Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 11 and 101

[Docket No. FDA-2011-F-0172]

RIN 0910-AG57

Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Proposed rule.

SUMMARY:

To implement the menu labeling provisions of the Patient Protection and Affordable Care Act of 2010 (Affordable Care Act), the Food and Drug Administration (FDA) is proposing requirements for providing certain nutrition information for standard menu items in certain chain restaurants and similar retail food establishments. The Affordable Care Act, in part, amended the Federal Food, Drug, and Cosmetic Act (FD&C Act), among other things, to require restaurants and similar retail food establishments that are part of a chain with 20 or more locations doing business under the same name and offering for sale substantially the same menu items to provide calorie and other nutrition information for standard menu items, including food on display and self-service food. Under provisions of the Affordable Care Act, restaurants and similar retail food establishments not otherwise covered by the law may elect to become subject to the Federal requirements by registering every other year with the FDA. Providing calorie and other nutrition information in restaurants and similar retail food establishments would assist consumers in making healthier dietary choices.

DATES:

Submit either electronic or written comments on the proposed rule by June 6, 2011. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by May 6, 2011 (see the “Paperwork Reduction Act of 1995” section of this document). See section III.G of this document for the proposed effective date of any rule that may publish based on this proposal.

ADDRESSES:

You may submit comments, identified by Docket No. FDA-2011-F-0172 and/or RIN 0910-AG57, by any of the following methods, except that comments on information collection issues under the Paperwork Reduction Act of 1995 must be submitted to the Office of Regulatory Affairs, Office of Management and Budget (OMB) (see the “Paperwork Reduction Act of 1995” section of this document).

Electronic Submissions

Submit electronic comments in the following way:

•

Federal eRulemaking Portal: http://www.regulations.gov.

Follow the instructions for submitting comments.

Written Submissions

Submit written submissions in the following ways:

•

FAX:

301-827-6870.

•

Mail/Hand delivery/Courier (for paper, disk, or CD-ROM submissions):

Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

Instructions:

All submissions received must include the Agency name, Docket No. FDA-2011-F-0172, and RIN 0910-AG57 for this rulemaking. All comments received may be posted without change to

http://www.regulations.gov,

including any personal information provided. For additional information on submitting comments, see the “Comments” heading of the

SUPPLEMENTARY INFORMATION

section of this document.

Docket:

For access to the docket to read background documents or comments received, go to

http://www.regulations.gov

and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Claudine Kavanaugh, Office of Foods, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, rm. 3234, Silver Spring, MD 20993, 301-796-4647.

SUPPLEMENTARY INFORMATION:

I. Background

A. Public Health Impacts of Overconsumption of Calories and Poor Nutrition

The U.S. Centers for Disease Control and Prevention (CDC) identifies as overweight an adult whose body-mass index, or BMI, (defined as weight in kilograms divided by the height in meters squared) is between 25 and 29.9. CDC defines an obese adult as a person 20 years of age or older whose BMI is 30 or above (Ref. 1). Data published by CDC indicate that 68 percent of the adult U.S. population is overweight or obese under this definition, including 34 percent who are considered obese (Ref. 1). For adults, being overweight or obese increases the risk for a number of chronic diseases, including coronary heart disease, type 2 diabetes, stroke, hypertension, arthritis, and certain types of cancer (Refs. 1 and 2). A BMI over 35 is associated with excess mortality, primarily from cardiovascular disease, diabetes, and certain types of cancer (Refs. 1, 3-5). Cardiovascular disease, cancer and diabetes are the leading causes of death and disability in the US, accounting for 70 percent of all deaths in the U.S. (Ref. 6). In 2005, 133 million Americans (almost one out of every two adults) had at least one chronic illness (Ref. 6). As noted previously, overweight and obesity are important contributors to the morbidity and mortality associated with these diseases.

CDC defines obesity in children as a BMI at or above the 95th percentile plotted on CDC BMI-for-age and sex growth charts. Overweight in children is defined as BMI-for-age from the 85th up to the 95th percentile (Ref. 7). Using this definition, CDC data indicate that about 32 percent of children and adolescents, aged 2 to 19, are overweight or obese (Ref. 8). Overweight and obesity in childhood is associated with a risk for obesity in adulthood, with the associated health risks. In addition, children with high BMI face health problems even in childhood, including elevated lipid concentrations and blood pressure (Ref. 8).

The primary risk factors for overweight and obesity in the general population are overconsumption of calories (

i.e.,

eating more calories than are needed to maintain body weight) and physical inactivity (

i.e.,

getting an amount of exercise below the amount required to burn excess calories consumed over the amount needed to maintain body weight) (Ref. 9 at pp. 1, 8, 9). Americans now consume an estimated one-third of their total calories on foods prepared outside the home (Ref. 10) and now spend almost half of their annual food dollars on foods prepared outside the home (Refs. 11 and 12.). Consumers are generally unaware of, or inaccurately estimate, the number of calories in restaurant foods (Ref. 13). In one survey of 193 adults, the participants underestimated the calorie content in foods prepared outside of the home they perceived to be “healthier” food choices by nearly half, an average of almost 650 calories per item (Ref. 14).

B. Nutrition Labeling Requirements That Currently Apply to Packaged Foods

The Nutrition Labeling and Education Act of 1990 (NLEA) amended the FD&C

Act, in part, by adding section 403(q), which specifies, in pertinent part and with certain exceptions, that a food is considered to be misbranded unless its label or labeling bears nutrition information. See 21 U.S.C. 343(q)(1)). In general, when a food is in package form, the required nutrition labeling information (Nutrition Facts) must appear on the label of the food. (Title 21 of the Code of Federal Regulations (CFR) § 101.9 (21 CFR 101.9). FDA's final regulations establishing nutrition labeling requirements were published in 1993 (58 FR 2079, January 6, 1993) and are found at § 101.9. Regulations implementing the NLEA require nutrition information for a food product intended for human consumption and offered for sale unless an exemption is provided for the product (§ 101.9(a)). The declaration of nutrition information on the label and labeling of food must include information about the levels of the following nutrients: total calories, calories from fat (unless the product contains less than 0.5 g of fat), total fat, saturated fat,

trans

fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugars, protein, vitamins, and minerals. Research conducted by FDA and others shows that many consumers use the Nutrition Facts to make their food choices (Ref. 15). However, this nutrition information is generally not available for foods sold in restaurants and similar retail food establishments, which make up an increasing proportion of the American diet.

C. The Exemption From Federal Nutrition Labeling Requirements for Food Sold in Restaurants and Other Retail Food Establishments Under NLEA

The NLEA amendments to the FD&C Act included an exemption for nutrition labeling for food that is “served in restaurants or other establishments in which food is served for immediate human consumption” or “sold for sale or use in such establishments” (403(q)(5)(A)(i)) (21 U.S.C. 343(q)(5)(A)(i)). The NLEA amendments to the FD&C Act also included an exemption for food of the type described in section 403(q)(5)(A)(i) that is primarily processed and prepared in a retail establishment, ready for human consumption, “offered for sale to consumers but not for immediate human consumption in such establishment and which is not offered for sale outside such establishment” (21 U.S.C. 343(q)(5)(A)(ii)). However, these exemptions were contingent on there being no nutrient content claims or health claims made on the label or labeling, or in the advertising, for the food. Current provisions in § 101.10 require restaurants and other establishments in which food is offered for human consumption that make either a nutrient content claim (defined in § 101.13) or health claim (defined in § 101.14) to provide certain nutrition information upon request. For example, if a menu lists an entrée as being low in fat, information about the amount of fat in the entrée must be available upon request. FDA notes that this requirement is and will still be in place if this proposed rule is finalized.

FDA provided examples of restaurants or other establishments in which food is offered for human consumption, in which food sold generally was exempted from nutrition labeling requirements under NLEA, in § 101.9(j)(2). The agency also provided in § 101.9(j)(3) examples of food sold in establishments in which food is processed and prepared, ready for human consumption, offered for sale to consumers but not for immediate consumption, and not offered for sale outside of the establishments. These regulations are further discussed in section III.A of this document.

In recent years, there has been growing support among public health experts for providing calorie and other nutrition information on restaurant menus in order to help consumers make more informed food choices. (Refs. 13, 16-18) There is also evidence of consumer preference for calorie information on menus. For example, more than 70 percent of respondents to a national telephone survey of 580 adults supported the idea of listing calorie information on restaurant menus (Ref. 19). In a subset of 150 individuals from an experimental study in Minneapolis-St. Paul, MN about the influence of nutritional labeling on fast-food meal choices, 79 percent of respondents said they would use calorie information if it was provided (Ref. 20).

Some State and local jurisdictions have enacted laws or regulations requiring calorie declaration for food offered for sale at restaurants and other establishments. However, the requirements of these laws differed among the States and local jurisdictions. For example, some laws applied to retail food establishments with 15 or more locations, while others applied to retail food establishments with 20 or more locations. Some jurisdictions required only calories on menus and menu boards while others required additional nutrient declarations (

e.g.,

variations of the following: total grams of

trans

fat, grams of saturated fat, grams of carbohydrates, and milligrams of sodium). Some State and local laws required a statement on menus and menu boards regarding daily intake amounts for calories and other nutrients and other laws did not require such a statement. The wording of those required statements varied (Refs. 21 and 22).

D. Requirements of Section 4205 of the Patient Protection and Affordable Care Act

On March 23, 2010, the Affordable Care Act (Pub. L. 111-148) was signed into law. Section 4205 of the Affordable Care Act (“section 4205”) amends section 403(q) of the FD&C Act, which governs nutrition labeling requirements, and section 403A of the FD&C Act, which governs Federal preemption of State and local food labeling requirements. As amended, section 403(q) requires restaurants and similar retail food establishments that are part of a chain with 20 or more locations doing business under the same name and offering for sale substantially the same menu items (“chain retail food establishments”) to provide calorie information for standard menu items, including food on display and self-service food, and to provide, upon consumer request, additional written nutrition information for standard menu items. Such food is deemed to be misbranded if these requirements are not met. More specifically, the following information must be provided for standard menu items that are sold in chain retail food establishments:

• The number of calories contained in each standard menu item as usually prepared and offered for sale on a menu or menu board (the calorie declaration must be “adjacent to” the name of the standard menu item, so as to be “clearly associated with” the item);

• A succinct statement concerning suggested daily caloric intake posted prominently on the menu or menu board designed to enable the public to understand in the context of a total daily diet, the significance of the calorie information provided on menus and menu boards;

• Additional nutrition information for standard menu items in a written form (“written nutrition information”), available on the premises, which must be made available to consumers upon request;

• A “prominent, clear, and conspicuous” statement on the menu or menu board regarding the availability of the written nutrition information; and

• The number of calories (per item or per serving) on a sign adjacent to self-service food and food on display. This food includes food sold at salad bars, buffet lines, cafeteria lines or similar self-service facilities, and self-service

beverages and food on display that is visible to consumers.

Section 4205 of the Affordable Care Act became effective on the date the law was signed, March 23, 2010; however, some provisions depend on FDA to issue rules before they can be required. With respect to chain retail food establishments, the provisions that became requirements upon enactment are:

• Disclosing the number of calories contained in each standard menu item as usually prepared and offered for sale on menus and menu boards;

• Providing written nutrition information to consumers upon request;

• Providing a “prominent, clear, and conspicuous” statement on menus and menu boards about the availability of the written nutrition information; and

• Providing calorie information (per serving or per food item) for self-service items and food on display, on a sign adjacent to each food item.

The law also specifies that FDA must issue regulations that:

• Establish requirements for a succinct statement concerning daily caloric intake, posted prominently on the menu or menu board, designed to enable the public to understand in the context of a total daily diet, the significance of the calorie information provided on menus and menu boards;

• Establish standards for determining and disclosing the nutrient content for standard menu items that come in different flavors, varieties, or combinations, but which are listed as a single menu item; and

• Specify how an authorized official of any restaurant or similar retail food establishment not subject to the requirements of section 403(q)(5)(H) may elect to be subject to the requirements by registering biannually the name and address of such restaurant or similar retail food establishment with FDA.

Although these provisions became requirements at the time the law was signed, FDA has previously announced that we intend to exercise our enforcement discretion until the final rule is published and in effect.

See

76 FR 4360 (Jan. 25, 2011). FDA believes that this approach to implementing section 4205 will minimize uncertainty and confusion among all interested persons. The agency also believes that expeditious completion of the rulemaking process will most rapidly lead to full and consistent availability of the newly required nutrition information for consumers.

Given that FDA does not intend to enforce the self-executing provisions at this time, we encourage our State and local partners to proceed in a similar way. We do, however, encourage establishments that already have calorie and nutrition information available to continue to provide that information to consumers.

Section 403(q)(5)(H)(x) requires that FDA propose implementing regulations no later than one year after enactment of the ACA (21 U.S.C. 343(q)(5)(H)(x)). In addition, section 4205 authorizes FDA to require, by regulation, chain retail food establishments to disclose information about a nutrient, not explicitly required to be disclosed by section 4205, in the written nutrition information, if FDA determines that such information should be disclosed for the purpose of providing information to assist consumers in maintaining healthy dietary practices (21 U.S.C. 343(q)(5)(H)(vi)).

Section 403(q)(5)(H)(viii)(I) establishes calorie disclosure requirements for certain articles of food sold from a vending machine that is operated by a person who is engaged in the business of owning or operating 20 or more vending machines (21 U.S.C. 343(q)(5)(H)(viii)(I)). Elsewhere in this issue of the

Federal Register

, FDA is publishing a proposal related to calorie declaration for food sold in vending machines.

Section 4205 required FDA to publish a notice in the

Federal Register

specifying the terms and conditions under which restaurants or similar retail food establishments and vending machine operators not subject to the requirements of section 4205 could elect to be subject to requirements by registering with FDA (21 U.S.C. 343(q)(5)(H)(ix)). FDA has published this notice. See 75 FR 43182, July 23, 2010. Voluntary registration is discussed in section III.C. of this document.

E. FDA Activities Related to Implementation of Section 4205

On July 7, 2010, FDA published a notice in the

Federal Register

entitled “Disclosure of Nutrient Content Information for Standard Menu Items Offered for Sale at Chain Restaurants or Similar Retail Food Establishments and for Articles of Food Sold From Vending Machines” (“docket notice”) (75 FR 39026 (July 7, 2010)), to solicit comments and suggestions on the new law. Comments to the docket were due September 7, 2010. In response to this docket notice, FDA received approximately 875 responses, each containing one or more comments. Many of these comments, in general, supported the nutrient disclosure requirements in chain retail food establishments and for food sold from vending machines, whereas some comments opposed such requirements.

On July 23, 2010, FDA published a

Federal Register

notice entitled, “Voluntary Registration by Authorized Officials of Non-Covered Retail Food Establishments and Vending Machine Operators Electing to Be Subject to the Menu and Vending Machine Labeling Requirements Established by Section 4205 of the Patient Protection and Affordable Care Act of 2010” (“registration notice”) (75 FR 43182 (July 23, 2010)). In response to this notice, FDA received seven responses, none of which addressed registration.

