 FR 11989 at 12004). We are reaffirming that conclusion in this final rule. The “as prepared” information on labels indicates the nutritional information per serving if a package is prepared according to package directions, which may require the use of additional ingredients. We disagree, however, with those comments that stated we should require dual-column labeling to be done only based on the as-prepared form, per serving and per package. If a consumer does not use the stated directions or uses substitute ingredients, then the information in the as-prepared portion of the label would not be accurate. Therefore it is important that each product include nutrition information for the product as packaged and not just the product as it is prepared. We also noted in the proposed rule that if products that voluntarily included one column of nutrition information for the prepared form of the food per serving and met the requirements for dual-column labeling, they would have to include at least three columns of nutrition information unless the products were subject to an exemption (79 FR 11989 at 12004). We are reaffirming our conclusion from the proposed rule that nutrition information based on the entire container of the unprepared food may be less meaningful to consumers than information based on a serving of the prepared form of the food and are therefore finalizing an exemption from the dual-column labeling requirements in § 101.9(b)(12)(i)(C) for those products that voluntarily include a second column of nutrition labeling for the as-prepared form of the food per serving.

We do not agree with comments that requested an exemption for products that provide an additional column that declares the nutrition information per 100 g or 100 mL, or per 1 oz or 1 fl oz of the food as packaged or purchased. In the introduction to section III.C., we discussed our basis for concluding that per-container information helps certain consumers recognize nutrient amounts per package and that the consumption data shows that consumers are reasonably likely to consume a full package containing at least 200 percent and up to an including 300 percent of the RACC. In contrast, consumers may not be able to readily measure 100 g or 100 mL amounts, so the information may not be useful to them. Because we have determined that nutrition information per serving and per container is more likely to be useful to consumers, and therefore is more

important than voluntary nutrition information given in metric or common household measurements (oz) for the food in the as-purchased form per serving, we decline to establish an exemption when a second column of nutrition information is provided per 100 g or 100 mL, or per 1 oz or 1 fl oz of the food as packaged or purchased. While nutrition information per 100 g or 100 mL cannot be listed in lieu of the information required under § 101.9(b)(2)(i)(D) and (b)(12)(i), § 101.9(b)(10)(i) allows the manufacturer to provide this information in an additional column (

e.g.,

a third column) on a voluntary basis.

We agree with the comment that requested that we expand the exemptions from dual-column labeling to include products that voluntary provide a second column of nutrition information for two or more groups for which RDIs are established (

e.g.,

both infants and children less than 4 years of age). Providing voluntary nutrition information for two or more groups for which RDIs are established provides useful information for the different populations that may consume the food product. Providing nutrition information for two subpopulations, such as infants 7 to 12 months old and children aged 1 through 3, will provide beneficial information to purchasers of these products. Such nutrition information will provide meaningful information about foods that are typically consumed in distinct amounts by distinct subpopulations. This exemption has been added to § 101.9(b)(12)(i)(C) in this final rule.

We note that in this final rule we are also providing an exemption from dual-column labeling for varied-weight products covered under § 101.9(b)(8)(iii), for which dual-column labeling would be less practical given the variation in product sizes.

(Comment 25) We received several comments questioning why popped popcorn needed a dual-column label listing nutrition information with one column for “as purchased” unpopped popcorn and another column for “as prepared popped” popcorn. The comments noted that no one consumed raw popcorn and that the “as purchased” popcorn information is unnecessary. One comment requested that the RACC for popcorn be changed from 30 g unpopped (raw) to 30 g as consumed because variations in hybrids, popping volume and other ingredients can significantly alter the amount of kernels in a single serving based on the household measure (typically tablespoons) for the finished product. The comment requested that we change the current declaration for uncooked popcorn to reflect how the product is actually consumed by the consumer versus “as packaged.” The comment noted that providing the nutrition information about unpopped popcorn could be confusing and misleading to the consumer and that no other snack has its raw form as the basis for its nutritional information.

