US FDA Menu Labeling Rule Final Guidance and Enforcement Date
SAFEGUARDS | Food NO. 096/16
On April 29, 2016 the United States Food and Drug Administration (US FDA) published the final guidance, Part II , to the “Nutritional Labeling of Standard Menu in Restaurants and Similar Retail Food Establishments”  that was published on December 1, 2014. The small entity guidance and part I of this guidance were previously published.  The US FDA intends to enforce this menu labeling final rule from May 2017.
Menu Labeling Rule
This rule helped to finalize the Menu Labeling Provisions of Section 4205 of the Patient Protection and Affordable Care Act of 2010, also known as the Affordable Care Act, that was signed into law on March 23, 2010.  Section 4205 of the Affordable Care Act became effective March 23, 2010, however some provisions required the FDA to issue final rules before they could be implemented. Section 4205 of the Affordable Care Act amends Section 403 of the Food Drug and Cosmetic Act of 1938.
The final rule requires restaurants and similar retail food outlets, including those in movie theatres and amusement park establishments, with 20 or more locations nationwide, doing business under the same name and offering for sale substantially the same menu items, to provide calorie information for standard menu items by the name or price of the item. “Seasonal menu items offered for sale as temporary menu items, daily specials, custom orders and condiments for general use typically available on a counter or table are exempt from the labeling requirements“ providing no nutritional or health claims are made or other nutrient information is provided.  Certain alcoholic beverages are now also included in this rule, and their calorie content must be listed. Additionally, mixed dish items such as pizza will now be allowed more flexibility in declaring calorie content. For example, for pizza the calories per slice can be declared instead of the whole item. The US FDA has clarified that food purchased from a retail establishment that is typically intended for more than one person to eat and requires additional preparation before consumption, is not covered by this rule.
Menu and menu boards are to include the statement “2,000 calories a day is used for general nutrition advice, but calorie needs vary”.  In addition, these companies are to provide, on consumer request, written nutrition information about total calories, calories from fat, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrates, fiber, sugar and proteins. This information may be provided by counter card, sign, poster, handout, booklet, loose-leaf binder, menu or electronic device or by other similar means.
Nutrient values, as per 21 CFR 101.11 (c), can be determined by nutrient databases, published cookbooks with nutritional information for the recipes, laboratory analysis or by other reasonable means, such as calculation from the recipe and label nutrition facts panels of the ingredients.
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