On April 29, 2016, the US Food and Drug Administration (“FDA”) issued the final guidance on menu labeling titled “A Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods – Part II.”
The guidance is the final step in clarifying the nutrition labeling requirements under the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) and the corresponding regulations. Enforcement of the Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments final rule will begin May 05, 2017. The law 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 to provide calorie and other nutrition information for standard menu items, including food on display and self-service food. Generally, covered entities under the final rule, must 1) display calories for standard menu items (i.e., 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); 2) display a succinct statement on the suggested daily caloric intake; 3) post a notice that written nutrition information (i.e., total calories, calories from fat, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrates, dietary fiber, sugars, and protein) for standard menu items is available to consumers who ask to see it, and make such information available to these consumers upon request; and 4) establish a process, including recordkeeping, to substantiate the nutrient content determination.
The guidance provides explanations and examples on many subjects that may not have been clear under the final rule. Some notable points addressed in the guidance are:
- The guidance clarifies that covered entities may include: bakeries, cafeterias, coffee shops, convenience stores, delicatessens, food service facilities and concession stands located within entertainment venues (such as amusement parks, bowling alleys, movie theatres, and sports arenas), food service vendors (such as ice cream shops and mall cookie counters), food takeout and delivery establishments (such as pizza takeout), grocery stores, retail confectionary stores, superstores, quick service restaurants, and table service restaurants, to the extent that such establishments satisfy the criteria for coverage.
- The guidance provides examples of non-covered establishments such as schools as defined by the United States Department of Agriculture (USDA) school lunch program or school breakfast programs, transportation carriers such as trains or airplanes, lunch wagons (food trucks and sidewalk carts), and in-patient only food-service facilities located in hospitals. Federal prisons and mobile vendors (who sell food from a tray while walking around stadiums and arenas) also fall outside of the rule requirements. Catered events are not included under the rule and the food served at these events does not need to be labeled, but the catering company must display calories on the catering menu that is used by customers to purchase food for the catered event.
Nutrient Labeling for Covered Establishments:
- The guidance clarifies what types of food are covered under the rule. The guidance mentions that while certain food may be located in a covered establishment, the food will be exempt from the labeling requirements. The food items include: condiments for general use, daily specials, temporary menu items that appear on the menu for less than 60 days per calendar year (e.g., holiday gift tins or Jack O’Lantern cookies), custom orders that deviate from the usual preparation from a menu item, self-service food, alcoholic beverages on display, and food that is used for a customary market test (i.e., food that appears on a menu or menu board for less than 90 consecutive days in order to test consumer acceptance of the product)
- Food items that involve additional preparation, such as reheating, before consuming and that are typically eaten over several occasions or stored for later use would generally not be covered.
- The guidance clarifies that in determining what constitutes a menu board the crucial factor to consider is whether the written material is the main or primary writing from which a customer makes an order selection.
- Advertising or marketing material (including coupons) generally would not be considered menus or menu boards. For a stand-alone coupon, if it can be used to place an order (i.e. it contains the name of a standard menu item, its price, and a phone number or website where the customer can place an order), then the calorie declaration would need to be provided. Coupons that are attached to a takeout menu that meets the labeling requirements would not require a calorie declaration.
- The guidance also confirmed that the calorie declaration requirements for electronic menus available on the Internet are the same as written or printed menus.
Determining Nutrient Values for Restaurant-Type Foods
- The guidance states that there must be a reasonable basis for determining the values for calorie and other nutrient information that is provided for the menu items. The guidance lists certain means that can be used to arrive at this value, such as the value listed in a cookbook, lab analysis of the menu items, or the use of Nutrition Facts on labels of packaged foods. The guidance also details specific requirements for each value.
- The guidance also states that covered establishments must keep records of how they arrived at the nutrient value and if the records are requested by the FDA, they must be submitted within a reasonable time period within 4-6 weeks after the request was made.
- The calorie value for the standard menu items must be current and accurate.
- For alcoholic beverages whose varieties and descriptions are listed separately but grouped in a single section in a menu and all of the varieties have the same calorie amounts, a single calorie declaration can be used, provided that the declaration specifies that the calorie amount listed represents the calorie amounts for each individual flavor or variety.
- The requirements do not apply to alcoholic beverages that are foods on display and are not self-service foods. Therefore, to the extent that beers on tap are not self-serve, they are exempt from the labeling requirements for standard menu items that are food on display.
- Calorie declarations for suggested alcohol pairings are not required if the alcohol beverages are not available as standard menu items at the establishment.
- Establishments that serve only beer or a single standard menu item are still required to provide calorie and nutrition information.
- The guidance also provides details for voluntary registration. The guidance clarifies that there is federal preemption for registrants under the rules, specifically an establishment registered in accordance with the federal rules, cannot be subject to state or local nutrition labeling requirements that are not identical to the federal requirements.
While this guidance is the final step in enforcing the menu labeling law and rules, there is legislation pending in Congress that may affect parts of the law. The Common Sense Nutrition Disclosure Act of 2015 passed the House earlier this year and is pending in the Senate. The Health Law Pulse will continue to cover updates regarding the pending legislation and any effects on the enforcement of the final rule.
Covered entities should review the guidance and begin compliance efforts in order to meet all requirements by the enforcement period starting next year.