WITHDRAWN - Draft Guidance for Industry: Questions and Answers Regarding Implementation of the Menu Labeling Provisions of Section 4205 of the Patient Protection and Affordable Care Act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
Contains Nonbinding Recommendations
Draft — Not for Implementation
This guidance document is being distributed for comment purposes only.
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit electronic or written comments on the draft guidance within 45 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition
Contains Nonbinding Recommendations
Draft — Not for Implementation
Table of Contents
Contains Nonbinding Recommendations
Draft — Not for Implementation
Guidance for Industry1
Questions and Answers Regarding Implementation of the Menu Labeling Provisions of Section 4205 of the Patient Protection and Affordable Care Act of 2010
The Food and Drug Administration (FDA) is issuing these Questions and Answers as guidance for industry and State and local governments affected by the enactment of section 4205 of the Patient Protection and Affordable Care Act ("Affordable Care Act”), which was signed into law on March 23, 2010. Section 4205 establishes requirements for nutrition labeling of standard menu items for chain restaurants, similar retail food establishments, and chain vending machine operators. It also requires FDA to issue proposed regulations to carry out the provisions of section 4205 no later than March 23, 2011.
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances, when finalized, describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
Americans now consume an estimated one-third of their total calories on foods prepared outside the home and spend almost half of their food dollars on such foods. (Refs. 1 and 2). Consumers are generally unaware of, or inaccurately estimate, the number of calories they consume from such foods. (Ref. 3). As evidence of that point, according to the Centers for Disease Control and Prevention (CDC), approximately 67% of adults, (Ref. 4) and 31.7% of children ages 2-19 are overweight or obese. (Ref. 5). Being overweight or obese increases the risk of a number of diseases, including coronary heart disease, type 2 diabetes, stroke, and certain types of cancer. (Ref. 6).
Calorie and other nutrition information that is readily available at the point that consumers are making their food selections in restaurants or at vending machines can help consumers make more healthful food choices and construct total daily diets consistent with current dietary recommendations.
Toward that end, section 4205 amends section 403 of the Federal Food, Drug, and Cosmetic Act (FFDCA) to require certain restaurants and similar retail food establishments with 20 or more locations (hereinafter "chain retail food establishments”) to provide calorie information for menu items, food on display, and self-service food, as well as additional written nutrition information for menu items. Section 4205 also requires vending machine operators who own or operate 20 or more machines (hereinafter "chain vending machine operators”) to disclose calories for food items. Restaurants and similar retail food establishments and vending machine operators that are not subject to section 4205 may elect to be subject to these federal requirements by registering every other year with the FDA. Ultimately, this provision offers consumers access to information that will empower them to make healthier choices by making accurate, clear, and consistent information available.
Section 4205 became effective on the date the law was signed, March 23, 2010; however, some provisions specifically require FDA to issue rules before FDA can implement them.
For chain retail food establishments, the provisions that became requirements immediately upon enactment of the law include:
(1) Disclosing the number of calories in each standard menu item on menus and menu boards (403(q)(5)(H)(ii) of the FFDCA),
(2) Making additional written nutrition information available to consumers upon request (403(q)(5)(H)(ii)(III) of the FFDCA),
(3) Providing a statement on menus and menu boards about the availability of the additional written nutrition information (403(q)(5)(H)(ii)(IV) of the FFDCA), and
(4) Providing calorie information (per serving or per food item) for most self-service items and food on display, on a sign adjacent to each food item (403(q)(5)(H)(iii) of the FFDCA).
In addition, chain vending machine operators must immediately disclose, in a clear and conspicuous manner, calories for articles of food that do not permit a prospective purchaser to examine the Nutrition Facts Panel before purchasing the article or do not otherwise provide visible nutrition information at the point of purchase.
These Questions and Answers, when finalized, will explain FDA’s current thinking on how these provisions should be implemented. FDA has also issued two separate documents addressing other issues related to the implementation of section 4205. FDA discusses the preemptive effect of section 4205 in "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”. FDA discusses voluntary registration in 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.” See 75 Federal Register 43182 (July 23, 2010). In addition, FDA published a notice in the Federal Register on July 7, 2010 (75 FR 39026) opening a docket to solicit comments, data, and other information helpful to the implementation of section 4205. See 75 Federal Register 39026 (July 7, 2010).