On August 25, 2010, FDA published a “Guidance for Industry: Questions and Answers Regarding the Effect of Section 4205 of the Patient Protection and Affordable Care Act of 2010 on State and Local Menu and Vending Machine Labeling Laws” (“preemption guidance”) (75 FR 52427 (August 25, 2010)). The preemption guidance discusses the preemptive effect of section 4205 and identifies the provisions of amended section 403(q) that became requirements upon enactment. Our current thinking on the preemptive effect of section 4205 is set out in section IX. of this document.

Also on August 25, 2010, FDA published a “Draft Guidance for Industry: Questions and Answers Regarding Implementation of the Menu Labeling Provisions of Section 4205 of the Patient Protection and Affordable Care Act of 2010” (“draft implementation guidance”) (75 FR 52426, August 25, 2010). The draft implementation guidance described which provisions became requirements upon enactment of the law and which provisions FDA would implement through rulemaking. FDA received approximately 80 responses to this draft implementation guidance, each containing one or more comments. On January 25, 2011, FDA published in the

Federal Register

a notice withdrawing the draft implementation guidance (76 FR 4360 January 25, 2011)). FDA now intends to complete the notice and comment rulemaking process for section 4205 before initiating enforcement activities. In the course of developing this proposed rule, we have considered the comments received on the draft guidance.

We describe in more detail and respond to the comments to the notices and guidance documents, including the withdrawn draft implementation guidance, in this proposal. Some of the comments to the notices and guidances are duplicative. Therefore, in this document, when responding to

comments from the docket notice, the registration notice, or the draft implementation guidance, we will generally refer to them simply as “comments” without identifying to which document these were submitted. Comments that are outside the proposed scope of this rulemaking, such as those concerning labeling of ingredients, allergen labeling, and labeling of genetically engineered foods, will not be discussed.

II. Legal Authority

As stated in section I.D. of this document, on March 23, 2010, the Affordable Care Act (Pub. L. 111-148) was signed into law. Section 4205 amended section 403(q)(5) of the FD&C Act (21 U.S.C. 343(q)(5)) by amending section 403(q)(5)(A) and by creating new clause (H), which requires, in relevant part, covered establishments to provide certain nutrient declarations for standard menu items. Under section 403(a)(1) of the FD&C Act (21 U.S.C. 343(a)(1)), such declarations must be truthful and nonmisleading. Because food that is not in compliance with section 403 is deemed misbranded, food to which these requirements apply is deemed misbranded if these requirements are not met. In addition, under section 201(n) of the FD&C Act (21 U.S.C. 321(n)), the labeling of a food is misleading if it fails to reveal facts that are material in light of representations actually made in the labeling. Section 403(q)(5)(H)(x) requires that the Secretary of Health and Human Services (Secretary) issue proposed regulations no later than one year after enactment. Section 701(a) (21 U.S.C. 371(a)) vests the Secretary with the authority to issue regulations for the efficient enforcement of the FD&C Act. Thus, FDA has the authority to issue this proposed rule under sections 201(n), 403(a)(1), 403(q)(5)(H), and 701(a) of the FD&C Act.

FDA is proposing requirements that covered establishments provide calorie and other nutrition information for standard menu items, including food on display and self-service food. Also, FDA is proposing the terms and conditions for voluntary registration by establishments that are not automatically subject to the requirements of section 4205 that elect to become subject to the requirements. FDA is proposing to set out these provisions in new § 101.11.

III. The Proposal

A. Summary

This proposal would add a new section 101.11 to 21 CFR and make additional changes to FDA's regulations as needed to conform existing regulations to the new statutory requirements. In this section, we explain the provisions of the new proposed section 101.11, beginning with the definitions of several key terms in the proposal.

B. Definitions

The menu labeling requirements of section 4205 apply to standard menu items offered for sale in “covered establishments”:

1. “Restaurants or similar retail food establishments” that are

• Part of a chain with 20 or more locations,

• “doing business under the same name”, and

• “offering for sale substantially the same menu items”; and

2. Other restaurants or similar retail food establishments that have been voluntarily registered to be subject to the Federal requirements by an “authorized official”.

Covered establishments must provide calorie information on “menus” and “menu boards,” and other nutrition information upon request, for “standard menu items,” including “combination meals,” “food on display,” “self-service food,” and “variable menu items.” The new nutrition labeling requirements do not apply to “custom orders,” “daily specials,” “food that is part of a customary market test,” and “temporary menu items.”

To establish the scope of establishments, labeling, and food covered by section 4205, FDA must define these and other key terms. Therefore, we are proposing in the introductory paragraph of § 101.11(a) that the definitions of terms in section 201 of the FD&C Act (21 U.S.C. 321) are applicable to these terms when used in proposed § 101.11. Additional terms are defined alphabetically in the proposed codified. Here, they are discussed in the order they are mentioned in the outline above, organized into three categories: (1) Terms related to the scope of establishments covered, (2) the terms menu and menu board, and (3) terms related to foods covered.

1. Scope of Establishments Covered

The menu labeling requirements in section 4205 of the Affordable Care Act apply to foods “offered for sale in a restaurant or similar retail food establishment that is part of a chain with 20 or more locations doing business under the same name (regardless of the type of ownership of the locations) and offering substantially the same menu items.” They also apply to restaurants or similar retail food establishments that voluntarily register to become subject to the Federal requirements. Some of the questions related to the scope of establishments covered are very complex, and FDA offers several alternatives for public comment.

Covered Establishment

We are proposing in § 101.11(a) that the term “covered establishment” means a restaurant or similar retail food establishment that is a part of a chain with 20 or more locations doing business under the same name (regardless of the type of ownership of the locations) and offering for sale substantially the same menu items, as well as restaurants or similar retail food establishments that voluntarily register to become subject to the Federal requirements. FDA derived this proposed definition from the criteria in sections 403(q)(H)(i) and (ix)(I) of the FD&C Act. Section 403(q)(H)(i) describes which restaurants and similar retail food establishments must meet the new requirements: Restaurants and similar retail food establishments that are part of a chain with 20 or more locations doing business under the same name (regardless of the type of ownership of the locations) and offering for sale substantially the same menu items. Section 403(q)(H)(ix)(I) allows restaurants or similar retail food establishments not otherwise subject to the requirements in section 403(q)(H) to register voluntarily to be subject to them (see section III.C below). Both restaurants and similar retail food establishments described in section 403(q)(H)(i) and those that register under section 403(q)(ix)(I) are subject to, or “covered” by, the nutrition labeling requirements of section 4205.

Terms within the definition of “covered establishment” are discussed below. We note that we have not proposed a definition for the statutory criterion, “part of a chain with 20 or more locations.” For the purposes of this proposal, FDA is assuming the common meanings of the words in that phrase. However, FDA requests comment on whether the phrase should be defined in the final rule. In particular, we request comment on the terms “chain” and “location” in the context of the various types of corporate or other business arrangements or structures that might be relevant, including contracting arrangements.

Restaurant and Similar Retail Food Establishment

While the core coverage may seem clear, the relevant statutory term

(“restaurants and similar retail food establishments”) is ambiguous. It is possible to imagine a range of interpretations, calling for relatively narrow coverage (including only restaurants and those establishments that are closely analogous to restaurants) or relatively broad coverage (including a range of establishments that sell food retail). FDA offers here a proposed interpretation alongside several alternatives for public comment. Under the proposed interpretation, explained in detail below, a retail food establishment is “similar” to a restaurant, and hence, covered, if it offers for sale restaurant or restaurant-type food and its primary business activity is the sale of food to consumers. FDA gives examples of included and excluded establishments below.

Statutory context.

As a starting point for developing a regulatory definition, we look to statutory context. As noted earlier, the 1990 NLEA amendments exempted two categories of food relevant for this discussion: (1) Food “which is served in restaurants or other establishments in which food is served for immediate human consumption or which is sold for sale or used in such establishments,” and (2) food “which is processed and prepared primarily in a retail establishment, which is ready for human consumption, which is the type described in [(1)] and which is offered for sale to consumers but not for immediate human consumption in such establishment and which is not offered for sale outside such establishment.” 21 U.S.C. 343(q)(5)(A)(i) and (ii). These are referred to in this document as “restaurant food” and “restaurant-type food,” respectively.

When promulgating regulations in 1993 to implement NLEA, FDA interpreted the categories of restaurant and restaurant-type food broadly. The agency provided the following examples of restaurant food: Food sold in institutional food service establishments, transportation carriers, delicatessens and retail confectionery stores where there are facilities for immediate consumption on the premises, food service vendors such as mall cookie counters, and sidewalk carts where foods are generally consumed immediately where purchased or while the consumer is walking away, including similar foods sold from convenience stores; and food delivery systems or establishments where ready-to-eat foods are delivered to homes or offices. 21 CFR 101.9(j)(2)(ii). The agency included the following examples of restaurant-type food: Ready-to-eat foods that processed and prepared on-site and sold by independent delicatessens, bakeries, or retail confectionary stores where there are no facilities for immediate consumption; by in-store delicatessen, bakery, or candy departments; or at self-service food bars such as salad bars. FDA also issued guidance on the labeling of foods sold in restaurants and other retail establishments selling restaurant or restaurant-type foods (Ref. 23).

Section 4205 amended the statutory exemption from Federal nutrition labeling requirements for restaurant and restaurant-type food. In determining the scope of section 4205, FDA considered which restaurant and restaurant-type foods should remain exempt from the Federal nutrition labeling requirements and which should be covered by the new Federal nutrition labeling requirements of section 4205.

Public comments.

In response to the docket notice and other

Federal Register

notices published in 2010, described in section I.E. above, FDA received numerous comments on the types of establishments that should be covered under section 4205. Some comments that were submitted to FDA supported the inclusion of a broad list of establishments such as those that had been exempted from nutrition labeling in FDA's implementing regulations of the NLEA. Some of these comments stated that concession stands at bowling alleys, amusement parks, stadiums, casinos, miniature golf courses, and other entertainment venues should be covered as well. These comments asserted that such establishments should be covered because consumers need to have access to calorie and other nutrition information for foods sold from such concession stands, and requiring nutrition information in all of these establishments provides a level playing field. A few of these comments maintained that establishments such as grocery stores and convenience stores contain facilities such as bakeries or cafes that are indistinguishable from their stand-alone counterparts and, therefore, should be covered by section 4205.

Other comments opposed the inclusion of concession stands at entertainment venues such as movie theaters, and restaurants at hotels, stating that the primary purpose of going to these establishments is not to buy food, but instead for entertainment or lodging. A few comments suggested that FDA adopt a definition that excludes establishments whose sale of prepared food (excluding pre-packaged snacks that already list nutritional information) is less than 35 percent of gross revenue. One comment suggested that FDA examine the percentage of sales derived at a particular retail location from food served for immediate consumption on the premises, and that, if more than 25 percent of total sales at a retail location are derived from the sale of food served for immediate consumption on the premises, the retail outlet is similar to a restaurant and should fall within the scope of § 4205.

Some comments opposed the inclusion of convenience stores and some grocery stores. The comments stated that not all chain convenience stores have menus or sell the same food items at all locations. The comments asserted that food in convenience stores is not standardized and that the foods differ depending on the techniques and preferences of the store employees preparing the foods. By contrast, according to the comments, food sold in restaurant chains is typically standardized and prepared in a homogeneous manner as dictated by corporate policy. The comments stated that some grocery stores have cafes, food courts, or otherwise sell restaurant food directly to consumers. Some comments contended that only grocery stores with seating areas should be covered. Other comments stated that FDA does not have authority under section 4205 to regulate individual departments or operations within a retail food establishment unless that establishment as a whole is similar to a restaurant.

FDA received a few comments regarding the possible inclusion of food-service contractors, which the comments described as companies that provide managed food and facility services to a variety of institutions, including hospitals, schools, stadiums/arenas and businesses, as covered establishments. Some of these comments stated that menus at establishments operated by food service contractors can vary from day-to-day and month-to-month. However, if food-service contractors have quick-service restaurants, the comments support calorie labeling in these establishments.

We considered these comments, in addition to the language and purpose of the statute, when deliberating on how to define restaurants and similar retail food establishments for purposes of this rulemaking. We also noted the existence of hybrid establishments, such as chain coffee vendors operating in retail bookstores and soup and sandwich counters, cafes, and food courts in grocery or convenience stores. For example, a grocery store may have a salad bar from which consumers select various foods that are ready for human consumption, processed and prepared primarily in the grocery store, and not offered for sale outside of the grocery

store. In addition, many establishments, such as certain coffee shops in bookstores, operate in or consist of multipurpose businesses, where entertainment, restaurant food and other goods and services are offered together or in close proximity.

Proposed definition.

FDA tentatively concludes that a retail food establishment is an establishment whose primary business activity is the sale of food to consumers

.

FDA also tentatively concludes that in order for a retail food establishment to be “similar” to a restaurant, it must offer for sale restaurant or restaurant-type food. Although there are many types of establishments where consumers come into contact with food for purchase, FDA notes that the statutory text focuses explicitly on restaurants and retail food establishments that are “similar” to restaurants, rather than on all establishments where food is sold (often incidentally to or quite separately from the establishment's primary purpose). In light of the statutory language, FDA is proposing in 101.11(a) that the term “restaurant or similar retail food establishment” means a retail establishment that offers for sale restaurant or restaurant-type food, where the sale of food is the primary business activity of that establishment. FDA acknowledges that the statutory language is not entirely clear, and invites comments on various alternatives, but currently believes that the proposed definition fits best with the natural meaning of the language and its proper scope.

The sale of food would be considered to be a retail establishment's primary business activity if either (1) the establishment presents or has presented itself publicly as a restaurant (

e.g.,

through consumer-, industry- or investor-oriented materials) or (2) greater than 50 percent of a retail establishment's gross floor area is used for the preparation, purchase, service, consumption, or storage of food. Examples of when an establishment is presenting itself as a restaurant could include calling itself a restaurant on a consumer-oriented Web site, listing itself under “Restaurants” in the phone book, and using the term “restaurant” in its signage. Note that if a portion of the establishment were to present itself publicly as a restaurant (

e.g.,

a “café car” on a train), the first criterion would not necessarily be satisfied; the question would be how the establishment as a whole presents or has presented itself. See the discussion of facilities within establishments below. For the second criterion, gross floor area would include all floor space, wall to wall, including areas under built-in counters, cooking equipment, seating, and similar furniture. Multi-purpose seating areas used substantially for activities other than food consumption, such as seating in entertainment venues (

e.g.,

shows, sport stadiums), would not be counted in the share of floor space devoted to the sale of food. FDA notes that some establishments may have seating outside for the consumption of food (

e.g.,

outdoor cafes). We seek comment on whether this space should be considered in determining gross floor area.

As an alternative to using percentage of gross floor area as an indicator of the primary business activity of an establishment, FDA is seeking comment on an approach based on the percent revenue of the business. Under this alternative approach, the sale of food would be considered to be a retail establishment's primary business activity if either (1) the establishment presents or has presented itself publicly as a restaurant or (2) more than 50 percent of the establishment's revenues are generated by the sale of food. FDA requests comment on this alternative means of determining an establishment's primary business activity. We specifically seek comment on whether 50 percent is the appropriate threshold or whether it should be higher or lower. We also welcome comment on other suggested alternative criteria for identifying the primary business activity of an establishment.

