Menu Labeling

The U.S. Food and Drug Administration (FDA) released two final rules for menu and vending machine labeling on Nov. 25. “Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments” significantly expands FDA’s regulatory reach into restaurants and beyond. The long-awaited rule stems from the Affordable Care Act, the comprehensive health care reform law of 2010, and comes more than three years after the proposed rule was issued in April 2011. Because the final rule differs in many respects from the proposed rule and includes potentially burdensome requirements, including certification of nutritional content, covered businesses should begin preparing now for the Dec. 1 compliance date. 

In a significant departure from the earlier proposed rule, FDA’s final rule expands the categories of covered establishments to potentially include not just restaurants, but also movie theaters, amusement parks, concession stands, bowling alleys and other entertainment venues, convenience stores, coffee shops, bakeries, delis, grocery stores, supercenters and fitness clubs. Schools and businesses that sell food but do not have a fixed location, such as trains, airplanes and food trucks, are excluded.

The menu labeling rules apply to restaurants and “similar retail food establishments” that have 20 or more locations, doing business under substantially the same name, and selling substantially the same menu items, regardless of type of ownership. 

Restaurants and similar retail food establishments are defined broadly to mean any retail establishment that offers “restaurant-type food,” which is food that is “[u]sually eaten on the premises, while walking away, or soon after arriving at another location” and either served in the establishment or processed and prepared primarily in the establishment.  

This definition eliminated the “primary business test” in the proposed rules, which would have limited coverage only to those establishments where more than 50 percent of the business’s revenue is generated from the sale of such food.   

FDA’s removal of the “primary business test” from the final rules was a surprise and means that many businesses that were not subject to the proposed rule are now required to comply with the final rule. 

Even if your business does not meet the rule’s definition of a covered establishment, a business can voluntarily register with FDA to be covered by the final rule. One reason why a business may want to voluntarily register to be covered by the final rule is to avoid state or local menu labeling requirements. The law specifies that state or local governments cannot have nutrition labeling requirements for foods sold in establishments covered by the final rule, unless such requirements are identical to the federal requirements. Establishments that are not covered under the federal rule would remain subject to applicable state or local menu labeling rules, unless they choose to voluntarily register with FDA to comply with the federal menu labeling requirements. 

By voluntarily registering with FDA, a business has the benefit of being subject to one consistent rule across all locations that could potentially be less restrictive than the state or local rules. Plus, if the business later expands to 20 or more locations, it is already compliant with the final rule and does not need to worry about changing its menus.   

Legislation has been introduced that would narrow the scope of covered establishments. The Common Sense Nutrition Disclosure Act would redefine “restaurant or similar retail food establishment” to include only those that “derive more than 50 percent of their total revenue from the sale” of restaurant-type food, thereby removing most grocery and convenience stores from the rule’s coverage. The bill would also allow for remote-access disclosure for establishments where most orders are placed off-premises, such as pizza facilities accepting orders online. The bill is slow-moving and businesses should not rely on the legislation passing before the Dec. 1 compliance date.  

What is required?

The main requirement of the final rule is that covered establishments must disclose calorie amounts for each standard menu item on menus and menu boards, and on signs adjacent to standard menu items that are self-serve or on display. 

Businesses should note that FDA’s concept of a “menu” is not limited to traditional menus and menu boards and potentially spans a broad range of other formats. “Menus” and “menu boards” are defined as “primary writings” of the business from which a consumer makes an order, which includes anything that shows the name and price of the menu item and can be used to place an order. 

But, as FDA reiterated in a recent webcast on the final rule, the rule does not require covered establishments to create a new menu or menu board if one does not already exist at the establishment.

Covered establishments must also post two prescribed statements on menus and menu boards: a statement regarding daily caloric intake and a statement regarding the availability of additional nutrition information.

In addition, businesses must maintain detailed, written nutrition information for standard menu items, including total calories, calories from fat, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrates, fiber, sugars and protein. This information must be made available to consumers upon request. 

FDA allows flexibility in how an establishment provides this information – it can be in a booklet, for example – so long as it is available to the consumer on the premises.