III. Questions and Answers
Restaurants and Similar Retail Food Establishments (SRFEs)
A. Covered Establishments
1. Which establishments are covered by section 4205?
Section 4205 applies to an establishment that is: (1) a restaurant or similar retail food establishment (SRFE), and (2) part of a chain (a) with 20 or more locations, (b) doing business under the same name (regardless of the type of ownership of the locations, e.g., individual franchisees), and (c) offering for sale substantially the same menu items.
To be covered, an establishment must be a restaurant or SRFE and be part of a chain that meets all three of the listed criteria.
2. What is a "restaurant or similar retail food establishment”?
FDA considers establishments that offer for sale directly to the consumer food intended for immediate consumption, consumed either on or off the premises where the food is purchased, to be “restaurants or SRFEs.” Food that is intended for immediate consumption would include food on a menu or menu board or on display or provided for self-service, carry-out, or delivery.
3. What is meant by “doing business under the same name”?
FDA considers this phrase to refer to establishments that share the same name and are owned, controlled, or operated by a single corporate entity (including those operated as franchised outlets of a parent company).
FDA considers the term “same name” to cover names that are the same in all relevant respects, including where slight variations exist in the name (e.g., “ABC” and “ABC Express”). FDA seeks comment on how we should apply this interpretation to contractors, such as managed food services, or other corporate entities that own, control or operate restaurants or SRFEs offering substantially the same menu items using names specific to a location.
4. What is meant by “offering for sale substantially the same menu items”?
The term “menu” or “menu board” is defined in the Affordable Care Act as “the primary writing of the restaurant or other similar retail food establishment from which a consumer makes an order selection.” Section 4205(b) (403(q)(H)(xi) of the FFDCA). Therefore, the term “menu item” refers to a food that is included in such a writing.
The agency considers the term “offering for sale substantially the same menu items” to mean that the establishments are 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.
5. What are some examples of establishments that would be covered because they 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”?
Generally, restaurants and SRFEs include table service restaurants, quick service restaurants, coffee shops, delicatessens, food take out and/or delivery establishments (e.g., pizza take out and delivery establishments), convenience stores, movie theatres, cafeterias, bakeries/retail confectionary stores, food service vendors (e.g., lunch wagons, ice cream shops, mall cookie counters, and sidewalk carts), and transportation carriers (e.g., airlines and trains). If these establishments are part of a chain that meets the other relevant characteristics (i.e., 20 or more locations, “doing business under the same name,” and “offering for sale substantially the same menu items”), they should comply with section 4205.
Many grocery stores have cafes, food courts, or otherwise sell food that is for immediate consumption directly to consumers. These establishments would be considered restaurants or SRFEs. If they are part of a chain that meets the other relevant characteristics (i.e., 20 or more locations, “doing business under the same name,” and “offering for sale substantially the same menu items”) they would be covered.
FDA intends to ensure that establishments that offer comparable food items for immediate consumption are treated comparably. Some grocery stores, whether or not they have cafes, food courts, or in-store restaurants, have facilities that offer foods that could be consumed immediately or could be purchased as traditional grocery items for future consumption, such as in-store bakeries, salad bars, pizza bars, or delicatessens. In this context FDA is seeking comments on what facilities in grocery stores, beyond the cafes, food courts, and in-store restaurants, should also be covered by section 4205.
FDA recognizes that similar issues may pertain to other establishments such as convenience stores. We are interested in comments with regard to these establishments as well.
6. If only 19 or fewer locations are all doing business under the same name and offering for sale substantially the same menu items, are they covered by section 4205?
No, a chain of restaurants or SRFEs with 19 or fewer locations would not be covered by section 4205. These restaurants however, could elect to be subject to section 4205 by voluntarily registering with the agency. See “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 Affordable Care Act of 2010.” See 75 Federal Register 43182 (July 23, 2010).
7. Are corporate caterers that operate 20 or more establishments but tailor the menu items to each client covered by section 4205?
In situations where corporate caterers tailor the menu to each client, the establishments would not be covered if the menu items do not generally follow the same recipes, prepared in substantially the same way, with substantially the same food components. Such establishments would not be “offering for sale substantially the same menu items.”
8. Are operations that cater individual events subject to the requirements of section 4205?
So long as the food is not sold directly to the consumer, this type of operation would not be considered a restaurant or SRFE.
9. Are covered establishments that are considered small businesses as defined in 21 CFR101.9(j) exempt from section 4205?
