08-1892-cv
New York State Restaurant Association v. New York City Board of Health


                                 UNITED STATES COURT OF APPEALS
                                     FOR THE SECOND CIRCUIT
                                  _______________________________

                                                August Term, 2007

(Argued: June 12, 2008                                                   Decided: February 17, 2009)

                                          Docket No. 08-1892-cv
                                    _______________________________

NEW YORK STATE RESTAURANT ASSOCIATION,

                           Plaintiff-Appellant,

                           v.

NEW YORK CITY BOARD OF HEALTH, NEW YORK CITY DEPARTMENT OF HEALTH
AND MENTAL HYGIENE, THOMAS R. FRIEDEN, in his official capacity as Commissioner
of the New York City Department of Health and Mental Hygiene,

                  Defendants-Appellees.
____________________________________

Before: POOLER, SOTOMAYOR, Circuit Judges, and RESTANI,* Judge.
____________________________________

         New York State Restaurant Association (“NYSRA”) appeals from a Memorandum

Opinion and Order of the Southern District of New York (Holwell, J.) dated April 16, 2008,

denying NYSRA’s motion for a preliminary injunction, denying NYSRA’s motions for

declaratory relief and summary judgment, and granting New York City Board of Health, New

York City Department of Health and Mental Hygiene, and Thomas R. Frieden’s cross-motion for

summary judgment. Because we conclude that New York Health Code § 81.50: (1) is not



         *
          The Honorable Jane A. Restani, Chief Judge of the United States Court of International
Trade, sitting by designation.
expressly preempted by the Nutrition Labeling and Education Act of 1990; and (2) does not

infringe on NYSRA’s member restaurants’ First Amendment rights, we AFFIRM.


                     KENT A. YALOWITZ and PETER L. ZIMROTH (Nancy G. Milburn,
                     Brandon C. Cowart, Amalia W. Jorns, on the brief), Arnold & Porter LLP,
                     New York, N.Y., for Plaintiff-Appellant.

                     FAY NG, Assistant Corporation Counsel, City of New York (Michael A.
                     Cardozo, Corporation Counsel, Pamela Seider Dolgow, Mark
                     Muschenheim, Assistant Corporation Counsels, City of New York;
                     Thomas Merrill, General Counsel, N.Y.C. Department of Health and
                     Mental Hygiene, on the brief), for Defendants-Appellees.

                     DAVID S. JONES, Assistant United States Attorney, Southern District of
                     New York, New York, N.Y. (Michael J. Garcia, United States Attorney,
                     James L. Cott, Assistant United States Attorney, Southern District of New
                     York, New York, N.Y.; Gregory G. Katsas, Acting Assistant Attorney
                     General, Douglas N. Letter, Michael E. Robinson, Attorneys, Appellate
                     Staff, Civil Division, U.S. Department of Justice; Thomas R. Barker,
                     Acting General Counsel, Gerald F. Masoudi, Chief Counsel, Food and
                     Drug Division, Karen E. Schifter, Associate Chief Counsel, Office of the
                     General Counsel, U.S. Department of Health and Human Services, on the
                     brief), for Amicus Curiae U.S. Food and Drug Administration, in support
                     of Defendants-Appellees.

                     Deepak Gutpa, Brian Wolfman, Public Citizen Litigation Group, for
                     Amici Curiae U.S. Congressman Henry Waxman, Former FDA
                     Commissioner David Kessler, Public Citizen, Center for Science in the
                     Public Interest, American College of Preventive Medicine, American
                     Diabetes Association, American Medical Association, American Public
                     Health Association, California Center for Public Health Advocacy, The
                     Medical Society of the State of New York, Trust for America’s Health,
                     Professors of Medicine, Nutrition, and Public Health, in support of
                     Defendants-Appellees.

                     Dennis J. Herrera, City Attorney, Danny Chou, Chief of Complex and
                     Special Litigation, Tara Steeley, Francesca Gessner, Deputy City
                     Attorneys, City and County of San Francisco, CA, for Amici Curiae City
                     and County of San Francisco, CA; Cities of Philadelphia, PA and West
                     Hollywood, CA; Los Angeles County, CA; King County, WA;
                     Montgomery County, MD; National League of Cities, National


                                              2
                       Association of County and City Health Officials, and International
                       Municipal Lawyers Association; California State Senators Alex Padilla
                       and Carole Migden, California Assembly Member Mark Desaulnier, New
                       York State Assemblyman Felix Ortiz, Chicago Alderman Edward M.
                       Burke, and Washington D.C. Councilmember Phil Mendelson, in support
                       of Defendants-Appellees.

                       Brian L. Bromberg, New York, N.Y., for Amici Curiae Robert Post, David
                       Boies Professor of Law, Yale Law School; Jennifer L. Pomeranz, Kelly D.
                       Brownell, Rudd Center for Food Policy & Obesity at Yale University, in
                       support of Defendants-Appellees.

                             _________________________________

POOLER, Circuit Judge:

       In this case, the New York State Restaurant Association (“NYSRA”), a not-for-profit

business association of over 7,000 restaurants, challenges the constitutionality of New York City

Health Code § 81.50, which requires roughly ten percent of restaurants in New York City,

including chains such as McDonald’s, Burger King and Kentucky Fried Chicken, to post calorie

content information on their menus and menu boards. See New York City, N.Y., Health Code

tit. 24, § 81.50 (2008) (“Regulation 81.50”). NYSRA contends that Regulation 81.50 is

unconstitutional because it is: (1) preempted by federal laws, specifically the Nutrition Labeling

and Education Act of 1990 (“NLEA”), and (2) infringes on its member restaurants’ First

Amendment rights. Proceeding pursuant to our jurisdiction under 28 U.S.C. § 1292(a)(1), we

conclude that Regulation 81.50 survives both challenges. As we will explain, the federal

statutory scheme regulating labeling and branding of food is a labyrinth and interpreting the

statute are a series of agency regulations that sometimes appear to conflict and are difficult to

harmonize. It is our view, however, that Congress intended to exempt restaurant food from the

preemption sections that are necessary to allow food to be sold interstate. In requiring chain


                                                  3
restaurants to post calorie information on their menus, New York City merely stepped into a

sphere that Congress intentionally left open to state and local governments. Furthermore,

although the restaurants are protected by the Constitution when they engage in commercial

speech, the First Amendment is not violated, where as here, the law in question mandates a

simple factual disclosure of caloric information and is reasonably related to New York City’s

goals of combating obesity.

I.     Background

       A.      Federal Statutory Scheme: the Nutrition Labeling and Education Act of 1990

       The Federal Food, Drug, and Cosmetic Act (the “FDCA”), enacted in 1938, generally

prohibits misbranding of food. Our discussion focuses on two sections of that act -- (q) and (r) --

which were added in 1990 through the passage of the Nutrition Labeling and Education Act (the

“NLEA”), Pub. L. No. 101-535, 104 Stat. 2353 (1990). The NLEA sought “to clarify and to

strengthen the Food and Drug Administration’s legal authority to require nutrition labeling on

foods, and to establish the circumstances under which claims may be made about nutrients in

foods.” H.R. Rep. No. 101-538, at 7 (1990), reprinted in 1990 U.S.C.C.A.N. 3336, 3337.1

       Sections 343(q) and (r) and their related preemption provisions, Sections 343-1(a)(4) and

(a)(5), are the statutory bases from which the preemption questions in this case stem. Section

343(q), entitled “[n]utrition information,” addresses mandatory information on nutrients, and

requires that basic nutrition facts be disclosed for most foods. The general public is well-




       1
          The FDA filed an amicus brief at our request. Numerous cities, counties, government
officials, and associations also appear as amici. All ask us to affirm the district court.