Under the proposal that includes gross floor space, restaurants and similar retail food establishments would likely include table service and quick-service (or fast food) dining establishments, cafeterias,

1

pastry and retail confectionary stores, coffee shops, snack bars, and ice cream parlors, as well as grocery stores and convenience stores that sell restaurant or restaurant-type food. In addition, multi-purpose establishments that offer restaurant or restaurant-type food and include areas for entertainment (

e.g.,

games or children's shows) would be restaurants or similar retail food establishments if they present themselves or have presented themselves publicly as restaurants, regardless of whether the amount of floor space dedicated to the sale of food is greater than 50 percent of the venue's gross floor space.

1

Many cafeterias located within other establishments,

e.g.,

most school and hospital cafeterias, would be considered part of larger establishments they are situated within and would not be covered by the proposed rule. See the discussion of facilities located within larger establishments below.

Correspondingly, establishments that do not sell restaurant or restaurant-type food or whose primary business activity is not the sale of food would not be considered restaurants or similar retail food establishments and would not have to comply with the menu labeling provisions of 403(q)(5)(H). For example, where a multi-purpose establishment has never presented itself publicly as a restaurant and the percentage of the establishment's gross floor area devoted to the sale of food is less than 50 percent, the establishment would not be a restaurant or similar retail food establishment under this proposal. FDA expects that most movie theaters, amusement parks, general merchandise stores with in-house concession stands, hotels, and transportation carriers such as trains and airplanes will not be considered restaurants or similar retail food establishments under this proposal, because, in general, they do not present themselves to the public as restaurants, nor are they likely to meet the floor space (or revenue) threshold.

The following table provides examples of establishments that FDA expects would be considered restaurants or similar retail food establishments under the proposal and those that would not. Note that whether a specific establishment would be considered a restaurant or similar retail food establishment would depend on whether that specific establishment met the proposed regulatory criteria. In addition, a restaurant or similar retail food establishment is covered by the new menu labeling requirements if it is part of a chain with 20 or more locations doing business under the same name and offering for sale substantially the same menu items, or it voluntarily registers with FDA.

Table 1—Are the Following Establishments “Restaurants or Similar Retail Food Establishments” Under the Proposed Rule?

Generally yes

Generally no

Table service dining establishments

Movie theaters

Quick service (fast food) establishments

Amusement parks

Cafeterias

General merchandise stores

Pastry and retail confectionary stores

Hotels

Coffee shops

Trains

Snack bars

Planes

Ice cream parlors

Multi-purpose establishments that have presented themselves publicly as restaurants

Establishments within larger establishments that are part of a chain with locations outside of the larger establishment's chain (

e.g.,

chain coffee shop in a bookstore; see discussion below)

Grocery stores

Convenience stores

Note:

While the appropriate categorization will often be straightforward, the word “generally,” used in the headings, is an important qualification. For example, some grocery and convenience stores may meet the definition of “restaurants or similar retail food establishments” under this proposed rule, while others may not.

Many facilities that sell restaurant or restaurant-type food are located within larger retail establishments, such as a coffee shop in a bookstore, a hot dog stand in a stadium, a quick-service counter in an establishment selling a range of packaged foods and household products (“Superstore XYZ”), or a concession stand in an entertainment venue. Some of these facilities would be considered separate retail establishments, while others would be considered part of their larger retail establishments.

If a facility selling restaurant or restaurant-type food is part of a chain with locations outside of the chain of the larger retail establishment, the facility would be considered a separate retail establishment. For example, if a coffee shop in a bookstore is part of a chain of coffee shops with locations outside of the chain of bookstores, the coffee shop would be considered a separate retail establishment. When determining the primary business activity of the coffee shop, only the representations of the coffee shop itself and the coffee shop's floor area would be considered. The coffee shop in the bookstore would most likely meet the proposed definition of a restaurant or similar retail food establishment.

If, by contrast, a facility selling restaurant or restaurant-type food is not part of a chain with locations outside of the chain of the larger retail establishment, the facility would be considered part of the larger retail establishment. For example, if Superstore XYZ has a café that appears only in other locations of the Superstore XYZ chain, the café would be considered part of Superstore XYZ. When determining the primary business activity of Superstore XYZ, the agency would ask whether the superstore as a whole presents or has presented itself as a restaurant and what percentage of the gross floor area of the superstore as a whole, including the café, is dedicated to the sale of food. Because the café would not be considered an “establishment,” it would not be eligible for being a “restaurant or similar retail food establishment” under this proposal. As a result, whether the cafe independently presents itself as a restaurant (

e.g.,

by listing itself in the phone book under “Restaurants”) or has greater than 50% of its floor space devoted to the sale of food would be irrelevant.

As another example, a movie theater concession stand that appears only in other movie theaters in that particular chain of movie theaters would not be considered a separate establishment for the purposes of this proposed rule. Because movie theaters usually do not present themselves as restaurants and do not dedicate more than 50 percent of their gross floor area to the sale of food, they generally would not fall within the definition of restaurant or similar retail food establishment in this proposed rule.

FDA requests comment on whether such facilities within larger establishments should be included within the definition of restaurants and similar retail food establishments in the final rule. FDA particularly requests comment on this approach with respect to movie theaters, other entertainment-type venues, and Superstores that offer restaurant or restaurant-type food.

An alternative.

One alternative to our proposed definition is to define “restaurant or similar retail food establishment” to mean a retail establishment where the sale of restaurant or restaurant-type food—as opposed to food in general—is the primary business activity of that establishment. Restaurant or restaurant-type food here would not include packaged food that is required to bear Nutrition Facts. Under this alternative, the agency would consider the sale of restaurant or restaurant-type food to be a retail establishment's primary business activity if either (1) the establishment presents itself or has presented itself publicly as a restaurant, or (2) a total of more than 50 percent of a retail establishment's gross floor area is used for the preparation, purchase, service, consumption, or storage of restaurant or restaurant-type food or its ingredients. As with the proposed definition, multi-purpose seating areas used substantially for activities other than food consumption, such as seating in entertainment venues (

e.g.,

shows, sport stadiums) would not be counted in the share of floor space devoted to the sale of restaurant or restaurant-type food. Under this alternative, FDA solicits comment on whether a percent revenue approach to determining an establishment's primary business activity is the sale of restaurant or restaurant-type foods.

Under this alternative, “restaurant or similar retail food establishment” would include table service and quick-service (or fast food) dining establishments, cafeterias, pastry and retail confectionary stores, coffee shops, snack bars, and ice cream parlors. Establishments where the primary business activity is not the sale of restaurant or restaurant-type food would not be considered restaurants or similar retail food establishments. In contrast with the proposed definition, establishments that are unlikely to be considered restaurants or similar retail food establishments under this alternative include grocery and convenience stores, in addition to hotels and transportation carriers such as trains and airplanes. The option would

not cover grocery and convenience stores because it would not count the floor space used to sell food that is not restaurant or restaurant-type food (

e.g.,

packaged food) in determining the primary business activity.

The following table provides examples of establishments that FDA expects would be considered restaurants or similar retail food establishments under the alternative and those that would not. Note that whether a specific establishment would be considered a restaurant or similar retail food establishment would depend on whether that establishment met the alternative regulatory criteria. In addition, a restaurant or similar retail food establishment is only covered by the new menu labeling requirements if it is part of a chain with 20 or more locations doing business under the same name and offering for sale substantially the same menu items.

Table 2—Are the Following Eestablishments “Restaurants or Similar Retail Food Establishments” Under the Alternative to the Proposed Definition?

Generally yes

Generally no

Table service dining establishment

Movie theaters

Quick service (fast food) establishments

Amusement parks

Cafeterias

General merchandise stores

Pastry and retail confectionary stores

Hotels

Coffee shops

Trains

Snack bars

Planes

Ice cream parlors

Grocery stores

Multi-purpose establishments that have presented themselves publicly as restaurants

Convenience stores

Establishments within larger establishments that are part of a chain with locations outside of the larger establishment's chain (

e.g.,

chain coffee shop in a bookstore; see discussion below)

Note:

While the appropriate categorization will usually be straightforward, the word “generally,” used in the headings, is an important qualification. For example, some grocery and convenience stores will qualify as similar retail food establishments under the rule, while others may not. The answer depends on the definition proposed in this section.

Requests for comment.

We request comment on the proposed definition and on the alternatives. We are also interested in comments on whether we should use “primary business activity,” or a different test, as a basis for determining whether an establishment is a restaurant or similar retail food establishment. We also request comment on whether we should choose a different number for the cutoff for the percent of gross floor area for determining the primary business activity of the retail establishment or whether we should choose the percent revenue approach discussed above or different criteria for determining primary business activity, such as whether the consumer pays for admission to the establishment.

As we have noted, some comments have urged a broader test on public health grounds. Any such test must explain how it is consistent with statutory language. For example, if FDA adopted a percentage revenue threshold test for determining primary business activity and set the threshold at 25%, as some comments suggested, would chain movie theater concessions be included? If so, would this test be appropriate, given the statutory language? We are also interested in comments on the impact of the proposed definition and alternatives on the sale of restaurant or restaurant-type food by large chain “Superstores” or by contractors servicing similar food outlets in 20 or more locations. FDA notes that one food contractor commented that it offers quick service or fast food concepts in some of its locations. The comment further stated that menus in these locations are highly standardized and consistent across locations. The comment supported calorie labeling on menus and menu boards and the availability of additional written nutrition information for these types of locations. Comments supporting or opposing the possible definitions discussed here should include a rationale and should explain the impact of the recommendation on the implementation of section 4205.

Doing Business Under the Same Name

The menu labeling requirements apply to restaurants and similar retail food establishments that are part of a chain with 20 or more locations “doing business under the same name.” We are proposing in § 101.11(a) that the term “doing business under the same name” means sharing the same name, where the term “same name” includes names that are either exactly the same, or are slight variations on each other due, for example, to the region, location or size.

In some cases, a chain retail food establishment's name may vary slightly from the names of other establishments in the same chain, often reflecting the location or size of the establishment. For example, a quick-service restaurant, “Joe's Burgers New York Ave.,” located on New York Avenue, might have another location on Pennsylvania Avenue called “Joe's Burgers Pennsylvania Ave.” As another example, a dine-in restaurant with the name “ABC” might have an outlet in an airport called “ABC Express” that offers take-out. FDA is proposing that the term “same name” includes names that are slight variations on each other, for example, based on region, location or size (

e.g.,

“Joe's Burgers New York Ave.” and “Joe's Burgers Pennsylvania Ave.” or “ABC” and “ABC Express”). FDA requests comment on this definition. Specifically, we request comment on whether the relevant term should be understood instead to refer to the underlying name of ownership, such as the name of a parent company, or the name of the entity conducting corporate business on behalf of the establishment, such as the name of a contractor operating an establishment, regardless of the public name used by individual establishments.

Offering for Sale Substantially the Same Menu Items

We are proposing in § 101.11(a) that the term “offering for sale substantially the same menu items” means offering for sale menu items that use the same general recipe and are prepared in substantially the same way with substantially the same food components, even if the name of the menu item varies. For example, a chain restaurant may make a sandwich and call it “Bay View Crab Cake,” whereas another restaurant in that chain that makes the same sandwich prepared the same way and with the same ingredients may call it “Ocean View Crab Cake.” These two restaurants would be offering for sale the same menu item. In addition, restaurants and similar retail

food establishments that are part of a chain can still be offering for sale substantially the same menu items if the availability of some menu items varies within the chain. For example, a covered restaurant in a chain may have a limited menu and not carry all the standard menu items as another restaurant in the chain. However, if most of the standard menu items in the restaurant with the limited menu are sold in the restaurant with the more extensive menu, these two restaurants would be offering for sale substantially the same menu items. As another example, a chain retail food establishment might offer standard menu items that are mostly the same, except for a few that are unique to that chain retail food establishment. That chain retail food establishment would still be offering for sale substantially the same menu items as the other establishments in the chain. In this proposed definition, the term “menu items” refers to food items that are offered for sale in a restaurant or similar retail food establishment.

Authorized Official

Restaurants and similar retail food establishments that are not automatically covered by the new menu labeling requirements can voluntarily register to be subject to them. Section 403(q)(5)(H)(ix) provides that “[a]n authorized official of any restaurant or retail food establishment * * * not subject to the requirements of this clause may elect to be subject to the requirements of such clause, by registering biannually the name and address of such restaurant or similar retail food establishment * * * with the Secretary, as specified by the Secretary by regulation.” We are proposing in § 101.11(a) that the term “authorized official of a restaurant or similar retail food establishment” means the owner, operator, agent in charge, or any other person authorized by the owner, operator, or agent in charge of a restaurant or similar retail food establishment not subject to the requirements of section 4205 to voluntarily register the establishment with FDA to become subject to the requirements of section 4205. FDA tentatively concludes that it is appropriate for the owners, operators, or agents in charge to be able to authorize other persons to register on their behalf.

Summary of Proposed Scope of Covered Establishments

When is an entity an establishment?

If an entity is free-standing, it would be an establishment. If an entity is inside an establishment, then the entity could be considered a separate establishment or it could be considered part of the establishment in which it is situated. If the entity is part of a chain with locations outside of the chain of the larger establishment, then the entity would be a separate establishment. If not, the entity would be considered part of the larger establishment.

Table 3—When Is an Entity an Establishment?

Is the entity an establishment?

The entity is free-standing.

Yes.

The entity is inside an establishment and:

• It only appears in locations of the larger establishment's chain (

e.g.,

Superstore XYZ Café in Superstore XYZ)

No.

• It is part of a chain with locations outside of the larger establishment's chain (

e.g.,

coffee shop in a bookstore that is part of a chain of coffee shops with locations that are free-standing)

Yes.

When is an establishment a restaurant or similar retail food establishment?

To be a restaurant or similar retail food establishment, an establishment must sell restaurant or restaurant-type food. In addition, the sale of food in general must be the establishment's primary purpose. The sale of food is an establishment's primary purpose if (1) the establishment publicly presents itself or has publicly presented itself as a restaurant, or (2) the establishment dedicates more than 50% of its floor space to the sale of food. This is demonstrated in following flow chart:

EP06AP11.010

When is a restaurant or similar retail food establishment a covered establishment?

A restaurant or similar retail food establishment is a “covered establishment” if (1) it is part of a chain with 20 or more locations, doing business under the same name, and offering for sale substantially the same menu items, or (2) it has voluntarily registered with FDA to be subject to the Federal requirements. FDA refers to the first category as “chain retail food establishments.”

Table 4—Statutory Criteria for Chain Retail Food Establishments:

Statutory criteria

Proposed interpretation

Part of a chain with 20 or more locations

The restaurant or similar retail food establishment is part of a chain with at least 19 other establishments.

Doing business under the same name

Establishments in the chain share the same name or have names that are slight variations on each other, due to, for example, region or size (e.g., ABC and ABC Express, Joe's Burgers New York Ave. and Joe's Burgers Pennsylvania Ave).

Offering for sale substantially the same menu items

Establishments in the chain offer for sale menu items that use the same general recipes and are prepared in substantially the same ways with substantially the same food components, even if the name of the menu item varies. Establishments can be offering for sale substantially the same menu items even if the availability of some menu items varies within the chain.