No, neither section 4205 nor 21 CFR 101.9(j) exempts small businesses from the menu labeling requirements of section 4205.
B. Covered Food
1. What food is covered?
Section 4205 applies to “food” that is a “standard menu item,” food sold at self-service facilities, and “food on display.”
The term “food” is defined in section 201(f) of the FFDCA, as articles used for food or drink by man or other animals, chewing gum, and components of any such article. See 21 U.S.C. 321(f). Therefore, all food items that are standard menu items on a “menu” or “menu board,” food on display and visible to consumers, or food for self-service, would be covered.
2. Are meat and poultry dishes and alcoholic beverages that are served in a covered restaurant or SRFE subject to the requirements in section 4205?
Yes. Meat and poultry dishes and alcoholic beverages are considered food as defined in the FFDCA (see Question B.1). Therefore, the nutrition disclosure requirements in section 4205 apply in cases where these foods are listed on a menu or menu board or are otherwise covered under section 4205, even though they may be regulated by other agencies in other circumstances.
3. What is a “standard menu item”?
FDA considers a “standard menu item” to be a food item routinely included in the primary writing of the restaurant or SRFE from which a consumer makes a food selection.
4. What is food sold at a self-service facility?
FDA considers “food sold at a self-service facility” to be food in a covered establishment, which is intended for immediate consumption, that is sold at a:
- Salad bar,
- Buffet line,
- Cafeteria line, or
- Similar self-service facility (including self-service beverages).
FDA considers the term “facility” as it is used in section 4205 to refer to a self-service fixture in a restaurant or SRFE, not to an entire retail establishment.
5. What is “food on display”?
- Intended for immediate consumption, whether consumed on or off the premises, and
- Visible to the customer, regardless of whether it is accessed by employees or customers.
6. What types of foods sold in covered establishments are not covered by section 4205?
Foods that should not be covered by the requirements of section 4205 are:
Foods that are not “standard menu items”, i.e,
- Items not listed on the menu or menu board such as condiments and other items placed on the table for general use,
- Daily specials,
- Temporary menu items appearing on the menu for less than sixty days per calendar year,
- Custom orders, and
- Food that is part of a customary market test appearing on the menu for less than ninety days, and
Pre-packaged food that bears complete nutrition information where prospective customers are able to examine the Nutrition Facts Panel prior to selection (e.g., pre-packaged sandwiches in a cooler or bagged snacks or cookies that the customer may choose as part of the meal).
FDA is seeking comment on whether and to what extent food offered for immediate consumption at grocery stores (other than the food offered in their cafes, food courts, or in-store restaurants) and convenience stores should be covered under section 4205 (see Question A5.). In addition, FDA recognizes that certain foods on display provide multiple servings, for example a whole cake or loaf of bread, and is soliciting comments on whether and how these foods are covered by the requirements of section 4205.
7. What are “custom orders”?
FDA considers a “custom order” to be an order that is prepared in a specific manner for an individual consumer, which requires the restaurant or SRFE to deviate from its usual preparation of a menu item.
Examples of custom orders include:
- A Cobb salad (described as coming with chicken, bacon, egg, and avocado), ordered without the bacon
- A fast food hamburger (which generally comes with a pickle, ketchup, and mustard), without the toppings
8. What is a “variable menu item”?
FDA considers a “variable menu item” to be a menu item that is available to the consumer with one or more listed options (e.g., toppings listed on a menu or menu board). Custom orders are different from variable menu items in that the deviation requested for a custom order generally involves removing ingredients or adding ingredients that are not listed on the menu or menu board as options.
Examples of variable menu items include:
- Pizzas prepared to order based on toppings listed on the menu
- Ice cream, where more than one flavor is listed or displayed
FDA cannot require disclosure of nutrient content information for variable menu items until FDA issues a final rule. FDA will issue recommended language in the proposed rule.
C. Disclosure of Calories/ Additional Written Nutrition Information
1. What is a “menu” or “menu board”?
Section 4205 states that a “menu” or “menu board” is “the primary writing of the restaurant or other similar retail food establishment from which a consumer makes an order selection.” Section 4205(b) (403(q)(5)(H)(xi) of the FFDCA). FDA considers primary writing to include all forms of primary writing, such as dessert menus, beverage menus, or other specialty type menus. The term “menu board” includes drive-through menu boards. See 403(q)(5)(H)(ii)(II)(aa) of the FFDCA.
