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The Patient Protection and Affordable Care Act recently signed into law by President Barack Obama contains an amendment to the Federal Food, Drug and Cosmetic Act directing that, within one year, the Secretary of Health and Human Services (presumably, through the Food and Drug Administration) propose regulations implementing calorie labeling on menus and menu boards in any restaurant with 20 or more locations that operate under the same name.

It is estimated that this requirement will affect at least 200,000 fast food and other chain restaurants.

The new law is designed to require disclosure of the calorie content of food items being purchased as they are being ordered. Currently, some restaurants post nutritional information on food wrappers, pamphlets, posters or on their websites. The new law would require that the calorie content be posted right on the menu or menu board (including drive-through menu boards) next to the name of the item. It also requires that a statement concerning suggested daily caloric intake, to be specified by the Secretary, be provided on menus and menu boards.

The new law was supported by the restaurant industry, which was facing different laws in various cities and states. New York City was the first city to require calorie posting and other states and cities have followed, including California, Maine, Massachusetts, New Jersey and Oregon. The new federal standard is intended to provide uniformity.

Custom meals and meals that will appear on the menu for less than 60 days will be exempt from the calorie menu requirement. Although only calories will need to be included on menus and menu boards, the following additional nutrition information will be required to be available upon request in written form: the total number of calories derived from any source/derived from the total fat in each serving size or other unit of measure; total fat; saturated fat; cholesterol; sodium; total carbohydrates; complex carbohydrates; sugars; dietary fiber; and the total protein contained in each serving size or other unit of measure.

The new law requires that an affected restaurant must have a “reasonable basis for its nutrient content disclosures,” which may include nutrient databases, cookbooks and laboratory analyses. The Secretary is directed to establish standards for determining and disclosing the nutrient content for standard menu items that come in different flavors, varieties or combinations, such as children’s combination meals, and may do so using “ranges, averages and other methods.”

The law also requires that unless the Nutrition Facts Panel of an item in a vending machine is visible to a customer prior to purchase, the vending machine operator must provide the calorie content of each item in close proximity to each item or the selection button. This requirement applies only to operators who own or operate 20 or more vending machines.

As noted above, the Secretary has one year to propose regulations implementing the law, which will be followed by a comment period and eventually the issuance of final regulations. Although the new law does not expressly so state, those involved with the legislation have indicated that it does not require any action by restaurants until the Secretary issues regulations.

For more information on the effect of these regulations on your business, please contact Dennis Wieczorek and Barry Heller.

For more information on DLA Piper’s Health Care practice generally, please contact Senator Tom Daschle, Tom Boyd, Kimberly K. Egan and James P. Rathvon.

Please read our other Alerts on ways health care reform may affect your business.