RECENT REGULATION HEALTH REGULATION — PATIENT PROTECTION AND AFFORDABLE CARE ACT — FOOD AND DRUG ADMINISTRATION FINALIZES REGULATIONS REQUIRING RESTAURANTS AND SIMILAR RETAIL FOOD ESTABLISHMENTS TO LABEL CALORIES ON MENUS. — Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments, 79 Fed. Reg. 71,156 (Dec. 1, 2014) (to be codified at 21 C.F.R. pts. 11, 101). Federal food-labeling laws enacted in the early 1990s exempted restaurants from nutrition-labeling requirements, but required the Food and Drug Administration (FDA) to define the term “restaurants or other establishments” in implementing the exemption.1 In the Patient Protection and Affordable Care Act2 (ACA), Congress expanded nutrition-labeling requirements to certain “restaurant[s] or similar retail food establishment[s] . . . with 20 or more locations,”3 again without defining “similar retail food establishment” or “locations.” Recently, the FDA finalized a menu-labeling rule that settles on a broad definition of “similar retail food establishment” to cover any establishment that sells “restaurant-type food.”4 Although the final rule’s broad definition of “similar retail food establishment,” which also expressly exempts schools,5 is legally permissible, the FDA acted on legally uncertain ground in exempting airplanes, trains, and food trucks through a surprising definition of “location.”6 On March 23, 2010, the ACA was signed into law, bringing federal nutrition-labeling requirements to restaurants for the first time.7 Sec- ––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– 1 See Nutrition Labeling and Education Act of 1990, 21 U.S.C. § 343(q)(5)(A)(i) (2006) (amended 2010). 2 Pub. L. No. 111-148, 124 Stat. 119 (2010) (codified as amended in scattered sections of 26 and 42 U.S.C.). 3 21 U.S.C. § 343(q)(5)(H)(i) (2012). 4 Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments, 79 Fed. Reg. 71,156, 71,163 (Dec. 1, 2014) [hereinafter Menu Labeling Final Rule] (to be codified at 21 C.F.R. pts. 11, 101). The rule defines restaurant-type food to include things like sit-down and drive-through meals, take-out and delivery pizza, buffets, salad bars, and foods intended for individual consumption (like sandwiches at a deli counter). See id. at 71,170. Food that “consumers usually store for use at a later time or customarily further prepare,” such as a loaf of bread or deli meat, is not restaurant-type food. Id. 5 See id. at 71,169. 6 See id. at 71,171. 7 See CTR. FOR FOOD SAFETY & APPLIED NUTRITION, FOOD & DRUG ADMIN., FDA2010-D-0370, DRAFT GUIDANCE FOR INDUSTRY: QUESTIONS AND ANSWERS REGARDING IMPLEMENTATION OF THE MENU LABELING PROVISIONS OF SECTION 4205 OF THE PATIENT PROTECTION AND AFFORDABLE CARE ACT OF 2010, at 4 (2010). 2098 2015] RECENT REGULATION 2099 tion 4205 of the ACA8 requires certain “restaurants and similar retail food establishments . . . with 20 or more locations” to provide specified nutrition information for “standard menu item[s].”9 The ACA requires covered establishments to disclose the calorie content “in a clear and conspicuous manner” directly on the menu along with “a succinct statement concerning suggested daily caloric intake.”10 The law also requires that covered establishments make additional nutrition information — such as sodium content — available in written form, and the menu must include a notice that this additional nutrition information is available upon request.11 The ACA set a deadline of March 23, 2011, for the FDA to issue implementing regulations.12 On July 7, 2010, the FDA solicited comments on how to implement the menu-labeling requirements.13 Although still receiving comments, the FDA published draft guidance to the industry in August 2010.14 In the draft guidance, the FDA interpreted the relevant portions of section 4205 to have gone into effect immediately upon enactment, but elected not to initiate any enforcement action until after a final rule had been promulgated.15 The draft guidance broadly interpreted “similar retail food establishments” to include entertainment venues like movie theaters, cafes and food courts in grocery stores, and “transportation carriers (e.g., airlines and trains).”16 It did not mention schools or define “locations.” The FDA withdrew the draft guidance on January 25, 2011,17 and issued its proposed menu-labeling rule for comments on April 6, 2011.18 The proposed rule identified the statutory term “similar retail food establishments” as ambiguous and proposed to define an establishment as similar to a restaurant (and therefore covered by the rule) “if it offers for sale restaurant or restaurant-type food and its primary ––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– 8 The nutrition-labeling provision was initially enacted as section 4205, Pub L. No. 111-148, § 4205, 124 Stat. 119, 573 (2010), and was codified at 21 U.S.C. § 343(q)(5). 9 21 U.S.C. § 343(q)(5)(H)(i). 10 Id. § 343(q)(5)(H)(ii). 11 See id. 12 See id. § 343(q)(5)(H)(x). 13 See Disclosure of Nutrient Content Information for Standard Menu Items Offered for Sale at Chain Restaurants or Similar Retail Food Establishments and for Articles of Food Sold from Vending Machines, 75 Fed. Reg. 39,026 (July 7, 2010). 14 CTR. FOR FOOD SAFETY & APPLIED NUTRITION, supra note 7, at 1. 15 Id. at 13. 16 Id. at 6. 17 Draft Guidance for Industry: Questions and Answers Regarding Implementation of the Menu Labeling Provisions of Section 4205 of the Patient Protection and Affordable Care Act of 2010; Withdrawal of Draft Guidance, 76 Fed. Reg. 4360 (Jan. 25, 2011). 18 Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments, 76 Fed. Reg. 19,192 (proposed Apr. 6, 2011) [hereinafter Menu Labeling Proposed Rule] (to be codified at 21 C.F.R. pts. 11, 101). 2100 HARVARD LAW REVIEW [Vol. 128:2098 business activity is the sale of food to consumers.”19 The proposed rule considered the sale of food to be an establishment’s “primary business activity” if the establishment either presented itself to the public as a restaurant or used greater than fifty percent of its gross floor area for the “preparation, purchase, service, consumption, or storage of food.”20 Under the primary-business test, grocery stores that sold restauranttype food would “generally” be covered by the rule, but movie theaters, trains, planes, schools, and hospitals would “generally” be exempted.21 On December 1, 2014, the FDA issued a final menu-labeling rule.22 Abandoning the primary-business test, the final rule applies to any establishment (including movie theaters) with 20 or more locations that “sell[s] restaurant-type food.”23 The rule exempts schools from the definition of “similar retail food establishment.”24 Where the statute applies to establishments with “20 or more locations,”25 the final rule defines “location” as “a fixed position or site,” thus exempting trains, airplanes, and food trucks from the menu-labeling requirements.26 Establishments must comply with the new rules by December 1, 2015.27 While the menu-labeling rule’s expansive reach has drawn popular criticism,28 the agency’s broad definition of “similar retail food establishment” is a permissible interpretation of the ACA, even though it in––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– 19 20 Id. at 19,196. Id. at 19,197. The FDA also sought comments on an alternative to the floor-area test that considered whether more than fifty percent of the establishment’s revenues are generated by food sales. Id. 21 See id. at 19,197 n.1, 19,198–99. Under certain proposed alternative primary-business tests (which relied on floor area used for the sale of restaurant-type food or percent of revenue generated by the sale of restaurant-type food), grocery stores would have generally not been covered. Id. at 19,198–99. 22 Menu Labeling Final Rule, supra note 4, at 71,156. 23 Id. at 71,164–66. 24 Id. at 71,169. 25 21 U.S.C. § 343(q)(5)(H)(i) (2012). 26 Menu Labeling Final Rule, supra note 4, at 71,171 (internal quotation marks omitted). The rule requires that covered establishments declare the calorie content of standard menu items on menus, menu boards, and signs adjacent to self-service food (like buffets), see id. at 71,158, 71,176–82, 71,191–205, 71,218–29, that additional written nutrition information be made available upon request, see id. at 71,158, 71,212–18, and that menus and menu boards include a “succinct statement” explaining the suggested daily calorie intake for adults, id. at 71,158, 71,205–11, and notifying customers that the additional nutritional information is available, see id. at 71,158, 71,211–12. The rule specifies how establishments will determine, see id. at 71,158, 71,229–33, and substantiate, see id. at 71,158, 71,233–37, their food’s nutrition content and establishes terms and conditions under which establishments not covered by the rule could voluntarily opt in to its requirements, see id. at 71,158, 71,237–38. 27 Id. at 71,240. 28 See, e.g., Sabrina Tavernise & Stephanie Strom, F.D.A. to Require Calorie Count, Even for Popcorn at the Movies, N.Y. TIMES (Nov. 24, 2014), http://www.nytimes.com/2014/11/25/us/fda -to-announce-sweeping-calorie-rules-for-restaurants.html. 2015] RECENT REGULATION 2101 cludes movie theaters and excludes schools. However, excluding airplanes, trains, and food trucks — under a definition of “location” that was introduced for the first time in the final rule — may be legally unsound as an impermissible interpretation and as a violation of noticeand-comment rulemaking procedures. The FDA’s interpretations of the statutory terms “similar retail food establishment” and “location” are governed by the two-step analysis laid out in Chevron U.S.A. Inc. v. Natural Resources Defense Council, Inc.29 First, a reviewing court determines whether a statutory term is ambiguous, and therefore open to agency interpretation, by looking to “whether Congress has directly spoken to the precise question at issue.”30 “Similar retail food establishment” is ambiguous under Chevron step one. Congress did not define the term in the statute. In a comment, the National Association of Theatre Owners argued that the language of the ACA indicates that Congress “clearly” intended to reach only “chain retail food establishments,” which “no one would associate with movie theaters and other establishments where the sale of food is incidental to or quite separate from the establishment’s primary purpose.”31 However, Congress’s choice to include the phrase “or other similar retail food establishment” indicates an intention to reach more broadly than just “restaurants,” delegating to the FDA the task of defining criteria by which an establishment can be judged to be “similar” to a restaurant. The ACA’s language is in fact more vague than the legislation in California and New York City on which it was modeled. Those jurisdictions were more explicit about defining establishments that are covered (New York City) or exempted (California) under their calorie-labeling requirements.32 If a court determines that “the statute is silent or ambiguous with respect to the specific issue,” it proceeds to Chevron step two and asks “whether the agency’s answer is based on a permissible construction of ––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– 29 30 31 467 U.S. 837 (1984). Id. at 842. National Association of Theatre Owners, Comment on Menu Labeling Proposed Rule, at 2 (July 5, 2011). The only relevant legislative history the organization cites is language in a 2012 House Committee on Appropriations Report opposing a rule that “would include establishments that are not primarily in the business of selling food for immediate consumption.” Id. at 2 n.6 (quoting H.R. REP. NO. 112-101, at 53 (2012)). A committee report from a Congress that has changed leadership since the passage of the ACA shines little light on the intent of the Congress that passed the ACA. Even if the Committee’s report were authoritative, the report does not assert that “similar retail food establishments” clearly precludes including entertainment venues; it advocates that the “FDA should define the term ‘restaurant’ to mean only restaurants . . . where the primary business is the selling of food for immediate consumption.” Id. (emphasis added) (quoting H.R. REP. NO. 112-101, at 53) (internal quotation mark omitted). 