Voluntary registration.

If a restaurant or similar retail food establishment is not part of a chain with 20 or more locations doing business under the same name and offering for sale substantially the same menu items, the establishment may voluntarily elect to be subject to the new Federal requirements by registering with FDA.

2. Menu and Menu Board

Covered establishments are required to post calories and other information on menus and menu boards. Section 403(q)(5)(H)(xi) provides that “the term `menu' or `menu board' means the primary writing of the restaurant or other similar retail food establishment from which a consumer makes an order selection.” We are proposing in § 101.11(a) to essentially codify this definition. The proposed regulatory definition also clarifies that menus include breakfast, lunch and dinner menus; dessert menus; beverage menus; children's menus; other specialty menus; electronic menus; and menus on the Internet. Menus may be in different forms,

e.g.,

booklets, pamphlets, or single sheets of paper. Menu boards include drive-through menu boards as well as display boards above ordering counters.

In developing this proposed definition, FDA considered comments expressing various opinions on what constituted a menu or menu board. According to several comments, FDA should allow electronic devices, such as Internet-enabled smart phones, text messaging, and kiosks, to serve as primary writings. One comment requested that FDA clarify whether a writing posted on the Internet would only be considered a menu if a consumer may place an order online. Several comments asserted that marketing materials (

e.g.,

banners, table tents) should not be considered menus.

FDA tentatively concludes that “menu” or “menu board” includes any writing of the covered establishment that is the primary writing from which a consumer makes an order selection.

FDA considered whether “primary” should be from the perspective of the establishment or the consumer. If covered establishments were only required to label the writing they consider to be their primary writing from which consumers make order selections, only one writing would be required to be labeled. For example, at a quick service restaurant that has two menu boards, one above a counter inside and one outside at a drive-through, the one the restaurant considers its “primary writing” would be labeled, but the other might not. Given the importance for all consumers to have access to nutrition information when making order selections, FDA proposes that “primary writing” should be interpreted from a consumer's vantage point. For example, while a printed menu may be the “primary writing” of a restaurant used by a customer ordering food while dining inside the restaurant itself, a menu mailed as a flyer mailed to another customer's home could be the “primary writing” of the restaurant used by that customer ordering take-out or delivery from the same restaurant. Both the printed menu and the menu flyer would meet the definition of “menu” or “menu board” under proposed § 101.11(a). We recognize that some establishments may send menus as a form of advertising. FDA tentatively concludes advertisements for food fall outside the scope of section 4205. However, take-out and delivery menus, which include all or a significant portion of items offered for sale and serve as the primary writing from which consumers make their order selections, would be menus under the proposed rule. FDA requests comment on these tentative conclusions.

FDA notes that many consumers order restaurant or restaurant-type food from restaurants or similar retail food establishments over the phone or Internet. FDA tentatively concludes that if consumers can order from a covered establishment online, over the phone, or by fax, using a writing of the covered establishment on the Internet as the primary writing from which he or she makes his or her order selection, then the writing on the Internet is a menu for the purposes of section 403(q)(5)(H).

3. Food Covered

Section 4205 requires covered establishments to provide calorie and other nutrition information for “food that is a standard menu item,” including combination meals, variable menu items, self-service food, and food on display. The new requirements do not apply to custom orders, daily specials, food that is part of a customary market test, and temporary menu items.

Food

The term “food” is defined in section 201(f) of the FD&C Act, in relevant part, as “articles used for food or drink for man * * * chewing gum, and articles used for components of any such article.” 21 U.S.C. 321(f). Under section 201 of the FD&C Act, this definition applies “for purposes of this Act.” Therefore, articles of food that are offered for sale in covered establishments as standard menu items, including food on display and self-service foods would generally be subject to section 403(q)(5)(H). The term “food” includes foods that are also regulated by other U.S. Government agencies, such as meat, poultry, and processed egg products, which are also regulated by the United States Department of Agriculture (USDA), and alcoholic beverages regulated by the Alcohol and Tobacco Tax and Trade Bureau (TTB) within the United States Department of the Treasury.

2

Comments submitted to FDA supported the position that meat, poultry, processed egg products, and alcoholic beverages are considered “articles of food” subject to the requirements of amended section 403(q) because they are foods as defined in the FD&C Act and they provide a significant amount of calories.

2

FDA exclusively regulates the labeling of alcoholic beverages that are not under TTB's jurisdiction, including beers that do not meet the definition of a “malt beverage” under the Federal Alcohol Administration Act (FAA Act) (27 U.S.C. 201

et seq.

) and wine beverages containing less than 7 percent alcohol by volume. See,

e.g.,

FDA, “Guidance for Industry: Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration; Draft Guidance.” August 2009.

Available at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/ucm166239.htm.

Malt beverage is defined in section 117(a)(7) of the FAA Act (27 U.S.C. 211(a)(7)) and TTB regulations at 27 CFR 7.10.

Other comments stated that TTB, which regulates the labeling of certain alcohol beverages pursuant to the provisions of the Federal Alcohol Administration Act (FAA Act) (27 U.S.C. 201

et seq.

), does not currently require nutrition labeling for the alcoholic beverages it regulates, as required for packaged food regulated by FDA. The comments stated further that while TTB requires a statement of average analysis on labels that make calorie or carbohydrate claims, this statement includes only calories, carbohydrates, protein, and fat. See TTB Ruling 2004-1.

http://www.ttb.gov/rulings/2004-1.pdf.

The comments noted that TTB does not require the declaration of sugar, fiber, sodium, or cholesterol content on a beer label. As a result, these comments stated that beer brewers would have to undertake a substantial testing program to be able to provide that nutrition information for consumers. In addition, one comment expressed concern with obtaining nutrition information, stating that beers produced by small brewers have greater variation in alcohol content and ingredients than beers within the existing “regular beer” category in USDA's nutrition database. However, this comment stated that general classifications can be established that will provide industry members and consumers with accurate calorie and nutritional information. The comment further stated that industry members could work with USDA to develop easily measured criteria, such as original gravity measurement, that would provide a consistent benchmark for brewers and accurate information for consumers. The comment also maintained that, absent agreement between FDA and TTB with respect to labeling formats, action by small brewers to provide nutrition information pursuant to amended section 403(q) would contradict current TTB guidance and create uncertainty when a pending TTB rulemaking on “serving facts” is completed.

3

Accordingly, the comment urged FDA to delay the application of the new requirements to alcohol beverages pending agreement between FDA and TTB on a consistent methodology.

3

In the

Federal Register

of July 31, 2007 (72 FR 41860), TTB published a proposed rule to amend its regulations to require a statement of the percentage of alcohol on all alcoholic beverages and a serving facts panel, which would include a statement of calories, carbohydrates, fat and protein. This proposed rule has not been finalized.

FDA has considered these comments and consulted with TTB and USDA in developing this proposed rule. Section 4205 amends section 403(q) of the FD&C Act (21 U.S.C. 343(q)), which generally provides nutrition labeling requirements for certain foods. Section 4205 provides nutrition labeling requirements directed specifically toward standard menu items sold in covered establishments. FDA tentatively concludes that the nutrition disclosure requirements in amended section 403(q)(5)(H) for standard menu items offered for sale in covered establishments apply to foods for human consumption, including meat, poultry, and processed egg products, even though they are also regulated by USDA. This tentative conclusion is consistent with FDA's position that FDA has jurisdiction under the FD&C Act over meat, poultry, and

processed egg products in interstate commerce.

While alcohol beverages are “food” under the FD&C Act, FDA recognizes that at least one court has held that TTB has exclusive jurisdiction over the labels of the alcohol beverages it regulates under the FAA Act.

Brown-Forman Distillers Corp.

v.

Mathews,

435 F. Supp. 5 (W.D.Ky. 1976). Providing nutrition information required in section 4205 for alcohol beverages should result in a similar public health benefit as providing the information for a food for which the labeling is exclusively regulated by FDA. However, it is not clear that Congress intended for the nutrition information disclosures required by section 4205 to apply to alcohol beverages, given that the labels of the majority of alcohol beverages are regulated by TTB. For the purposes of this proposal, FDA tentatively concludes that the new menu labeling requirements do not apply to alcohol beverages. Therefore, proposed § 101.11(b)(1)(ii) provides that the labeling requirements do not apply to alcohol beverages. We request comment on whether alcohol beverages should be within the scope of the requirements of section 4205 and proposed 21 CFR 101.11. In any case, the provisions of section 4205 do not apply to and have no effect on the labels of food products sold in packaged form, including meat, poultry and processed egg products that are regulated by USDA or on the labels of alcoholic beverages regulated by TTB under the FAA Act.

Restaurant Food

We are proposing in § 101.11(a) that “restaurant food” means food that is served in restaurants or other establishments in which food is served for immediate human consumption,

i.e.,

to be consumed either on the premises where the food is purchased or while walking away, or that is sold for sale or use in such establishment. This definition corresponds to the way the agency uses the term “restaurant food” in § 101.10, “Nutrition labeling of restaurant foods.” See 61 FR 40320 (Aug. 2, 1996). It also reflects the food described in section 403(q)(5)(A)(i) of the FD&C Act.

Restaurant-Type Food

We are proposing in § 101.11(a) that “restaurant-type food” means food of the type described in the definition of “restaurant food” that is ready for human consumption, offered for sale to consumers but not for immediate consumption, processed and prepared primarily in a retail establishment, and not offered for sale outside of that establishment. This definition reflects the food described in section 403(q)(5)(A)(ii).

Standard Menu Item

We are proposing in § 101.11(a) that the term “standard menu item” means a restaurant or restaurant-type food that is routinely included on a menu or menu board or that is routinely offered as a self-service food or food on display. FDA notes that, unlike the term “menu,” the term “standard menu item” is not defined in section 4205. In developing this proposed definition, FDA considered the relationships between sections 403(q)(5)(H)(i), (ii), and (iii). Section 403(q)(5)(H)(i), entitled “General requirements for restaurants and similar retail food establishments,” requires covered establishments to “disclose the information described in subclauses (ii) and (iii),” “in the case of food that is a standard menu item.” Sections 403(q)(5)(H)(ii)(I)(aa) and (II)(aa) require calorie declarations on menus and menu boards, respectively, and section 403(q)(5)(H)(iii) requires calorie declarations for self-service food and food on display.

FDA considered whether only self-service food and food on display that appear on menus or menu boards should be covered. However, the examples Congress provides for self-service food and food on display in section 403(q)(5)(H)(iii) (“food sold at a salad bar, buffet line, cafeteria line, or similar self-service facility, and for self-service beverages or food that is on display and that is visible to customers”) generally do not appear on menus or menu boards—customers often simply pick up their selections and pay a cashier. In addition, in certain establishments where customers do order self-service food or food on display,

e.g.,

where “salad bar” or “breakfast buffet” is listed on a printed menu at a sit-down restaurant, the individual items on the salad bar or the breakfast buffet generally are not listed on the printed menu. Any signs identifying the individual foods on the salad bar or buffet are intended to be viewed after the customer orders.

These examples—salad bars, buffet lines, and cafeteria lines—are explicitly named in section 403(q)(5)(H)(iii), so they must fall within the scope of the new law. Therefore, FDA proposes to interpret “standard menu item” to mean a food that is routinely listed on a menu or menu board or that is routinely offered as self-service food or food on display. For example, a hamburger, a combination meal, and a specific type of pizza (

e.g.,

“deluxe pizza”) that regularly appear on a restaurant menu would be considered standard menu items. Potato salad that is routinely offered at a salad bar, pancakes that are routinely offered at a buffet, and pudding that is routinely offered at a cafeteria line would be considered standard menu items, as well. This interpretation allows for the types of foods on display and self-service foods described in section 403(q)(5)(H)(iii) to be covered and gives meaning to the reference in section 403(q)(5)(H)(i) to section 403(q)(5)(H)(iii) (“in the case of food that is a standard menu item * * * the [covered establishment] shall disclose the information described in subclauses (ii) and (iii).”). Correspondingly, FDA tentatively concludes that “menu item” should be considered a food item that is listed on a menu or menu board or that is offered as a self-service food or food on display. FDA requests comment on the proposed definition of standard menu item.

Multiple Servings

Some comments contended that foods sold in multiple servings such as a bucket of chicken pieces, rotisserie chicken, and full rack of ribs are not standard menu items because they are not sold for immediate consumption. Other comments stated that bakery items such as individually sold bagels or cookies also should not be covered. Other comments did not oppose a requirement for providing some calorie and other nutrition information for these multiple-serving foods, but recommended that the calorie declaration for them be by serving, which, they contended, would be more meaningful. Two industry comments stated that they received consumer complaints when the calories were declared for whole pizzas, as was required by some jurisdictions. The comments stated that the consumers claimed that this type of declaration was confusing and impractical, and they asserted that nutrition and calorie information should be disclosed per slice. Other comments stated that the calories should be declared for the food offered for sale and not for each serving.

FDA disagrees with the comments that stated that multi-serving foods are not standard menu items. Section 403(q)(5)(H) requires that calories be disclosed for standard menu items at covered establishments, regardless of how many servings included in the item. Multi-serving foods that are routinely included on a menu or menu board (

i.e.,

the primary writing of the restaurant or similar retail food establishment from which a customer makes an order selection) or routinely offered as a self-service food or food on

display would meet FDA's proposed definition of standard menu item. FDA requests comments on this issue.

Combination Meal

We are proposing in § 101.11(a) that the term “combination meal” means a standard menu item that consists of more than one food item; for example, a meal that includes a sandwich, a side item, and a drink would be a combination meal. A combination meal may be represented on the menu or menu board in narrative form, numerically, or pictorially. A combination meal may include one or more variable items and may itself be a variable menu item, as that term is defined in this section. For example, the side item may have several options (

e.g.,

fries, salad, or onion rings) or the drink may vary (

e.g.,

soft drinks, milk, or juice), and the customer selects which of these items will be included in the meal.

Variable Menu Item

We are proposing in § 101.11(a) that the term “variable menu item” means a standard menu item that comes in different flavors, varieties, or combinations, and is listed as a single menu item. As examples, variable menu items may have flavoring options, (

e.g.,

a milkshake that is available in vanilla, chocolate, or strawberry flavors) or topping options (

e.g.,

pizza prepared with a selection of toppings).

Self-Service Food

We are proposing in § 101.11(a) that the term “self-service food” means restaurant or restaurant-type food that is offered for sale at a salad bar, buffet line, cafeteria line, or similar self-service facility, and self-service beverages. This definition covers food that the customer serves himself or herself, such as food at hot and cold food bars or beverages in a self-service beverage machine in a restaurant. FDA considers the term “facility” as it is used in section 403(q)(5)(H)(iii) to refer to a self-service fixture in a covered establishment, and not necessarily to the entire establishment. For example, a salad bar in a pizzeria would be a self-service facility, while the pizzeria as a whole would be a covered establishment if it as part of a chain of 20 or more locations doing business under the same name and offering for sale substantially the same menu items. Self-service foods are a subset of food on display.

