Nutrition Labeling of Standard Menu Items at Chain Restaurants

Posted on April 22, 2010 | Comments (2)

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Key Developments

Background

Although the Federal Food, Drug, and Cosmetic Act (FDCA) imposes nutrition labeling requirements for most foods offered for sale in the United States, the FDCA exempts restaurants from the requirements.[1] Given the federal exemption, and in an effort to combat the obesity epidemic in the U.S., several states and localities have passed laws requiring restaurants to list the number of calories and other nutrition information for menu items on print menus and menu boards.[2] This has resulted in a patchwork of menu labeling requirements across the country.

Changes Made by the Health Reform Law
P.L. 111-148, § 4205

The health reform law preempts state and local nutrition labeling laws with regard to “chain” restaurants and “similar retail food establishments” with twenty or more locations by eliminating the FDCA exemption for these facilities, and provides uniform nutrition labeling requirements for standard menu items. It also extends to vending machine operators with twenty or more machines.

The law requires each “restaurant or similar retail food establishment that is part of a chain with twenty 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” to disclose the following:

Chain restaurants’ “menu” listings (e.g., print menus) and/or “menu boards”:[3]

  • Next to each “standard menu item” on a menu listing and/or menu board (including drive-thru menu boards) “so as to be clearly associated with the standard menu item,” provide in a “nutrient content disclosure statement” the number of calories contained in the item as it is “usually prepared and offered for sale.”
  • Post prominently on the menu and/or menu board a “succinct statement” regarding the recommended number of calories individuals should consume each day, “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.”
  • Provide written nutrition information upon request describing the total number of calories in each food item and the total number of calories derived from fat, as well as the amount of the following nutrients in each serving: total fat, saturated fat, cholesterol, sodium, total carbohydrates, complex carbohydrates, sugars, dietary fiber, and total protein. Restaurants are required to have such information readily available to consumers at each location upon request, and must post on the menu or menu board, “a prominent, clear, and conspicuous statement regarding the availability” of such information.

Restaurants with “self-service” items and “food on display” (e.g., salad bar, buffet line) are required to provide a sign that lists the number of calories contained in each serving next to each item offered.[4]

Reasonable basis:

  • For purposes of complying with these requirements, restaurants must have a “reasonable basis” for their nutrient content disclosures, including nutrient databases, cookbooks, laboratory analyses, other reasonable means as described in 21 CFR 101.10 (regarding nutrition labeling at restaurants) or any successor regulation, or in a related guidance of the Food and Drug Administration (FDA).

The above requirements do not apply to the following foods:[5]

  • Items not listed on a menu or menu board, such as condiments or other items placed on a table for general use.
  • Daily specials, temporary menu items appearing on the menu for less than 60 days per year, or custom orders.
  • Food that is part of a customary market test appearing on the menu for less than 90 days.

Menu Variability

  • The law requires the FDA to establish standards for determining and disclosing nutrition information for food items that come in different flavors, varieties, or combinations, but which are listed as a single menu item (e.g., pizza, soda, ice cream, doughnuts, and kids’ combination meals).[6]

Vending Machines

  • The law requires vending machine operators owning twenty or more vending machines to display the number of calories in each vending machine food item, either by ensuring that a prospective purchaser can read the nutrition label on each item before purchasing the item, or by posting a sign in “close proximity” to each item or the selection button which displays a “clear and conspicuous statement” disclosing the number of calories in each item.[7]

Voluntary Registration

  • Any restaurant or vending machine operator not subject to these requirements may elect to be subject to the requirements by registering biannually with the Department of Health and Human Services “the name and address of such restaurant or similar retail food establishment or vending machine operator.” The law prohibits the Secretary from requiring an application, review, or licensing process for this purpose.[8]