32 See Act of Sept. 30, 2008, ch. 600, § 2(a)(1)(A)–(I), 2008 Cal. Stat. 4288, 4289, repealed by Act of Oct. 2, 2011, ch. 415, § 2, 2011 Cal. Stat. 4185, 4186; N.Y.C., N.Y., HEALTH CODE §§ 81.01, 81.50 (2015). 2102 HARVARD LAW REVIEW [Vol. 128:2098 the statute.”33 Here, the FDA has developed criteria to define “similar retail food establishment” that are permissible under Chevron step two. The FDA’s construction has precedent: the Nutrition Labeling and Education Act of 199034 (NLEA), in defining what establishments were exempt from nutrition-labeling requirements, had included among restaurants “other establishments in which food is served for immediate human consumption or which is sold for sale or use in such establishments.”35 The ACA explicitly amended the NLEA to remove this exemption. The menu-labeling rule defines “similar retail food establishments” to include establishments, like movie theaters, that are like restaurants in that they offer prepared food that is “ready for human consumption”36 and eaten on the premises or very soon after leaving.37 The menu-labeling rule thus covers establishments for the same reasons that they were included in the NLEA’s exemption. Additionally, the FDA’s decision to exclude schools is permissible. The FDA responded to a comment advocating including “a school food service contractor that uses a central kitchen or cooks the same food for 20 schools” as a covered establishment under the rule.38 Although the FDA’s previous regulations implementing the 1990 NLEA included schools in the category of restaurants and other similar establishments that were then exempt from labeling requirements, the FDA can also choose to treat schools separately from restaurants now that restaurants must label their menus.39 In interpreting the ambiguous ACA term “similar retail food establishments” to exclude schools, the FDA found that “the traditional and long-standing role” of the Department of Agriculture (USDA) in regulating school meals was a sufficiently reasonable basis on which to decide to exclude food vendors in schools.40 The determination is the same even though the ACA requires the FDA to promulgate regulations to define covered establishments.41 While in Massachusetts v. EPA42 the Court precluded an ––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– 33 34 35 Chevron, 467 U.S. at 843. Pub. L. No. 101-535, 104 Stat. 2353 (codified as amended in scattered sections of 21 U.S.C.). See Menu Labeling Final Rule, supra note 4, at 71,165 (quoting 21 U.S.C. § 343(q)(5)(A)(i) (2006) (amended 2010)) (internal quotation mark omitted). In regulations, the FDA defined “other establishments” to include “e.g., institutional food service establishments, such as schools, hospitals, and cafeterias; transportation carriers, such as trains and airplanes; . . . [and] food service vendors, such as lunch wagons.” 21 C.F.R. § 101.9(j)(2)(ii) (2014). 36 Menu Labeling Final Rule, supra note 4, at 71,165 (quoting 21 U.S.C. 343(q)(5)(A)(i) (2012)). 37 See id. 38 Id. at 71,169; see also Robert Wood Johnson Foundation Center to Prevent Childhood Obesity, Comment on Menu Labeling Proposed Rule, at 2 (July 5, 2011) (advocating including schools in menu-labeling requirements). 39 Menu Labeling Final Rule, supra note 4, at 71,169. 40 Id. 41 See 21 U.S.C. § 343(q)(5)(H)(x)(I). 42 549 U.S. 497 (2007). 2015] RECENT REGULATION 2103 agency from relying on statutorily irrelevant factors — like the USDA’s authority over school meals — in refusing to exercise rulemaking authority under an unambiguous statute,43 the ambiguity of “similar retail food establishments” gives the FDA the authority to look to factors outside of the statute and decide to exclude schools from the menu-labeling rule.44 The FDA’s decision to exclude airplanes, trains, and food trucks, however, is legally questionable. The final rule suggested for the first time that the statute’s application to establishments with “20 or more locations” is ambiguous and defines “location” as “a fixed position or site,”45 thereby exempting airplanes, trains, and food trucks. The FDA introduced its definition of “location” in response to a comment asking for clarification about whether multiple locations of the same establishment in the same mall would count toward the “20 or more locations” that make a chain subject to the rule.46 The definition is also in response to a comment seeking clarification that “mobile facilities (such as food trucks),” which were not mentioned in the proposed rule, would be covered if they had twenty or more locations.47 With no legislative history relevant to the question of how to understand “location” in these examples, the FDA concluded that “location” required further definition, suggesting that it is an ambiguous statutory term under Chevron step one. The FDA consulted dictionaries to conclude that “the common meaning of the word ‘location’ involves a specific or fixed position on land or portion of land.”48 Thus, the rule counts two storefronts in the same mall as two locations, but does not cover “food facilities that do not have a fixed position or site,” including trains, airplanes, and food trucks.49 Even if uncertainty about how to count multiple storefronts within the same mall supports the FDA’s Chevron step one conclusion that ––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– 43 44 Id. at 529, 533–34. Cf. WildEarth Guardians v. U.S. EPA, 751 F.3d 649 (D.C. Cir. 2014). In that case, the D.C. Circuit upheld the EPA’s decision not to include coal mines under its interpretation of the Clean Air Act, which requires the EPA to regulate a “stationary source[] . . . [that] causes, or contributes significantly to, air pollution which may reasonably be anticipated to endanger public health or welfare.” 42 U.S.C. § 7411(b)(1)(A) (2012). The EPA did not determine whether coal mines contribute to air pollution that endangers public health but denied the petition for rulemaking because it “must prioritize its actions in light of limited resources and ongoing budget uncertainties.” WildEarth Guardians, 751 F.3d at 651 (quoting Notice of Final Action on Petition from Earthjustice to List Coal Mines as a Source Category and to Regulate Air Emissions from Coal Mines, 78 Fed. Reg. 26,739 (May 8, 2013) (to be codified at 40 C.F.R. pt. 63)) (internal quotation mark omitted). 45 Menu Labeling Final Rule, supra note 4, at 71,171. 46 Id. 47 Id. 48 Id. (emphasis added). 49 Id. 2104 HARVARD LAW REVIEW [Vol. 128:2098 “location” is ambiguous, the FDA’s construction to exclude mobile sites is likely impermissible under Chevron step two. When a court evaluates the reasonableness of an agency’s interpretation under Chevron step two, it examines the interpretation’s “‘fit’ with the statutory language as well as its conformity to statutory purposes.”50 While “location” may be ambiguous at the margins where two stores are operating on opposite ends of a mall, the FDA’s construction of “location” as tied to a tract of land is inconsistent with the statutory purpose of section 4205 of the ACA, which is to define a unit by which to count the number of franchises in a chain. Although airplanes, trains, and food trucks move their locations, they have unique, countable locations at any given moment in time.51 The result of the FDA’s construction is that a chain that operates nineteen storefronts and one food truck, or serves food on hundreds of airplanes, would not be covered by the rule, but a chain that operates twenty storefronts in the same mall would be. This construction focuses on a statutorily irrelevant factor — whether a location can move — to undermine the statute’s purpose, which is to provide consumers with nutrition information when they order restaurant-type food. Not only is the FDA’s definition of “location” vulnerable under Chevron, but it is also procedurally vulnerable. The Administrative Procedure Act (APA), which governs notice-and-comment rulemaking,52 requires that the final rule an agency adopts be the “logical outgrowth” of the rule proposed.53 The logical outgrowth requirement is an interpretation of the APA requirement that agencies provide in a notice of proposed rulemaking “either the terms or substance of the proposed rule or a description of the subjects and issues involved.”54 This requirement serves the principle of providing “fair notice.”55 ––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– 50 Abbott Labs. v. Young, 920 F.2d 984, 988 (D.C. Cir. 1990); see also Goldstein v. SEC, 451 F.3d 873, 881–84 (D.C. Cir. 2006) (finding SEC’s designation of investors in a hedge fund as “clients” of that fund inconsistent with the relevant statute’s text and purpose). 51 Although an agency often wins a case at Chevron step two, see Jason J. Czarnezki, An Empirical Investigation of Judicial Decisionmaking, Statutory Interpretation, and the Chevron Doctrine in Environmental Law, 79 U. COLO. L. REV. 767, 775 (2008), some scholars have argued that the two steps of Chevron are in fact two ways of articulating the same inquiry, see, e.g., Matthew C. Stephenson & Adrian Vermeule, Essay, Chevron Has Only One Step, 95 VA. L. REV. 597 (2009). Thus, it is possible to articulate the legal issue with the FDA’s construction of “location” as a Chevron step one problem: the statutory context in which “location” appears — as a unit by which to count the number of franchises in a chain — unambiguously prohibits the FDA from defining “location” as necessarily connected to a “tract of land”; the mobility or immobility of a location is irrelevant to the purpose of the statute in which “location” appears. 52 5 U.S.C. § 553(b)–(c) (2012). 53 Long Island Care at Home, Ltd. v. Coke, 551 U.S. 158, 174 (2007) (quoting Nat’l Black Media Coal. v. FCC, 791 F.2d 1016, 1022 (2d Cir. 1986)) (internal quotation marks omitted). 54 5 U.S.C. § 553(b)(3). 55 Long Island Care, 551 U.S. at 174; see also AFL-CIO v. Donovan, 757 F.2d 330, 338–40 (D.C. Cir. 1985) (invalidating for failure to provide adequate notice a final rule that introduced for 2015] RECENT REGULATION 2105 Public comments are likely insufficient to provide fair notice,56 especially here, where the two comments about “location” raised questions for clarification and did not propose definitions of “location.”57 The FDA’s decision to define “location” for the first time in a final rule fails the logical outgrowth test. Neither the draft guidance nor the proposed rule mentioned food trucks specifically, and the public could not have been on notice that the agency would treat food trucks separately from restaurants (under the primary-business test, food trucks would presumably be covered). Similarly, while the public was on general notice that whether airplanes and trains would be included within the definition of “similar retail food establishment” was at least up for debate, the public had no fair notice of, and thus no meaningful opportunity to comment on, the wisdom of using the definition of “location” to exclude those businesses. By contrast, the public had fair notice that the agency was considering whether “similar retail food establishments” should include movie theaters and exclude schools because both of those establishments were discussed in the proposed definition of “similar retail food establishment.”58 The public was therefore on notice that movie theaters could be included or excluded from the definition of “similar retail food establishment,” and their inclusion is a “logical outgrowth” of the proposed rule. A large buttered popcorn can pack up to 1,200 calories,59 which is 60% of the total daily suggested calorie intake for an adult.60 The FDA acted legally in bringing this information to consumers at the concession stand — and in choosing to leave school meals to the USDA. But for vendors in airplanes, trains, and food trucks, the FDA should open up its definition of “location” to public comment to vet the legality and wisdom of failing to disclose nutrition information to their customers. ––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– the first time a “substantial performance” test for whether a contract was performed in the United States); Chocolate Mfrs. Ass’n of U.S. v. Block, 755 F.2d 1098, 1105–07 (4th Cir. 1985) (invalidating for failing to provide adequate notice a final rule banning flavored milk from the Women, Infants, and Children (WIC) program even though the proposed rule indicated that the agency was looking to limit the “sugar, fat, and salt” content of permitted foods, id. at 1106). 