                                                 4
acquainted with this provision through the “Nutrition Facts” panel on packaged foods that

informs buyers of the “the total number of calories” per serving,

along with the quantities of various nutrients contained in the

foods. 21 U.S.C. § 343(q).2 Restaurants, NYSRA’s membership,

are exempt from Section 343(q)’s mandatory nutrition

information labeling requirements; they do not have to attach a

Nutrition Facts panel to food they serve. Id. § 343(q)(5)(A)(i).

       Section 343(r), entitled “[n]utrition levels and health-

related claims,” addresses voluntary information, that is, those

claims that a food purveyor may choose to add to its product

label about the nutrient content (for example, “low sodium”) or

health benefits (for example, “fiber reduces cholesterol”) of its


       2
         Specifically, Section 343(q)(1) provides in relevant part, that “[a] food shall be deemed
to be misbranded”
       if it is a food intended for human consumption and is offered for sale, unless its
       label or labeling bears nutrition information that provides--
                 (A)(i) the serving size . . .,
                 (B) the number of servings . . .,
                 (C) the total number of calories--
                           (i) derived from any source, and
                           (ii) derived from the total fat,
       in each serving size . . .,
                 (D) the amount of the following nutrients: Total fat, saturated fat,
                 cholesterol, sodium, total carbohydrates, complex carbohydrates,
                 sugars, dietary fiber, and total protein contained in each serving
                 size . . .,
                 (E) any vitamin, mineral, or other nutrient required to be placed on
                 the label and labeling of food under this chapter before October 1,
                 1990, if the Secretary determines that such information will assist
                 consumers in maintaining healthy dietary practices.
21 U.S.C. § 343(q)(1).

                                                  5
product. See id. § 343(r). It prohibits the use of terms that “characterize[]” the level of any

nutrient in a food unless they conform to definitions established by the FDA, and requires that

claims about the relationship between nutrients and health conditions be supported by scientific

consensus.3 See id.; 21 C.F.R. § 101.14(c) (“FDA will promulgate regulations authorizing a

health claim only when it determines . . . that there is significant scientific agreement, among

experts qualified by scientific training and experience to evaluate such claims, that the claim is

supported by such evidence.”). Specifically, that section states that:

       A food shall be deemed misbranded [if it]
              (A) characterizes the level of any nutrient which is of the type
              required by [Section 343 (q)(1) or (q)(2)] to be in the label or
              labeling of the food unless the claim is made in accordance with
              [Section 343 (r)(2)], or
              (B) characterizes the relationship of any nutrient which is of the
              type required by [Section 343(q)(1) or (q)(2)] to be in the label or
              labeling of the food to a disease or a health-related condition unless
              the claim is made in accordance with [Section 343(r)(3) or (5)(D)].

21 U.S.C. § 343(r)(1)(A)-(B). However, Section 343(r) adds that “[a] statement of the type

required by [Section 343(q)] that appears as part of the nutrition information required or

permitted by such paragraph is not a claim which is subject to this paragraph.” Id. § 343 (r)(1).

In contrast to Section 343(q), restaurants are not exempt from Section 343(r)’s regulation of

“claims.” Thus, when a restaurant chooses to “characterize[] the level of any nutrient which is of

the type required by [Section 343(q)] to be in the label or labeling of the food,” id. §


       3
         FDA Regulations define nutrient content claims for a range of specific descriptive terms
such as “free,” “low” “good source,” “antioxidant,” and “high potency.” 21 C.F.R. §§ 101.13,
101.54, 101.56. For instance, the FDA Regulations provide that the term “high potency” “may
be used on the label or in the labeling of foods to describe individual vitamins or minerals that
are present at 100 percent or more of the [Reference Daily Intake] per reference amount
customarily consumed.” Id. §§ 101.54(f)(1)(i); see also id. § 101.9(c)(8)(iv) (establishing the
nomenclature and reference daily intakes for various vitamins and minerals).

                                                  6
343(r)(1)(A), it must conform to Section 343(r)’s requirements.

          The NLEA contains two express preemption provisions relating to both Sections 343(q)

and (r). Section 343-1(a)(4), which relates to Section 343(q), preempts any state or local

“requirement for nutrition labeling of food that is not identical to the requirement of [S]ection

343(q) . . ., except a requirement for nutrition labeling of food which is exempt under [Section

343(q)(5)(A)(i)],” that is, the restaurant exception. Id. § 343-1(a)(4) (emphasis added).4 Section

343-1(a)(5), which relates to Section 343(r), expressly preempts state or local governments from

imposing any requirement on nutrient content claims made by a food purveyor “in the label or

labeling of food that is not identical to the requirement of [S]ection 343(r) . . ., except a

requirement respecting a claim made in the label or labeling of food which is exempt under

[S]ection 343(r)(5)(B).” Id. § 343-1(a)(5) (emphasis added);5 21 C.F.R. § 101.13(q)(5)(A).

Thus, states are not preempted from adopting nutrition information labeling laws as defined by

Section 343(q), but are preempted from adopting nutrient claim laws as defined by Section

343(r).

          Though appearing complex, this scheme is simple when it comes to restaurant food -- the

NLEA does not regulate nutrition information labeling on restaurant food, and states and

localities are free to adopt their own rules. The NLEA, however, does generally regulate



          4
          Only the restaurant exception is relevant in this case, but we note that Section 343-
1(a)(4) also provides a preemption exception for “food which is exempt under [Section
343(q)(5)(A)(ii)].” That subsection refers to food sold for immediate consumption in retail
establishments such as grocery stores.
          5
          Section 343(r)(5)(B) refers to claims relating to (1) cholesterol, (2) saturated fat, (3)
dietary fiber, or (4) nutrients that increase the risk of diet-related health conditions, and is, as
NYSRA agrees, inapplicable here. See NYSRA Br. 10.

                                                    7
nutrition content claims on restaurant foods, and states and localities may only adopt rules that

are identical to those provided in the NLEA.

       B.      New York City Adopts Regulations Governing Calorie Labeling in
               Restaurants; NYSRA Challenges those Regulations.

       Seeking to combat rising rates of obesity and associated health care problems, in

December 2006, the New York City Board of Health adopted the precursor to the current

Regulation 81.50, by amending Article 81 of the Health Code and adding a new Section 81.50.

The 2006 regulation, which was to become effective on July 1, 2007, mandated that any food

service establishment voluntarily publishing calorie information post such information on its

menus and menu boards. This regulation was met with vigorous objection from the restaurants

and prompted many to stop voluntarily making such information available. On behalf of the

restaurants, NYSRA subsequently sued the New York City Board of Health, the New York City

Department of Health and Mental Hygiene, and Thomas R. Frieden (also appellees here, together

“New York City” or the “City”) in the Southern District of New York. In a decision issued on

September 11, 2007, the district court concluded that Regulation 81.50 as adopted was

preempted by 21 U.S.C. § 343-1(a)(5) -- the claims preemption provision -- because, to the

extent it applied only to restaurants that had voluntarily provided calorie information, it regulated

nutrient content claims. N.Y. State Rest. Ass’n v. N.Y. City Bd. of Health (NYSRA I), 509 F.

Supp. 2d 351, 361-63 (S.D.N.Y. 2007). However, in so holding, the district court stated that

       By making its requirements contingent on a voluntary claim, Regulation 81.50
       directly implicates [Section] 343(r) and its corresponding preemption provision.
       New York City, although free to enact mandatory disclosure requirements of the
       nature sanctioned by [Section] 343(q) (and proposed or enacted in other
       jurisdictions), has adopted a regulatory approach that puts it in the heartland of
       [Section] 343(r) and has subjected its regulation to preemption under [Section]


                                                  8
       343-1(a)(5).