Food on Display

We are proposing in § 101.11(a) that the term “food on display” means restaurant or restaurant-type food that is visible to the customer before the customer makes a selection, so long as there is not an ordinary expectation of further preparation by the consumer before consumption. Under the proposed definition, food on display would include food packaged at the customer's request, such as a slice of pizza sold at a counter or an entrée item served on a buffet line, or pre-wrapped by the establishment for direct customer selection, such as a sandwich prepared on the premises and displayed in a case. FDA tentatively concludes that this term includes food that is behind a glass counter or another viewing apparatus for the purposes of showing a serving or meal suggestion. Food on display would not encompass meats and cheeses sold at delicatessens in grocery stores, given that there is an ordinary expectation that the consumer will further prepare those foods before consumption,

e.g.,

by using the meat and cheese to make a sandwich.

Custom Order

We are proposing in § 101.11(a) that the term “custom order” means a food order that is prepared in a specific manner based on an individual consumer's request, which requires the restaurant or similar retail food establishment to deviate from its usual preparation of a menu item. For example, a club sandwich ordered without the bacon would be considered a custom order if the establishment usually includes bacon in its club sandwich.

Daily Special

We are proposing in § 101.11(a) that the term “daily special” means a menu item that is prepared and offered for sale on a particular day, that is not routinely listed on a menu or offered by the covered establishment, and that is promoted by the covered establishment as a special menu item for that particular day. Often, such items are added to the menu on a particular day through inserted slips of paper or written on erasable menu boards. However, an item that is offered for sale every week on Mondays is routinely offered and therefore would not be considered a daily special. In addition, if a standard menu item is offered at a discounted price on a particular day, the item would not be considered a daily special. For example, if a turkey club sandwich is a standard menu item at a restaurant and normally costs 5 dollars, but on Fridays the same turkey club sandwich is specially advertised as costing only 4 dollars, FDA tentatively concludes that the nutrient content disclosure requirements for standard menu items would still apply to the turkey club sandwich on Fridays; the sandwich would not be considered a “daily special” under § 101.11(a) merely because it is specially discounted. Similarly, if a covered establishment offers individual menu items together at a discount on a particular day, they would also not be a daily special. FDA requests comment on this definition.

Food That Is Part of a Customary Market Test

We are proposing in § 101.11(a) that the term “food that is part of a customary market test” means food that is marketed in a covered establishment for fewer than 90 consecutive days in order to test consumer acceptance of the product.

Some comments from industry stated that the 90-day time period should be calculated per market, not per chain, and asked that we clarify when the 90-day time period begins. These comments also stated that 90 days may not be long enough for a test market.

FDA points out that the 90-day time period is a statutory requirement. FDA proposes to interpret the 90-day time period to mean consecutive days beginning when the menu item is first offered for sale in the specific location. This interpretation is based on FDA's understanding of how test marketing is ordinarily done. FDA requests comment about our interpretation of a 90-day consecutive time frame on the test marketing of products.

Temporary Menu Item

We are proposing in § 101.11(a) that the term “temporary menu item” means a food that appears on a menu or menu board for less than a total of 60 days per calendar year. As with the 90-day time period for food that is part of a customary market test, the 60-day time period for temporary menu items is a statutory requirement. To provide flexibility, the 60 days includes the total of consecutive and non-consecutive days the item appears on the menu.

C. Requirements for Covered Establishments

1. Applicability

FDA is proposing in § 101.11(b)(1)(i) that menu labeling requirements apply to standard menu items offered for sale in covered establishments. As discussed in section I.D., under 403(q)(5)(H)(i), menu labeling requirements apply to food that is a standard menu item that is offered for sale in a restaurant or similar retail food establishment that is a part of a chain with 20 or more locations doing business under the same

name and offering for sale substantially the same menu items. Whether a chain has 20 or more locations does not depend on the type of ownership of its locations (

e.g.,

whether owned by the corporate owner of the chain or individual franchisees).

As discussed in section III.C. of this document, section 403(q)(5)(H)(ix) includes a provision that permits restaurants and similar retail food establishments not subject to the requirements of section 403(q)(5)(H) (

e.g.,

a restaurant that is part of a chain with fewer than 20 locations) to register with FDA to voluntarily elect to become subject to the requirements of section 403(q)(5)(H). Consequently, FDA is proposing in § 101.11(b)(1) (ii) that the menu labeling requirements apply to foods that are standard menu items offered for sale in chain retail food establishments and restaurants or similar retail food establishments that voluntarily register with FDA.

2. Foods to Which the Requirements of Section 4205 Do Not Apply

Section 4205 provides that the menu labeling requirements do not apply to certain foods. These foods are “items that are not listed on a menu or menu board (such as condiments and other items placed on the table or counter for general use); daily specials, temporary menu items appearing on the menu for less than 60 days per calendar year, or custom orders; or such other food that is part of a customary market test appearing on the menu for fewer than 90 days, under terms and conditions established by the Secretary” (21 U.S.C. 343(q)(5)(H)(vii)).

FDA received several comments on these foods to which the menu labeling requirements in section 4205 are nonapplicable. Some comments stated that these foods should not be exempt from the requirements of section 4205. Some of these comments stated that condiments that come with meals should be included as part of the calorie declaration. One comment stated that if the condiment is non-nutritive, it should be excluded from the calorie labeling requirement, but if the condiment contains more than 10 calories per serving (

e.g.,

salad dressing, mayonnaise, pickles, olives, maple syrup, or honey), calorie labeling requirements should apply. Another comment suggested that FDA remove the calorie declaration exemption for 60-90-day temporary items so that restaurants cannot continually change their menus to avoid calorie labeling.

We note that section 403(q)(5)(H)(vii)(I)(aa) provides that the nutrient content disclosure requirements in sections 403(q)(5)(H)(i)-(vi) do not apply to “items not listed on a menu or menu board (such as condiments and other items placed on the table or counter for general use).” (21 U.S.C. 343(q)(5)(H)(vii)(I)(aa)). FDA tentatively concludes that this provision should be read narrowly, based on the parenthetical language. If the provision is read broadly to deem all “items not listed on a menu or menu board” beyond the scope of the law, then most self-service food and food on display would not be covered, including food at salad bars, buffet lines, and cafeteria lines. Given that Congress explicitly named these as examples of self-service facilities to which the calorie disclosure requirements in section 403(q)(5)(H)(iii) apply, the current proposal narrowly interprets this provision.

Given the phrase “for general use,” FDA tentatively concludes that it is reasonable to interpret this provision to apply to food, such as many condiments, that are available for use by any customer in the covered establishment, regardless of the customer's particular order or food selection. Examples include salt and pepper placed on tables for use by whomever sits there, large ketchup and mayonnaise dispensers placed on a counter to be used by any customer, and lemons placed near a drink station. In contrast, the nutrient content disclosure requirements in section 403(q)(5)(H) would apply to salad dressing at a salad bar that is only available to customers who order the salad bar. The labeling requirements would also apply to salad dressing at salad bars where customers pay for salad by weight, where the weight of the salad dressing affects the price of the item.

FDA tentatively concludes that section 403(q)(5)(H)(vii)(I)(aa) does not refer to condiments that are part of a standard menu item, as it is usually prepared and offered for sale (

e.g.,

mustard, mayonnaise, and ketchup that are part of a hamburger or sandwich as usually prepared and offered for sale). Sections 403(q)(5)(H)(ii)(I)(aa) and (II)(aa) specify that covered establishments must provide, on menus and menu boards, “the number of calories contained in the standard menu item, as usually prepared and offered for sale.” 21 U.S.C. 343(q)(5)(H)(ii)(I)(aa) and (II)(aa). Caloric value of these condiments must be included as part of the total caloric declaration for a standard menu item, because the condiments are a part of the standard menu item as it is usually prepared and offered for sale.

As discussed in III.B. of this document, FDA proposes to define a temporary menu item as one that appears on a menu or menu board of a covered establishment for less than 60 days per calendar year. For example, a pumpkin-flavored latte that only appears on the menu of a coffee shop in November would be a temporary menu item. FDA tentatively interprets the 60-day calendar limit to mean less than 60 days per year in total; the 60 days do not have to be consecutive.

Also discussed in III.A. of this document, FDA proposes to define a food that is part of a customary market test to be a food appearing on a menu or menu board for less than 90 days for which the covered establishment wishes to test consumer acceptance. For example, many restaurants advertise “for a limited time only” sandwiches that have new components. FDA recognizes that in some cases, a chain of restaurants or similar retail food establishments tests a new product in different locations within the chain and in more than one region of the country at different times. FDA tentatively concludes that “a customary market test,” for the purposes of this section, refers to a test in a single covered establishment. Based on FDA's understanding of how test marketing is generally conducted, FDA proposes that a food that is part of a market test is an item that appears on a menu or menu board of a covered establishment for less than 90 consecutive calendar days. A food may be part of a customary market test at more than one location of a chain at a time. A food might also be a standard menu item at one location while being part of a customary market test at another.

Note that self-service food and food on display that do not appear on menus or menu boards would not be considered temporary menu items or food that is part of a customary market test. Based on the statutory language, both of these categories of nonapplicability only capture food “appearing on the menu” for a limited amount of time. Therefore, even if a self-service food or food on display that does not appear on a menu or menu board is only offered by a covered establishment for a limited time, such as a pumpkin-spice muffin available only in November, the nutrition information declaration requirements in section 403(q)(5)(H) would still apply. Self-service foods or foods on display in covered establishments that do not appear on menus can still belong to other categories of food to which the nutrition information declaration requirements do not apply, such as daily specials or custom orders.

Based on the reasons above, FDA is proposing in § 101.11(b)(1)(ii) that the requirements in § 101.11(b)(2) shall not apply to condiments and other items placed on the table for general use; daily specials; temporary menu items; custom orders; or food that is part of a customary market test. In addition, as discussed in III.B. of this document, FDA is proposing that the requirements in § 101.11(b)(2) shall not apply to alcohol beverages.

3. Information That Must Be Declared by Covered Establishments

a. Calorie declaration on menus and menu boards.

Section 403(q)(5)(H)(ii) requires covered establishments to disclose on menus and menu boards, in a clear and conspicuous manner, the number of calories contained in standard menu items as usually prepared and offered for sale. The covered establishment must provide the calorie information adjacent to the name of the standard menu item so as to be clearly associated with the standard menu item (

e.g.,

21 U.S.C. 343(q)(5)(H)(ii)(I)(aa)).

Some comments stated that the statutory requirements for menu labeling should apply only to the menu that most consumers use the most; for example, one national pizzeria chain stated that most of its customers order through the Internet and that therefore the information should only be required to be posted there. Another comment suggested that each company should be permitted to select its own “primary” menu on which calories must be disclosed, based on technological capabilities and customer ordering patterns. FDA disagrees with these comments. Based on section 403(q)(5)(H)(ii), FDA tentatively concludes that these calorie declarations must be provided on all menus and menu boards of the covered establishment. For example, section 403(q)(5)(H)(ii)(I)(aa) states that a calorie disclosure must appear “on the menu listing the item for sale.” The same standard menu item could be listed on multiple menus,

e.g.

, a 12” cheese pizza at a pizzeria might appear on the menu for customers dining in and also on the online menu for customers ordering over the Internet. The calorie declaration for each standard menu item must appear on each menu that lists the standard menu item, in accordance with section 403(q)(5)(H)(ii). FDA requests comments on this approach to calorie declarations and multiple menus.

Some comments stated that FDA should allow flexibility for drive-through menu boards and allow calorie disclosures on stanchions (free-standing boards, generally placed next to drive-through menu boards, used to post calorie information) because of lack of space. These comments stated that the drive-through menu boards are not large enough to add calorie labeling and that some local zoning laws do not permit restaurants with drive-through windows to build larger menu boards.

FDA tentatively concludes that stanchions inadequately convey calorie information. A situation in which customers need to look to one board (the menu board) for important food-selection information, such as price, and another (the stanchion) for calories, is likely to be more difficult for customers attempting to use the declared calorie information at the point of selection. This is particularly true in the drive-through context, where customers have a restricted field of vision from their car windows, and they may have a relatively short time to consider the menu board prior to ordering, because customers often cannot view the full menu while waiting in line. Moreover, we note that 403(q)(5)(H)(II)(aa) requires the number of calories contained in standard menu items to be disclosed on the menu board itself. Therefore, we have not included separate stanchions as an option for displaying calories at drive-through restaurants and similar retail food establishments. FDA requests comment on how the use of stanchions would enable customers to use calorie information when they are making selections from a drive-through menu board.

In the draft implementation guidance that was subsequently withdrawn, FDA recommended that calories be declared in a type size at least as large as the name of the standard menu item or price, whichever is larger, and with the same prominence,

i.e.

, the same color and contrasting background as the standard menu item.

Some comments supported FDA's draft guidance on type size, color, and background. Other comments stated that these recommendations were too prescriptive and went beyond the statutory requirement that calorie information must be disclosed in a clear and conspicuous manner. Some comments stated that having the calories in the same color makes the calorie declaration less prominent. Other comments suggested different colors or the use of check marks based on calorie content,

e.g.

, for particular foods, check marks may be made by the food to inform consumers how many times a day or week they should consume that food. One comment suggested that FDA require that the calories be “easily readable, in a typeface similar to other information about each standard menu item, and in a font no less than nine points.”

FDA recognizes that menus and menu boards come in a variety of sizes. Therefore, it would not be appropriate to require a specific type size and font for all menus and menu boards. However, if the calorie declarations on menus and menu boards are not declared in a clear and conspicuous manner, the declarations would not be in compliance with the requirements in section 403(q)(5)(H)(ii). FDA tentatively concludes that a calorie declaration on a menu or menu board would not be disclosed in a clear and conspicuous manner if the declaration is too light in color or is presented in a color that does not sufficiently contrast with the background. FDA agrees with the comments asserting that the agency should provide more flexibility with regard to calorie declarations than was suggested in the draft implementation guidance. FDA proposes in § 101.11(b)(2)(i)(A)(

1

) that a calorie declaration must be made in the same color, or in a color at least as conspicuous as, the color of the name of the associated standard menu item on the menu or menu board. Further, FDA proposes that a calorie declaration must have the same contrasting background as the background used for the name of the associated standard menu item on the menu or menu board. In addition, the calorie declaration must be in a font size large enough to be “clear and conspicuous.” We understand that menus and menu boards often have limited space. We think that it is important to provide flexibility to businesses while, at the same time, fulfilling the requirements of the statute and providing consumers with easily readable information. FDA is proposing that a calorie declaration must be no smaller than the type size of the name or price of the associated standard menu item on the menu or menu board whichever is smaller. We request comment on this tentative conclusion.

FDA is proposing in § 101.11(b)(2)(i)(A)(

3

) that the term “Calories” or “Cal” must appear as a heading above a column listing the number of calories for each standard menu item on that menu or menu board, or adjacent to the number of calories for each standard menu item. If a column is used for the listing of calories, the term “Calories” or “Cal” must appear in a type size no smaller than the smallest type size of the name or price of any menu item and in the same color, or in a color at least as conspicuous as and in the same contrasting background as that name or price. If the term “Calories” or

“Cal” appears adjacent to the number of calories for the standard menu item, the term “Calories” or “Cal” must appear in the same type size and in the same color and contrasting background as the number of calories.

We tentatively conclude that permitting the flexibility of using the abbreviation “Cal” would assist covered establishments that have limited space on their menus or menu boards in meeting the requirements of section 403(q)(5)(H). Allowing calories to be stated as a header of a column would provide additional flexibility.