(Response 25) We decline to amend the way in which nutrition information is required to be presented for popcorn, which is that popcorn must provide nutrition information on the “as packaged” or “purchased” form of the food (

i.e.,

unpopped form), as described in § 101.9(b)(9). We disagree with the assertion that providing nutrition information about popcorn in the “as packaged” form is unnecessary and that the “as packaged” nutrition information should not be required to appear on the product label if the “as prepared” information is provided. The “as prepared” information on labels indicates whether a package is prepared according to package directions, which may require the use of additional ingredients. If a consumer does not use the stated directions or uses substitute ingredients, then the information in the as-prepared portion of the label would not be accurate. Therefore it is important that each product include nutrition information for the product as packaged and not just the product as it is prepared. We note, however, that although it is not permitted for popcorn to provide a single-column label containing only as-purchased information, our regulations provide that popcorn products can provide a second column of nutrition information “per cup popped” for popcorn in a multiserving container (§ 101.9(b)(10)(iii)); many popcorn products already voluntarily have a second column of nutrition information per serving for the “as popped” form. We are not changing this voluntary provision. In addition, we have provided an exemption from the dual-column labeling provisions in § 101.9(b)(12)(i) for products that require further preparation, which would apply to popcorn products that contain at least 200 percent and up to and including 300 percent of the RACC and voluntarily provide an additional column of nutrition information on the “as popped” form.

With regard to the comment that stated that listing popcorn on the as-purchased basis would be confusing to consumers, the comment did not explain the basis on which the as-purchased information would be confusing or misleading, and we do not agree that such information would be confusing or misleading. With regard to the assertion that no other snack has its raw form as the basis for its nutritional information, we disagree. All products are required to provide nutritional information for the as-packaged form, so any products that are packaged in their raw form are required to provide nutritional information for the raw form.

We also decline the request to change the RACC of popcorn to 30 g popped per serving “as consumed.” In the preamble of the 1993 serving size final rule (58 FR 2229 at 2265 to 2266), we discussed comments that requested that popcorn be able to use a volume-based rather than a weight-based reference amount. We declined to follow the recommendation from those comments because we determined that there is no well-established standard procedure for determining the weight equivalents of the household measures. This is still true today. However, for the benefit of those consumers who consume popcorn on a volume basis, we permit the use of a voluntary dual-column label with the second column of nutrition information being based on a per cup popped basis. Therefore we decline to change the popcorn RACC to an as-consumed amount.

(Comment 26) A few comments requested clarity on whether raw fruits and vegetables would be exempt from dual-column labeling when nutrition labeling is voluntarily provided or when claims are made for such products. An example used in the comment was a medium avocado that has a proposed RACC of 50 g, or about

1/3

of the avocado. According to the comment, the entire avocado would be about 150 g and would require dual-column labeling if nutrition labeling is voluntarily provided or if claims are made for such product in labeling or advertising. Another comment requested that we exempt all fruits and vegetables without added sugar, salt, or fat from dual-column labeling.

(Response 26) Under § 101.9(j)(10), raw fruits, vegetables, and fish are exempt from mandatory nutrition labeling, contingent on the food bearing no nutrition claims or other nutrition information in any context on the label or in labeling or advertising. The labeling of such products is generally done on a voluntary basis, with guidelines for such labeling set forth under § 101.45. Under § 101.45(a)(3)(i), such products are not required to provide information about the number of servings per container. Because the number of servings per container would vary from container to container, we do not expect those selling raw fruit,

