FDA Issues Nutritional Labeling Proposed Rule

Apr 11, 2011   

The U.S. Food and Drug Administration (FDA) has just issued two proposed rules involving a provision of the Patient Protection and Affordable Care Act (“PPACA”), the 2010 Healthcare Reform Law, which requires certain food establishments and vending machines to post caloric and nutritional information on menus, including drive-thru windows. As we have previously blogged (here, here, here, and here) this provision amends the Federal Food, Drug, and Cosmetic Act (“FDCA”) in attempt to provide uniformity in menu nutritional labeling around the country and to assist consumers in making healthier food choices while eating out.

Under the PPACA, restaurants, bakeries, grocery stores, convenience stores, coffee shops and other establishments with 20 or more locations operating under the same name and offering for sale substantially the same food items are required to post caloric information directly on the menu and have nutritional information available upon request. Under the proposed rule, the calorie declaration must be “adjacent to” the name of the standard menu item, so as to be “clearly associated with” it. For standard menu items that come in different flavors, varieties, or combinations but are listed as a single menu item, such as combination meals or ice cream that comes in different flavors, the FDA is proposing allowing calorie ranges as opposed to median (middlemost) or mean (statistical average) calories. Self-service establishments such as buffets and cafeterias must display the caloric information on a sign adjacent to the food.

The PPACA requires that menus post a clear and conspicuous statement regarding the availability of nutrition information upon request. Under the proposed rule, this statement must be no smaller than the smallest type size for any calorie declaration, be on the first page of the menu, and be prominently displayed (i.e., the same color and contrasting background as the standard menu item).

Additionally, a succinct statement concerning the total daily suggested caloric intake must be prominently displayed “to enable the public to understand…the context.” An example of this statement is “A 2,000 calorie daily diet is used as the basis for general nutrition advice; however, individual calorie needs may vary.” The FDA has been using the 2,000 calorie reference point since at least 1993. The proposed rule requires this statement on the bottom page of each page of the menu.

We previously blogged regarding whether movie theaters would be covered under the proposed rule. In the proposed rule, movie theatres, amusement parks, bowling alleys, trains, airplanes, general merchandisers, hotels and other business operations who do not primarily sell food items are generally exempted from the nutritional labeling requirements.

For vending machines, the proposed rule requires that caloric information be posted adjacent to the vending machine, but not necessarily attached to the vending machine. The number of calories contained in the article should be expressed to the nearest 5-calorie increment up to and including 50 calories, and 10-calorie increment above 50 calories. Foods that have fewer than 5 calories may be expressed as zero. For vending machines that sell varieties, such as different flavors and types of hot beverages (e.g., coffee), caloric information should be listed for each flavor or variety in close proximity to each selection rather than posting a single range for the item.

Only vending machines operated by a person engaged in the business of owning or operating 20 or more vending machines are covered under the PPACA. It is believed that 90-95 percent of vending machine operators have 20 or more machines, and therefore, will be included.

Any food establishment or vending machine operator not covered under the PPACA may voluntarily participate and register with the FDA every two years. Interestingly, the posting of calories and nutritional information for beer, wine, and other alcoholic beverages is exempt. Food not in compliance with the final rule will be deemed misbranded under the act and subject to FDA enforcement.

The FDA is seeking comments on the proposed rules. The comment period for the proposed rule for menu labeling is 60 days (until June 6, 2011), and comments on the proposed rule on vending machines is 90 days (until July 5, 2011). Once implemented, these rules will preempt state and local food labeling requirements for restaurants, similar retail food establishments, and vending machines that are covered under the proposed rules. Establishments not covered under PPACA and the proposed rules will remain subject to existing state and local laws. The FDA plans to issue final rules before the end of the year and begin enforcement in 2012. For more information regarding the labeling of food products, the misbranding provisions of the FDCA, or how the PPACA will impact your business, please contact us at (305) 350-5690 or contact@fidjlaw.com.