56 Chocolate Mfrs., 755 F.2d at 1103 (finding a lack of fair notice notwithstanding the fact that the agency explained its rule through reference to seventy-eight comments (out of over 1,000) that called for banning flavored milk from the WIC program). 57 See Menu Labeling Final Rule, supra note 4, at 71,171. 58 Menu Labeling Proposed Rule, supra note 18, at 19,197–98, 19,197 n.1. 59 Jayne Hurley & Bonnie Liebman, BIG: Movie Theaters Fill Buckets . . . and Bellies, CENTER FOR SCI. PUB. INT. (Dec. 2009), http://www.cspinet.org/nah/articles/moviepopcorn .html [http://perma.cc/GKR7-2JQ2]. 60 The menu-labeling rule requires restaurants to post the following succinct statement: “2,000 calories a day is used for general nutrition advice, but calorie needs vary.” Menu Labeling Final Rule, supra note 4, at 71,256. Copyright © 2015 by The Harvard Law Review Association. Copyright of Harvard Law Review is the property of Harvard Law Review Association and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. PUBLIC HEALTH POLICY BRIEFS Supplementing National Menu Labeling The US Food and Drug Administration’s forthcoming national menu labeling regulations are designed to help curb the national obesity epidemic by requiring calorie counts on restaurants’ menus. However, posted calories can be easily ignored or misunderstood by consumers and fail to accurately describe the healthiness of foods. We propose supplemental models that include nutritional information (e.g., fat, salt, sugar) or specific guidance (e.g., “hearthealthy” graphics). The goal is to empower restaurant patrons with better data to make healthier choices, and ultimately to reduce obesity prevalence. (Am J Public Health. 2012;102: e11–e13. doi:10.2105/AJPH. 2012.301028) James G. Hodge Jr, JD, LLM, and Lexi C. White, BA FORTHCOMING NATIONAL menu labeling regulations from the US Food and Drug Administration (FDA)1 will equip Americans with new information to help guide their menu choices when they eat out. Based on requirements already in place in New York City (2008); Seattle---King County, Washington (2009); California (2009); Massachusetts (2009); and other jurisdictions, the FDA’s regulations will require chain restaurants nationwide to post caloric information on menus and menu boards. Although some restaurants already voluntarily provide such information via printed or electronic media, many of these resources are confusing, inaccessible, and largely ineffective.2 Lacking data at the point of sale in most cases, Americans largely order “in the dark” without actual knowledge of the calorie content or other nutritional facts about their restaurant meals. The overriding public health goal of menu labeling is to help people make healthier choices, consume fewer calories, lower their weights, and improve their health outcomes. Combined with increased physical activity and other measures, reductions in daily caloric intake are a central strategy in addressing the obesity epidemic nationally. Posting calories on restaurant offerings, much like those provided on packaged foods since 1968,3,4 may lead restaurant patrons to choose lower-calorie foods. Some data suggest that current menu labeling positively alters consumer habits and vendor practices. A New York City study in 2007, for example, found that Subway restaurant December 2012, Vol 102, No. 12 | American Journal of Public Health patrons who saw posted calorie information purchased on average 52 fewer calories per order than those who did not.5 Calorie postings on menus may also increase transparency and heighten restaurants’ accountability for the foods they serve.6 Not surprisingly, menu labeling has strong support from federal, state, and local public health advocates. Even the National Restaurant Association and many larger restaurants endorse forthcoming federal requirements, although largely because of the regulations’ preemptive effect on divergent state and local menulabeling practices.7 In principle, national menu labeling should work. In reality, however, it may not. Americans’ appetite for fast food coupled with sophisticated industry practices to design and market inexpensive, oversized portions loaded with unhealthy fats, salt, and sugars may undermine its positive effects. Lacking necessary data to make informed decisions against a constant marketing barrage of oversized, cheap, and easy restaurant meals, many individuals may still consume far more calories than they intend when they eat out. Some research suggests that menu labeling may have only limited effects on consumers’ behaviors, especially among adolescent or lower-income consumers who comprise a large part of the fast food market and tend to order on the basis of taste and price, not calories.8 Consumers may simply look past or ignore calorie information or fail to understand the nutritional meaning of calorie data. Within a social and economic environment that increasingly promotes the consumption of unhealthy foods, providing restaurant patrons with enhanced information to make nutritional decisions is paramount. NATIONALIZING MENU-LABELING PRACTICES The FDA’s national menulabeling requirements seek to (1) raise consumer awareness of the calorie content of restaurant offerings, (2) reduce the calorie content of existing menu items, and (3) increase the number of lowercalorie options. Applying to more than 275 000 restaurant or other retail food establishments with more than 20 locations, the regulations will require the posting of calorie data on menus, menu boards, and drive-thrus via text that is in similar font, size, and color as used to describe menu items and their price. Variable menu items offering different choices or size options, such as combination meals, must include an accurate calorie range (e.g., 350 to 510 calories).1 Though extensive, the FDA’s proposed regulations are limited in their scope. They do not presently apply to 75% of the nation’s restaurants (because they are not chains). Nor do they apply to hotels, movie theaters, convenience stores, or other entities whose primary business is not food service (even though they serve similar foods as chain restaurants). Only standard menu items prepared by restaurants on site, as well as self-serve salad bars and beverage dispensers, are covered. Calories will not be posted for condiments, alcoholic beverages, prepackaged foods (such Hodge and White | Peer Reviewed | Public Health Policy Briefs | e11 PUBLIC HEALTH POLICY BRIEFS a b Biggie Burger $3.99 550 Cal. Cal. 27% Biggie Burger $3.99 550 Cal. c Sodium 61% Fat 44% Biggie Burger $3.99 Sugar 8% d 550 Cal. Fat 29 g Sodium 996 mg Sugar 9g Biggie Burger $3.99 550 Cal. Note. FDA = US Food and Drug Administration. FIGURE 1—Supplemental models for menu labeling as follows (a) FDA menu labeling requirements, (b) model 1, (c) model 2, (d) model 3. as salad dressing), or temporary or “test” items that appear on the menu for 90 days or fewer per year (e.g., specialty sandwiches, drinks, or appetizers). Because of purported space limits on menus and boards and other factors, the FDA’s regulations also do not include more extensive nutritional data. All that the FDA requires in this regard are brief statements about the US Department of Agriculture’s daily calorie standard and how consumers may request additional, available nutritional data.1 SUPPLEMENTAL INFORMATION TO GUIDE HEALTHY CHOICES In addition to coverage-based limitations of the FDA’s menu labeling provisions are several practical shortcomings. Especially in fast-food environments where consumers tend to order rapidly, mere posting of calories is an insufficient guide for patrons to assess the nutritional qualities of menu items.8 For example, persons ordering single menu items may not be able to review or add calories accurately before they order. Concerning combination meals, the FDA allows reporting of wide ranges of calories depending on consumer options (e.g., fruit vs fries). More importantly, calorie data provide only a fraction of relevant nutritional data consumers need. As such, they are an incomplete proxy for restaurant patrons to use in distinguishing healthy from unhealthy foods.9 Ideally, health-conscious consumers may consider not only the e12 | Public Health Policy Briefs | Peer Reviewed | Hodge and White calories of menu items, but also their saturated or trans fat, sodium, and sugar contents, among other factors. More comprehensive nutritional information available on food wrappers, placemats, in-store posters, or online are easily ignored or available only after placing an order (e.g., data printed on fast food packaging). Limited space on menus and consumers’ capacity to apprehend data do not allow for exhaustive recitation of nutritional guidance on menus like what appears on packaged foods. Nor do consumers always need voluminous nutritional data to make healthy choices. What they do need, however, is something more than calorie data. Subject to additional research to identify and validate the most effective options to better inform consumers, we suggest that the FDA consider 3 alternatives to supplement basic calorie posting on menus as illustrated in Figure 1. Each of these alternatives is designed to fit within reasonable allotments of space on restaurant menus and boards. Model 1 provides core nutritional data for each menu item based on a percentage of recommended daily values of calories, fat, salt, and sugar in a pie chart format that many consumers can assess more easily than mere calorie information to order healthier options. Still, some patrons may find it difficult to scan or understand these statistical data when glancing quickly at a menu or menu board (note that the same can be said for numerical calorie counts). To help improve rapid comprehension of nutritional data, model 2 uses well-recognized “stoplight” imagery to denote a hierarchy of healthiness for each food item. The premise is simple: the more green lights a consumer sees, the healthier the food item may be. Colored indicators coupled with raw data may cater to more consumers, some of whom may be more receptive to statistical information, and others to more illustrative figures. Similar models supported by the National Health Service have shown promise in the United Kingdom where some manufacturers voluntarily provide comparable images of nutritional data on packaged foods.10 Model 3 offers an alternative approach. By using “heart healthy” figures featured on some existing packaged foods, menu items may be distinguished as “healthy” or “unhealthy” through markettested graphics that are wellknown and understood. Backed by additional FDA guidance on how to draw clear distinctions American Journal of Public Health | December 2012, Vol 102, No. 12 PUBLIC HEALTH POLICY BRIEFS between healthy and unhealthy foods, this model obviates a restaurant patron’s calculation of nutritional facts and assists them in choosing menu items on the basis of the items’ essential health qualities. Posting calorie counts on menus is one thing; requiring subjective classifications of menu items is another. We recognize that these models may evoke individual and political concerns about government attempts to moralize consumers’ food choices. Restaurants and their associations may object on issues of cost, practicality, and