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Monday, June 1, 2015

Coming soon to a restaurant near you

Menu Labeling Coming to a Restaurant Near You

Many of you know that six months from now, as of December 1, 2015, any restaurant or “similar retail food establishments” (SRFEs) that are part of a chain with 20 or more locations must comply with the new menu labeling regulations.  These regulations require that calorie content be displayed along with pricing on all menus and menu boards for standard menu items as well as on any “food on display” as in restaurants that allow the customer to pick and choose from a range of ingredients such as sandwich or burrito fillings as they direct the assembly of their meal.  Additional nutrition information (fat, carbohydrate, protein, cholesterol, sodium, etc.) must be available upon request. Similar regulations are also coming into effect for vending machines.

FDA wrote these regulations as a result of the passage of the Patient Protection and Affordable Care Act of 2010. The regulations identify the businesses subject to these rules as
1.      Retail establishments that sell “restaurant type food” that is meant to be eaten immediately or taken away for immediate consumption.  This includes concession stands, self-serve salad or hot food bars in grocery stores and all kinds of cafes serving food.
2.      They are part of a chain with 20 or more fixed locations (food trucks do not count).
3.      The covered businesses do business under the same name or as part of the same parent entity, including slight variations in the name.
4.      They offer substantially the same menu items (even with name variations) that use the same general recipe and are prepared in substantially the same way with substantially the same ingredients.
It is important to note that restaurants and SRFEs do not have to provide calorie/nutrition information on items that the patron customizes or for daily specials and condiments.

One of the most interesting requirements of the regulation is that alcoholic beverages that appear on a menu or menu board are included even though they are not otherwise subject to calorie labeling. Beers and other alcoholic beverages may voluntarily list nutritional information on their labels but I have been told by industry insiders many brewers do not even accurately know the amount of alcohol in their products let alone what the calorie content is. (FYI alcohol provides 7 calories per gram—almost as much as fat.).

It is also interesting that states or other localities (cities, counties) may petition the FDA to be exempt from the Federal preemption to their local menu labeling regulations.  Some localities require menu labeling even for establishments with fewer than 20 locations.  In a recent webinar (March 2015) on the topic FDA noted that they had already received a petition for exemption from preemption from the City of Philadelphia.  The regulations also allow for petitions from companies with fewer than 20 that wish to be covered under the regulations and the accompanying inspections of their data. The voluntary registration also allows the restaurants to be subject to FDA’s regulations rather than to local menu labeling regulations.

Speaking of data, the regulations require that the nutrition information provided be accurate.  They also require  a statement certifying that the information contained in the nutrient analysis is complete and accurate  The statement must be signed by signed and dated by a “responsible individual” that is employed at the restaurant (or SRFE),  corporate headquarters or parent entity.  The regulations also require a statement signed and dated by a “responsible individual” employed at the restaurant certifying that the restaurant has taken reasonable steps to ensure that the preparation and amount of food provided conforms to the factors used to determine the nutritional information. In the case of violations fo the requirement to be accurate, the FD&C Act along with the Park Doctrine allow FDA to take enforcement action against the signers of those statements.  How’s that for added pressure for restaurant managers?

The nutritional data can be obtained from nutrient databases, cookbooks, ingredient nutrition facts labels, lab analyses or a combination of these.  Based on my experience working in the food industry, it will be important to have this data checked and double checked.  I also recommend carrying out laboratory analyses on at least a sampling of menu items to check that cookbook and database values enabled accurate calculations.

This brief post cannot begin to touch upon all the requirements and interpretations of the rule in the 104 page Federal Register Notice that was published December 1, 2014 so contact us with any questions you have on the topic.

As always, we hope you find these occasional updates interesting. If so, you may use this link to subscribe to our occasional email newsletters regarding FDA regulations and other topics of interest to FDA-regulated companies.  We send messages targeted to the dietary supplement, cosmetic, food, OTC drug and medical device industry sectors.  You may subscribe to one or all of the newsletters and you may unsubscribe at any time. Please post any questions you may have.  My associates and I stand ready to help you with your FDA regulatory issues.

All the best to you!
Evelyn & Associates

1 comment:

  1. Note that FDA has pushed back the deadline for compliance with nutrition information on chain restaurant menu to December 2016.