Id. at 363 (footnote omitted). Having decided for NYSRA on preemption, the district court did

not reach NYSRA’s First Amendment claim.

       Taking its cue from the district court’s opinion, on January 22 2008, the New York City

Board of Health repealed and modified the 2006 regulation, producing the current version of

Regulation 81.50. See Dep’t of Health and Mental Hygiene Bd. of Health, Notice of Adoption of

a Resolution to Repeal and Reenact § 81.50 of the New York City Health Code (Jan. 22, 2008)

[hereinafter Notice of Adoption].6 The revised Regulation 81.50 requires all chain restaurants

with fifteen or more establishments nationally to make statements showing calorie content in the

precise manner prescribed by the regulation. For those restaurants covered by the regulation, the

calorie information must be presented clearly and conspicuously, adjacent or in close proximity

to the menu item, and the font and format of calorie information must be as prominent in size and

appearance as the name or price of the menu item. See Notice of Adoption at 12-14. Now, every

time New Yorkers walk into or use the drive-through of certain chain restaurants, they are

informed, for instance, that the taco salad contains 840 calories, the sausage and egg breakfast

sandwich contains 450 calories, and the premium hamburger sandwich with mayonnaise contains

670 calories but without mayonnaise contains 510 calories. Regulation 81.50 expressly permits

the restaurants to provide “additional nutritional information” and to provid[e] . . . disclaimer[s]

stating that there may be variations in calorie content values across servings based on slight



       6
          New York City also filed a notice of appeal to NYSRA I, however, the parties stipulated
that the appeal should be dismissed as moot with prejudice in view of the modifications to
Regulation 81.50. N.Y. State Rest. Ass’n v. N.Y. City Bd. of Health, No. 07-4378-cv (2d Cir.
Feb. 5, 2008) (stipulation and order dismissing appeal).

                                                  9
variations in serving size, quantity of ingredients, or special ordering.” Id. at 14.

         NYSRA’s member restaurants, some of which already provided nutrition information to

their customers, just not on their menus and menu boards, were not much happier with the City’s

latest effort at calorie disclosure on menus and menu boards specifically. They proposed

alternatives to menu/menu board posting including signs directing consumers to nutrition

information at the restaurants, posters, food wrappers, counter mats, stanchions, flip-charts, and

brochures, with such information. Failing to convince the City -- which concluded that

customers often did not see the nutrition information already provided by the restaurants, see id.

at 7-8 -- of the superiority of these alternatives, NYSRA filed another action in the Southern

District of New York, again seeking to declare the revised Regulation 81.50 preempted by

federal law and/or unconstitutional, and to enjoin its enforcement; New York cross-moved for

summary judgment on the preemption claim. Reasoning that “Regulation 81.50 is not preempted

by [the] NLEA because that statute explicitly leaves to state and local governments the power to

impose mandatory nutrition labeling by restaurants,” the district court rejected NYSRA’s

preemption challenge and granted the City summary judgment on this claim. N.Y. State Rest.

Ass’n v. N.Y. City Bd. of Health (NYSRA II), No. 08cv1000, 2008 WL 1752455, at *1

(S.D.N.Y. Apr. 16, 2008). NYSRA also asked the district court to conclude that Regulation

81.50 impermissibly infringed on its members’ First Amendment rights. But, the district court

instead concluded that “the required disclosure of caloric information is reasonably related to the

government’s interest in providing consumers with accurate nutritional information and therefore

does not unduly infringe on the First Amendment rights of NYSRA members.” Id. NYSRA

then appealed. It also sought a stay pending appeal, which we denied without prejudice to


                                                 10
renewal at or after oral argument, based upon the City’s representations that the “no fines” period

would be extended. We set an expedited briefing schedule, and subsequently denied the renewed

motion for a stay. N.Y. State Rest. Assoc. v. N.Y. City Bd. of Health, No. 08-1892-cv (2d Cir.

Apr. 29, 2008, June 16, 2008) (orders denying stay). We held oral argument on June 12, 2008,

during which we heard from counsel for NYSRA, the City, and the FDA.

II.    Discussion

       We review the district court’s grant of New York City’s cross-motion for summary

judgment de novo, and the burden is on New York City to establish that it is entitled to judgment

as a matter of law. Price v. N.Y. State Bd. of Elections, 540 F.3d 101, 107 (2d Cir. 2008). We

review the denial of NYSRA’s motion for a preliminary injunction for abuse of discretion.

Sunward Elecs., Inc. v. McDonald, 362 F.3d 17, 24 (2d Cir. 2004). A party seeking a

preliminary injunction ordinarily must show: (1) a likelihood of irreparable harm in the absence

of the injunction; and (2) either a likelihood of success on the merits or sufficiently serious

questions going to the merits to make them a fair ground for litigation, with a balance of

hardships tipping decidedly in the movant’s favor. Id. In deciding this appeal, we will discuss

the motions relating to preemption together since on all motions, the question before us is one of

law -- whether the NLEA preempts Regulation 81.50. We will then turn to the denial of a

preliminary injunction on NYSRA’s First Amendment claims, and “review the district court’s

judgment for abuse of discretion, although our review of its application of the law is de novo.”

In re Northwest Airlines Corp., 483 F.3d 160, 165 (2d Cir. 2007). As will be discussed,

Regulation 81.50 is not preempted nor does it violate the restaurants’ First Amendment rights.




                                                 11
       A.      Preemption

       Under the Supremacy Clause of the United States Constitution, “state laws that conflict

with federal law are without effect,” Altria Group, Inc. v. Good, 129 S. Ct. 538, 543 (2008)

(quotation marks omitted), and are preempted. The “purpose of Congress is the ultimate

touchstone in every pre-emption case,” id. (quotation marks omitted), and “‘we start with the

assumption that the historic police powers of the States were not to be superseded by the Federal

Act unless that was the clear and manifest purpose of Congress.’” United States v. Locke, 529

U.S. 89, 107 (2000) (quoting Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230 (1947). The

presumption against preemption is heightened “where federal law is said to bar state action in

fields of traditional state regulation.” N.Y. State Conference of Blue Cross & Blue Shield Plans

v. Travelers Ins. Co., 514 U.S. 645, 655 (1995). Given the traditional “primacy of state

regulation of matters of health and safety,” Medtronic, Inc. v. Lohr, 518 U.S. 470, 485 (1996),

courts assume “that state and local regulation related to [those] matters . . . can normally coexist

with federal regulations.” Hillsborough County v. Automated Med. Labs., Inc. 471 U.S. 707,

718 (1985); see also Desiano v. Warner-Lambert & Co., 467 F.3d 85, 94 (2d Cir. 2007), aff’d by

equally divided court sub nom Warner-Lambert & Co. v. Kent, 128 S. Ct. 1168 (2008). As a

result, where the text of a preemption clause is ambiguous or open to more than one plausible

reading, courts “have a duty to accept the reading that disfavors pre-emption.” Bates v. Dow

Agrosciences LLC, 544 U.S. 431, 449 (2005).

       Helpfully, the NLEA is clear on preemption, stating that it “shall not be construed to

preempt any provision of State law, unless such provision is expressly preempted under [21

U.S.C. § 343-1(a)] of the [FDCA].” Pub. L. No. 101-535, § 6(c)(1), 104 Stat. 2353, 2364 (21


                                                 12
U.S.C. § 343-1 note) (emphasis added). As already noted, as it pertains to restaurants, the NLEA

does not preempt New York City from adopting its own requirements for nutrition information

labeling, see 21 U.S.C. § 343-1(a)(4), but it does generally preempt it from adopting different

rules for nutrient content claims, id. § 343-1(a)(5). In light of the NLEA’s express preemption

provisions, therefore, the issue in this case is less whether the NLEA is clear on preemption, but

more whether the quantitative calorie disclosures Regulation 81.50 mandates that chain

restaurants place on their menus and menu boards are “claims” falling under Section 343(r) and

are thus preempted, or are “nutrition information” falling under Section 343(q) and thus are not

preempted. Since NYSRA’s argument that Regulation 81.50 pertains to claims turns primarily

on the meaning of “claim” as used in the NLEA, some exposition of that term, especially as

compared to the meaning of “nutrition information,” is required.