Preemption of State and Local Laws

  • The law expressly preempts state and local laws that conflict with the nutritional labeling requirements as they pertain to chain restaurants with twenty or more locations doing business under the same name and to restaurants that voluntarily register to be subject to the nutrition labeling requirements under the law.[9] Establishments and vending machine operators falling outside the scope of the law may be subject to state or local requirements regarding nutrient content disclosures on restaurant menus or menu boards and for vending machines.[10] The law does not preempt any state or local laws regarding warning labels with respect to the safety of foods.[11]

Implementation

Agency and Timeline

The FDA, an agency within the Department of Health and Human Services, is the responsible agency for implementing the law. Within 120 days of enactment, the Secretary of HHS must publish a notice in the Federal Register specifying the terms and conditions for implementation of the voluntary registration program, pending promulgation of regulations governing the law. The Secretary must issue proposed regulations to carry out the law’s requirements not later than March 23, 2011 (one year after the date of enactment). The Secretary must submit quarterly reports that describe progress toward promulgating final regulations to the House of Representatives Committee on Energy and Commerce and to the Senate Committee on Health, Education, Labor, and Pensions.[12]

Process

The nutrition labeling provisions will be implemented through a formal rulemaking process, as described above (See “Agency and Timeline”). The regulations must specify the format and manner in which restaurants will provide calorie and nutrient information for food items. In developing the regulations, the Secretary must consider standardization of recipes and methods of preparation, reasonable variation in serving size and formulation of menu items, space on menus and menu boards, inadvertent human error, training of food service workers, and variations in ingredients.[13]

Key Implementation Issues

  • Timeline: How quickly will final regulations be implemented? Will there be a transition period for entities subject to the law to come into compliance with these requirements?
  • Entities subject to the law: How will “chain” restaurants or “similar retail food establishments” be defined and thus subject to the law’s requirements?
  • Foods subject to labeling requirements: How will the FDA determine what foods are “standard menu items” subject to the law’s labeling requirements? What will constitute a “serving” with regard to self-service items and how will restaurants convey this information to consumers?
  • Consumer protections: How will the requirements for nutrient content disclosure statements and suggested daily caloric intake be established and enforced? What standards will be established for the written statement of nutrition information and notice to consumers of its availability?
  • “Reasonable basis”: How will the reasonable basis standard restaurants use for nutrient content disclosures be validated?
  • Exemptions: How will the FDA monitor the exemption policy to ensure that the market test and special items exemptions are not used to circumvent the provision’s intent?
  • Vending machines: What parameters will be established to determine whether calorie information is visible before purchase and whether the requirement for signage is triggered? What constitutes “close proximity” to the item for the signage display?
  • Enforcement: How will the law’s requirements be enforced and what penalties will be imposed for noncompliance? How often will restaurants and vending machines be subject to inspections? Will enforcement mechanisms and penalties differ for those restaurants and vending machine operators that voluntarily register to be subject to the law’s requirements?
  • State and local laws: If an existing state or local regulation is at least as complete as the federal regulation, will the FDA deem the establishment in compliance with the federal rules if it already meets the state or local standard?
  • Voluntary registration: Will food establishments and vending machine operators that fall outside the scope of the law that voluntarily register to be subject to the federal requirements be exempt from complying with stricter state or local laws regarding nutrient content disclosures for foods offered for sale?
  • Federal, state and local roles: Which agency or agencies will conduct inspections to monitor compliance? Will the FDA contract with state and local public health departments (or other relevant state and local agencies) to carry out this work, or will the FDA conduct this work itself? If state and local agencies conduct the inspections and monitoring, how will the FDA ensure compliance? And would state and local health departments have discretion over how to handle the inspections, such that they varied by state or locality?
  • Funding: To what extent will the FDA be funded to implement the law’s inspection, monitoring, and enforcement requirements? If the FDA contracts with state and local agencies to conduct this work, to what extent will the FDA fund these agencies?

Recent Agency Action

No action has been taken as of this writing.