One comment asserted that drive-thru menu boards are limited in size and space as compared to interior menu boards, thus making it challenging to list calories in a clear and conspicuous manner. The comment recommended that FDA only should require the statement “Nutrition information is available upon request” on the drive-through menu boards of a covered establishment and require the establishment to have brochures available at the drive-through window. However, FDA notes that section 403(q)(5)(H)(ii)(II) expressly requires covered establishments to post calorie declarations on menu boards, including drive-through menu boards. Therefore, proposed § 101.11(b)(2)(i)(A) would apply to all menu boards at covered establishments, including drive through menu boards.

FDA is proposing in § 101.11(b)(2)(i)(A)(

2

) to require that covered establishments declare calories on menus and menu boards to the nearest 5-calorie increment up to and including 50 calories, and to the nearest 10-calorie increment above 50 calories. For foods that have fewer than 5 calories, the declaration may be expressed as zero. These rounding rules are consistent with the declaration of calories for packaged foods as provided in § 101.9(c)(1).

b. Determination of calories for standard menu items that come in different flavors, varieties, or combinations.

Section 403(q)(5)(H)(v)) requires that FDA establish, by regulation, standards for determining and disclosing the nutrient content for standard menu items that come in different flavors, varieties, or combinations, that are listed as single menu items (21 U.S.C. 343(q)(5)(H)(v)). This section includes as examples of these foods soft drinks, ice cream, pizza, doughnuts, and children's combination meals. As discussed in section II.A. of this document, FDA proposes to define these items as variable menu items. Section 403(q)(5)(H)(v) states that FDA may establish these standards as averages, ranges, or other methods.

FDA recognizes that, under this proposal, some combination meals as discussed in section III. A. of this document would be variable menu items, while others would not. The calorie declaration on a menu or menu board for a combination meal that consists of a fixed combination, where the customer has no choice as to which flavors, varieties, or combinations of items are included, would be governed by proposed § 101.11(b)(2)(i)(A) and (B). Such a combination meal would not be considered a variable menu item.

Some standard menu items come in different varieties, such as a single scoop of ice cream that comes in different flavors and a medium soft drink that comes in a variety of sodas. For some of these variable menu items, the difference between the number of calories in the lowest calorie variety and the highest could be wide. For example, calories for a large soft drink could range from zero calories for a diet soft drink to more than 400 calories for a non-diet soft drink. For combination meals, the difference in caloric value has the potential to be especially large, given that multiple items in the combination meal might vary. A combination meal may contain a sandwich, side dish and drink. The side dish may be fries, onion rings, or a salad. The number of calories may be much fewer if the consumer chooses the salad with light dressing and bottled water or a diet drink than if the consumer chooses the fries and a sweetened drink. On the other hand, for other variable menu items, the range of calories in the possible varieties is likely small (

e.g.,

donuts with different flavors of icing), such that a calorie or other nutrient difference among the varieties is not nutritionally significant.

Section 403(q)(5)(H)(v) specifically states that we must establish standards for determining and disclosing the nutrient content information for standard menu items that come in different flavors, varieties, or combinations, through means determined by FDA, including averages, ranges, or other methods. Some comments supported the use of ranges because, they asserted, displaying an average calorie content when the lower and upper limits are so dissimilar would be misleading. Other comments suggested that FDA require median values for calories if the values for all flavors, varieties, or combinations are within 20 percent of the median and require ranges if calories are not within 20 percent of the median. Some comments maintained that sugar-free (no calorie or very low calorie) should be listed separately from sugar-sweetened beverages. A few comments recommended that FDA allow covered establishments to pick among ranges, medians, and averages. Some comments disagreed with permitting ranges and suggested that the foods must be labeled individually. One comment suggested that FDA require covered establishments to group similar items where the item of greatest caloric value contains less than 5 percent more calories that the item of lowest caloric value and display items separately if the calorie difference is greater than 5 percent. A few comments recommended that the calorie information for items such as sandwiches, pizza, or burritos that are intended to be prepared in a large number of different ways be displayed for the standard preparation of the item, with the standard preparation of the item clearly noted on the menu, menu board, or food tag or next to the food on display. The calorie content for each additional food component, according to the comment, should then be displayed on the menu, menu board, food tag, or next to the food on display for each food component.

FDA is proposing in § 101.11(b)(2)(i)(A)(

4

) that the calories must be declared as a range for standard menu items that come in different flavors, varieties, or combinations but are listed as a single menu item. For example, the calories for different flavors of ice cream or combination meals would be disclosed in the format “xx-yy” where “xx” is the caloric content of the lowest calorie flavor or combination, and “yy” is the caloric content of the highest calorie flavor or combination. However, we considered a number of other options in developing this proposal.

Option 1: Single value.

We considered requiring calorie values for all variable menu items to be presented as single values, either in the form of an average (obtained by summing up the calorie content of all options and then dividing by the number of options) or a median of all options (obtained by determining the “middle” number of calories from the list of options). For example, if there were three options for a sandwich, one with 400 calories, one with 450 calories, and one with 600 calories, the average would be 483 calories ((400+450+600)/3 = 483) (which would be rounded to 480 for the calorie declaration), and the median would be 450. The tradeoff between using an average or median value is between closer reflection of the distribution of possible choices and simplicity of calculation. If the median

is declared, a change in this number would change the declared calories, even if no other variation had a change in calorie content and even if the overall range of calories did not change. On the other hand, changes in numbers other than the middle number would not generally affect the median. Taking the example above, if the calories in the middle option for the sandwich changed from 450 to 420 (

e.g.,

because the covered establishment changed the cheese in that sandwich to lower fat cheese), then the number of calories disclosed would be 420, because 420 is the new median. In contrast, if the calories in the middle option stayed 450, but the calories in the highest option changed from 600 to 750 (

e.g.,

because the establishment changed the sandwich's sauce formulation and changed the bun on the sandwich to a bun with higher fat content), number of calories disclosed would be 450, because 450 remains the median.

If the average is declared, the calorie declaration would likely change in response to a calorie change in any option. As a result, the reported number is less prone to manipulation. For example, if the calories in the middle option in the sandwich above changed from 450 to 420, the average would change from 483 (rounded to 480 for the calorie declaration) to 473 (rounded to 470 for the calorie declaration). If the highest option for the sandwich above changed from 600 to 750, the average would change from 483 (rounded to 480 for the calorie declaration) to 533 (rounded to 530 for the calorie declaration).

Presenting calorie declarations of variable menu items as single values—whether as averages or median values—offers the benefit of maximizing space on a menu or menu board. However, single values have a drawback in that they fail to convey to consumers the nutrient content of the specific choices available within that variable menu item group. Posting an average or median value may also mask dramatic differences that can exist in caloric intake for certain variable menu items, especially where calorie ranges are large.

Option 2: Range.

We considered requiring calories for all variable menu items to be reported in the form of a range. FDA recognizes that there may be some cases where disclosing a range may be more difficult than disclosing a single value, such as when menu space is limited. In addition, a range is arguably less useful to consumers in cases where calorie ranges are very small or where calorie ranges are very large and consumers cannot distinguish which varieties or combinations of items may offer lower calories or determine the exact amount of calories in their specific choice. However, a range format provides consumers with more information about the caloric content of the options available within a given variable menu item group; it provides the lowest value, the highest value, and therefore the window within which a consumer's choice will fall.

Option 3: Hybrid combining averages and ranges.

We considered a number of approaches that would require declaration of a single average value for variable menu items whose calorie ranges fall within specified bounds and declaration of a range for variable menu items whose calorie ranges fall outside those bounds. This option has the benefit of allowing single values to be used on a menu or menu board for variable items that have relatively narrow ranges, while ensuring that the full range of calories is provided for wider ranges.

Within this option, we considered different approaches for determining when a range and when an average value should be reported. First, we considered requiring an average value unless the highest calorie option contains over 25 percent more calories than the lowest calorie option. At that point, a range would be disclosed instead. For example, if the lowest calorie item contains 400 calories, the calorie declaration would be an average unless the highest calorie item exceeds 500 calories (400 × 25% = 100; 400 + 100 = 500). Taking a variable menu item that has 400, 430, or 490 calories, the number of calories in the highest calorie item (490) is less than 25% more than the number of calories in the lowest calorie item (490 < 500), so the calorie declaration would be the average: 440 ((400+430+480)/3 = 440). Taking a variable menu item that has 400, 430, or 550 calories, the highest calorie item (550) has more than 25% more calories than the lowest calorie item (550 > 500), so the calorie declaration would be a range: 400-550.

Our rationale for considering the 25 percent is based in our nutrient content claim regulations. FDA permits a “reduced calorie” claim on a food if the food contains at least 25 percent fewer calories per reference amount customarily consumed than an appropriate reference food. In the preamble for the regulations on nutrient content claims (58 FR 2302 at 2348), FDA stated that the terms “less” and “reduced” should be used only when a nutritionally significant reduction in the level of the nutrient has been reached so as not to mislead consumers into believing that a product would provide a nutritionally significant reduction in the level of a nutrient when it would not. FDA concluded that an appropriate minimum reduction for the terms “reduced” and “less” is 25 percent based on various factors.

Second, we considered an approach that would require an average value to be reported for all variables that fall within 20 percent of the average value; a range would otherwise be required. Using 20 percent as a cutoff for determining whether to use an average or a range would be consistent with the number used for compliance purposes. See § 101.9(g). For example, if the calories for a variable menu item are 400, 430 or 490, the highest calorie option has 22.5% more calories than the lowest calorie option, so the calorie declaration under the 20 percent cutoff approach would be the range: 400-490 calories.

An additional approach could be to have a special rule for low calorie foods. The number of calories in low calorie foods, i.e., those with 40 or fewer calories, could be declared by an average even if the difference in the calories between the lower and higher calorie variable menu item is greater than 25 or 20 percent. For example, if the calories for flavored teas ranged from 5 to 20 calories, a difference of 300 percent ((20-5)/5 × 100), the range would not be necessary, and an average,

e.g.,

12.5 calories could be used. In addition, consistent with calorie declaration of packaged food, calories less than 5 would be declared as 0. Therefore, the average calories for the flavored tea would be 10 ((20+0)/2). The rationale for using 40 calories as the cutoff is that foods that contain 40 calories or less are eligible to bear a “low calorie” claim (§ 101.60(b)(2)).

We note that a difference of 20 or 25 percent may translate into a substantial amount of calories where the calorie values are high (

e.g.

, for some combination meals), resulting in the reporting of single values for some large calorie ranges. So, we also considered using a fixed 100 calorie maximum range as a cutoff. Using this approach, variable items with large numbers of calories in all options would declare the range of calories more often than if we used a percentage cutoff. Variable items with smaller numbers of calories for all options would declare a range less often. For example, a hamburger combination meal that ranges from 1,000 to 1,200 calories would be listed as a single calorie value (1,100 calories) under the 25 percent approach, but as a range (1,000-1,200 calories) under the 100 calorie cutoff approach, since the

difference between the two values is greater than 100 calories. On the other hand, under the 25 percent approach, calories for a single ice cream scoop that varies from 240 to 320 calories depending on the flavor would be displayed as a range, because the highest calorie option is 33 percent more caloric than the lowest calorie option ((320-240)/240 = 33%). But because the difference is only 80 calories, under the 100 calorie rule, the average,

i.e.

280 calories, would be disclosed.

Option 4.

If only 2 options are available for an item (

e.g.

, a sandwich with fries or with fruit), provide both numbers with a forward slash between (

e.g.

, 450/350). If three or more options are available, provide the range in calories. We considered this option because some variable menu items may have only two choices and the use of a slash may be more reflective of the fact that there are two choices than the use of a dash. For example, for a chicken sandwich that comes in grilled and crispy versions, with 470 and 610 calories, respectively, declaring the calories as 470/610 may better reflect the two discrete choices than declaring the calories as 470-610. On the other hand, the calorie declaration for a combination meal that comes with a choice of sides,

e.g.

, tater tots or French fries, and various soft drinks would be a range (

e.g.

, 1380-1810).

Option 5.

If only 2 options are available for an item (

e.g.

a sandwich with fries or with fruit), provide both numbers with a forward slash between (

e.g.

450/350). For foods with 3 or more options, use one of the hybrid approaches outlined in Option 3.

Since many of these options could result in menus with different formats and wide variations in the ranges, we intend to conduct consumer research to evaluate how well consumers understand the caloric information presented in each of the formats and whether mixed formats on a single menu or menu board might be confusing to consumers. FDA intends to make the results of our consumer research available to the public prior to publication of the final rule and will allow sufficient time for interested stakeholders to comment on the results of our research.

FDA is proposing that the calorie declaration be in a range for all variable menu items (Option 2). Requiring a range for all variable menu items gives consumers a consistent format across all items. FDA recognizes that in some instances, the calorie range may be so wide that the consumer may still need the calorie information for the particular menu item before he or she can make a fully informed purchase decision. We want to ensure that the calorie declaration is understood by consumers and will help them make better food choices. We seek comment on whether the proposed method of declaring calories is appropriate and would not be misleading to consumers. We are especially interested in any consumer research on the issue. We are also interested in comment and research on the options that we considered but did not propose and whether any of the other options individually or in combination would be preferable and why. In developing the final rule on this proposal, we will consider the results of our research and all relevant comments and data.

FDA also requests comment on complexities that may be raised by certain variable menu items. For example, some menus with combination meals list an option to increase the size of components of those meals for a discounted additional price. FDA is considering whether those listings should be labeled with the number or range of calories they add to the standard combination meal, and requests comment. FDA also recognizes that the Internet may allow for the use of different methods for disclosing calories. For example, interactive menus online may present opportunities for more innovative ways of providing tailored calorie information,

e.g.,

providing a calorie tracker in the ordering frame that tallies calories as customers make order selections. FDA requests comment on this issue. While this may be especially suitable for ordering certain variable menu items, such as when selecting a crust and toppings for pizza, FDA requests comment on whether different methods should be used for nutrient content declarations for interactive internet menus in general.

4. Succinct Statement Concerning Suggested Daily Caloric Intake Required on Menus and Menu Boards

Sections 403(q)(5)(H)(ii)(I)(bb) and (II)(bb) require that chain retail food establishments post a succinct statement concerning suggested daily caloric intake (“succinct statement”) on menus and menu boards, as specified by the Secretary by regulation, that is designed to enable the public to understand, in the context of a total daily diet, the significance of the caloric information that is provided on the menu and menu board (21 U.S.C. 343(q)(5)(H)(ii)(I)(bb) and (II)(bb)). Some comments stated that the succinct statement should take into account the different caloric needs of individuals based on age, gender, and physical activity. Comments suggested various statements including:

• “2,000 calories meets the daily caloric needs of most adults; however, individual dietary needs may vary.”

• “A 2,000 calorie diet is being used as a basis for general nutrition advice. However, individual calorie needs may vary.”

• “This is __ percent of a 2,000 calorie diet.”

• “To maintain a healthy weight, most adults need no more than 2,000 calories per day.”