design. None of these objections, however, has prevented packaged food manufacturers from providing considerably more nutritional data on their packages. Restaurants may also raise First Amendment commercial speech and other legal challenges, especially if posting information consistent with these models causes consumers to change their buying habits. Commercial speech objections may stem from claims that government is mandating unwarranted speech without justification. Our models do not require overly burdensome, subjective speech that courts tend to prohibit under strict analyses. Instead, they reflect fact-based guidelines based on national nutrition standards that have already survived similar First Amendment arguments by the food and beverage industries. Like calorie posting, the purpose of our supplemental models is neither to vilify restaurants nor to force consumers to make healthier choices. We do not seek to restrict what restaurants can serve or limit what consumers can order. Rather, equipping consumers with more complete, nationally consistent nutritional data at the point of sale can help them make better informed choices about restaurant foods. Ultimately, enhanced menu labeling beyond mere calorie postings may positively change consumer and vendor habits and potentially help quell the rising obesity epidemic. j About the Authors James G. Hodge Jr and Lexi C. White are with the Sandra Day O’Connor College of Law, Arizona State University, Tempe. Correspondence should be sent to James G. Hodge Jr, JD, LLM, Lincoln Professor of Health Law and Ethics, Sandra Day O’Connor College of Law, Arizona State University, PO Box 877906, Tempe, AZ 85287-7906 (e-mail: james.hodge.1@asu. edu). Reprints can be ordered at http://www. ajph.org by clicking the “Reprints” link. This article was accepted August 6, 2012. Contributors Each author provided original research, drafting, and editing for all phases of the production of the article, including its initial design and conception stages. 6. Menu Labeling, Does Providing Nutrition Information at the Point of Purchase Affect Consumer Behavior? A Research Synthesis. Princeton, NJ: Robert Wood Johnson Foundation; 2009. 7. NRA files comments with FDA on menu-labeling regulations. National Restaurant Association; 2011. Available at: http://www.restaurant.org/nra_news_blog/ 2011/07/nra-asks-fda-to-make-menulabeling-rules-more-workable for-restaurants. cfm. Accessed June 21, 2011. 8. Parker-Pope T. After menu labels, parents and kids order same foods. New York Times. February 16, 2011. Available at: http://well.blogs.nytimes.com/ 2011/02/16/after-menu-labels-parentsand-kids-order-same-foods. Accessed May 25, 2012. 9. Wu HW, Sturm R. What’s on the menu? A review of the energy and nutritional content of US chain restaurant menus. Public Health Nutr. 2012(11): 1---10. 10. National Health Services. Food labels. Available at: http://www.nhs.uk/ livewell/goodfood/pages/food-labelling. aspx. Accessed May 25, 2012. Acknowledgments The authors would like to thank Chase Millea, Andrew Sorensen, and Daniel G. Orenstein at the Sandra Day O’Connor College of Law, Arizona State University, for their review and input concerning previous drafts of the article. Human Participant Protection No human participants were involved in the production of this research or article and, thus, no institutional review board approval was sought. References 1. Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments, 76 Federal Register 19,192 (April 6, 2011) (to be codified at 21 CFR, pt 11, 101). 2. Elbel B, Kersh R, Brescoll VL, Dixon LB. Calorie labeling and food choices: a first look at the effects on low-income people in New York City. Health Aff (Millwood). 2009;28(6):w1110---w1121. 3. Fair Packaging and Labeling Act, 15 USC §1451---1461 (1966). 4. Nutrition Labeling and Education Act of 1990, 21 USC §343 (1990). 5. Bassett MT, Dumanovsky T, Huang C, et al. Purchasing behavior and calorie information at fast-food chains in New York City 2007. Am J Public Health. 2008;98(8):1457---1459. December 2012, Vol 102, No. 12 | American Journal of Public Health Hodge and White | Peer Reviewed | Public Health Policy Briefs | e13 Copyright of American Journal of Public Health is the property of American Public Health Association and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. AJPH RESEARCH Predicted Impact of the Food and Drug Administration’s Menu-Labeling Regulations on Restaurants in 4 New Jersey Cities Jessie Gruner, PhD, RDN, Robin S. DeWeese, PhD, RDN, Cori Lorts, PhD, MPH, RDN, Michael J. Yedidia, PhD, and Punam Ohri-Vachaspati, PhD, RD Objectives. To determine the proportion of restaurants that will be required to post calorie information under the Food and Drug Administration’s menu-labeling regulations in 4 New Jersey cities. Methods. We classified geocoded 2014 data on 1753 restaurant outlets in accordance with the Food and Drug Administration’s guidelines, which will require restaurants with 20 or more locations nationwide to post calorie information. We used multivariate logistic regression analyses to assess the association between menu-labeling requirements and census tract characteristics. Results. Only 17.6% of restaurants will be affected by menu labeling; restaurants in higher-income tracts have higher odds than do restaurants in lower-income tracts (odds ratio [OR] = 1.55; P = .02). Restaurants in non-Hispanic Black (OR = 1.62; P = .02) and mixed race/ethnicity (OR = 1.44; P = .05) tracts have higher odds than do restaurants in nonHispanic White tracts of being affected. Conclusions. Additional strategies are needed to help consumers make healthy choices at restaurants not affected by the menu-labeling law. These findings have implications for designing implementation strategies for the law and for evaluating its impact. (Am J Public Health. 2018;108:234–240. doi:10.2105/ AJPH.2017.304162) See also Kraak, p. 158. T he proportion of calories consumed from food sources outside the home, including restaurants, has increased significantly since the 1970s and now constitutes roughly a third of daily calories consumed by both children and adults.1 Food purchased outside the home is typically larger in portion sizes, higher in fat and calories, and lower in fiber than is food prepared at home.1–4 Additionally, restaurant meals tend to be energy dense and nutrient poor and often exceed the typical calorie recommendations for single eating occasions.5–7 Although fast-food restaurants have been shown to contribute the most calories to food consumed away from home8 and typically serve food of poor dietary quality,7 some evidence suggests that meals from small chain and independent restaurants are more energy dense than are those from large, national chain restaurants.6 Furthermore, meal consumption 234 Research Peer Reviewed Gruner et al. away from home varies by sociodemographic characteristics. Higher-income individuals derive a greater proportion of calories from all sources away from home, but the contribution of calories from fast-food restaurants among lower-income individuals recently surpassed that for higher-income individuals.8,9 NonHispanic Black adults consume significantly more calories when dining out than do nonHispanic Whites and Hispanics.10 Overconsumption of calories is a primary risk factor for weight gain and obesity11; thus, it is not surprising that consumption of food away from home is associated with higher body weight.12 According to National Health and Nutrition Examination Survey data, 36% of adults and 17% of youths aged 2 to 19 years were obese (having a body mass index [defined as weight in kilograms divided by height in meters squared] ‡ 30.0) in 2011 through 2014.13 Because of the magnitude of the problem, finding strategies to prevent obesity is a public health priority. Restaurants have been identified as possible venues to target obesity prevention efforts, because both adults and children frequently consume meals in restaurants.14,15 The US surgeon general’s 2001 call to action to prevent obesity first proposed calorie menu labeling in restaurants as a strategy to prevent and decrease the burden of overweight and obesity.16 Soon after, the Food and Drug Administration (FDA) and the Institute of Medicine encouraged the restaurant industry to enact voluntary menu labeling.17 State and local governments also began trying to pass menu-labeling laws in 2003; however, these efforts encountered resistance from the restaurant industry. In 2006 New York City was the first local jurisdiction to pass menu labeling, and in 2008 California was the first state to successfully implement a statewide law.18 By 2010, 20 states and localities had passed varied menu-labeling policies,19 leading to different stakeholders coming together to negotiate uniform standards across all 50 states that would preempt more restrictive state or city policies. Menu labeling was finally passed into law nationwide as part of the Patient Protection ABOUT THE AUTHORS Jessie Gruner, Robin S. DeWeese, Cori Lorts, and Punam Ohri-Vachaspati are with the School of Nutrition and Health Promotion, Arizona State University, Phoenix. Michael J. Yedidia is with the Rutgers Center for State Health Policy, New Brunswick, NJ. Correspondence should be sent to Punam Ohri-Vachaspati, School of Nutrition and Health Promotion, Arizona State University, 500 N 3rd Street, Phoenix, AZ 85001 (e-mail: pohrivac@asu.edu). Reprints can be ordered at http://www.ajph.org by clicking the “Reprints” link. This article was accepted September 26, 2017. doi: 10.2105/AJPH.2017.304162 AJPH February 2018, Vol 108, No. 2 AJPH RESEARCH and Affordable Care Act in 2010.20 The primary goal of menu labeling is to help consumers make informed dietary choices,1 as studies show the average consumer and even nutrition professionals have trouble estimating the caloric content of meals eaten away from home.21,22 The FDA, tasked with creating guidelines for implementing menu labeling, released the final rules in December 2014, which require restaurants and similar food establishments with 20 or more locations nationwide to post calorie information on menus and menu boards.23 The FDA’s final guidance requires eligible restaurants to post calorie information by May 7, 2018.24 Research shows that in restaurant settings, although the majority of customers notice menu labeling, only 15% to 33% of patrons use the information when determining food or beverage choices.25–30 Therefore, studies examining the overall impact of menu labeling find no significant reduction in calorie purchases or consumption.28,31–34 However, studies looking at those who actively use calorie information show that users purchase fewer calories than do nonusers.26,29,30,35,36 Furthermore, there are disparities in who uses menu labeling. Adults with higher-income levels,26,30,37,38 adults aged 25 to 44 years,25 and adults who consume fast food more frequently37 are more likely to use menu labeling. The format for displaying menu labeling can also influence its effectiveness; for example, use of colors to identify healthier options has been shown to enhance comprehension and reduce caloric intake.39 As part of the upcoming FDA regulations, restaurants will also be required to add contextual language to help consumers understand menu labeling with respect to daily calorie recommendations (e.g., “2,000 calories a day is used for general nutrition advice, but calorie needs vary” for adults and “1,200 to 1,400 calories a day is used for general advice for children ages 4 to 8 years, but calorie needs vary” for children).23 Such statements have been shown to be beneficial in informing customers’ purchases.40 Systematic reviews examining the impact of menu labeling have reported mixed results.31,39,40 A 2015 meta-analysis concluded that menu labeling has the potential to reduce the number of calories purchased and consumed.39 Other reviews conclude that menu labeling may work only in specific contexts40 February 2018, Vol 