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PHILIP C. OLSSON OLSSON FRANK WEEDA JOLYDA O. SWAIMRICHARD L. FRANK TERMAN BODE MATZ PC JONATHAN M. WEINRIEBDAVID F. WEEDA (1948-2001) ATTORNEYS AT LAW NANCY W. MATHEWSONDENNIS R. JOHNSON MCKAY R. TOLBOE*ARTHUR Y. TSIEN COUNSELJOHN W. BODE* SUITE 400 ROGER R. SZEMRAJSTEPHEN D. TERMAN 1400 SIXTEENTH STREET, N.W. OF COUNSELMARSHALL L. MATZ WASHINGTON, D.C. 20036 (202) 789-1212 JUR T. STROBOSMICHAEL J. OFLAHERTY www.ofwlaw.com KENNETH D. ACKERMANDAVID L. DURKIN MARK L. ITZKOFFNEIL F. OFLAHERTY ELLIOT BELILOSBRETT T. SCHWEMER SENIOR POLICY ADVISORSTISH E. PAHL JOHN R. BLOCKROBERT A. HAHN CHARLES W. STENHOLMEVAN P. PHELPS GEORGE McGOVERNGARY H. BAISE SALLY S. DONNERDAVID A. BIEGING MEMORANDUM BRENT W. GATTISKATHRYN E. BALMFORD BARBARA J. MASTERS*PRACTICE WITHIN THE DISTRICT OF COLUMBIAIS LIMITED TO MATTERS AND PROCEDURE S March 24, 2010BE FO RE FE DE RA L CO URT S AND AGE NCIE S FROM: Olsson Frank Weeda Terman Bode Matz PC RE: Mandatory Nutrition Labeling Requirements for Restaurants On March 23, 2010, President Obama signed the Patient Protection and Affordable Care Act (H.R. 3590) into law. This health care reform legislation includes a provision, Section 4205, requiring mandatory nutrition labeling for food sold at chain restaurants and similar retail food establishments. Specifically, Section 4205 amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) by requiring that food sold at restaurants, similar retail food establishments, and vending machines that are part of a chain with 20 or more locations (or vending machines) must provide certain nutrition labeling information. Until now, restaurants and similar retail food establishments have been exempt from the FD&C Act’s nutrition labeling requirements that apply generally to packaged foods. See 21 U.S.C. § 343(q)(5)(A)(i) and (ii). The new requirements are aimed at providing consumers with greater nutrition information when consuming food away from home, while providing uniform nutrition labeling requirements that restaurants can implement nationwide. We provide below a summary of the provisions of section 4205. A. MANDATORY NUTRITION LABELING (New 21 U.S.C. § 343(q)(5)(H)) The legislation requires mandatory nutrition labeling of standard menu items offered for sale in a restaurant or similar retail food establishment that is part of a chain with 20 or more locations doing business under the same name (regardless of type of ownership) and offering substantially the same menu items. 21 U.S.C. § 343(q)(5)(H)(i).
OLSSON FRANK WEEDA TERMAN BODE MATZ PCMarch 24, 2010Page 2 The term “similar retail food establishment” is not defined in section 4205. However,based on the Food and Drug Administration’s (FDA) regulations implementing the nutritionlabeling requirements for packaged foods, the term likely is to be interpreted to meanestablishments where food is served for immediate human consumption (e.g., institutional foodservice establishments, such as schools, hospitals, and cafeterias; transportation carriers, such astrains and airplanes; bakeries, delicatessens, and retail confectionery stores where there arefacilities for immediate consumption on the premises; food service vendors, such as lunchwagons, ice cream shops, mall cookie counters, and sidewalk carts where foods are generallyconsumed immediately where purchased or while the consumer is walking away, includingsimilar foods sold from convenience stores; and food delivery systems or establishments whereready-to-eat foods are delivered to homes or offices). See 21 C.F.R. § 101.9(j)(2)(ii). Inaddition, the term appears also to include retail establishments that sell takeout food. See 21U.S.C. § 343(q)(5)(A)(ii); 21 C.F.R. § 101.9(j)(3). 1. Disclosure of Nutrition Information Restaurants and similar retail food establishments covered by the legislation are requiredto disclose: (1) calories on the menu or menu board (including drive-through menu boards), and(2) additional nutrition information available in writing in the establishment upon theconsumer’s request. In addition to disclosing the number of calories per standard menu item as usuallyprepared and offered for sale, the menu or menu board must also include a succinct statementconcerning the suggested daily caloric intake. Section 4205 requires FDA to specify the wordingof the succinct statement, which must be designed to enable the public to understand, in thecontext of the daily diet, the significance of the nutrition information provided. Finally, menusand menu boards must provide a clear and conspicuous statement notifying consumers of theavailability of additional nutrition information. Covered establishments are also required to make available to consumers upon requestadditional nutrition information in writing (e.g., a brochure), on the premises. This additionalnutrition information must include the amounts of the following macronutrients per serving sizeor other unit of measure: calories, calories from fat, total fat, saturated fat, cholesterol, sodium,total carbohydrates, sugars, dietary fiber, and protein. 1 Unlike packaged foods, section 4205 doesnot require declaration of vitamins and minerals for standard menu items.1 Although declaration of “trans fat” is not required under the language of the FD&C Act,FDA subsequently mandated the declaration of “trans fat” for packaged foods via rulemaking.Again, we anticipate that FDA will adopt the same approach with respect to restaurant foods.Section 4205 provides that FDA may, by regulation, require written disclosure of additional 2