Some comments stated that a different statement should be used on children's menus because children have different caloric needs. According to one comment, if 2,000 calories is used as a reference point, parents may overestimate the caloric needs of their children. One comment suggested the following for a children's menu:

The recommended caloric intake for a day varies from __ to __ for adolescents and adults, from __ to __ for school-age children, and from __ to __ for pre-school children above age two years.

Caloric declarations on menus and menu boards in covered establishments that provide the number of calories contained in standard menu items will give consumers information that is useful in selecting more healthful food choices. FDA recognizes that individual daily caloric needs may differ based on several factors including gender, age, and activity level (Ref. 9 at page 13). For this reason, it is important that consumers be able to place the calorie declarations in the context of their individual dietary needs. As described in section I. B of this document, nutrition labeling on packaged foods has been required for approximately 20 years, and consumers are familiar with and use this information. The Nutrition Facts on packaged foods uses 2,000 calories as a reference amount on which to base recommended intake for macro- and micronutrients for individuals 4 years of age and older (§ 101.9(c)(9)). A 2,000-calorie reference value is close to the midpoint of the range of energy requirements for sedentary adults (1,600-2,600 cals) (Ref. 9 at page 14).

FDA initially proposed a reference value of 2,350 for the Nutrition Facts (55 FR 29476 at 29486); in response to comments, however, FDA selected 2,000 as the reference value in the 1993 final rule. As stated in the preamble to the final rule: “The rationale for selecting 2,000 calories as opposed to other lower values varied, but reasons given included the fact that it is consistent with widely used food plans, it

approximates the caloric requirements for postmenopausal women who are at-risk for excessive intake of calories and fat, and it is a “rounded down” value for 2,350 calories.” FDA also noted in the preamble to the final rule that some comments noted that “2,000 calories is easier to use in quick, mental calculations compared to other calorie levels such as 1,900 or 2,350 calories.” 58 FR 2206 at 2217.

FDA tentatively concludes that 2,000 calories is an appropriate reference value to include in the succinct statement. However, not everyone should eat 2,000 calories per day. Individual caloric needs differ depending on various factors such as age, gender, and physical activity. For example young children and sedentary adults may have caloric needs below 2,000 calories (1,200-1,600 calories) whereas some adult men and active adults of either sex may need more than 2,000 calories (2,200-3,200). Considering the statutory directive and current nutrition advice (Ref. 9), FDA tentatively concludes that, to help ensure that the succinct statement is designed to enable consumers to understand, in the context of a total daily diet, the significance of the calorie information provided on menus and menu boards, certain principles should be met:

• The statement should be succinct;

• The statement should be in plain language that consumers can understand;

• The total caloric value should be framed appropriately so that it is not viewed as a recommendation for daily intake for every consumer;

• The statement should give consumers a means to compare the calorie declaration for a menu item to total calories and;

• The statement should inform consumers that individual needs vary.

Using these principles and considering suggestions from the comments, FDA developed the following statements:

• “Using 2,000 calories per day as a reference point, consider how the menu item you select fits within your total daily calorie needs, which may be higher or lower depending on age, physical activity, gender.”

• “A 2,000 calorie daily diet is used as a general reference point for nutrition advice. Individual calorie needs vary depending on age, physical activity, gender.”

• “Typical daily caloric intake for women is 1,600 to 2,000 calories, for men is 2,000 to 3,000 calories and for children (ages 4 to 14) is 1,800 to 2,500 calories. Be sure to include the calories of the menu item you select as a part of your total daily caloric intake.”

4

4

This statement was developed for focus group testing based on the data upon which the 2,000 calorie reference value used in the Nutrition Facts was derived. The aim was to test a data-derived statement that provided specific calorie ranges for various subpopulations. More recent data from the 2010 Dietary Guidelines suggest that these ranges should be revised; however, the difference in numbers does not impact the objective of testing the utility and comprehension of the statement by the focus group participants.

We have also included the following statement that was suggested from comments because we tentatively concluded that the statement satisfied the principles described above.

• “A 2,000 calorie daily diet is used as the basis for general nutrition advice; however, individual calorie needs may vary.”

FDA concludes that the above statements satisfy the principles developed by the Agency to ensure that the succinct statement is designed to enable consumers to understand, in the context of a total daily diet, the significance of the calorie information provided on menus and menu boards. FDA seeks comment on the principles developed by the agency, including whether all the principles are needed to help consumers understand the significance of the calorie information provided on menus and menu boards. In addition, we have concerns about whether consumers will understand the statements, especially those statements that use terms such as “reference point,” “fits within,” and “calorie needs vary.”

When deliberating on which of the four (4) bulleted statements listed above should be required on menu and menu boards, FDA considered the language in each statement, our previously noted concerns with certain phrases, the availability of space on menu boards, and the statutory directive regarding the succinct statement. Given these considerations, we tentatively conclude that the statement that best addresses these considerations is “A 2,000 calorie daily diet is used as the basis for general nutrition advice; however, individual calorie needs may vary.” We are proposing in § 101.11(b)(2)(i)(B) to require this statement be posted on menus and menu boards.

FDA seeks comment on whether this proposed statement is adequately designed to enable the public to understand, in the context of a total daily diet, the significance of the caloric information provided on menus and menu boards. FDA is particularly interested in comments with alternative suggested statements that are consistent with the principles identified above and requests that any such statements be accompanied by data, such as consumer research.

Some comments stated that FDA should consider a different succinct statement on children's menus and reference the calorie needs for children in specific age ranges. We seek comment on whether FDA should require a different statement on menus that are targeted to children. Such a statement may include language such as “The daily caloric intake for children __ years of age is __ to __ depending on whether they are boys or girls as well as their age and level of physical activity.” (The blanks are to be filled in with information on current dietary guidelines.) Comments submitted to the agency on whether a different statement should be required or recommended for children's menus should provide a rationale, data (

e.g.

consumer research), or other information supporting such statement. The agency is particularly interested in any consumer research that demonstrates that the statement is understood by consumers.

We intend to conduct consumer research to evaluate consumer response to these statements. FDA intends to make the results of our consumer research available to the public prior to publication of the final rule and to allow sufficient time for interested stakeholders to comment on the results of our research.

Section 4205 requires that the succinct statement be posted on menus and menu boards prominently and in a clear and conspicuous manner. We are proposing in § 101.11(b)(2)(i)(B)(1) that the required succinct statement appear in a type size no smaller than the smallest type size for any calorie declaration appearing on the same menu or menu board with the same color, or in a color at least as conspicuous, as the caloric declaration and with the same contrasting background as the caloric declarations. FDA is proposing in § 101.11(b)(2)(i)(B)(2) that for menus, the succinct statement must appear on the bottom of each page of the menu. On menu pages that also bear the statement regarding the availability of the written nutrition information described in section III.C.5. of this document, the succinct statement must appear directly above that statement of availability. FDA is proposing in § 101.11(b)(2)(i)(B)(3) that the succinct statement appear on the bottom of menu boards, directly above the statement of availability. FDA tentatively concludes that these requirements will help ensure that the succinct statement is prominent, clear, and conspicuous, as required by sections 343(q)(5)(H)(ii)(I)(bb) and (II)(bb) (21

U.S.C. 343(q)(5)(H)(ii)(I)(bb) and (II)(bb)).

5. Nutrition Information That Must Be Made Available in a Written Form

Section 403(q)(5)(H)(ii)(III) requires that covered establishments must provide, in a written form and upon consumer request, the nutrition information required under clauses (C) and (D) of section 403(q)(1) of the FD&C Act. 21 U.S.C. 343(q)(5)(H)(ii)(III). The written nutrition information must be available on the premises of the establishment and the establishment must post on the menu or menu board a prominent, clear and conspicuous statement regarding the availability of the information (21 U.S.C. 343(q)(5)(H)(ii)(III) and (IV)). FDA requests comment on interpreting the phrase “on the premises” for menus appearing on the Internet.

a.

Statement of availability.

Section 403(q)(5)(H)(ii)(IV) requires that covered establishments post on menus and menu boards a prominent, clear, and conspicuous statement regarding the availability of the written nutrition information (21 U.S.C. 343(q)(5)(H)(ii)(IV)). Therefore, FDA is proposing in § 101.11(b)(2)(i)(C) to require the following statement regarding the availability of the written form of additional nutrition information proposed in § 101.11(b)(2)(ii)(A) on menus and menu boards in covered establishments:

Additional nutrition information available upon request.

FDA is also proposing in § 101.11(b)(2)(i)(C) that this statement (“statement of availability”) appear in a type size no smaller than the smallest type size for any calorie declaration appearing on the same menu or menu board, with the same prominence,

i.e.,

the same color, or in a color as least as conspicuous as and in the same contrasting background as the calorie declarations. FDA is proposing that for menus, the statement of availability must appear on the bottom of the first page with menu items in the same type size and font as the calorie declaration and must appear immediately below the succinct statement proposed in § 101.11(b)(2)(i)(B). For menus with more than two (2) pages, the statement must appear either on every page with menu item, or on the first page, so long as a symbol (

e.g.,

asterisk) follows the term “Calories” or “Cal” where it first appears on each subsequent page, clearly referring to the statement of availability appearing on the first page of the menu. FDA is proposing that the statement appear on the bottom of menu boards, immediately below the succinct statement required in § 101.11(b)(2)(i)(B). FDA tentatively concludes that this manner of providing the statement of availability will satisfy the requirements in amended section 403(q)(5)(H)(ii)(IV) that the statement be prominent, clear, and conspicuous. We seek comment on whether the statement of availability will adequately inform consumers about the availability of the written nutrition information. In addition, we seek comment on whether the placement, font, and background requirements are appropriate to ensure that the statement of availability is prominent, clear, and conspicuous.

FDA recognizes that some restaurants or similar retail food establishments have relatively few standard menu items, and, as a result, may have menu boards that list relatively few items in very large font. FDA requests comment on whether it is appropriate in these cases to tie the font size of the two statements required to appear at the bottom of menu board to the calorie disclosures.

b. Required nutrients.

Section 403(q)(5)(H)(ii)(III) specifies that the written form must provide “the nutrition information required under clauses (C) and (D) of subparagraph (1) [21 U.S.C. 343(q)(1)(C) and (D)],” which require declaration of the following nutrition information:

• The total number of calories derived from any source, and the total number of calories derived from the total fat;

• The amount of each of the following nutrients: Total fat, saturated fat, cholesterol, sodium, total carbohydrates, complex carbohydrates, sugars, dietary fiber, and total protein.

FDA is proposing in § 101.11(b)(2)(ii)(A) to require that the nutrition information in written form contain the information listed above, with two changes. The nutrition labeling requirements under sections 403(q)(1)(C) and (D) were added to the FD&C Act by NLEA and are the nutrients originally required to be provided in the mandatory nutrition information for packaged foods. FDA has since revised by regulation the nutrients required to be provided on the label or labeling of food in relevant part by removing the complex carbohydrates requirement from section 403(q)(1)(D) and requiring that information regarding the amount of

trans

fats be included in the label or labeling of food subject to section 403(q)(1). FDA proposes to make analogous revisions with respect to the written form required by section 403(q)(5)(H)(ii)(III). These are explained further below.

In addition, we note that, because section 403(q)(5)(H)(ii)(IV) refers only to clauses (C) and (D) of section 403(q)(1), covered establishments are currently not required to provide the information about vitamins and minerals required to be on the labels and labeling of foods pursuant to clause (E) of section 403(q)(1).

c. Removal of complex carbohydrates from the requirements of 403(q)(1)(D).

Section 403(q)(2)(B), which was added to the FD&C Act by NLEA, provides that “[i]f the Secretary determines that the information relating to a nutrient required by subparagraph (1)(C), (1)(D), or (1)(E) or clause (A) of this subparagraph to be included in the label or labeling of food is not necessary to assist consumers in maintaining healthy dietary practices, the Secretary may by regulation remove information relating to such nutrient from such requirement.” Pursuant to this authority, FDA removed the requirement for bearing the amount of complex carbohydrates in the label or labeling of food, based on a determination that for complex carbohydrates “there was no consensus on a clear definition for the term `complex carbohydrates' as it relates to physiological effects, health benefits, or dietary guidelines,” there was a “lack of methods for reliably determining the amounts present,” and without a specific definition for “complex carbohydrates it [was] not possible to include quantitative information in the nutrition label that would assist consumers in maintaining healthy dietary practices.” (58 FR 2079 at 2101, Jan. 26, 1993); See § 101.9(c)(1) (no regulation requiring that labeling bear nutrition information regarding complex carbohydrates). Because the agency removed the requirement that the label or labeling of food include information regarding “complex carbohydrates” from section 403(q)(1)(D), declaration of complex carbohydrates is no longer a requirement under section 403(q)(1)(D). As a result, this proposed rule does not include complex carbohydrates among the nutrients that must be included in the written form required to be available to consumers under section 403(q)(5)(H)(ii)(III). FDA also received a comment stating that FDA should not include complex carbohydrates in the nutrition information in written form because, among other reasons, the amount of complex carbohydrates is not required to be included on the Nutrition Facts of packaged foods.

d. Addition of trans fat to the requirements of 403(q)(5)(H)(ii)(III).

Section 403(q)(5)(H)(vi) provides that “if the Secretary determines that a nutrient,

other than a nutrient required under [section 403(q)(5)(H)(ii)(III)], should be disclosed for the purpose of providing information to assist consumers in maintaining healthy dietary practices, the Secretary may require, by regulation, declaration of such nutrient in the written form” (21 U.S.C. 343(q)(5)(H)(vi)). Similarly, section 403(q)(2)(A) (21 U.S.C. 343(q)(2)(A)) provides that “[i]f the Secretary determines that a nutrient other than a nutrient required by subparagraph (1)(C), (1)(D), or (1)(E) should be included in the label or labeling of food subject to subparagraph (1) for [the] purposes of providing information regarding the nutritional value of such food that will assist consumers in maintaining healthy dietary practices, the Secretary may by regulation require that information relating to such additional nutrient to be included in the label or labeling of such food.” 21 U.S.C. 343(q)(2)(A).

In 2003, FDA amended its regulations on nutrition labeling, through rulemaking (68 FR 41434, July 11, 2003), to require in § 101.9(c)(2)(ii) that

trans

fatty acids be declared in the label or labeling of conventional foods subject to section 403(q)(1) of the FD&C Act. In that rulemaking, FDA determined that the current scientific evidence consistently showed that

trans

fats are associated with increased low density lipoprotein (LDL)-cholesterol levels and, therefore, that lower intakes of both saturated and

trans

fats are important dietary factors in reducing the risk of coronary heart disease (CHD) in the general population and for those at increased risk for CHD. Further, FDA stated that the current authoritative reports at that time, such as the 2000 Dietary Guidelines for Americans (Ref. 24 at p. 30), recommended that Americans cut back or limit the intake of

trans

fats. Thus, the agency concluded that persons interested in following these recommendations and maintaining optimal LDL-cholesterol levels must be able to determine levels of both saturated and

trans

fats in food products. Information on saturated fat content was already available in the Nutrition Facts on the labels of certain foods. The agency determined that the most practical way to inform consumers of the level of

trans

fat in these foods was for that information to be included in the Nutrition Facts. In the time since the final rule on

trans

fat labeling was published in 2003, the scientific evidence on

trans

fat has continued to support the relationship between

trans

fat and risk of CHD. Authoritative reports published since 2000 have included recommendations on the reduction of intake of

trans

fat. For example, the Institute of Medicine (IOM) has stated that

trans

fat consumption should be kept as low as possible while consuming a nutritionally adequate diet (Ref. 25). Additionally, the 2010 Dietary Guidelines for Americans recommended that

trans

fat intake be as low as possible (Ref. 9 at pp. x and 25). Therefore, for the same public health reasons that supported the requirement that the amount of

trans

fat be declared on the label or labeling of conventional foods subject to 403(q)(1) of the FD&C Act, we are proposing to require covered establishments to declare the amount of

trans

fat in standard menu items in the written form required by section 403(q)(5)(H)(ii)(III).

e. Nutrients in insignificant amounts.

