The U.S. Food and Drug Administration recently released new federal draft guidance documents on the implementation of Section 4205 of the Affordable Care Act, the long-awaited federal menu labeling law.
Covered Establishments
As noted in our previously published newsletter, the new
requirements will apply to restaurants or similar retail food
establishments ("SRFEs") that are part of a chain with 20
or more locations doing business under the same name (regardless of
the type of ownership of the locations) which offer for sale
substantially the same menu items. The new guidance makes it clear
that it will only apply to establishments offering food directly to
the consumer which is intended for immediate consumption. According
to the guidance, this will include table service restaurants, quick
service restaurants, coffee shops, delicatessens, food take-out
and/or delivery establishments (e.g., pizza take-out and delivery
establishments), convenience stores, movie theatres, cafeterias,
bakeries/retail confectionary stores, food service vendors (e.g.,
lunch wagons, ice cream shops, mall cookie counters, and sidewalk
carts), and transportation carriers (e.g., airlines and trains). In
addition, grocery stores that have cafes or food courts will be
covered by the new legislation. The FDA has not yet determined, and
is still seeking guidance, on what other items in a grocery store
should be covered, such as salad bars, delis, and in-store
bakeries. Corporate caterers may even be covered if the other
elements of the statute are met.
The guidance interprets the required element of the offer for sale of "substantially the same menu items" to mean that covered establishments must offer menu items using the "same general recipe, prepared in substantially the same way, with substantially the same food components."
Finally, the establishments must have 20 or more locations "doing business under the same name." The FDA considers this to mean that establishments must share the same name and be owned, controlled or operated by a single corporate entity (including those operated as franchised outlets of a parent company). The FDA is seeking further guidance on how to handle variations in named locations that still offer substantially the same menu items.
Covered Food
The new guidelines will apply to standard menu items, food sold at
self-service locations, and food on display. The term
"food" includes drinks, extending to both non-alcoholic
and alcoholic beverages. Standard menu items are those routinely
included on the menu and food at self-service facilities (including
salad bars, buffet lines, cafeteria lines, and self-service
beverages). Food on display is that that is visible to the
consumer, including food packaged at the customer's request or
pre-wrapped. It does not include food that has pre-printed
nutritional information that the customer can see prior to
purchasing it.
Food specifically not covered includes:
- Daily specials;
- Temporary menu items (60 days or less) or food part of a market test (90 days or less);
- Custom orders;
- Items not on the menu, such as condiments.
Required Information
The regulations will require specific nutrition information to be
disclosed on the menu, which can include an Internet menu or
takeout menu if it can be used as the primary writing from which a
consumer will make a selection. Specific language prescribed by the
statute will be required (which has not been released), along with
the number of calories in each standard menu item "as usually
prepared and offered for sale," and a statement regarding
availability of full nutritional information. The guidelines
provide additional specifications as to how the nutritional
information must be listed, both on the menu board and in a
separate disclosure providing full nutritional information.
The covered entity must have a "reasonable basis" for its nutrient content calculations, such as nutrient databases, cookbooks, laboratory analyses, and other reasonable means.
Timing
The FDA guidance provides that certain provisions of the
new legislation came into effect in March 2010, when the provisions
were signed into law. The requirements already in effect are: (1)
disclosure of the number of calories in standard menu items; (2)
making additional written information available upon request; (3)
providing a statement about the availability of additional
information on the menu; and (4) providing caloric information for
self-service items and food on display.
However, importantly, the guidance also indicates that the FDA is aware that the industry needs additional guidance and time to comply. As such, it indicated that it will refrain from enforcement actions until after a time period established in final guidance, which is anticipated in December 2010. Regardless, franchisors that fall under the guidance should begin preparations to comply with the federal menu labeling requirements.
Other
The guidance makes clear that covered establishment may voluntarily
provide additional disclosures not provided for the in new
legislation. In addition, establishments that are not covered by
the requirements of the legislation may register to be subject to
the requirements of the statute, "so long as they are not in
violation of state or local law."
To view the draft guidance, click here.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