Authorized Funding Levels

The change is regulatory in nature and therefore does not direct the award of federal funds. The FDA will need resources to implement and enforce the requirements of Section 4205. No resources are specifically appropriated for this purpose in the law.


[1] 21 U.S.C. § 343(q)(5)(A)(i)-(ii).
[2] Center for Science in the Public Interest, “State and Local Menu Labeling Policies,” February 2010. Available at: http://cspinet.org/new/pdf/ml_map.pdf
[3] § 4205(b).
[4] § 4205(b).
[5] § 4205(b).
[6] § 4205(b).
[7] § 4205(b).
[8] § 4205(b).
[9] § 4205(c).
[10] § 4205(c).
[11] § 4205(d).
[12] § 4205(b).
[13] § 4205(b).

Center for Science in the Public Interest, “State and Local Menu Labeling Policies,” February 2010. Available at: http://cspinet.org/new/pdf/ml_map.pdf

Comments (2)

  • There are many important environmental and societal changes needed to reverse the childhood obesity epidemic. Including menu labeling requirements in the Patient Protection and Affordable Care Act is one of them. Menu labeling presents a great opportunity to educate the public about calorie counts, portion and serving size, and how to use the new information to make healthy choices.

    Over the past several decades, changes in our environment and in the way we live have made it difficult, and sometimes impossible, for families to make healthy choices. This has created an imbalance in the amount of energy taken in through foods and beverages and energy expended through physical activity and daily living. The result is an unprecedented obesity epidemic.

    According to the USDA Economic Research Service, one of the societal changes we’ve seen is the increase in meals consumed outside the home. Dining out rose by more than two-thirds over the past two decades and now accounts for about half of the total U.S. food expenditure. In addition, the calorie consumption for children nearly doubles when they eat at a restaurant compared to eating at home.

    Making healthy choices in restaurants is difficult considering that something as healthy sounding on a menu as “Fresh Chicken and Broccoli Pasta” can contain more calories than a “value meal” of a double cheeseburger, French fries, and soda. Furthermore, most adults significantly underestimate the number of calories in restaurant food. In fact, a study conducted by the Center for Science in the Public Interest and New York University revealed that even trained nutrition professionals have trouble figuring out the calorie content of typical restaurant meals.

    Requiring clear caloric content of menu items will empower people to make informed decisions and take some of the guesswork out of making healthy choices. To be most effective, menu labeling should be explicit in reflecting the portion size people actually order and consume.

    There are steps to be taken before menu labeling provisions are fully in place, including the development and issuing of regulations. We look forward to working with the FDA on this matter and urge policy makers to make sure that the agency has the resources needed to effectively implement, monitor, and enforce the menu labeling provision. We also encourage all major chain restaurants to show leadership and to get a head start in displaying this valuable information – before the FDA issues regulations.

    Given that a number of states and jurisdictions have already implemented menu labeling, we encourage policy makers to look to, and learn from, the experiences of California, Maine, New Jersey, New York City, Philadelphia, Seattle, and other jurisdictions where some form of menu labeling has been or is being implemented. In particular, a close look should be given to monitoring and enforcement.

    The current legislation applies to restaurant chains with twenty or more locations and vending operators with twenty or more machines. While this addresses the majority of meals eaten away from home, smaller chains and individual restaurateurs could better serve their customers by following the same guidelines.

    Obesity is a crisis that touches the lives of everyone in one way or another, affecting not only our quality of life, but the overall productivity of our citizens, the sustainability of our health care system, and even national security. It will take the action of many to create an environment that empowers people to make healthy choices for themselves and their families.

    Joseph W. Thompson, MD, MPH

    Director, Robert Wood Johnson Foundation Center to Prevent Childhood Obesity

    Arkansas Surgeon General

    Director, Arkansas Center for Health Improvement

The Food and Drug Administration has requested comment on the implementation of section 4205 of the health reform law, which requires nutrition information be posted in settings such as chain restaurant menus and vending machines.