2. Are Internet menus and take-out menus considered to be “menus” under section 4205?
An Internet menu or a take-out menu can be a “menu” under section 4205 if it can be used as the primary writing from which a consumer makes a selection. An establishment may have multiple types of menus, any one of which may be used by various consumers as the primary writing to make selections. For example, if the establishment’s take-out menu is posted on the Internet and it serves as a primary writing from which a customer makes selections over the phone or Internet for take-out, deliver, or dine-in service, then it is a menu under section 4205 and, therefore, requires calorie disclosure.
3. What information is required by section 4205 to be disclosed on a menu or menu board?
Information that must be disclosed on a menu or menu board in a covered establishment includes:
- The number of calories in each standard menu item “as usually prepared and offered for sale” (the calorie disclosure must be “clear and conspicuous” and “adjacent to” the name of the standard menu item) (403(q)(5)(H)(ii)),
- A statement that puts the calorie information in the context of a total daily caloric intake (403(q)(5)(H)(ii)), and
- A statement regarding the availability of the written nutrition information (403(q)(5)(H)(ii)(IV)).
As set out below, some of these requirements apply now, while FDA will implement others after engaging in rulemaking to specify the requirements with more particularity.
4. Is there required language for the succinct statement of suggested daily caloric intake?
FDA will not require a succinct statement of suggested daily caloric intake until FDA issues a final rule. FDA will provide specific language for this statement in the proposed rule.
5. How should calories be disclosed on a menu or menu board (is there a recommended format)?
Section 4205 requires that the calorie disclosure on menus and menu boards be clear, conspicuous, and adjacent to the name of the menu item. To meet these requirements, the calorie disclosure should be adjacent to the listing of the menu item so that it is clear to the consumer that it is associated with the menu item and the consumer has the information available to make the best choices for his or her health. The calorie disclosure should state the number of calories and may use either the term “Calories” or “Cal”. FDA generally prefers use of the term “Calories” but recognizes that some menus or menu boards may have limited space. Both the number of calories and the term “Calories” or “Cal” should be in a type size at least as large as the name or the price of the menu item, whichever is larger, with the same prominence, i.e., the same color and contrasting background as the menu item. For purposes of disclosing calories on menus or menu boards, restaurants may list the caloric content of each item in a single column titled “Calories” or “Cal” adjacent to the listing of the menu item. Further, calorie disclosure should be expressed in the nearest 5-calorie increments for menu items containing up to and including 50 calories, and in 10-calorie increments above 50 calories, except that amounts less than 5 calories may be expressed as zero.
6. Where and how should the statement of availability regarding the additional written nutrition information be disclosed? Is a certain statement recommended? Are there any format recommendations?
The statement regarding the availability of the additional written nutrition information must appear on the menu board (including drive-through menu boards) and on all forms of the primary writing of the restaurant or other similar retail food establishment from which a consumer makes an order selection. On the menu board, the statement “Additional nutrition information is available upon request” should be in a type size at least as large as the name or the price of a menu item with the same prominence, i.e., the same color and contrasting background as the calorie disclosures themselves. For menus, the same statement should appear on the bottom of the first page in the same type size and font as the calorie disclosure. For menus with more than 2 pages, the statement may appear either on every page or the first appearance of the term “Calories” on succeeding pages after the first page should be followed by a symbol linking it to the required statement appearing on the first page of the menu.
7. What must be disclosed in the additional written nutrition information?
The nutrition information that must be available in a written form to consumers upon request includes:
- The total number of calories derived from any source
- The total number of calories derived from the total fat
- Total fat
- Saturated fat
- Total carbohydrate
- Dietary fiber
- Total protein
In addition to these nutrients, FDA believes that the written nutrition information should also include information about the amount of trans fat in standard menu items served in the restaurant or SRFE. While this information is not currently required for standard menu items, it is required to be disclosed in the Nutrition Facts Panel of pre-packaged food.
8. Are there any particular written media (e.g., a brochure or a poster) in which the additional nutrition information should be disclosed?
The nutrition information in written form may be provided on a counter card, sign, poster, handout, loose leaf binder, booklet or electronic device such as a computer, or in a menu.
9. What information must be disclosed for food sold in self-service facilities and “food on display” and how should the information be disclosed? Is there a recommended format?