vegetables, and fish to be able to provide information about the number of servings for an individual container and therefore do not expect them to be able to provide a second column of information with nutrition information per container. Additionally, when voluntary nutrition information for raw fruits, vegetables, and seafood is provided under § 101.45(a)(1), it should be displayed at the point of purchase by an appropriate means such as by a label affixed to the food or through labeling including shelf labels, signs, posters, brochures, notebooks, or leaflets that are readily available and in close proximity to the foods. The nutrition labeling information that is voluntarily provided may also be supplemented by a video, live demonstration, or other media. Because no information about the number of servings per container is generally required in voluntary labeling, and because the nutrition labeling for such products is often provided in a non-standardized manner, we agree that such products should be exempt from dual-column labeling. Therefore, we will amend § 101.9(b)(12)(i)(B) to provide that raw fruits, vegetables, and seafood will be exempted from the dual-column labeling requirements, regardless of whether voluntary nutrition information is provided for the product, either in labeling or in advertising, or whether nutrition claims are made for the product.

We decline to exempt canned or frozen fruits and vegetables without added sugar, salt, or fat from the dual-column labeling requirements. Unlike raw fruits and vegetables, the presentation of nutrition information, including the number of servings per container, has been established in § 101.9 for canned or frozen fruits and vegetables, regardless of whether they contain added sugar, salt, or fat. It is therefore less difficult for canned or frozen fruits and vegetables to provide dual-column labeling when the applicable dual-column labeling requirements would apply.

(Comment 27) One comment requested that bottled water products be exempt from the requirements of dual-column labeling. Other comments questioned the benefits to consumers of requiring dual-column labeling for bottled water products when most of the values in the two columns would be zero. The comments further noted that many bottled water products are already exempt from the nutrition labeling requirements under § 101.9(j)(4) because they contain insignificant amounts of all nutrients required to be declared in the nutrition facts label, and requested that we amend § 101.9(j)(4) to clarify that such products would be exempt. The comments noted that under the proposed rule, the RACC for bottled water products would increase from 240 mL (8 oz) to 360 mL (12 oz) and that this increase in the RACC would mean that the sodium content per RACC in some bottled water products would exceed the current 5 mg per serving threshold, below which the amount of sodium would be considered insignificant. Therefore, the comment requested that we revise the definition of an insignificant amount in § 101.9(j)(4) to be an “amount that allows a declaration of zero in nutrition labeling, except that for sodium, it shall be an amount that exceeds a declaration of zero percent of the daily value, and except that for total carbohydrate, dietary fiber, and protein, it shall be an amount that allows a declaration of less than 1 gram.”

(Response 27) We decline to establish an exemption to the dual-column requirements in this final rule for bottled water products. We also decline to amend § 101.9(j)(4) at this time as suggested by the comment. We intend to consider the applicability of an exemption from nutrition labeling requirements in a future rulemaking with respect to certain products. Until such time as we have had the opportunity to consider such matters further, we intend to consider the exercise of enforcement discretion with respect to mandatory nutrition labeling on bottled water products and other products that would have been exempt under § 101.9(j)(4) prior to the effective date of this rule and the Nutrition Facts final rule.

(Comment 28) One comment stated that providing nutrition information on a “per container” basis for a consumer who intends to eat some now and some later, or for a consumer who will share the container with others, is not useful information. The comment asserted that consumers have all the nutrition information they need to make food choices in the “per serving” declaration.

(Response 28) To the extent that this comment asserts dual-column labeling does not provide additional, useful information to consumers, we disagree. The intent of dual-column labeling is to provide nutrition information for products that may be consumed by one consumer in a single eating occasion, over several eating occasions, or shared among multiple consumers. A dual-column nutrition label provides easy-to-interpret nutrition information for a consumer who may eat the contents of a package in one sitting. Dual-column labeling serves as a contextual cue that there is more than one serving in a package and helps consumers to easily figure out how much is in the entire container.

(Comment 29) We received a comment requesting that we exempt foods specifically represented or marketed to infants or children 1 to 3 years of age. The comments stated that presenting the nutrition information for the entire container could inappropriately communicate that a young child could reasonably consume the entire contents of a container. The comment used juice as an example with an RACC of 4 fl oz and noted that a 16 fl oz juice container marketed for children 1 to 3 years would need to include a column for the entire container under the proposed rule. The comment stated that such labeling could indicate to consumers that juice is recommended to be consumed in greater quantities and would conflict with portion guidance provided to parents regarding limiting juice consumption to no more than 4 fl oz per day.

