FDA on August 24 released two guidance documents relating to implementation of the menu labeling requirements contained in the Patient Protection and Affordable Care Act of 2010 (PPACA), commonly known as the health care bill. Under the PPACA, certain chain restaurants with more than 20 locations are required to post calorie counts for all standard menu items on the menu boards.

Guidance Regarding Effect of PPACA Menu Labeling Requirements on State and Local Laws

The first guidance covers whether and to what extent restaurants and vending machine operators must comply with the menu labeling requirements imposed by states or localities. The menu labeling requirements preempt any such laws to the extent they are not identical to those enacted under the PPACA as they apply to restaurants with 20 or more locations. Smaller restaurants may opt in to the PPACA requirements and seek exemption from state or local requirements. States or local governments may petition FDA for exemption from preemption.

Draft Guidance Regarding Implementation of the Menu Labeling Requirements of the PPACA

FDA also released a draft guidance that attempts to answer questions posed to date by industry stakeholders and others regarding how and when the labeling requirements will be implemented. Some key aspects include:

• Regulated establishments include movie theaters, coffee shops, convenience stores, and even transportation carriers (e.g. airlines and trains)
• Regulated food articles include alcohol and meat/poultry dishes
• Establishments can voluntarily provide additional nutritional information on menus beyond what is required by PPACA
• FDA is requiring implementation of some PPACA requirements now, while other requirements will wait until FDA prepares a final rule
• Final guidance is expected in December 2010. FDA will refrain from enforcing provisions of the PPACA until it has issued its final guidance