Labeling Menu Items

While FDA significantly broadened the types of establishments that are covered by the rule, it narrowed the types of food that will require labeling. The labeling requirements apply to standard menu items offered for sale in the establishment. 

“Standard menu item” means a restaurant-type food that is routinely included on a menu or menu board or routinely offered as a self-service food or food on display. 

Specific calorie labeling requirements apply to combination meals, multiple-serving menu items, and menu items offered in different flavors or varieties, as well as items on display or available for self-service (e.g., salad bars, bakery items or self-serve fountain beverages).

One surprising departure from the proposed rule is that the final rule covers beer, wine and mixed drinks that are standard menu items. But beer or bottles of liquor behind a bar or mixed drinks ordered from the bar that do not appear on a menu or menu board are not covered.

Other menu items excluded from the labeling requirements include condiments (unless listed on the menu), daily specials, temporary menu items (less than 60 days in a calendar year), custom orders, and food offered for sale for less than 90 consecutive days as part of a market test. 

Certain foods that are eaten over several eating occasions such as whole cakes or loaves of bread, as well as foods that are not self-serve and intended for more than one person to eat or that require additional preparation before consuming, such as deli salads sold by weight and deli meats, are also not covered because they are not considered “restaurant-type foods”.

Nutrient Content

Your business must have a “reasonable basis” for nutrient content declarations and take reasonable steps to ensure that the method of preparation and serving amounts adhere to the factors on which nutrient values were determined. Upon FDA’s request, a business must provide information substantiating nutrient values.

Nutrient values may be determined based on nutrient databases, cookbooks, laboratory analyses, nutrition facts on packaged foods, or other “reasonable” means. 

Notably, a business must provide two signed statements: one signed by a responsible individual employed at the establishment or its corporate headquarters certifying that the information contained in the nutrient analysis is complete and accurate; and another signed by a responsible individual employed at the establishment certifying that it has taken reasonable steps to ensure that the preparation and amount of the menu item adhere to the labeled nutrient values.

FDA Enforcement

Both the effective date and compliance date for the rule are Dec. 1. Failure to comply with the rule will render the food misbranded under the Food, Drug and Cosmetic Act (FDCA). 

Significantly, misbranding under the FDCA – even if unintentional – is a misdemeanor.  FDA has the discretion to hold criminally liable those with authority, including “responsible individuals” with a duty to implement measures to ensure compliance.

Although FDA is somewhat vague in describing how it will enforce the rules, it expects enforcement to be similar to that involving other misbranded food – including interfacing with state agencies – and will be “considered on a case-by-case basis.” 

FDA recently issued guidance for small entities that restates the requirements of the final rule and will issue more comprehensive guidance in the near future. 

Industry and other stakeholders will have an opportunity to comment on the draft guidance before it is finalized by the FDA. 

In a recent webcast on the final rule, FDA stated that the first year of the rule that starts Dec. 1 will be more focused on education and helping establishments comply with the rules, rather than on enforcement.

Deadline Preparation

You will want to ensure that you have accurate and up-to-date nutritional information for your business’s menu items, which may mean requiring this information from your supply chain and possibly amending existing contracts to address nutrition information. Your business will need this information to determine the nutrient content for the calorie disclosures and additional nutrition information. 

It goes without saying that your business will likely need to revise its menus and menu boards and possibly implement additional signage for self-serve items or items on display. This will require a close reading and comprehensive understanding of the final rule’s detailed requirements. 

Keep in mind that the type of ownership of an establishment generally does not matter under the final rule, so you may be liable for franchisees’ noncompliance if you are a franchisor. 

Training employees to precisely follow recipes and preparation instructions will be crucial to ensure that the calorie information on the menu is accurate and not misleading. 

In addition to written training procedures, your business should develop cross-functional menu labeling compliance policies and procedures that involve your culinary, R&D, marketing, quality assurance, legal and establishment-level team members. 

These policies should address issues on how to handle changes in menu items or ingredients, how to determine the nutrient content of a new menu item in compliance with the rule and procedures to periodically review compliance. The designated individuals who are responsible for the two signed certification statements should also be reviewed. 


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