       As explained, the NLEA defines nutrition “information,” to include “the total number of

calories” in a food product. Id. § 343(q)(1)(C); see also 21 C.F.R. § 101.9(c)(1) (“The

declaration of nutrition information on the label and in labeling of a food shall contain . . . [a]

statement of the caloric content per serving . . . .”). Nutrition “claims” are statements “made in

the label or labeling of the food which expressly or by implication . . . characterize[] the level of

any nutrient which is of the type required by [Section 343(q)].” 21 U.S.C. § 343(r)(1)(A)

(emphasis added). However, “[a] statement of the type required by [Section 343(q)] that appears

as part of the nutrition information required or permitted by such paragraph is not a claim.” Id. §

343(r)(1) (emphasis added).

       An initial reading of these sections of the statute suggests a quantitative-qualitative

distinction according to which nutrition “information” refers to quantitative statements such as


                                                  13
“100 calories” and nutrition “claims” refers to descriptive or qualitative statements, such as

“heart healthy.”7 See Webster’s Third Int’l Dictionary 376 (2002) (defining to “characterize” as

“to describe the essential character or quality of”); id. at 414 (defining “claim” as “an assertion,

statement, or implication (as of value, effectiveness, qualification, eligibility) often made or

likely to be suspected of being made without adequate justification”). By that view, Regulation

81.50, a regulation which merely requires the disclosure of quantitative information listed in

Section 343(q), would not be preempted by the NLEA.

       Such a simple path is not to be ours, however, because the FDA, as the agency charged

with implementing the FDCA and NLEA, has defined “claims” with more nuance. See United

States v. Mead Corp., 533 U.S. 218, 227 (2001) (“When Congress has explicitly left a gap for an

agency to fill, there is an express delegation of authority to the agency to elucidate a specific

provision of the statute by regulation” (quotation marks omitted)); see also Pub. L. No. 101-535,

§ 3(b)(1)(A)(i), 104 Stat. 2353, 2361 (stating that the FDA “shall identify claims described in

section [343(r)(1)(A)] . . . which comply with [S]ection [343(r)(2)].”); 21 U.S.C. § 343(r)(2)(A)

(listing conditions under which a claim can be made). In several regulations, the FDA embraces

the quantitative-qualitative distinction using terms such as “characterizes,” “describes,” and

“suggests,” to define claims.8 In listing terms that characterize nutrient levels, the regulations


       7
          NYSRA argues that the doctrine of collateral estoppel prevents New York City from
relitigating the qualitative-quantitative distinction because it chose to dismiss its appeal from
NYSRA I with prejudice. As we do not ground our decision in this distinction, we do not reach
this question.
       8
         For instance, Regulation 101.13(b) defines a “nutrient content claim” as “[a] claim that
expressly or implicitly characterizes the level of a nutrient of the type required to be in nutrition
labeling under [the regulations implementing Section 343(q)].” 21 C.F.R. § 101.13(b) (emphasis
added). Regulation 101.13(b)(2) defines “an implied nutrient content claim” as “any claim that:”

                                                  14
point to terms and phrases such as “rich in,” “excellent source of,” “enriched,” “fortified.” See

21 C.F.R. §§ 101.54-101.69. As is particularly pertinent here, the regulations describe “calorie

content claims” to include “‘calorie free,’ ‘free of calories,’ . . . ‘without calories,’ ‘trivial source

of calories,’ ‘negligible source of calories,’ [and] ‘dietarily insignificant source of calories.’” Id.

§ 101.60(b)(1). Further, the regulations that discuss the labeling requirements for restaurants

making nutrient content claims differentiate between “nutrient amounts” (a phrase indicative of a

quantitative statement), and “claims,” by permitting restaurants to provide “the nutrient amounts

that are the basis for the claim.” Id. § 101.10.

        But, other FDA regulations provide for a definition of claims that includes quantitative

statements of the sort listed in Section 343(q). First, Regulation 101.13(b)(1) defines an

“expressed nutrient content claim” as “any direct statement about the level (or range) of a

nutrient in [a] food” including “contains 100 calories.” 21 C.F.R. § 101.13(b)(1). As the district

court pointed out in NYSRA I, the FDA treats “contains” as either a nutrient content claim or a

“simple verb” depending on how it is used. 509 F. Supp. 2d at 359 n.9; see also FDA, Guidance

for Indus.: A Labeling Guide for Rests. and Other Retail Establishments Selling

Away-From-Home Foods ¶ 30 (Apr. 2008), available at

http://www.cfsan.fda.gov/~dms/labrguid.html (last visited Jan. 13, 2009) [hereinafter FDA,




        (i) Describes the food or an ingredient therein in a manner that suggests that a
        nutrient is absent or present in a certain amount (e.g., “high in oat bran”); or
        (ii) Suggests that the food, because of its nutrient content, may be useful in
        maintaining healthy dietary practices and is made in association with an explicit
        claim or statement about a nutrient (e.g., “healthy, contains 3 grams (g) of fat”).
Id. § 101.13(b)(2) (emphases added).

                                                   15
Guidance for Indus.].9 In the phrase “contains fiber,” “contains” is a nutrient content claim

meaning “good source” of fiber. See 21 C.F.R. § 101.54(c) (defining “contains”); see also FDA,

Guidance for Indus., at ¶ 30. In the phrase “contains 2 grams of fiber,” by contrast, “contains” is

a “simple verb” and the FDA considers the quantitative declaration “2 grams” to be a nutrient

content claim whether or not the word “contains” is employed. FDA, Guidance for Indus., at ¶

30. And, at other points, by emphasizing that quantitative statements such as “100 calories” are

not “implicit characterizations,” the regulations seem to suggest that they can be express

characterizations. For instance, 21 C.F.R. § 101.13(i) states that

       Except as provided in § 101.9 or § 101.36, as applicable, or in paragraph (q)(3) of
       this section, the label or labeling of a product may contain a statement about the
       amount or percentage of a nutrient if . . . [t]he statement does not in any way
       implicitly characterize the level of the nutrient in the food and it is not false or
       misleading in any respect (e.g., “100 calories” or “5 grams of fat”), in which case
       no disclaimer is required.

21 C.F.R. § 101.13(i)(3) (emphases added).10

       If we were merely faced with such ambiguous regulations, we might adhere to the



       9
          In their briefs, the parties cite to a version of this document that has since been
superseded. See FDA, Food Labeling: Questions and Answers, Volume II, A Guide for Rests.
and Other Retail Establishments (Aug. 1995), http://vm.cfsan.fda.gov/~frf/qaintro.html (last
visited Jan. 13, 2009).
       10
          Confusing matters even more, the FDA suggests that quantitative caloric statements can
neither be express or implied characterizations, but simultaneously seems to allow that they can
be express characterizations. It states:
        [B]ased on the comments and its review of the 1990 amendments, FDA finds that
        there are some circumstances in which an amount claim cannot be considered to
        characterize in any way the level of a nutrient in a food. For example, the
        statement “100 calories” or “5 grams of fat” on the principal display panel of a
        food would be a simple statement of amount that, by itself, conveys no implied
        characterization of the level of the nutrient.
58 Fed. Reg. 2302-01, 2310 (Jan. 6, 1993) (emphases added).