108, No. 2 AJPH or may result in very small declines in calories purchased.31 Irrespective of differences in conclusions, all reviews support menu labeling as a relatively low-cost strategy that may encourage consumers to purchase fewer calories. The FDA projections for the cost benefit attributed to menu labeling in terms of improved health and longevity, primarily related to predicted reductions in obesity prevalence, range from $3.7 billion to $10.4 billion.1 These depend on the extent to which patrons shift their consumption behaviors toward healthier diets consistent with the Dietary Guidelines for Americans. The FDA and the National Restaurant Association, a long-time supporter of a uniform standard for displaying calorie information at chain restaurants, predict that menu labeling will affect 36% to 40% of US restaurants (approximately 298 600 establishments in 2130 chains).1,41 Because less than half of all restaurants are projected to be affected, we asked whether all communities would be equally exposed to menu labeling. We sought to determine the proportion of restaurants that will be affected by the new menu-labeling regulations in 4 urban, high-minority, low-income cities in New Jersey. Although other factors may contribute to consumer response to labeling, exposure is a precondition to its use. We also investigated whether such exposure to menu labeling will vary by the income and race/ ethnicity of census tracts within these cities. Considering that fast-food restaurants cluster in lower-income and racial/ethnic minority neighborhoods,42–45 we hypothesized that restaurants in lower-income census tracts and restaurants in census tracts with higher proportions of racial/ethnic minorities will be more likely to be affected by menu labeling. METHODS We obtained 2014 geocoded data on restaurant outlets in 4 New Jersey cities (Camden, New Brunswick, Newark, and Trenton) from InfoUSA and classified them using a standard protocol developed for a National Institutes of Health–funded study.46 The final analysis included 1753 restaurant locations. Consistent with the literature, we defined chain restaurants as establishments with multiple locations doing business under the same name, regardless of ownership type (e.g., individual franchise), that offer approximately the same menu items.47 Chain restaurants can be full or limited service. Limited-service restaurants, often referred to as fast-food restaurants or quick service restaurants, are establishments where patrons order and pay before eating. In full-service restaurants, patrons order and are served while seated and pay after eating.48 Because the menu-labeling law will be applied to all types of outlets with 20 or more locations nationwide, including full- and limited-service restaurants, we did not separate out the different restaurant types. We distinguished between restaurants that will (i.e., any restaurant with 20 or more locations nationwide) and those that will not (i.e., restaurants with fewer than 20 locations nationwide) be affected by menu-labeling regulations. Outcome Variable We first classified restaurants located in the 4 cities using a list of the top 100 chain restaurants from a published Technomic, Inc. report49; all restaurants on this list had 20 or more locations nationwide. For restaurants that were not on the Technomic list, we used store locater features available on restaurant web pages to determine whether the restaurant had 20 or more locations. In accordance with the FDA’s guidelines,23 we identified restaurants that are part of a chain with 20 or more locations doing business under the same name as establishments likely to be affected by menu-labeling regulations, which we coded as 1 (vs 0 for others). Explanatory Variables We obtained census tract characteristics using data from the 2011 through 2015 American Community Survey.50 We included only tracts with restaurants in the analysis (n = 267). Of the 312 census tracts across the 4 New Jersey cities, 45 did not have a restaurant located in the tract; we excluded these from our analysis. Explanatory variables included median household income and racial/ethnic characteristics of census tracts where restaurants were located. We used these variables in categorical formats to allow our examination of differences between the groups that are furthest apart (e.g., lowest vs highest income), as is often done in similar studies examining neighborhood context.9,44,45,51,52 We categorized the median Gruner et al. Peer Reviewed Research 235 AJPH RESEARCH household income for each tract on the basis of tertiles to create lower-, middle- and higher-income categories. We used the proportions of non-Hispanic Whites, nonHispanic Blacks, and Hispanics to calculate a majority race variable, coding tracts with predominately non-Hispanic Whites (> 50% of the population) as 1, tracts with predominately non-Hispanic Blacks as 2, tracts with predominately Hispanics as 3, and tracts with no predominate race/ethnicity category as 4. Analysis We used multivariate logistic regression analyses to assess the association between being subject to menu-labeling requirements and census tract characteristics. We ran multivariate and descriptive analyses using SPSS version 23 (IBM-SPSS Statistics, Inc., Somers, NY). We set the a-level of significance at .05 for all analyses. RESULTS A summary of the restaurants in the 4 New Jersey cities that meet the criteria for being subject to menu labeling is presented in Table 1. Of the 1753 restaurants located in the study area, 308 (17.6%) belonged to chains with 20 or more locations and will therefore be required to post calorie information. Of the restaurants to be affected by menu labeling, 245 locations belonged to chains with a top 100 ranking on the basis of sales,49 and 63 locations were part of local or unranked chains with at least 20 locations. Chains most frequently represented in the study sample that will be required to post menu labels included Dunkin Donuts, Subway, McDonald’s, Burger King, Domino’s Pizza, Wendy’s, Kentucky Fried Chicken, and Popeyes Louisiana Kitchen. Conversely, 1445 restaurants (approximately 82% of all restaurants in New Jersey), which were independent or chains with fewer than 20 locations nationwide, will not be affected by the FDA’s menu-labeling regulations. Table 2 shows the characteristics, including race/ethnicity, population density, and land mass, of census tracts in which restaurants were located. Median household income across all tracts was $47 426. We 236 Research Peer Reviewed Gruner et al. TABLE 1—Number of Restaurants in Cities Projected to Be Affected by Menu-Labeling Regulations: 4 New Jersey Cities, 2014 Restaurant Chain McDonald’s Starbucks No. Locationsa (n = 1753) Rank on Technomic Top 100b (n = 245) 17 1 4 2 Subway 36 3 Burger King 15 4 Wendy’s 11 5 Taco Bell 6 6 Dunkin’ Donuts 63 7 Pizza Hut 6 9 Applebee’s 3 10 Panera Bread 1 11 KFC 10 12 Domino’s Pizza 11 13 Chipotle Mexican Grill 2 15 Chili’s Bar and Grill 1 17 Little Caesars 6 19 Dairy Queen 3 20 Arby’s 1 22 IHOP 3 23 Papa John’s 9 24 10 27 1 32 Popeyes Louisiana Kitchen Texas Roadhouse Jimmy John’s 1 36 TGI Fridays 1 37 Five Guys Burgers & Fries 2 43 Church’s Chicken 1 50 Hooters 1 51 Boston Market 3 68 Baskin-Robbins 2 73 White Castle 5 74 Jamba Juice 1 78 Famous Dave’s 1 82 Quiznos 1 84 Checkers/Rally’s 4 86 On the Border Mexican Grill and Cantina 1 94 Cold Stone Creamery Other chain restaurants (identified through 2 98 63 Not ranked store locater web searches) Note. IHOP = International House of Pancakes; KFC = Kentucky Fried Chicken. Of the total number of restaurant locations, 1445 (82.4%) will not be affected by the menu labeling and 308 (17.6%) will be affected. a Included restaurant locations in Camden, New Brunswick, Newark, and Trenton. b 2015 Technomic Inc., Top 100 Chain Restaurant Report. All restaurants included in the list had > 20 locations nationwide and so are eligible for menu labeling. AJPH February 2018, Vol 108, No. 2 AJPH RESEARCH TABLE 2—Characteristics of Census Tracts Where Restaurants Were Located: 4 New Jersey Cities, 2014 Characteristic Total Mean land area, km2 (SD) Population Density, People/km2, Mean 6SD Land Area, km2, Mean 6SD 0.73 60.51 1.51 (3.06) 2 Mean population density, people/km (SD) 5 788 (3 829) Mean median household Income, $ (SD) 47 426 (20 563) Lower tertile, $ < 36 997 6 186 63 001 Middle tertile, $ 36 997–52 557 7 249 64 215 1.03 61.71 Higher tertile, $ > 52 557 3 977 63 414 2.60 64.55 Majority non-Hispanic White, % 18.0 4 047 64 078 2.38 63.03 Majority non-Hispanic Black, % 36.8 6 128 62 843 0.85 61.66 Majority Hispanic, % 20.8 8 227 64 232 0.92 61.91 No majority, % 24.4 4 498 63 449 2.35 64.74 Race/ethnicity proportionsa Note. Number of census tracts was n = 267. The cities were Camden, New Brunswick, Newark, and Trenton. a Majority categories defined as census tracts with > 50% of residents of the specified race/ethnicity. categorized approximately 37% of census tracts as majority non-Hispanic Black, 24.4% as mixed race/ethnicity tracts, approximately 21% as majority Hispanic, and 18% as nonHispanic White. Mean population density and mean land area across all tracts and across income and racial/ethnic categories are also presented. Table 3 shows, for all census tracts having at least 1 restaurant, the number of restaurants and the proportion required to post menu labels, by income and race/ethnicity of the tracts. Middle-income tracts had the largest number of restaurants, followed by high-income tracts. Higher-income tracts had the greatest proportion of restaurants (20.7%) projected to TABLE 3—Total Restaurants and Proportion of Restaurants Required to Post Menu Labels by Census Tract, and Adjusted Associations Between Menu-Labeling Status and Census Tract Characteristics: 4 New Jersey Cities, 2014 Characteristic No. Restaurants No. Required to Post Menu Labels (%) 1753 308 (17.6) Total ORa (95% CI) b Income categories, tertile, $ Lower, < 36 997 506 78 (15.4) Middle, 36 997–52 557 689 114 (16.5) 1.25 (0.90, 1.73) Higher, > 52 557 552 114 (20.7) 1.55 (1.08, 2.23) 1 (Ref) Race/ethnicityc Majority non-Hispanic White 339 56 (16.5) Majority non-Hispanic Black 487 100 (20.5) 1.62 (1.08, 2.43) 1 (Ref) Majority Hispanic 405 44 (10.9) 0.74 (0.47, 1.17) No majority 521 108 (20.7) 1.44 (1.01, 2.07) Note. CI = confidence interval; OR = odds ratio. Cities were Camden, New Brunswick, Newark, and Trenton. a From multivariate logistic regression analysis used to assess associations between menu-labeling status and census tract characteristics, adjusting for income and race/ethnicity. b Income information missing for 6 census tracts; regression models adjusted for race/ethnicity. c Race/ethnicity information missing for 1 census tract; majority categories defined as tracts with > 50% of residents of the specified race/ethnicity; regression models adjusted for income. February 2018, Vol 108, No. 2 AJPH be affected by menu labeling, followed by middle-income tracts (16.5%). Lower-income tracts had the smallest proportion of restaurants that met the criteria for menu labeling at 15.4%. Tracts with no racial/ethnic majority had the most restaurants, followed by majority non-Hispanic Black tracts, majority Hispanic tracts, and majority non-Hispanic White tracts. Tracts with no racial/ethnic majority had the largest proportion of restaurants projected to be affected by menu labeling, at 20.7%; followed by majority non-Hispanic Black neighborhoods, at 20.5%; and majority nonHispanic White neighborhoods, at 16.5%. Majority Hispanic tracts had the smallest proportion of restaurants likely to be subject to menu labeling, at 10.9%. Results from logistic regression assessing the independent association between the potential for being affected by menu labeling and restaurant census tract characteristics are also presented in Table 3. Restaurants located in the highest-income tracts have 55% higher odds of being affected by menu labeling than do restaurants in lowest-income