On the same day that FDA’s menu labeling regulation became effective for compliance by industry, the agency published notice of the availability of its finalized Menu Labeling: Supplemental Guidance for Industry (May, 2018). This guidance is “supplemental” because FDA also already has published 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): Guidance for Industry (Apr. 2016) and Questions and Answers on the Menu and Vending Machines Nutrition Labeling Requirements (page last updated May 7, 2018).
The menu labeling regulation applies to restaurants and similar retail food establishments, if they are part of a chain of 20 or more locations, doing business under the same name, and offering for sale substantially the same menu items. Covered establishments must disclose on menus and/or menu boards the number of calories in standard menu items; and for self-service and on display foods, must disclose calorie information in close proximity to, and clearly associated with, the standard menu items. On menus and menu boards, a statement must be included concerning daily caloric intake, indicating that 2,000 calories a day is used for general nutrition advice, but calorie needs vary. Covered establishments must also provide for standard menu items, upon request, the following nutrition information: total calories, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrates, sugars, fiber, and protein. In addition, a statement must be displayed on menus and menu boards about the availability of such written information.
A significant change from the supplemental guidance proposed last November is that the finalized supplemental guidance expresses FDA’s intent to exercise enforcement discretion regarding the “calories from fat” nutrient declaration otherwise required by the regulation to be part of the additional written nutrition information provided at covered establishments. FDA is taking this position because current science supports a view that the type of fat is more relevant with respect to the risk of chronic disease than to the overall caloric fat intake, consistent with its removal of “calories from fat” from mandatory information in revising its Nutrition/Supplement Facts rules.
The finalized supplemental guidance addresses several topic areas, including:
- Calorie disclosure signage for self-service food, including buffets and grab-and-go food;
- Various methods for providing calorie disclosure information, including those for pizza;
- Criteria for distinguishing between menus and marketing materials; Methods for providing calorie disclosure information;
- Compliance and enforcement, indicating the agency would consider the following to be minor violations:
- Minor discrepancies in the type size or contrast of declarations;
- Minimal variations or errors that minimally impact nutrition information; and
- Not rounding declarations correctly;
- “Reasonable basis,” including the criteria for considering the natural variation of foods, when determining calorie and additional nutrition labeling;
- Criteria for “covered establishments”;
- “Standard menu items;” and
- Menu labeling for alcohol.
The supplemental guidance provides many new examples of alternatives (including a number of useful graphic depictions) to aid stakeholders with compliance and to convey FDA’s present thinking on a variety of topics.