                                                16
quantitative-qualitative distinction. However, Regulation 101.13(c) unequivocally provides that

quantitative statements can be claims:

       Information that is required or permitted . . . to be declared in nutrition labeling,
       and that appears as part of the nutrition label, is not a nutrient content claim and is
       not subject to the requirements of this section. If such information is declared
       elsewhere on the label or in labeling, it is a nutrient content claim and is subject to
       the requirements for nutrient content claims.

21 C.F.R. 101.13(c) (emphases added). This regulation reflects the FDA’s view that a

quantitative statement as to a nutrient amount, 100 calories for example, is not a claim when such

a statement appears in the nutrient panel required by Section 343(q), but is one when it does not.

And asked, during the notice and comment period, to exclude statements about “simple factual

information” from the definition of “nutrient content claim” on the theory that such a statement is

not “a claim that ‘characterizes’ the level of any nutrient” within the meaning of the NLEA, the

FDA refused, stating that the regulations pertaining to claims “apply to statements of the amount

of a nutrient in food as well as to statements of the level of a nutrient in food.” 58 Fed. Reg.

2302-01, 2303-04 (1993).11


       11
         The full context of this statement is below:
       The agency advises that while it can agree that the terms “nutrient descriptor” and
       “nutrient descriptor claim[]” may be used to describe the claims subject to section
       403(r)(1)(A) of the act and these regulations, it does not agree that the scope of
       the statute and the regulations excludes statements of the amount of a nutrient in a
       food. The distribution the comment draws between “nutrient descriptors” and
       “nutrient content” claims is unpersuasive. In fact, one of the sponsors of the 1990
       amendments in the Senate specifically used the term “nutrition content claim” to
       refer to claims covered under section 403(r)(1) (A) (136 Cong. Rec. S16608
       (October 24, 1990)). Moreover, the statement in section 403(r)(1) of the act
       referred to by the comment as excluding from coverage statements of the type
       contained in nutrition labeling, in fact excludes “a statement of the type required
       by paragraph (q) that appears as part of the nutrition information required or
       permitted by such paragraph * * *.” FDA stated in the general principles proposal
       (56 FR 60421 at 60424), that the legislative history of this provision specifically

                                                 17
       Though we might have interpreted the NLEA differently, we owe deference to the FDA’s

reading, as it has some support in the statute. See 21 U.S.C. § 343(r)(1) (“[A] statement of the

type required by paragraph (q) . . . that appears as part of the nutrition information required or

permitted by such paragraph is not a claim . . .”) (emphasis added); Pub. L. No. 101-535, §

3(b)(1)(A)(iv), 104 Stat. 2353, 2361 (instructing FDA to promulgate regulations to implement

Section 343(r), to define terms that characterize the level of any nutrient in food “unless the

Secretary finds that the use of any such term would be misleading,” and “[to] permit statements

describing the amount and percentage of nutrients in food which are not misleading and are

consistent with the terms defined in section [343(r)].”); see also Mead, 533 U.S. at 227 (“[A]ny

ensuing regulation [ensuing from authority delegated by Congress to agencies] is binding in the

courts unless procedurally defective, arbitrary or capricious in substance, or manifestly contrary


       states that the identical information will be subject to the descriptor requirements
       if it is included in a statement in another portion of the label (136 Congressional
       Record H5841 (July 30, 1990)). In addition, section 403(r)(2)(E) of the act
       specifically exempts from the limitations on claims established in section
       403(r)(2)(A)(i) through (r)(2)(A)(v), “a statement in the label or labeling of food
       which describes the percentage of vitamins and minerals in the food which
       describes the percentage of such vitamins and minerals recommended for daily
       consumption by the Secretary.” If such declarations as “10 percent of the U.S.
       RDA for vitamin C” were not within the scope of section 403(r)(1)(A) of the act,
       there would have been no need for Congress to provide a specific exemption for
       such claims. Furthermore, section 3(b)(1)(A)(iv) of the 1990 amendments
       provides that the mandated regulations “shall permit statements describing the
       amount and percentage of nutrients in food which * * * are consistent with the
       terms defined in section 403(r)(2)(A)(i) of such Act.” Again, if statements of the
       amount and percentage of nutrients were not subject to section 403(r)(1)(A) of the
       act, there presumably would have been no need for Congress to express its desire
       that such claims be permitted by the regulations. Accordingly, FDA concludes
       that section 403(r)(1)(A) of the act and therefore these final regulations apply to
       statements of the amount of a nutrient in food as well as to statements of the level
       of a nutrient in food.
58 Fed. Reg. 2302-01, 2303-04 (1993) (emphases added).

                                                 18
to the statute.”). Thus, like the district court, we conclude that “under the FDA regulations,

statements as to nutrient amount, including calorie content, may be a ‘claim’ subject to the

requirements of [Section] 343(r) and its implementing regulations.” NYSRA I, 509 F. Supp. 2d

at 360.

          Since quantitative statements of the type listed in Section 343(q) can be claims, we are

brought back, almost full circle, to the question of when such statements are claims and state and

local regulations are thus preempted, and when they are simply labeling requirements and state

and local regulations are not preempted. The district court concluded that such statements, that

is, of the type listed in Section 343(q), are claims when voluntary, but not so when mandatory.

NYSRA II, 2008 WL 1752455, at *3. In contending that the district court erred, NYSRA states

that the statute and FDA regulations compel the conclusion that while New York City is free to

require restaurants to disclose nutrition information under Section 343-1(a)(4), it may do so only

if its regulations are identical to federal regulation of such information under Section 343(q);

otherwise the “nutrition information” becomes a “claim,” subject to Section 343(r), and

preempted by Section 343-1(a)(5). Thus, NYSRA goes one step further than the district court --

to avoid preemption, it is not sufficient for Regulation 81.50 to be mandatory, it must also be

identical to Section 343(q).

          We do not agree. In urging this interpretation of the statute, NYSRA points to Section

343(r)(1), which, as we have noted, states that “[a] statement of the type required by [Section

343(q)] that appears as part of the nutrition information required or permitted by such paragraph

is not a claim,” 21 U.S.C. § 343(r)(1) (emphasis added), and reads these words to mean that: (1)

in order for a Section 343(q)-type statement not to be a claim, (2) it must appear with all the


                                                  19
other information listed in Section 343(q)’s complete Nutrition Fact panel. However, in

promoting this view, NYSRA renders meaningless Sections 343(q)(5)(A)(i) and 343-1(a)(4). We

are not at liberty to do likewise. Together, these sections provide that states are not preempted

from establishing, or put differently, are permitted to establish “any requirement [for restaurants]

for nutrition labeling of food that is not identical to the requirement of [S]ection 343(q).” Id. §

343-1(a)(4) (emphasis added). Since those sections permit states to adopt non-identical labeling

rules for restaurants, Section 343(r)(1)’s reference to nutrition labeling “required or permitted” by

Section 343(q), does not necessarily pertain to the complete list of nutrient information noted in

Section 343(q), but rather to whatever (identical or non-identical) requirements that states or

localities choose to adopt as it relates to restaurant food. Thus, we read Section 343(r)(1) to

provide that: (1) in order for a Section 343(q)-type statement not to be a claim, (2) it must appear

with the other information required or permitted by the NLEA for packaged food, or applicable

state or local law for restaurant food, which here, would be that required by Regulation 81.50 --

the total number of calories. As NYSRA notes, therefore, isolated quantitative statements of the

type listed in Section 343(q) can be claims, but only if Section 343(q), or the state law addressing

restaurant food, requires it to appear along with other nutrient information such as those required

by Section 343(q).12


       12
           One of the sponsors of the Act expressed the view that the NLEA recognizes the
authority of states to require restaurants to disclose nutrition content to their customers through
rules that are not identical to Section 343(q). See 136 Cong. Rec. S16607 (Oct. 24, 1990)
(Statement of Sen. Metzenbaum) (“Because food sold in restaurants is exempt from the nutrition
labeling requirements of section 403(q)(1)-(4), the bill does not preempt any State nutrition
labeling requirements for restaurants.” (emphasis added)). Further, this conclusion makes sense
because Congress chose to exempt restaurants from Section 343(q) in part because it was of the
view that full nutrition labeling of restaurant food would be “impractical,” H.R. Rep. No.
101-538, at 7. Labeling requirements were met with “vociferous opposition” by restaurants.