tracts (odds ratio [OR] = 1.55; confidence interval [CI] = 1.08, 2.23; P = .02). Restaurants located in majority non-Hispanic Black tracts have 62% greater odds of being affected by menu labeling than do restaurants located in majority non-Hispanic White tracts (OR = 1.62; CI = 1.08, 2.43; P = .02). Restaurants located in census tracts with no majority racial/ethnic group have 44% greater odds of being affected by menu labeling than do restaurants in majority non-Hispanic White tracts (OR = 1.44; CI = 1.01, 2.07; P = .048). We also ran regression models with continuous variables (data not shown), and we observed similar results for racial/ethnic characteristics; restaurants in neighborhoods with higher proportions of non-Hispanic Black residents were more likely to be eligible for menu labeling. However, when we used income as a continuous variable, the incremental association was not significant. DISCUSSION Less than a fifth (17.6%) of restaurants in 4 New Jersey cities (Camden, New Brunswick, Newark, and Trenton) will be required to comply with the mandated US menulabeling law, set to take effect on May 7, 2018. Gruner et al. Peer Reviewed Research 237 AJPH RESEARCH The proportion of restaurants subject to menu-labeling regulations in this sample is less than half of what the FDA and the National Restaurant Association project nationally (36%–40%).1,41 We found the most restaurants overall in middle-income tracts and tracts with no racial/ ethnic majority. Low-income tracts and majority non-Hispanic White tracts had the fewest restaurants. Previous research on restaurant density and neighborhood characteristics produced mixed results. Although most studies found that both full- and limitedservice restaurants are more likely to be located in low- and middle-income neighborhoods,43–45,53 as well as in predominately Black or mixed race/ethnicity neighborhoods,42–44 this is not always the case. Wang et al.,52 using a sample from 4 cities in California, found that residents of middle socioeconomic status tracts lived closer to fast-food restaurants than did residents of low and high socioeconomic status. In a nationally representative sample, Powell et al.,45 found that minority communities were less likely to have fast-food or sit-down restaurants than were White neighborhoods. Finally, Mazidi and Speakman found that full-service restaurants and fast-food restaurants were more likely to be located in wealthier, more educated neighborhoods.54 We found that anticipated exposure to menu labeling varies by neighborhood income and race/ethnicity. Restaurants located in the highest-income tracts (median income above $52 557) are more likely to be affected by menu labeling than are those located in the lowest-income tracts (median income below $36 997), and restaurants located in majority non-Hispanic Black or majority mixed race/ethnicity tracts are also more likely to be affected by the menu-labeling mandate. These findings are consistent with the research of Austin et al.,51 who found that fast-food chain restaurants in Chicago, Illinois, were more likely to be located in high-income areas and that few restaurants were located in low-income neighborhoods (neighborhoods with median household incomes below $30 300). Currently, only chain restaurants (those with 20 or more locations nationwide) are required to post calorie information and provide additional nutrition information to customers on request. Austin et al. argue that chain restaurants may be hesitant to locate in 238 Research Peer Reviewed Gruner et al. impoverished areas.51 Similar results have been observed with grocery stores, with low-income neighborhoods having fewer supermarkets than do high-income areas.55 Market demand and land availability may explain location decisions for both restaurants and grocery stores.55 Notably, a relatively high proportion of restaurants in nonHispanic Black neighborhoods, the population among whom obesity prevalence is the highest,9 will be subject to menu labeling. A similar prevalence was not observed in majority Hispanic tracts, however. These findings raise multiple concerns with regard to the impending implementation of the national menu-labeling law. First, less than a fifth of all restaurants in lowincome communities are projected to be required to display calorie menu labels. Furthermore, the odds of having restaurants with calorie menu labeling are lower in the lowest-income neighborhoods and in Hispanic neighborhoods—communities with higher rates of obesity. The consequences in terms of health equity of this differential exposure to menu labeling for obesity prevention may be further exacerbated by the fact that adults with lower-income levels are less likely to notice and use menu labeling.26,30,37,38 Therefore, additional interventions are needed in low-income areas to help consumers make healthier choices when dining out to prevent further health disparities among at-risk populations. Strengths and Limitations To our knowledge, we are the first to assess the extent to which restaurants located in low-income and high-minority communities will be affected by menu-labeling regulations. We are also the first to investigate differences in menu-labeling exposure on the basis of variations in neighborhood demographics, including income and race/ethnicity. A distinguishing strength of our study is that we categorized restaurants using a standardized process, with commercially available sources and web searches. A study limitation was the inclusion of only 4 low-income urban cities in the sample. Additionally, we confined food outlets to restaurants; other eating establishments, including movie theaters, corner stores, grocery stores, and vending machines, will also be subject to the menu-labeling mandate. The FDA estimates that an additional 20% of other food establishments will be affected by the final menu-labeling rule, including 18% of grocery stores, 30% of convenience stores, and 54% of movie theaters.1 Exposure to menu labeling will be increased in communities with these venues. Public Health Implications Previous research indicates that individuals who use menu labeling purchase fewer calories than do those who do not. Because only 15% to 33% of patrons report using menu labeling in restaurants that display the information, educational and promotional campaigns have the potential to increase menu label use among those exposed to it. However, because less than a fifth of the restaurants we studied are projected to be required to comply with menu-labeling requirements, low exposure—particularly in low-income communities and in Hispanic and non-Hispanic White communities—may limit the impact of the policy on population health and health inequities. Additional strategies are needed to help consumers make healthier choices when eating in restaurants that will not be affected by menu labeling under the current law. One strategy would be to increase menu-labeling exposure at restaurants not currently covered by the law. Expanding menu labeling may require technical assistance and financial incentives if smaller chains and independent restaurants, which have been shown to serve energy-dense meals,6 are to offer nutrition information to consumers. The FDA estimates the cost of nutrition analysis to be between $32 800 and $120 500 per chain.1 Although this cost is likely to be affordable for larger chains, economic incentive may be critical for others. Consumer demand may also promote expansion of menu labeling; results from previous studies suggest that the majority of customers want to see calorie information posted in restaurants.56,57 Effective communication strategies are needed to raise consumer awareness, understanding, and use of menu labeling. Other strategies for helping consumers make healthier choices when eating out include reformulating restaurant meals to lowercalorie options, adding healthier sides and AJPH February 2018, Vol 108, No. 2 AJPH RESEARCH entrée options, modifying and standardizing portion sizes, and promoting options that meet specific nutritional guidelines.39,58–60 Such efforts should target low-income communities, which already carry a disproportionate burden of poor diet quality and health outcomes, to address diet-related health inequities. CONTRIBUTORS J. Gruner collected data, conducted the analysis, and wrote the first draft of the article. R. S. DeWeese created the database. R. S. DeWeese, C. Lorts, and M. J. Yedidia revised the article. C. Lorts collected the data. M. J. Yedidia interpreted the findings. M. J. Yedidia and P. Ohri-Vachaspati procured grant funding. P. Ohri-Vachaspati conceptualized the study, analyzed the data, and developed the article. HUMAN PARTICIPANT PROTECTION The Arizona State University and Rutgers University institutional review boards approved this study. REFERENCES 1. Food and Drug Administration. Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments. US Department of Health and Human Services: Washington, DC; 2014. 11. Malik VS, Willett WC, Hu FB. Global obesity: trends, risk factors and policy implications. Nat Rev Endocrinol. 2013;9(1):13–27. 29. Pulos E, Leng K. Evaluation of a voluntary menulabeling program in full-service restaurants. Am J Public Health. 2010;100(6):1035–1039. 12. Fulkerson JA, Farbakhsh K, Lytle L, et al. Away-fromhome family dinner sources and associations with weight status, body composition, and related biomarkers of chronic disease among adolescents and their parents. J Am Diet Assoc. 2011;111(12):1892–1897. [Erratum in J Am Diet Assoc. 2012;112(5):762] 30. Green JE, Brown AG, Ohri-Vachaspati P. Sociodemographic disparities among fast-food restaurant customers who notice and use calorie menu labels. J Acad Nutr Diet. 2015;115(7):1093–1101. 13. Ogden CL, Carroll MD, Fryar CD, Flegal KM. Prevalence of Obesity Among Adults and Youth: United States, 2011–2014. Hyattsville, MD: National Center for Health Statistics; 2015. NCHS data brief no. 219. 14. Smith LP, Ng SW, Popkin BM. Trends in US home food preparation and consumption: analysis of national nutrition surveys and time use studies from 1965–1966 to 2007–2008. Nutr J. 2013;12:45. 15. Poti JM, Popkin BM. Trends in energy intake among US children by eating location and food source, 1977– 2006. J Am Diet Assoc. 2011;111(8):1156–1164. 16. US Department of Health and Human Services. The Surgeon General’s Call to Action to Prevent and Decrease Overweight and Obesity. Rockville, MD; 2001. 17. Koplan J, Liverman C, Kraak V. Preventing Childhood Obesity: Health in the Balance. Washington, DC: National Academies Press; 2005. 18. Armstrong K. Menu Labeling Legislation: Options for Requiring the Disclosure of Nutritional Information in Restaurants. St. Paul, MN: Tobacco Law Center; 2008. 2. Lakdawalla D, Philipson T. The Growth of Obesity and Technological Change: A Theoretical and Empirical Examination. Cambridge, MA: National Bureau of Economic Research; 2002. NBER working paper 8946. 19. Center for Science in the Public Interest. Menu labeling timeline. 2017. Available at: https://cspinet. org/sites/default/files/attachment/menulabeling.pdf. Accessed July 24, 2017. 3. Philipson TJ, Posner RA. The Long-Run Growth in Obesity as a Function of Technological Change. Cambridge, MA: National Bureau of Economic Research; 1999. NBER working paper 7423. 20. Patient Protection and Affordable Care Act, Pub L No. 111-148, 124 Stat. 855 (March 2010), section 4205. 4. Lin B-H, Guthrie J. Nutritional Quality of Food Prepared at Home and Away From Home. Washington, DC: US Department of Agriculture, Economic Research Service; 2012. 21. Backstrand J, Wootan MG, Young L, Hurley J. Fat Chance. Washington, DC: Center for Science in the Public Interest; 1997. 31. Long MW, Tobias DK, Cradock AL, Batchelder H, Gortmaker SL. Systematic review and meta-analysis of the impact of restaurant menu calorie labeling. Am J Public Health. 2015;105(5):e11–e24. 32. Sinclair SE, Cooper M, Mansfield ED. The influence of menu labeling on calories selected or consumed: a systematic review and meta-analysis. J Acad Nutr Diet. 2014;114(9):1375–1388.e1315. 