FDA Announces Availability of Two New Draft Guidance Documents on Implementation of PPACA Section 4205August 26, 2010
By Susan J. Matthees –
FDA announced yesterday the availability of two new draft guidance documents regarding implementation of the menu labeling provisions of section 4205 of the Patient Protection and Affordable Care Act (“PPACA”). As we reported last month, FDA requested comments on how to implement PPACA § 4205, which requires restaurants with 20 or more locations and vending machines owned by companies operating 20 or more vending machines to display calorie information for their food products. The two new draft guidance documents explain how FDA will enforce PPACA § 4205 and identify those aspects of the law for which FDA will delay enforcement until the agency promulgates implementing regulations.
The first draft guidance is a short document that addresses the effect of PPACA § 4205 on state and local menu labeling laws. PPACA § 4205 expressly preempts local and state laws that are not “identical to” the federal law. FDA explains that preemption only applies to large chain restaurants and vending machines, so state or local laws that require nutrition labeling for businesses with fewer than 20 locations are not preempted.
The second draft guidance document consists of commonly asked questions and answers about implementation of PPACA § 4205. Topics include what establishments are covered by the law, which foods are covered by the law, criteria for disclosure of calories and additional nutrition information, and the timing of compliance.
The question and answer draft guidance contains several interesting comments by FDA. First, FDA notes that grocery stores with cafes, food carts, or that otherwise sell food for immediate consumption will be subject to the law if they meet the definition of a chain restaurant (i.e., 20 or more locations doing business under the same name and offering for sale substantially similar menu items), and requests comments on what additional facilities in grocery stores might be covered by the law. Similarly, FDA requests comments on what foods in grocery stores and convenience stores should be covered. FDA also states that alcoholic beverages will be covered by § 4205, even though most alcoholic beverages are not subject to nutrition labeling requirements.
The agency will not require nutrient content disclosure information for variable menu items, such as pizza and ice cream, or the daily caloric intake disclaimer until the final rules are implemented. FDA will not take any enforcement action until after the final guidance has been published, which FDA anticipates to be in December of this year. Meanwhile, interested parties may submit comments to the draft guidance.