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 http://eepurl.com/Imbjv
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.
Note that FDA has pushed back the deadline for compliance with nutrition information on chain restaurant menu to December 2016.
ReplyDelete