33. Swartz JJ, Braxton D, Viera AJ. Calorie menu labeling on quick-service restaurant menus: an updated systematic review of the literature. Int J Behav Nutr Phys Act. 2011;8:135. 34. Cantor J, Torres A, Abrams C, Elbel B. Five years later: awareness of New York City’s calorie labels declined, with no changes in calories purchased. Health Aff (Millwood). 2015;34(11):1893–1900. 35. Krieger JW, Chan NL, Saelens BE, Ta ML, Solet D, Fleming DW. Menu labeling regulations and calories purchased at chain restaurants. Am J Prev Med. 2013;44(6): 595–604. 36. Bassett MT, Dumanovsky T, Huang C, et al. Purchasing behavior and calorie information at fast-food chains in New York City, 2007. Am J Public Health. 2008; 98(8):1457–1459. 37. Wethington H, Maynard LM, Haltiwanger C, Blanck HM. Use of calorie information at fast-food and chain restaurants among US adults, 2009. J Public Health (Oxf). 2014;36(3):490–496. 38. Ellison B, Lusk JL, Davis D. Looking at the label and beyond: the effects of calorie labels, health consciousness, and demographics on caloric intake in restaurants. Int J Behav Nutr Phys Act. 2013;10:21. 22. Elbel B. Consumer estimation of recommended and actual calories at fast food restaurants. Obesity (Silver Spring). 2011;19(10):1971–1978. 39. Littlewood JA, Lourenço S, Iversen CL, Hansen GL. Menu labelling is effective in reducing energy ordered and consumed: a systematic review and meta-analysis of recent studies. Public Health Nutr. 2016;19(12):2106–2121. 23. Food and Drug Administration. Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments. Washington, DC: US Department of Health and Human Services; 2014. 40. VanEpps EM, Roberto CA, Park S, Economos CD, Bleich SN. Restaurant menu labeling policy: review of evidence and controversies. Curr Obes Rep. 2016;5(1):72–80. 6. Urban LE, Lichtenstein AH, Gary CE, et al. The energy content of restaurant foods without stated calorie information. JAMA Intern Med. 2013;173(14):1292–1299. 24. Food and Drug Administration. Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Extension of Comment. Washington, DC: US Department of Health and Human Services; 2017. 41. Health Affairs. The FDA’s menu-labeling rule (updated). 2015. Available at: http://www.healthaffairs. org/do/10.1377/hpb20150713.56602/full. Accessed July 22, 2017. 7. Kirkpatrick SI, Reedy J, Kahle LL, Harris JL, OhriVachaspati P, Krebs-Smith SM. Fast-food menu offerings vary in dietary quality, but are consistently poor. Public Health Nutr. 2014;17(4):924–931. 25. Dumanovsky T, Huang CY, Bassett MT, Silver LD. Consumer awareness of fast-food calorie information in New York City after implementation of a menu labeling regulation. Am J Public Health. 2010;100(12):2520–2525. 42. Larson NI, Story MT, Nelson MC. Neighborhood environments: disparities in access to healthy foods in the US. Am J Prev Med. 2009;36(1):74–81. 8. Guthrie J, Lin B-H, Smith TA. Linking federal food intake surveys provides a more accurate look at eating out trends. 2016. Available at: https://www.ers.usda.gov/ amber-waves/2016/june/linking-federal-food-intakesurveys-provides-a-more-accurate-look-at-eating-outtrends. Accessed July 24, 2017. 26. Dumanovsky T, Huang CY, Nonas CA, Matte TD, Bassett MT, Silver LD. Changes in energy content of lunchtime purchases from fast food restaurants after introduction of calorie labelling: cross sectional customer surveys. BMJ. 2011;343:d4464. 5. Urban LE, Weber JL, Heyman MB, et al. Energy contents of frequently ordered restaurant meals and comparison with human energy requirements and U.S. Department of Agriculture database information: a multisite randomized study. J Acad Nutr Diet. 2016;116(4): 590–598.e596. 9. Zagorsky JL, Smith PK. The association between socioeconomic status and adult fast-food consumption in the US. Econ Hum Biol. 2017;27(pt A):12–25. 27. Elbel B, Gyamfi J, Kersh R. Child and adolescent fast-food choice and the influence of calorie labeling: a natural experiment. Int J Obes (Lond). 2011;35(4): 493–500. 10. Nguyen BT, Powell LM. The impact of restaurant consumption among US adults: effects on energy and nutrient intakes. Public Health Nutr. 2014;17(11): 2445–2452. 28. Elbel B, Kersh R, Brescoll VL, Dixon LB. Calorie labeling and food choices: a first look at the effects on low-income people in New York City. Health Aff (Millwood). 2009;28(6):w1110–w1121. February 2018, Vol 108, No. 2 AJPH 43. Block JP, Scribner RA, DeSalvo KB. Fast food, race/ ethnicity, and income: a geographic analysis. Am J Prev Med. 2004;27(3):211–217. 44. Morland K, Wing S, Diez Roux A, Poole C. Neighborhood characteristics associated with the location of food stores and food service places. Am J Prev Med. 2002;22(1):23–29. 45. Powell LM, Chaloupka FJ, Bao Y. The availability of fast-food and full-service restaurants in the United States: associations with neighborhood characteristics. Am J Prev Med. 2007;33(4 suppl):S240–S245. 46. Ohri-Vachaspati P, Martinez D, Yedidia MJ, Petlick N. Improving data accuracy of commercial food outlet databases. Am J Health Promot. 2011;26(2):116–122. Gruner et al. Peer Reviewed Research 239 AJPH RESEARCH 47. Department of Health and Human Services. A labeling guide for restaurants and retail establishments selling away-from-home foods—part II (menu labeling requirements in accordance with the Patient Protection Affordable Care Act of 2010). Fed Regist. 2016;81: 27067–27068. 48. US Census Bureau. North American industry classification system. 2017. Available at: https://www.census. gov/cgi-bin/sssd/naics/naicsrch?code=722511&search=2017% 20NAICS%20Search. Accessed July 22, 2017. 49. Romero P. New top 500 chain ranking shows cracks in the status quo. 2015. Available at: http://www. restaurantbusinessonline.com/financing/new-top500-chain-ranking-shows-cracks-status-quo. Accessed November 12, 2015. 50. US Census Bureau. American Community Survey (ACS). Available at: https://www.census.gov/programssurveys/acs/methodology.html. Accessed November 12, 2015. 51. Austin SB, Melly SJ, Sanchez BN, Patel A, Buka S, Gortmaker SL. Clustering of fast-food restaurants around schools: a novel application of spatial statistics to the study of food environments. Am J Public Health. 2005;95(9): 1575–1581. 52. Wang MC, Kim S, Gonzalez AA, MacLeod KE, Winkleby MA. Socioeconomic and food-related physical characteristics of the neighbourhood environment are associated with body mass index. J Epidemiol Community Health. 2007;61(6):491–498. 53. Larson N, Neumark-Sztainer D, Laska MN, Story M. Young adults and eating away from home: associations with dietary intake patterns and weight status differ by choice of restaurant. J Am Diet Assoc. 2011;111(11): 1696–1703. 54. Mazidi M, Speakman JR. Higher densities of fast-food and full-service restaurants are not associated with obesity prevalence. Am J Clin Nutr. 2017;106(2):603–613. 55. Karpyn A, Treuhaft S. The Grocery Gap: Who Has Access to Healthy Food and Why It Matters. New York, NY: PolicyLink; Food Trust; 2010. 56. Fitch RC, Harnack LJ, Neumark-Sztainer DR, et al. Providing calorie information on fast-food restaurant menu boards: consumer views. Am J Health Promot. 2009; 24(2):129–132. 57. Bleich SN, Pollack KM. The publics’ understanding of daily caloric recommendations and their perceptions of calorie posting in chain restaurants. BMC Public Health. 2010;10:121. 58. Anzman-Frasca S, Mueller MP, Sliwa S, et al. Changes in children’s meal orders following healthy menu modifications at a regional US restaurant chain. Obesity (Silver Spring). 2015;23(5):1055–1062. 59. Cohen DA, Story M. Mitigating the health risks of dining out: the need for standardized portion sizes in restaurants. Am J Public Health. 2014;104(4):586–590. 60. Kraak VI, Englund T, Misyak S, Serrano EL. A novel marketing mix and choice architecture framework to nudge restaurant customers toward healthy food environments to reduce obesity in the United States. Obes Rev. 2017;18(8):852–868. 240 Research Peer Reviewed Gruner et al. AJPH February 2018, Vol 108, No. 2 Copyright of American Journal of Public Health is the property of American Public Health Association and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. AJPH EDITORIALS Comprehensive Restaurant-Sector Changes Are Essential to Reduce Obesity Risk for All Americans See also Gruner et al., p. 234. Advocates celebrated a victory when the 111th US Congress enacted the Affordable Care Act, Public Law 111-148 (HR 3590), which was signed into law on March 23, 2010.1 Section 4205 mandated that food vendors and quick-service restaurant, fast-casual restaurant, and full-service restaurant chains with more than 20 US locations would be required to disclose calories on menus and menu boards and make other nutrition information available to customers upon request (bit.ly/ 2y8d403). The law directed the Food and Drug Administration to provide guidance and oversight for industries affected by the law.1 Public health advocates could not have predicted that it would take 15 years to champion this legislation—seven years to translate local advocacy efforts into a national law and eight years to finalize the regulatory guidance requiring chain restaurants to post calorie information starting May 7, 2018. In this issue of AJPH, using geocoded data for 1753 restaurant outlets in four New Jersey cities in 2014, Gruner et al. (p. 234) report on the predicted impact of the Food and Drug Administration’s menu-labeling regulation. The results showed that 84% of independent nonchain restaurants in the four large cities would not need to comply with the restaurant menu-labeling law unless they 158 Editorial Kraak voluntarily choose to do so. These results have important implications for other locations that operate profitable restaurant franchises and small restaurant businesses across the country. Gruner et al. also found that people with a median income at or higher than $52 560 are more likely to see and benefit from restaurant menu labeling than Americans living in low-income communities with a median income less than $37 000 and majority Hispanic track neighborhoods. They acknowledged health equity concerns for lowincome adults disproportionately impacted by higher obesity rates and diet-related noncommunicable diseases who are less likely to use menu labeling. Mandatory restaurant menu labeling is necessary but insufficient to raise consumers’ awareness and influence restaurant policies and practices to reformulate and market healthy offerings to reduce obesity and noncommunicable disease risks among Americans. This editorial describes opportunities and challenges for the US restaurant sector to make transformative changes that promote healthy choices as the norm and not the exception. trade association representing more than 500 000 food-service businesses, projected US eating establishment sales to exceed $551 billion in 2017, representing 48% of household income spent on food.2 One in three Americans got their first job experience in a restaurant, and half of all adults have worked in the restaurant industry at some point during their lives.2 A majority of adults report that dining out with friends and family is preferable to cooking at home and cleaning up.2 A 2017 market research survey found that Americans who frequent quick-service restaurant chains prioritize staff friendliness, value for money spent, food quality, service speed, cleanliness, and atmosphere over the healthfulness of food offerings.3 Given these trends, one can understand why nearly two thirds of American adults visit quick-service restaurant chains and 40% visit fast-casual restaurant chains weekly, and 30% to 40% of children and adolescents visit quick-service restaurant chains daily.4 RECOMMENDED NUTRIENT TARGETS Between 2006 and 2016, 16 government, industry, and expert public health bodies recommended nutrient targets for the US restaurant sector, including standardizing portions and reducing the total energy to 700 or fewer