Health Regulation - Patient Protection and Affordable Care Act - Food and Drug Administration Finalizes Regulations Requiring Restaurants and Similar Retail Food Establishments to Label Calories on Menus

Harvard Law Review, May 2015 | Go to article overview

Health Regulation - Patient Protection and Affordable Care Act - Food and Drug Administration Finalizes Regulations Requiring Restaurants and Similar Retail Food Establishments to Label Calories on Menus


HEALTH REGULATION--PATIENT PROTECTION AND AFFORDABLE CARE ACT--FOOD AND DRUG ADMINISTRATION FINALIZES REGULATIONS REQUIRING RESTAURANTS AND SIMILAR RETAIL FOOD ESTABLISHMENTS TO LABEL CALORIES ON MENUS--Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments, 79 Fed. Reg. 71,156 (Dec. 1, 2014) (to be codified at 21 C.F.R. pts. 11, 101).

Federal food-labeling laws enacted in the early 1990s exempted restaurants from nutrition-labeling requirements, but required the Food and Drug Administration (FDA) to define the term "restaurants or other establishments" in implementing the exemption. (1) In the Patient Protection and Affordable Care Act (2) (ACA), Congress expanded nutrition-labeling requirements to certain "restaurant[s] or similar retail food establishments] ... with 20 or more locations," (3) again without defining "similar retail food establishment" or "locations." Recently, the FDA finalized a menu-labeling rule that settles on a broad definition of "similar retail food establishment" to cover any establishment that sells "restaurant-type food." (4) Although the final rule's broad definition of "similar retail food establishment," which also expressly exempts schools, (5) is legally permissible, the FDA acted on legally uncertain ground in exempting airplanes, trains, and food trucks through a surprising definition of "location." (6)

On March 23, 2010, the ACA was signed into law, bringing federal nutrition-labeling requirements to restaurants for the first time. (7) Section 4205 of the ACA (8) requires certain "restaurants and similar retail food establishments ... with 20 or more locations" to provide specified nutrition information for "standard menu item[s]." (9) The ACA requires covered establishments to disclose the calorie content "in a clear and conspicuous manner" directly on the menu along with "a succinct statement concerning suggested daily caloric intake." (10) The law also requires that covered establishments make additional nutrition information --such as sodium content--available in written form, and the menu must include a notice that this additional nutrition information is available upon request. (11) The ACA set a deadline of March 23, 2011, for the FDA to issue implementing regulations. (12)

On July 7, 2010, the FDA solicited comments on how to implement the menu-labeling requirements. (13) Although still receiving comments, the FDA published draft guidance to the industry in August 2010. (14) In the draft guidance, the FDA interpreted the relevant portions of section 4205 to have gone into effect immediately upon enactment, but elected not to initiate any enforcement action until after a final rule had been promulgated. (15) The draft guidance broadly interpreted "similar retail food establishments" to include entertainment venues like movie theaters, cafes and food courts in grocery stores, and "transportation carriers (e.g., airlines and trains)." (16) It did not mention schools or define "locations."

The FDA withdrew the draft guidance on January 25, 2011, (17) and issued its proposed menu-labeling rule for comments on April 6, 2011. (18) The proposed rule identified the statutory term "similar retail food establishments" as ambiguous and proposed to define an establishment as similar to a restaurant (and therefore covered by the rule) "if it offers for sale restaurant or restaurant-type food and its primary business activity is the sale of food to consumers." (19) The proposed rule considered the sale of food to be an establishment's "primary business activity" if the establishment either presented itself to the public as a restaurant or used greater than fifty percent of its gross floor area for the "preparation, purchase, service, consumption, or storage of food." (20) Under the primary business test, grocery stores that sold restaurant-type food would "generally" be covered by the rule, but movie theaters, trains, planes, schools, and hospitals would "generally" be exempted. …

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