OLSSON FRANK WEEDA TERMAN BODE MATZ PCMarch 24, 2010Page 3 2. Self Service Food and Food on Display For foods that are available at self-service facilities (e.g., a salad bar, buffet line orcafeteria line) and self-service foods or beverages that are on display and visible to consumers,covered establishments are required to place a sign adjacent to each food item that disclosescalories on a per item or per serving basis. 3. Reasonable Basis Determination Section 4205 provides that nutrition information disclosed for standard menu items mustbe determined with reasonable basis. A reasonable basis determination may be based onnutrient databases, cookbooks, laboratory analyses and other reasonable means described inFDA’s regulations and related guidance. 4. Menu Variability For standard menu items that are available in different flavors, varieties or combinations,but which are listed as a single menu item (e.g., soft drinks, ice cream, pizza, doughnuts orchildren’s combination meals), FDA is required to establish standards (i.e., ranges, averages, orother methods) for determining and disclosing the nutrient content of such items. 5. Applicability The menu labeling requirements of section 4205 do not apply to the following fooditems: · Items that are not listed on the menu or menu board (e.g., condiments and other items placed on the table/counter for general use); · Daily specials; · Temporary menu items appearing on the menu for less than 60 days per calendar year; · Custom orders; and · Food that is part of a customary market test appearing on the menu for less than 90 days. 2nutrients for the purpose of providing information to assist consumers in maintaining healthydietary practices. 21 U.S.C. 343(q)(5)(H)(vi).2 Section 4205 directs FDA to establish the terms and conditions for foods seekingexemption as part of a customary market test. 3
OLSSON FRANK WEEDA TERMAN BODE MATZ PCMarch 24, 2010Page 4 6. Vending Machines Section 4205 also imposes mandatory nutrition labeling for foods sold from a vendingmachine that is operated by a person engaged in the business of owning or operating 20 or morevending machines. Unless the vending machine permits prospective consumers to examine theNutrition Facts panel before purchasing the food or otherwise provides visible nutritioninformation at point of purchase, the operator must provide a sign in close proximity to eacharticle of food or selection button that includes a clear and conspicuous statement of the numberof calories in that article of food.B. VOLUNTARY NUTRITION INFORMATION Foods served at restaurants or similar retail food establishments that are not part of achain of 20 or more locations are not required to provide nutrition information under section4205. However, restaurants, similar retail food establishments, and vending machine operatorsthat are not covered by Section 4205 may elect to participate in a voluntary nutrition labelingprogram. If they elect to voluntarily comply with Section 4205, they will be shielded from non-identical state or local requirements under the national uniformity provision of the FD&C Act(section 403A(a)(4)) (see Section D below). In order to participate in the voluntary program, the restaurant, similar retail foodestablishment, or vending machine operator must register biannually with FDA. Section 4205requires FDA to publish a notice in the Federal Register specifying the terms and conditions forimplementation of the voluntary program within 120 days of enactment (i.e., July 21, 2010), andto promulgate implementing regulations at a later date.C. IMPLEMENTING REGULATIONS Section 4205 requires FDA to promulgate proposed regulations to implement themandatory nutrition labeling requirements within one year of enactment. Although section 4205does not require FDA to issue final regulations within a prescribed timeframe, FDA is requiredto provide Congress with quarterly reports describing its progress toward issuing finalregulations. The implementing regulations will specify the format and manner in which requirednutrition information must be presented (e.g., typesize, contrast). FDA will be called upon towork through the practical challenges presented by nutrition labeling of restaurant foods, whichare served in numerous forms. In particular, section 4205 requires FDA to consider thefollowing: · Standardization of recipes and methods of preparation; · Reasonable variation in serving size and formulation of menu items; 4
OLSSON FRANK WEEDA TERMAN BODE MATZ PCMarch 24, 2010Page 5 · Space on menus and menu boards; · Inadvertent human error; · Training of foods service workers; · Variations in ingredients; and · Other factors as FDA determines.D. NATIONAL UNIFORMITY Section 4205 provides for federal preemption of non-identical state and local laws.Specifically, section 4205 amends the FD&C Act’s national uniformity provision regardingnutrition labeling requirements. The amended language prohibits non-identical state or localrequirements applicable to: · Food items for which nutrition labeling is provided in accordance with the new mandatory requirements in 21 U.S.C. § 343(q)(5)(H)(i); and · Food items for which nutrition labeling is provided in accordance with the voluntary program outlined in 21 U.S.C. § 343(q)(5)(H)(ix). Importantly for restaurants and similar retail food establishments, this provision preemptsnutrition labeling requirements (e.g., State/local laws that require calories or other nutrients to beposted on the menu or menu board) and requirements arising under state fair trade statutes, thatare materially different from the new federal nutrition labeling requirements. * * * * * We trust this information is useful. This is intended as a brief overview of the recentlysigned legislation. Please let us know if you have any questions, or would like further detailregarding the menu labeling provisions of section 4205. 5