                                                 20
       But NYSRA further contends that the FDA Regulations do not read the statute as we

have. Placing particular emphasis on Regulation 101.13(c), it states that the FDA regulations

provide that in order not to be a claim, the nutrition information must meet three criteria. Thus,

       Information that [1] is required or permitted by § 101.9 or § 101.36, as applicable,
       to be declared in nutrition labeling, and that [2] appears as part of the nutrition
       label, is not a nutrient content claim and is not subject to the requirements of this
       section. If such information [3] is declared elsewhere on the label or in labeling,
       it is a nutrient content claim and is subject to the requirements for nutrient content
       claims.

NYSRA Supp. Br. 5 (quoting 21 C.F.R. § 101.13(c) (alterations in NYSRA Supp. Br.).

However, this regulation, even as parsed by NYSRA, does not change our reading of the statute,

because we conclude that it does not address nutrition “information” on restaurant food, but

rather on non-restaurant food. This conclusion is based both on the understanding, as explained

by the FDA to us, that Regulation 101.13 was adopted with packaged food in mind, see FDA



Laura S. Sims, The Politics of Fat: Food and Nutrition Policy in America 200 (1998). Further,
21 C.F.R. § 101.10, which describes what happens when restaurants make a claim and allows
that when a claim is made, a statement of the quantified specific caloric content may qualify as
the “functional equivalent” of information required in nutrition labeling under Section 343(q),
indicates that the FDA Regulations recognized that restaurants can make single statements as to
nutrient information without providing a complete Nutrition Fact panel. See also FDA,
Guidance for Indus., at ¶ 106 (“States would be free to apply nutrition labeling and claims
requirements to claims on menus. Furthermore, because the [FDCA] exempts restaurant foods
that do not bear a claim from mandatory nutrition labeling, State requirements for the nutrition
labeling of such foods would not be preempted . . . . State requirements of the type required by
[Section 343(q)] and [Section 343(r)] would not be preempted for foods that are exempt from the
Federal requirements.”); Keystone Ctr., The Keystone Forum on Away-from-Home Foods:
Opportunities for Preventing Weight Gain and Obesity 74 (2006), available at
http://www.cfsan.fda.gov/~dms/nutrcal.html (last visited Jan. 13, 2009) [hereinafter Keystone
Report] (“[T]he FDA does not have regulatory authority to require nutrition information in
restaurants. The U.S. Congress and state legislatures do have the authority to require the
provision of nutrition information, and a number of these elected bodies have considered
nutrition labeling bills.”).


                                                21
Amicus Br. 19, and the language of the regulation itself. As an initial matter, the “first prong”

provides that for Regulation 101.13(c) to transform a Section 343(q) statement into a claim, the

information at issue must first be “required or permitted” by either FDA Regulation 101.9, which

pertains to the federal requirements for “nutrition labeling of food” or FDA Regulation 101.36,

which addresses federal requirements for “nutrition labeling of dietary supplements,” and is

inapplicable here. The regulation counterpart to Section 343(q)(5)(A) is Regulation

101.9(j)(2)(i), which exempts restaurant food from Regulation 101.9’s labeling requirements.13

Thus, since the regulations noted in Regulation 101.13 -- 101.9 and 101.36 -- do not apply to

nutrition information mandated by state or local law to be placed on restaurant food, the “third

prong’s” reference to “such information” does not speak to “information” relating to restaurant

food.14 Finally, the “second prong” which references information that appears “as part of the

nutrition label,” confirms this reading. The FDCA defines “label” as any “display of written,

printed, or graphic matter upon the immediate container of any article,” 21 U.S.C. § 321(k)

(emphasis added), and “labeling” as “all labels and other written, printed, or graphic matter (1)



       13
          Regulation 101.9(j)(2)(i) provides: “The following foods are exempt from this section
or are subject to special labeling requirements: . . . Food products which are: . . . Served in
restaurants, Provided, That the food bears no nutrition claims or other nutrition information in
any context on the label or in labeling or advertising. Claims or other nutrition information
subject the food to the provisions of this section . . . .” 21 C.F.R. § 101.9(j)(2)(i). Because
NYSRA appears to suggest otherwise, we note that this provision simply recognizes that food
served in restaurants is exempt from Regulation 101.9(j)(2)(i)’s requirements, but then notes an
exception for claims. It does not transform quantitative statements of the type covered by
Section 343(q) and Regulation 101.9(j) and mandated by state or local law, into claims.
       14
          The reference in Regulation 101.13(c) to information “permitted” does not refer to the
restaurant exception. Pursuant to Section 343(q)(2)(A), in addition to listing information that
must be provided on a Nutrition Fact panel, Regulation 101.9 also lists information that may
voluntarily be included. It is to that voluntary information that the term “permitted” refers.

                                                22
upon any article or any of its containers or wrappers, or (2) accompanying such article,” id. §

321(m). Therefore, although restaurant food might have labeling, most would not have labels.

Stated differently, an order of pasta at Olive Garden Italian Restaurant does not come with a label

printed on the bowl.

       Our above analysis perhaps simply comes down to this: accepting NYSRA’s position --

that states or municipalities choosing to regulate nutrition information labeling by restaurants

may do so only by adopting labeling requirements that are identical to those listed in Section

343(q) and Regulation 101.9 -- would render Section 343-1(a)(4)’s exception for preemption

meaningless.15 See FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 133 (2000) (“It

is a fundamental canon of statutory construction that the words of a statute must be read in their

context and with a view to their place in the overall statutory scheme.” (quotation marks

omitted)). It is well settled that in view of the “primacy of state regulation of matters of health

and safety,” Medtronic, Inc., 518 U.S. at 485, “state and local regulation related to [those]

matters . . . can normally coexist with federal regulations,” Hillsborough County, 471 U.S. at

718. Therefore, if there is any ambiguity in the NLEA and FDA regulations, we are bound to

“accept the reading that disfavors pre-emption.” Bates, 544 U.S. at 449; see also 136 Cong. Rec.

H5836 (July 30, 1990) (Statement of Rep. Waxman) (“[A]ny preemption provision must



       15
           NYSRA’s contention that Section 343-1(b) resolves this issue is unpersuasive. That
section allows the FDA to, if certain conditions are met, grant a case-by-case waiver to proposed
state and local regulations that are preempted by the NLEA. See 21 U.S.C. § 343-1(b); see also
21 C.F.R. § 100.1(d) (listing requirements to obtain waiver). This uncertain prospect of securing
an individual waiver does not give life to those sections of the NLEA that provide for an
unconditional exception to preemption. Thus, as to nutrition information on restaurant food, the
statute itself already provides the requisite waiver, and Section 343-1(b) addresses regulations
that are actually preempted.