calories per meal for adults and adolescents and 600 or fewer calories per meal for children younger than 12 years.5 Most restaurant offerings still exceed the Dietary Guidelines for Americans and other recommended targets for calories (£ 600 to 700 calories/meal), fat (£ 35% total calories), saturated fat (£ 10% total calories), added sugars (£ 35% total calories), and sodium (£ 210 mg to 410 mg/ meal item).5 US RESTAURANT SECTOR PROGRESS US chain and nonchain restaurants can make voluntary changes by using comprehensive marketing-mix and choicearchitecture strategies to normalize healthy options. These include changes to place (ambience and atmospherics), profile (nutrient composition), portion, pricing, promotion (responsible marketing), healthy default picks, priming or prompting (information and labeling), and proximity (positioning; bit.ly/2zGCTks).4 A US restaurant-sector progress evaluation (2016–2017) used 12 performance metrics developed from the recommended nutrient targets for these eight strategies. Results showed that the restaurant sector made ABOUT THE AUTHOR PRESENCE OF RESTAURANTS IN AMERICANS’ LIVES The National Restaurant Association, which is the major Vivica I. Kraak is with the Department of Human Nutrition, Foods, and Exercise, Virginia Tech, Blacksburg. Correspondence should be sent to Vivica I. Kraak, Assistant Professor of Food and Nutrition Policy, Department of Human Nutrition, Foods, and Exercise, Virginia Tech, 223 Wallace Hall, 295 W Campus Dr, Blacksburg, VA 24061 (e-mail: vivica51@vt.edu). Reprints can be ordered at http://www.ajph.org by clicking the “Reprints” link. This editorial was accepted October 31, 2017. doi: 10.2105/AJPH.2017.304217 AJPH February 2018, Vol 108, No. 2 AJPH EDITORIALS limited progress to use profile, pricing, promotion, healthy default picks, and priming or prompting, and only some progress to reduce and standardize portion sizes.5 Nutrientprofile changes examined in 18 out of 25 studies documented either a modest or no reduction in total calories to meet the recommended 700 or fewer calories per adult meal or 600 or fewer calories per child meal. Three studies found that chain restaurants that had introduced new items between 2012 and 2015 had 26 to 67 fewer calories. Few restaurants have met the targets for percentage of calories from fat and saturated fat.5 Nine studies showed either no reduction, a modest decline, or an increase in the sodium content of menu items.5 CHILDREN’S MEALS AND RESPONSIBLE MARKETING Restaurants that participated in the National Restaurant Association’s Healthy Dining Kids LiveWell Program were more likely to have reduced children’s entrees by about 40 calories per meal between 2012 and 2014. Nevertheless, less than 11% of children’s meals met recommended healthy nutrition criteria by 2013.5 Most chains used marketing practices not covered by voluntary pledges to target children younger than 12 years, and no pledges protect adolescents, aged 12 to 17 years, from marketing of unhealthy products.5 February 2018, Vol 108, No. 2 AJPH Americans will accept healthy default choices such as fruit or vegetables instead of fries or water instead of sweetened soda.5 Between 2008 and 2016, 38 chains with children’s menus had reduced sugary beverage availability from 93% to 74%, accompanied by modest replacement of water and low-fat milk as default beverages.6 No similar actions were taken by restaurant chains to create healthy defaults for adolescents or adults. A separate 2016 Rudd Center evaluation of six leading quick-service restaurant chains found that voluntary pledges to offer healthy side dishes and to remove unhealthy beverages as the default for children’s meals were implemented inconsistently at different restaurant chains.7 Only McDonald’s, Subway, and Panera had established fruits and vegetables as healthy side dishes for children’s meals by 2016.5 Pricing is a powerful policy tool to address population-based health disparities.4 Yet no major quickservice restaurant or fast-casual restaurant chain has reduced price promotions on large portions or used competitive or proportionate pricing to encourage healthy purchases.5 LEADERSHIP TO NORMALIZE HEALTHY CHOICES The underwhelming progress made by the US restaurant sector demonstrates that the National Restaurant Association and leading quick-service restaurant, fast-casual restaurant, and full-service restaurant chains are not yet fully committed to change industry-wide practices that drive poor diet quality, obesity, and noncommunicable disease rates. Mandatory menu-labeling law is important but insufficient to change social norms and customers’ expectations. Bold leadership and technical assistance provided by the National Restaurant Association and leading chains could change industry-wide expectations and chain and nonchain restaurant practices to promote healthy and profitable choices. Civil society organizations and citizens could use their purchasing power to demand smaller and standardized portions and use social media to hold restaurants accountable for promoting healthy and affordable choices that establish a healthy restaurant culture for all Americans. Vivica Ingrid Kraak, PhD, RDN ACKNOWLEDGMENTS Funding for this article was provided by Virginia Tech’s Department of Human Nutrition, Foods, and Exercise. Restaurant Association; 2017. Available at: https://www.restaurant.org/ Downloads/PDFs/News-Research/ Pocket_Factbook_FEB_2017-FINAL. pdf. Accessed October 26, 2017. 3. Market Force Information. New study from Market Force Information reveals America’s favorite quick-service restaurants. 2017. Available at: http://www. marketforce.com/consumers-favoriteQSRs-2017-Market-Force-research. Accessed October 26, 2017. 4. Kraak VI, Englund T, Misyak S, Serrano EL. Development of a novel marketing mix and choice architecture framework for the restaurant sector to nudge customers toward healthy food environments and reduce obesity in the United States. Obes Rev. 2017;18(8): 852–868. 5. Kraak V, Englund T, Misyak S, Serrano E. Progress evaluation for the restaurant industry’s use of marketing-mix and choice-architecture strategies to nudge American customers toward healthy food environments, 2006–2017. Int J Environ Res Public Health. 2017;14(7):760. 6. Ribakove S, Almy J, Wootan MG. Soda on the menu. Improvements seen but more change needed for beverages on restaurant children’s menus. Washington, DC: Center for Science in the Public Interest; 2017. Available at: https:// cspinet.org/kidsbeveragestudy. Accessed October 26, 2017. 7. Harris J, Hyary M, Seymour N, Choi YY. Are fast-food restaurants keeping their promises to offer healthier kids’ meals? Hartford, CT: UConn Rudd Center for Food Policy and Obesity; 2017. Available at: http://www. uconnruddcenter.org/healthierkidsmeals. Accessed October 26, 2017. REFERENCES 1. Department of Health and Human Services, Food and Drug Administration. Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments. Final Regulatory Impact Analysis. Office of Regulations, Policy, and Social Sciences. 2014. FDA2011-F-0172. Available at: https:// www.fda.gov/downloads/Food/ IngredientsPackagingLabeling/ LabelingNutrition/UCM423985.pdf. Accessed October 26, 2017. 2. 2017 Restaurant Industry Pocket Factbook. Washington, DC: National Kraak Editorial 159 AJPH EDITORIALS CONTRIBUTORS Both authors contributed equally to this editorial. ACKNOWLEDGMENTS S. A. Bialous is partially funded by the Tobacco-Related Disease Research Program, Mackay California-Pacific Rim Tobacco Policy Scholar Award 25MT0033. S. A. Glantz’s work was supported by National Cancer Institute grant CA087472. S. A. Bialous serves as a consultant to the Secretariat of the World Health Organization Framework Convention on Tobacco Control, which promotes ratification of the Protocol to Eliminate Illicit Tobacco Trade. Note. The funding agencies played no role in the conduct of this research or preparation of this editorial. REFERENCES 1. Jha P, Marquez PV, Dutta S. Tripling tobacco taxes: key for achieving the UN Sustainable Development Goals by 2030. Available at: http://blogs.worldbank.org/ health/tripling-tobacco-taxes-keyachieving-un-sustainable-developmentgoals-2030. Accessed October 20, 2017. 2. Mamudu HM, Hammond R, Glantz S. Tobacco industry attempts to counter the World Bank report Curbing the Epidemic and obstruct the WHO Framework Convention on Tobacco Control. Soc Sci Med. 2008;67(11):1690–1699. 3. Bialous S. The tobacco industry and the illicit trade in tobacco products. Prepared for the Secretariat of the WHO Framework Convention on Tobacco Control. Available at: http://www.who.int/fctc/ publications/The_TI_and_the_Illicit_ Trade_in_Tobacco_Products.pdf. Accessed October 21, 2017. 4. Iglesias RM, Szklo AS, Souza MC, de Almeida LM. Estimating the size of illicit tobacco consumption in Brazil: findings from the Global Adult Tobacco Survey. Tob Control. 2017;26(1):53–59. Prevention of Elevated Blood Lead Levels Among Child Refugees and Other Susceptible Populations See also Kotey et al., p. 270. The toxicity of lead and its effects on child neurodevelopment have been well documented for decades.1 The dramatic decrease in average blood lead levels in the United States over the past several decades is an undeniable public health achievement. Over the same period it has been recognized that, unfortunately, there is no safe level of lead exposure.1,2 The continued presence of lead in water pipes, paint, and soils results in continued elevated blood lead levels (EBLLs) among children, particularly those of lower socioeconomic status.3 Globally, many nations are still using lead in industrial processes, gasoline, paint, or consumer products.2 Thus, lead exposure remains an important health concern in the United States and globally. Refugee children have previously been identified as a population at high risk for lead exposure,4 but there are still very few data available on this topic. The current global refugee crisis has resulted in an increasing February 2018, Vol 108, No. 2 AJPH number of refugees, which underscores the need for additional research in this area. For these reasons, the report by Kotey et al. (p. 270) in this issue of AJPH on blood lead levels among refugee children in Kentucky is timely as well as important. ELEVATED BLOOD LEAD LEVELS IN CHILD REFUGEES Kotey et al. examined data from refugee health screening records to estimate the prevalence of EBLL (> 5 mg/dL) and found potential sources of lead exposure among child refugees in Kentucky. They found that roughly 11% of refugee children had elevated blood lead concentrations compared with approximately 0.36% of similarly aged children in Kentucky. Kotey et al. were highly creative in their ability to identify variables in the data set that could approximate different exposure sources. They found that an increased proportion of EBLL was associated with a shorter time between resettlement and health screening (suggesting non-US sources of lead exposure). They also found an interaction between having a US residence in an area with older housing stock and intestinal infestation (suggesting US sources of lead exposure). As noted by the authors, the study does have some limitations. Because the health screenings were voluntary, selection bias could have influenced the results. Kotey et al. report that the prevalence of EBLLs is roughly 30 times higher among refugee children than among Kentucky children, which suggests that even if there is selection bias, it is likely that refugee children experience EBLLs at substantially higher rates than do other US children. 5. Ministerio da Fazenda, Receita Federal. Cigarros—Arrecadação de tributos federais. 2017. Available at: http://idg. receita.fazenda.gov.br/orientacao/ tributaria/regimes-e-controles-especiais/ cigarros-arrecadacao-tributos-federais. Accessed October 20, 2017. 6. Secretaria-Executiva da CONICQ. Prevalência de tabagismo. 2017. Available at: http://www2.in...
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