Earlier this month, the Food and Drug Administration released its “Guidance for Industry: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Small Entity Compliance Guide”. This document serves as an easier-to-understand version of the final rules the agency released in November 2014, which covers almost everything restaurants need to know about the regulations.
Why almost everything?
In a presentation by Felicia Billingslea, the FDA’s director of food labeling and standards, to the National Restaurant Association’s Food and Healthy Living Committee board meeting, Billingslea stated that the FDA received many questions and menu scenarios since the final rules were released. She explained that it will be difficult to answer all the questions within the guidance document, and that there is flexibility for restaurants, as long as they meet the overall requirements of the legislation.
The first paragraph of the Guidance for Industry states: “This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate the bind the FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the telephone number listed on the title page of this guidance.”
How accurate does the FDA require nutrition information to be?
The flexibility that the FDA provides in the presentation of the nutrition information is not extended when it comes to accuracy of the nutrition information. The FDA rules and guidance make it very clear that a standardized recipe, accurate analysis and preparation protocol are important factors in compliance.
The final rules state that two letters providing a statement substantiating the accuracy of the nutrient values and training procedures may be requested by the FDA. The first letter must be signed and dated by a “responsible individual, employed at the covered establishment or its corporate headquarters or parent entity, who can certify that the information contained in the nutrient analysis is complete and accurate,” and the second letter must be signed and dated by a “responsible individual employed at the covered establishment certifying that the covered establishment has taken reasonable steps to ensure that the method of preparation (e.g., types and amounts of ingredients in the recipe, cooking temperatures) and amount of a standard menu item offered for sale adhere to the factors on which its nutrient values were determined.”
What is Included in the guidance document?
The Guidance for the Industry contains seven major sections:
I. Introduction: This section explains that the guidance document “restates in plain language the requirements” of the final rule. However, “The rule is binding and has the full force and effect of law,” and “The guidance describes our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in our guidances means that something is suggested or recommended, but not required.”
II. What restaurants and what foods are covered: This section provides the definitions that the FDA uses throughout the rules and guidance, including “restaurant-type food,” “standard menu item,” “variable menu item,” and “combination meal,” as well as which alcoholic beverages are covered in the legislation.
III. Compliance dates: This section is one sentence: “You must comply with the rule by December 1, 2015, if you are subject to the requirements of the rule on or before that date.”
IV. Labeling requirements: This section is the most robust of all of the guidance. It includes in-depth information on how the calorie information should be formatted for standard, variable and combination items, as well as toppings and self-serve foods and beverages. Examples are also included which show how three sizes of pizza with a few different toppings can be presented. This section also provides the details for the “succinct statement” and the “additional written information” requiring the eleven nutrients for all standard menu items.
V. Determination and substantiation: This section provides the specifics for the information required to substantiate the nutrient values, as well as the criteria for the two statements that substantiate the accuracy of the nutrition information and adherence to training protocol.
VI. Voluntary registration: This section provides information for restaurants with fewer than 20 locations that are not subject to the legislation but may want to voluntarily register and comply under the federal nutrition labeling rules, and thus not be subject to local or state rules, which may require smaller chains to meet a different set of standards.
VII. Misbranding: This section briefly describes the consequences of failing to label a food under this legislation.
Healthy Dining will provide a six-part series offering step-by-step guidance on how to comply with the menu labeling rules. Send your questions to [email protected] and Healthy Dining’s team of registered dietitians will do their best to find answers for you.
This story has been revised to reflect the following correction:
Correction: March 31, 2015 An earlier version of this story misstated some requirements of the accuracy of the information required by the FDA. The final rules state that two letters providing a statement substantiating the accuracy of the nutrient values and training procedures may be requested by the FDA.
Anita Jones-Mueller, MPH, is president of Healthy Dining. With 25 years of nutrition expertise in the restaurant industry, and hundreds of thousands of restaurant recipes analyzed, Healthy Dining is the most experienced restaurant nutrition services provider in the world. Healthy Dining’s team of registered dietitians supports thousands of restaurants in meeting the expanding nutrition needs of their customers, as well as helps them comply with the new FDA menu labeling regulations. Most of Healthy Dining’s clients are featured on HealthyDiningFinder.com. The National Restaurant Association has named Healthy Dining as its exclusive nutrition partner for the industry. Additionally, Healthy Dining has been selected by the National Institutes of Health (NIH) to implement a variety of restaurant nutrition-related research projects through the Small Business Innovative Research (SBIR) Program.