                                                 23
recognize the important contribution that the State can make in regulation, and it must leave a

role for the states.”). That our decision might result in NYSRA’s members being subject to

multiple, inconsistent local regulations is the result of the choice that Congress made to permit

localities to mandate restaurants to disclose nutrition information about the food they serve. It is

not a permissible basis to conclude that the NLEA preempts Regulation 81.50.16

       As previously noted, prior to oral argument in this appeal, we invited the FDA to submit

an amicus brief to enlighten us as to its views on preemption. It did so and we may consider the

views expressed therein for persuasive value. See Skidmore v. Swift & Co., 323 U.S. 134, 140

(1944) (stating that agency interpretations “constitute a body of experience and informed

judgment to which courts and litigants may properly resort for guidance. The weight of [an

agency’s] judgment in a particular case will depend upon the thoroughness evident in its

consideration, the validity of its reasoning, its consistency with earlier and later pronouncements,

and all those factors which give it power to persuade, if lacking power to control.”); Schneider v.

Feinberg, 345 F.3d 135, 143 (2d Cir. 2003) (explaining Skidmore deference).17 The FDA


       16
         We have not been asked to conclude that Regulation 81.50 is impliedly preempted by
the FDCA and thus do not reach that question. Pub. L. No. 101-535, § 6(c)(3), 104 Stat. 2353,
2364. See Sprietsma v. Mercury Marine, 537 U.S. 51, 65 (2002) (stating that inclusion of
express preemption provision does not bar ordinary working of “conflict” or “implied”
preemption principles).
       17
          NYSRA urges us not to give the FDA’s views even Skidmore deference because
“[a]bsent a showing that the regulation leads to absurd results, the ‘plain meaning of language in
a regulation governs . . . .’” NYSRA Supp. Br. 13 (quoting Lin v. U. S. Dep’t of Justice, 459 F.3d
255, 262 (2d Cir. 2006)). As explained previously, we think NYSRA’s alternative approach,
which would permit states to adopt nutrition labeling requirements for restaurants only if those
labeling requirements are identical to those provided in the NLEA, renders Section 343-1(a)(4)’s
exception for preemption meaningless, an unacceptable and absurd result. See APWU v. Potter,
343 F.3d 619, 626 (2d Cir. 2003) (“A basic tenet of statutory construction, equally applicable to
regulatory construction, is that a text should be construed so that effect is given to all its

                                                 24
advances the view that a statement is nutrition information exempt from the NLEA’s preemption

provisions if two criteria are met.

       First, the statement must be “[1] of the type required by [Section 343(q)] [2] that
       appears as part of the nutrition information required or permitted by . . . [Section
       343(q)].” 21 U.S.C. § 343(r)(1). Second, a state or municipal regulatory authority
       must require the statement to be disclosed with regard to restaurant food as part of
       nutrition labeling (and the information must be disclosed pursuant to that
       authority.”). Id. §§ 343-1(a)(4) [(noting exceptions that are inapplicable here)].

FDA Amicus Br. 14-15. The first criterion tracks our above analysis, and thus we find it

persuasive.18 The second criterion, plainly stated as above, is also unobjectionable since Section

343-1(a)(4)’s exception to preemption concerns “nutrition labeling.” 21 U.S.C. § 343-1(a)(4). In

defending the second criterion, the FDA attempts to reconcile Regulation 101.13(c) to restaurant

food by asking us to conclude that labeling requirements are met when a nutrition information

statement appears, “for packaged food, in the nutrition information section of the food label or,

for non-packaged foods that bear no label, as part of the nutrition information for food in a place

appropriate for such information at the point of purchase.” FDA Amicus Br. 19. That is, that

“the term ‘nutrition label’ as used in [Regulation] 101.13(c)” should be interpreted “to include, in

the context of restaurant food, nutrition information whose disclosure is required by a state or

local regulatory body, whether it is placed somewhere that meets the narrow definition of ‘label’


provisions, so that no part will be inoperative or superfluous, void or insignificant, and so that
one section will not destroy another unless the provision is the result of obvious mistake or
error.”) (alterations and quotation marks omitted).
       18
          Briefly, first: (1) Section 343(q) lists types of information that fall under the rubric of
“nutrition information” to include “total number of calories” and thus the nutrient information
regulated by Regulation 81.50 is “of the type” required by Section 343(q). Second, because
Section 343(q) permits states to adopt non-identical nutrition information requirements for
restaurants, the information required by Regulation 81.50 appears as part of the nutrition
information permitted by Section 343(q).

                                                  25
advanced by NYSRA, or whether it instead is placed, as [under Regulation 81.50], in appropriate

labeling.” Id. at 19-20; see 21 C.F.R § 101.45(a)(1) (“Nutrition labeling information should be

displayed at the point of purchase by an appropriate means such as by a label affixed to the food

or through labeling including shelf labels, signs, posters, brochures, notebooks, or leaflets that

are readily available and in close proximity to the foods.”); id. § 101.10 (stating as to “Nutrition

labeling of restaurant foods” that “Presentation of nutrition labeling may be in various forms,

including those provided in § 101.45 and other reasonable means.”). Put simply, the FDA asks

us to read “label” as stated in Regulation 101.13’s reference to “nutrition label,” as “appropriate

labeling.” Accordingly, for restaurants, a menu or menu board would fall within Section

101.13’s definition of “label.” We have concerns about reading the regulation as the FDA

proposes, but might be required to do so if it were the only way to keep the structure and

meaning of the NLEA intact. However, we think a better approach is to conclude, as we have,

that Regulation 101.13(c) does not pertain to restaurant food, but we adopt the FDA’s test,

quoted above, see supra, at 25, as our own.

       B.      First Amendment

       NYSRA’s other objection to Regulation 81.50 is that it impermissibly infringes on

NYSRA’s member restaurants’ First Amendment rights. It is undisputed that commercial speech

is entitled to the protection of the First Amendment. Zauderer v. Office of Disciplinary Counsel,

471 U.S. 626, 637 (1985). As commercial speech is speech that proposes a commercial

transaction, id., and Regulation 81.50 “requires disclosure of calorie information in connection

with a proposed commercial transaction -- the sale of a restaurant meal,” NYSRA II, 2008 WL

1752455, at *6, the form of speech affected by Regulation 81.50 is clearly commercial speech.


                                                 26
However, the protection afforded commercial speech is “somewhat less extensive than that

afforded noncommercial speech.” Zauderer, 471 U.S. at 637 (quotation marks omitted). And,

within the class of regulations affecting commercial speech, we accord varying levels of

protection depending on the type of commercial speech at issue.

       This is where NYSRA’s objection to the district court’s decision lies. It argues that

Regulation 81.50 should be subjected to heightened scrutiny, and not, as the district court

concluded, “rationality.” However, the district court’s conclusion was compelled by this

Circuit’s law, which rested on our interpretation of Supreme Court precedent. The Supreme

Court has stated that there are “material differences between [purely factual and uncontroversial]

disclosure requirements and outright prohibitions on speech,” id. at 650, and that regulations that

compel “purely factual and uncontroversial” commercial speech are subject to more lenient

review than regulations that restrict accurate commercial speech. Id. at 651. In light of Zauderer,

this Circuit thus held that rules “mandating that commercial actors disclose commercial

information” are subject to the rational basis test. Nat’l Elec. Mfrs. Ass’n v. Sorrell, 272 F.3d

104, 114-15 (2d Cir. 2001). We explained that:

       Commercial disclosure requirements are treated differently from restrictions on
       commercial speech because mandated disclosure of accurate, factual, commercial
       information does not offend the core First Amendment values of promoting
       efficient exchange of information or protecting individual liberty interests. Such
       disclosure furthers, rather than hinders, the First Amendment goal of the discovery
       of truth and contributes to the efficiency of the “marketplace of ideas.” Protection
       of the robust and free flow of accurate information is the principal First
       Amendment justification for protecting commercial speech, and requiring
       disclosure of truthful information promotes that goal. In such a case, then, less
       exacting scrutiny is required than where truthful, nonmisleading commercial
       speech is restricted.