Calories per food item or per serving must be disclosed for food sold at self-service facilities and food on display in a clear and conspicuous manner in a sign adjacent to each food offered. See 403(q)(5)(H)(iii) of the FFDCA. It should be clear to the customer that the caloric disclosure is associated with the food item. The calorie disclosure should state the number of calories and use the term “Calories” or “Cal”. If the food item is labeled with a food tag (i.e., a sign adjacent to the food item with the name or price of the food) both the number of calories and the term “Calories” or “Cal” should be in a type size at least as large as the name of the food item or the price, with the same prominence, i.e., the same color and contrasting background. If both the name and the price of an item appear on a tag, then the number of calories and the term “Calories” or “Cal” should be in a type size at least as large as the name of the food item or the price, whichever is larger, with the same prominence, i.e., the same color and contrasting background.
10. How must calories and other nutrient content disclosures be calculated?
Section 4205 states that a restaurant or SRFE shall have a reasonable basis for its nutrient content disclosures, including nutrient databases, cookbooks, laboratory analyses, and other reasonable means, as described in Title 21 Code of Federal Regulations, section 101.10. (Section 403(q)(5)(H)(iv) of FFDCA)
11. Must calories for variable menu items and combination meals be disclosed?
FDA will not require posting calories of variable menu items and combination meals until FDA issues a final rule. FDA will provide recommended language in the proposed rule.
D. Timing of Compliance
1. Does FDA intend to begin taking enforcement action against chain retail food establishments and chain vending machine operators that are not in compliance with the provisions of section 4205 that became requirements immediately upon enactment of the law?
No. FDA is aware that industry may need additional guidance from FDA and time to comply with the provisions of section 4205 that became requirements immediately upon enactment of the law. Accordingly, FDA expects to refrain from initiating enforcement action until after a time period established in the final guidance. FDA is interested in comments on the appropriate time period for enforcement after the issuance of final guidance. FDA anticipates issuing final guidance in December 2010.
E. Voluntary Provision of Nutrition Information
1. Can covered restaurants and SRFEs provide nutritional information on menus and menu boards that go beyond the disclosures required under section 4205?
Yes. Establishments voluntarily may make additional disclosures on menus and menu boards. Establishments interested in continuing disclosures on menus and menu boards are permitted to do so.
2. Can restaurants or SRFEs that are not chain retail food establishments, or vending machine operators that are not chain vending machine operators, voluntarily provide the nutrition information required of entities covered by section 4205 of the Affordable Care Act or other nutrition information?
Yes. If these restaurants, SRFEs, and vending machine operators wish to voluntarily provide the nutrition information required by section 4205 of the Affordable Care Act or other nutrition information, they may do so even if they do not register to be subject to the requirements of section 4205, so long as they are not in violation of State or local laws.
We have placed the following references on display in the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. You may see them at that location between 9 a.m. and 4 p.m., Monday through Friday. As of August 19, 2010, FDA had verified the Web site address for the references it makes available as hyperlinks from the Internet copy of this guidance, but FDA is not responsible for any subsequent changes to Non-FDA Web site references after August 19, 2010.
1. “Backgrounder – The Keystone Forum on Away-From-Home Foods: Opportunities for Preventing Weight Gain and Obesity Report,” Food and Drug Administration, June 2006, available at, http://www.fda.gov/Food/LabelingNutrition/ReportsResearch/ucm082064.htm.
2. “Food Safety Working Group: Key Findings,” President’s Food Safety Working Group, July 7, 2009, available at
3. Burton, S., E.H. Creyer, J. Kees, and K. Huggins, “Attacking the Obesity Epidemic: The Potential Health Benefits of Providing Nutrition Information in Restaurants,” American Journal of Public Health 96(9):1669-1675, September 2006.
4 FastStats Internet Webpage “Obesity and Overweight,” Centers for Disease Control and Prevention, available at http://www.cdc.gov/nchs/fastats/overwt.htm.
5. Ogden, C.L., M. Carroll, L. Curtin, et al., “Prevalence of High Body Mass Index in US Children and Adolescents, 2007-2008,” Journal of American Medical Association,303(3), 242-249, 2010.
6. Overweight and Obesity Internet Webpage: “Health Consequences,” Centers for Disease Control and Prevention, available at http://www.cdc.gov/obesity/causes/health.html.
1. This guidance has been prepared by the Office of Nutrition, Labeling, and Dietary Supplements in the Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration.