FDA has published a Level 1 guidance document, entitled “A Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods—Part II (Menu Labeling Requirements in Accordance with 21 CFR 101.11).” 81 Fed. Reg. 27,067 (May 5, 2016). The guidance document is issued consistent with the agency’s good guidance practices regulation (21 C.F.R. § 10.115), and finalizes (for the time being) the draft guidance document it published on September 15, 2015. See our prior article published on 09/14/2015.
The finalized guidance document has been modified in response to submitted comments, as appropriate, by revising several questions and answers, and adding new questions and answers. The new questions and answers are at:
- 5.5: I am a covered establishment that offers off-site catering for private events. Menu items for these events are typically purchased by one or two persons from my catering menu for a large group to consume at an event at no cost. Does the catered event have to provide calorie declarations to its guests?
- 5.7: I am the owner of a chain of over 20 restaurants. Twelve of my restaurants are full-service restaurants and operate under the name Ed’s Bar & Grill. My other restaurants operate under Super Studio 3, Super Studio Lite and Super Studio Grill. These establishments are generally found in movie theaters or may be stand alone in malls. We offer four variations of expanded menus in each establishment. How would I determine whether my restaurants are covered establishments?
- 5.11: If a covered establishment has a menu item that they offer occasionally, for example once or twice a month, is that food considered a standard menu item?
- 5.17: If a pizza coupon that states “1 large 2 topping pizza $9.99” is attached to a takeout menu, does the menu item on this coupon require calorie information?
- 5.35: My menu lists pizzas and other menu items in various sizes with the option of adding various toppings. How do I declare the calories for these items?
- 7.11: We are a covered establishment that does not offer for sale alcohol beverages as standard menu items, but we include suggested alcohol pairings with our menu items (such as, “goes great with red wine”). Do we need to include calorie information for the suggested alcohol pairings?
- 7.12: Are establishments that only sell beer, such as concession stands within a stadium, covered by the menu labeling requirements?
Changes to the guidance include additional examples and explanations to clarify how the provisions of the rule would apply to various situations.
Importantly, pursuant to section 747 of the Consolidated Appropriations Act, 2016 (Pub. L. 114–113), publication of this Level 1 guidance document sets May 5, 2017, as the effective date for FDA’s final rule, entitled ‘‘Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments,” 79 Fed. Reg. 71,156’(Dec. 1, 2014). So implementation of calories labeling for standard menu items in covered establishments is now just a year away.