(Response 29) We decline to exempt foods specifically represented or marketed to infants or children 1 to 3 years of age from mandatory dual-column labeling. The purpose of dual-column labeling is to 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, and to help consumers more easily understand the contents of a particular package both on a per-serving and per-container basis. In terms of consumers misconstruing the serving size as a recommended amount of food, we noted previously in section III.A. that we will engage in consumer education to help clarify the meaning of the serving size. We note that since we have lowered the upper level of dual-column labeling to 300 percent of the RACC, the example stated in the comment would not occur.

4. Research and Consumer Understanding of Dual-Column Labeling

(Comment 30) We received comments that questioned the research cited in the proposed rule in support of dual-column labeling (Ref. 14). Some comments stated that consumer research should include an evaluation of whether consumers would use the dual-column information to modify dietary choices when provided. Comments stated that the limited amount of research on dual-column labeling was not enough to require mandatory dual-column labeling for all products.

Various comments questioned the format of the dual-column labels used in the studies. Some comments pointed out that both studies cited in the

proposed rule evaluated the current label format with dual columns, rather than the proposed new label format with dual columns. The comments stated that with the proposed label formats, dual-column labeling is not needed because the values consumers need to determine the total calories in the container would already be available to the consumer.

Some comments questioned the results of the study conducted by Antonuk and Block that was cited in the proposed rule. These comments stated that the results of the study are not generalizable because the study was conducted with undergraduate students in a classroom setting. Some comments stated that the study only used labels for snack food products and that the results should not be used to evaluate the effects of dual-column labels on other product categories. Other comments questioned the different results for dieters versus nondieters.

(Response 30) We disagree with the comments that suggest that in order to support the requirement for dual-column labeling, research must demonstrate that dual-column information modifies dietary choices. As noted previously, the purpose of dual-column labeling is to provide nutrition information for multiple ways that people are likely to consume a product that contains at least 200 percent and up to and including 300 percent of the RACC. Consumption data shows that while some people eat such products in a single eating occasion, others eat the product over time or share it. Dual-column labeling provides nutrition information for all of these scenarios.

The comment incorrectly asserts that the studies on which we relied in the proposed rule used only labels for snack food products. The labels tested in the Lando and Lo study (Ref. 15), which were also cited in the proposed rule, included sample Nutrition Facts labels for frozen meals, which are not considered “snack foods.” Additionally, since the publication of the proposed rule, we have conducted further research on dual-column labeling. The new study has tested dual-column labels using the proposed label formats, recruited participants from a Web-based panel of English speaking adults, and examined multiple food products (Ref. 19). The results from the research showed that dual-column labeling significantly improved respondents' ability to identify the amount of nutrients in the entire container of a two-serving package compared to both a single-column label and a dual-calorie label. Based on this research, as well as the research cited in the proposed rule, we conclude that consumers can more easily and more accurately comprehend the nutrient contents of an entire package when dual-column labeling is available, and we disagree with those comments that stated that dual-column labeling is not needed.

With respect to comments that questioned whether the results of the study conducted by Antonuk and Block that was cited in the proposed rule are generalizable, we acknowledge the study's limitations as noted in the comments. In spite of the fact that the results are not generalizable, we note that the study suggests that, at least under circumstances that are the same as or similar to those in the study, it is possible that some consumers may behave like the study participants. The finding of this study is consistent with other research that we are aware of; therefore, we are convinced by the totality of the research that dual-column labeling can help consumers better understand the nutrition contents of containers of certain sizes and assist them in maintaining healthy dietary practices.

(Comment 31) Several comments stated that providing nutrition information for the entire package will cause consumer confusion a

This text is long and has been trimmed here. Open the source document for the complete record.