FDA recognizes that some standard menu items may contain insignificant amounts of the nutrients required to be disclosed in the written form. See 21 U.S.C. 343(q)(5)(H)(ii)(III). Section 403(q)(5)(C) of the FD&C Act states that: “ * * * If a food contains insignificant amounts, as determined by the Secretary, of all the nutrients required by subparagraphs (1) and (2) to be listed in the label or labeling of food, the requirements of such subparagraphs shall not apply to such food if the label, labeling or advertising of such food does not make any claim with respect to the nutritional value of such food. If a food contains insignificant amounts, as determined by the Secretary, of more than one-half the nutrients required by subparagraphs (1) and (2) to be in the label or labeling of the food, the Secretary shall require the amounts of such nutrients to be stated in a simplified form prescribed by the Secretary.”

As directed by this statutory provision, FDA determined that “[a]n `insignificant amount' shall be defined as that amount that allows a declaration of zero in nutrition labeling, except that for total carbohydrates, dietary fiber, and protein, it shall be an amount that allows a declaration of “less than 1 gram.” § 101.9(f)(1). Further, FDA established regulations at § 101.9(j)(4) that exempt foods that contain insignificant amounts of all the nutrients required to be included in the declaration of nutrition information on the label and labeling of food, provided that the food bears no nutrition claims or other nutrition information in any context on the label, labeling or advertising. FDA tentatively concludes that if a standard menu item contains insignificant amounts of all of the nutrients required to be declared in the written form pursuant to section 403(q)(5)(H)(ii)(II) (i.e., the nutrition information required under clauses (C) and (D) of section 403(q)(1)), a covered establishment is not required to include nutrition information regarding such food in the written form provided that the food does not make a nutrient content claim as defined in § 101.13 or Subpart D of part 101 or a health claim as defined in § 101.13 and permitted by regulation in Subpart E in part 101.

In addition, FDA established regulations at § 101.9(f)(1) that allow for the use of a simplified form of nutrition information labeling if a food contains insignificant amounts of more than one-half of the nutrients required to be disclosed in the label or labeling of food in sections 403(q)(1) and (2) of the FD&C Act. Specifically, § 101.9(f) provides that the declaration of nutrition information may be presented in the simplified format, set forth in the regulation, when a food contains insignificant amounts of eight (8) or more of the following fourteen (14) nutrients: Calories, total fat, saturated fat,

trans

fat, cholesterol, sodium, total carbohydrates, dietary fiber, sugars, protein, vitamin A, vitamin C, calcium, and iron. In addition, § 101.9(f)(2)(i) requires that the simplified format must include information on the following nutrients: Total calories, total fat, total carbohydrate, protein, and sodium. In the preamble to the 1993 final rule on nutrition labeling for packaged food, FDA explained that this nutrition information is “essential to aid consumers in learning about the relative nutritional qualities of all foods, and it allows them to judge the consequences of the food selections they make.” (58 FR 2079, 2142 (Jan. 6, 1993)).

Section 4205 provides that section 403(q)(5)(C) shall apply to any regulations promulgated by FDA regarding the written nutrition information required by section 403(q)(5)(H)(ii)(II). However, section 403(q)(5)(C) and § 101.9(f) address some nutrients that are not required to be declared in the written nutrition information, specifically vitamin A, vitamin C, calcium, and iron. A covered establishments only is required to declare, in the written form, the nutrition information required under clauses (C) and (D) of 403(q)(1), which does not include vitamins and minerals. See 21 U.S.C. 343(q)(5)(H)(ii)(III). Consequently, at this time, FDA tentatively concludes that a covered establishment is required only to declare, in the written nutrition information, ten of the fourteen nutrients specified in § 101.9(f), specifically: Calories (derived from any

source, and derived from the total fat), total fat, saturated fat,

trans

fat, cholesterol, sodium, total carbohydrates, dietary fiber, sugars, and protein. As a result, FDA tentatively concludes that if a standard menu item contains insignificant amounts of more than one-half of the nutrients required to be declared in the written nutrition information under proposed § 101.11(b)(2)(ii)(A), this nutrition information may be presented in a simplified format for that standard menu item. FDA is proposing in § 101.11(b)(2)(ii)(B) that the written nutrition information for a standard menu item offered for sale in a covered establishment may be presented in a simplified format when the standard menu item contains insignificant amounts of six (6) or more of the following ten (10) nutrients: Calories, total fat, saturated fat,

trans

fat, cholesterol, sodium, total carbohydrates, dietary fiber, sugars and protein. In addition, we are proposing that the simplified format must include information on the nutrients required in § 101.9(f)(2)(i) and (ii) (

i.e.,

total calories, total fat, total carbohydrate, protein, and sodium). The statement “Not a significant source of __ (with the blank filled in with the names of the nutrients required to be declared in the written nutrient information and calories from fat that are present in insignificant amounts) must appear following the written nutrition information. (See example in section III.B.3.e. of this document.) FDA tentatively concludes that this nutrition information is essential to aid consumers in learning about the relative nutritional qualities of all foods, and it allows them to judge the consequences of the food selections they make.

f. Standards for determining and disclosing the nutrient content of foods for variable menu items.

Section 403(q)(5)(H)(v) requires that FDA establish, by regulation, standards for determining and disclosing the nutrient content for standard menu items that come in different flavors, varieties, or combinations, but which are listed as a single menu item, such as soft drinks, ice cream, pizza, doughnuts, or children's combination meals (21 U.S.C. 343(q)(5)(H)(v)) (proposed to be called “variable menu items”). Further, this section provides that FDA may establish these standards through means determined by the agency, including averages, ranges or other methods. Consequently, we considered these means in developing standards for disclosing nutrition information in the written form for standard variable menu items, as well as the comments. FDA considered the following options:

Option 1.

List the nutrition information for each nutrient in the variable menu item as a range.

For example, nutrition information for a meal that consists of a cheeseburger, side dish (fries or salad with fat-free dressing), and medium soft drink (diet or regular) would be provided in a written form that provides the following information:

• Total calories: 620-1,150 calories

• Calories from fat: 220-410 calories

• Total fat: 24-46 g

• Saturated fat: 8-15 g

• Trans fat: 0-1 g

• Cholesterol: 75-90 mg

• Sodium: 1,240-1,560 mg

• Total carbohydrates: 70-155 g

• Sugars: 21-66 g

• Dietary fiber: 4-7 g

• Protein: 29-34 g

For variable menu items with variations that contain calorie amounts and levels of nutrients that vary widely, this type of nutrient declaration minimally assists consumers in maintaining healthy dietary practices, since it does not provide them with a way to determine the nutrient levels of the particular variations they are choosing between. The consumer may not be able to determine how to make a selection to get fewer of the nutrients the consumer wishes to avoid and more of the nutrients that the consumer wants to consume.

Option 2.

List the nutrition information for each component in the variable menu item.

Using the example described above in option 1, for a meal that consists of a cheeseburger, side dish (fries or salad with fat-free dressing), and medium soft drink (diet or regular), under option 2, the covered establishment would be required to provide information for the required nutrients for each component of the meal,

i.e.,

the cheeseburger, the fries, the salad with fat-free dressing, a medium soft drink, and a diet soft drink. The declaration may appear as follows, which includes the proposed simplified formats for the medium cola and diet cola:

Cheeseburger:

• Total calories 470 calories

• Calories from fat 190 calories

• Total fat 21 g

• Saturated fat 8 g

• Trans fat 1 g

• Cholesterol 75 mg

• Sodium 880 mg

• Total carbohydrate 43 g

• Sugars 10 g

• Dietary fiber 2 g

• Protein 26 g

Medium fries:

• Total calories 420 calories

• Calories from fat 180 calories

• Total fat 20 g

• Saturated fat 3.5 g

• Trans fat 0 g

• Cholesterol 0 mg

• Sodium 500 mg

• Total carbohydrate 54 g

• Sugars 0 g

• Dietary fiber 6 g

• Protein 5 g

Garden salad with fat-free dressing:

• Total calories 150 calories

• Calories from fat 30 calories

• Total fat: 3 g

• Saturated fat 0 g

• Trans fat 0 g

• Cholesterol 0 mg

• Sodium 340 mg

• Total carbohydrate 27 g

• Sugars 11 g

• Dietary fiber 2 g

• Protein 3 g

Medium Cola:

• Total calories 200 calories

• Total fat 0 g

• Sodium 5 mg

• Total carbohydrate 56 g

• Sugars 56 g

• Protein 0 g

• Not a significant source of calories from fat, saturated fat, trans fat, cholesterol, and dietary fiber.

Medium Diet Cola:

• Total calories 0 calories

• Total fat 0 g

• Sodium 40 mg

• Total carbohydrate 0 g

• Sugars 0 g

• Protein 0 g

• Not a significant source of calories from fat, saturated fat, trans fat, cholesterol, and dietary fiber

This option provides the consumer with all the required nutrient information for each component of the combination meal in a format that facilitates quick comparisons between different menu items. This option also likely reduces duplication, particularly for combination meals, since most items in combination meals are likely to be available as individual standard menu items.

In addition, when the nutrition information for different flavors, varieties, or components of combinations are the same, the nutrition information for these food items would need only be listed once, with the food items grouped together. For example:

Raspberry or Peach Flavored Iced Tea (14 ounces):

• Total calories 5 calories

• Total fat 0 g

• Sodium 15 mg

• Total carbohydrate 1 g

• Sugars 0 g

• Protein 0 g

• Not a significant source of calories from fat, saturated fat, trans fat, cholesterol, and dietary fiber

For some variable menu items, the number of possible variations is so large that providing the nutrient information required in proposed § 101.11(b)(2)(ii)(A) in written form would be impractical if FDA required the information to be disclosed for each conceivable option. For example, a pizza with a choice among many toppings has a very large number of possible permutations. FDA tentatively concludes that it is more reasonable to require written nutrition information for the basic preparation of the pizza (

e.g.,

plain, deep- dish 12” pizza) and then provide the additional written nutrition information for each possible topping. Therefore, FDA proposes that the nutrition information required in § 101.11(b)(2)(ii)(A) must be provided for the basic preparation of the item and, separately, for each topping or other variable component.

Option 3.

If a standard menu item only has two variations (

e.g.

a sandwich with fruit or with fries), provide both numbers for each nutrient in each option with a forward slash between (

e.g.

450/700). If three or more options are available, provide the range in calories. For example, for a grilled chicken sandwich with either small fries or fruit the nutrients would be declared as:

• Total calories: 450/700 calories

• Calories from fat: 70/200 calories

• Total fat: 7/23 g

• Saturated fat: 1.5/4.5 g

• Cholesterol: 90/90 mg

• Trans fat: 0/0 g

• Sodium: 1160/1430 mg

• Total carbohydrate 63/87 g

• Sugars 27/9 g

• Dietary fiber 3/6 g

• Protein 35/38 g

This option could result in a mixed format within the written nutrition information,

i.e.,

two different types of declarations, one with numbers separated by slashes and one with numbers separated by dashes. We question whether this approach has the potential to be confusing to consumers due to the mixed format and if consumers would be able to distinguish that the nutrient declarations separated by a slash represent the actual amount of nutrients in the two options and that the nutrients declarations separated by a dash actually represents a range of nutrients where the actual amount of nutrients for the item they decide to choose could be anywhere within that range.

For the reasons described above in this section, FDA tentatively concludes that Option 2 provides the most direct and clear information for consumers. Consequently, we are proposing in § 101.11(b)(2)(ii)(C) that for foods that come in different varieties, flavors, and combinations, the nutrient information in the written form required in § 101.11(b)(2)(ii)(A) must be declared for each variety, flavor, and each food component of the combination meal. For those foods that come in different varieties, flavors, and combinations where the number of possible variations is so large that providing the nutrition information in written form for each permutation would be impractical (e.g., pizza, ice cream), FDA is proposing that the nutrition information required in § 101.11(b)(2)(ii)(A) must be provided for the basic preparation of the item and, separately, for each topping or other variable component. The nutrition information in written form may also be provided for every possible variation. FDA specifically requests comment on this proposed requirement as well as alternatives that would provide clear, truthful, and non-misleading information to the consumers about the specific food they purchase.

FDA is also proposing that if the calories and other nutrients are the same for different flavors, varieties, and each substitutable component of the combination meal, each variety, flavor, and substitutable component of the combination meal is not required to be listed separately. All items that have the same nutrient levels could be listed together with the nutrient levels listed only once.

g. Format and manner for the written nutrition information.

FDA is proposing that the nutrition information must be presented in the order listed in proposed § 101.11(2)(ii) and that the information must be presented in a clear and conspicuous manner.

FDA is not proposing a specific manner for providing the written nutrition information. Instead, FDA is proposing in § 101.11(2)(ii)(D) that the written nutrition information may be provided on a counter card, sign, poster, handout, loose leaf binder, booklet, or electronic device, such as a computer, on a menu or in any other material that similarly permits the declaration in written form of the required nutrient content information for all standard menu items.

FDA's proposed approach is consistent with the many comments that stated that the manner in which the written nutrition information is made available should be flexible. One comment recommended that the written nutrition information should be made available electronically at kiosks in lieu of paper copies. Some comments recommended that the information appear on the register tape and others recommended that it appear on the menus themselves. A few comments stated that the information should be allowed on food wrappers or tray liners, while one comment opposed the use of liners and wrappers, stating that the information should be provided immediately prior to or at the point of purchase. FDA would not object to the use of tray liners or wrappers to be used as a means to provide nutrition information, as long as the tray liners or wrappers are available upon request to the consumers, and the tray liner or wrapper contains nutrition information for all standard menu items offered for sale at the covered establishment.

Another comment recommended that FDA provide additional nutrition information in Spanish and other languages depending on the region of the country in which the retail food establishment is located. FDA would not object to covered establishments providing information in other languages, in addition to English. FDA notes, however, that if the information is provided in other languages, all of the required information must be provided in that language. This is consistent with labeling requirements for packaged foods, except that covered establishments in Puerto Rico may provide the information in Spanish only. § 101.15(c).

Unlike the statutory requirements about calorie declarations, which must be placed on menus and menu boards, there is more opportunity for the industry to determine how best to present the written nutrition information. In determining how to present the nutrition information in written form, a covered establishment might consider the extensiveness of the menu and levels of technology capability, among other factors. Allowing flexibility in meeting the requirements of this section is consistent with the current regulation for nutrition labeling in restaurant foods in § 101.10, which permit the disclosure of nutritio

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