                                                 27
Id. at 113-14 (footnote and citations omitted);19 cf. Riley v. Nat’l Fed’n of the Blind of N.C., Inc.,

487 U.S. 781, 796 n.9 (1988) (stating that “[p]urely commercial speech is more susceptible to

compelled disclosure requirements” than is personal or political speech).

       In arguing both that Sorrell was incorrectly decided and that it does not govern this case,

NYSRA makes the following three arguments. First, United States v. United Foods, Inc., 533

U.S. 405 (2001), issued three months before Sorrell and which Sorrell does not discuss, limited

the rational basis test described in Zauderer to those situations in which the law at issue furthers

the State’s interest in preventing deception of consumers. Second, International Dairy Foods

Association v. Amestoy (IDFA), 92 F.3d 67 (2d Cir. 1996), in which we applied intermediate

scrutiny pursuant to Central Hudson Gas & Elec. Corp. v. Pub. Serv. Commission of New York,

447 U.S. 557 (1980), is more akin to this case.20 Third, the parties in Sorrell did not dispute the

significance of the facts that they were being asked to disclose. In contrast, NYSRA’s member

restaurants, which do not believe that disclosing calorie information would reduce obesity, and

would prefer to provide complete nutrition information, are instead forced, as counsel informed

us during oral argument, to “cram” calorie information “down the throats” of their customers.

       We think NYSRA reads too much into United Foods. The paragraph on which NYSRA



       19
         In Sorrell, we also observed that “[t]o the extent commercial speakers have a legally
cognizable interest in withholding accurate, factual information, that interest is typically
accommodated by the common law of property and its constitutional guarantors.” 272 F.3d at
114.
       20
          Under the Central Hudson test, a court considers (1) whether the regulated expression
concerns lawful activity and is not misleading; (2) whether the asserted governmental interest is
substantial; (3) whether the regulation directly advances the governmental interest asserted; and
(4) whether the regulation is more extensive than is necessary to advance that interest. 447 U.S.
at 566.

                                                 28
relies simply distinguishes Zauderer on the basis that the compelled speech in Zauderer was

necessary to prevent deception of consumers; it does not provide that all other disclosure

requirements are subject to heightened scrutiny. United Foods, 533 U.S. at 416. Of course, there

is no error in this distinction as Zauderer addressed deceptive advertising. Nor was this

distinction lost on us in Sorrell, when we held that Zauderer’s holding was broad enough to

encompass nonmisleading disclosure requirements. Sorrell, 272 F.3d at 115.21 We stated:

       To be sure, the compelled disclosure at issue here was not intended to prevent
       “consumer confusion or deception” per se, Zauderer, 471 U.S. at 651 (internal
       quotation marks omitted), but rather to better inform consumers about the
       products they purchase. Although the overall goal of the statute is plainly to
       reduce the amount of mercury released into the environment, it is inextricably
       intertwined with the goal of increasing consumer awareness of the presence of
       mercury in a variety of products. Accordingly, we cannot say that the statute’s
       goal is inconsistent with the policies underlying First Amendment protection of
       commercial speech, described above, and the reasons supporting the distinction
       between compelled and restricted commercial speech. We therefore find that it is
       governed by the reasonable-relationship rule in Zauderer.

Sorrell, 272 F.3d at 115. We have not been alone in accepting this broader reading. See Pharm.

Care Mgmt. Ass’n v. Rowe, 429 F.3d 294, 310 n.8 (1st Cir. 2005) (“[W]e have found no cases

limiting Zauderer [to ‘potentially deceptive advertising directed at consumers’].”) (decided four

years after United Foods). Thus, “Zauderer, not Central Hudson[], describes the relationship

between means and ends demanded by the First Amendment in compelled commercial disclosure




       21
           Alternatively, New York City argues that even if United Foods so constrained
Zauderer, Regulation 81.50 was adopted to prevent misleading advertising practices and would
still be subject to rational basis. Because we conclude that laws mandating factual disclosures
are subject to the rational basis test even if they address non-deceptive speech, we do not reach
this argument.

                                                29
cases.” Sorrell, 272 F.3d at 115.22

       With NYRSA’s challenge to Sorrell’s holding disposed of, its claim that this case is more

akin to IDFA, clearly fails. In Sorrell, we explained that our decision in IDFA “was expressly

limited to cases in which a state disclosure requirement is supported by no interest other than the

gratification of ‘consumer curiosity.’” Sorrell, 272 F.3d at 115 n.6. Given New York’s interest in

preventing obesity, which is further explained below, see also Mem. of Law in Supp. of Pl.’s

Mot. for Declaratory Relief and a Preliminary Injunction, at 34, No. 08cv1000 (S.D.N.Y. filed

Feb. 14, 2008) (conceding that New York City has a substantial interest in passing Regulation

81.50), IDFA is inapplicable.

       NYSRA’s final objection is also resolved by Sorrell, which clearly held that laws that

compel the reporting of “factual and uncontroversial” information by commercial entities are

scrutinized for rationality. Sorrell, 272 F.3d at 114-15; see also Zauderer, 471 U.S. at 650-51.

Thus, “[t]he question that we must answer is whether [Regulation 81.50’s] labeling . . .

requirements are compelled speech in violation of the Constitution or simply requirements of

purely factual disclosures.” Entm’t Software Ass’n v. Blagojevich, 469 F.3d 641, 652 (7th Cir.


       22
         As in Zauderer, we also reject NYSRA’s suggestions that heightened review is
appropriate because New York City has alternative means of achieving its goals or because
Regulation 81.50 impacts only ten percent of New York City restaurants.
       Because the First Amendment interests implicated by disclosure requirements are
       substantially weaker than those at stake when speech is actually suppressed, we do
       not think it appropriate to strike down such requirements merely because other
       possible means by which the State might achieve its purposes can be
       hypothesized. Similarly, we are unpersuaded by appellant’s argument that a
       disclosure requirement is subject to attack if it is “under-inclusive”-- that is, if it
       does not get at all facets of the problem it is designed to ameliorate. As a general
       matter, governments are entitled to attack problems piecemeal, save where their
       policies implicate rights so fundamental that strict scrutiny must be applied.
Zauderer, 471 U.S. at 651 n.14.

                                                 30
2006) (applying strict scrutiny to disclosure requirement requiring placement of “18” sticker that

met the statute’s definition of “sexually explicit” because it was “more opinion-based than the

question of whether a particular chemical is within any given product” unlike in Sorrell).

NYSRA does not contend that disclosure of calorie information is not “factual”; it only claims

that its member restaurants do not want to communicate to their customers that calorie amounts

should be prioritized among other nutrient amounts, such as those listed in Section 343(q)’s

Nutrition Fact panel. However, the First Amendment does not bar the City from compelling such

“under-inclusive” factual disclosures, see Zauderer, 471 U.S. at 651 n.14, where as discussed

below, the City’s decision to focus its attention on calorie amounts is rational.

       A.      Rational Basis Review

       Accordingly, rational basis applies and NYSRA concedes that it will not prevail if we

apply that test. Our review reveals the concession to be warranted; New York City has plainly

demonstrated a reasonable relationship between the purpose of Regulation 81.50’s disclosure

requirements and the means employed to achieve that purpose. Citing what it termed an “obesity

epidemic,” New York City enacted Regulation 81.50 to: (1) reduce consumer confusion and

deception; and (2) to promote informed consumer decision-making so as to reduce obesity and

the diseases associated with it. See Notice of Adoption. Identifying numerous studies, the

Notice of Adoption made the following relevant findings.23 First, that obesity is epidemic and is

a serious and increasing cause of disease; in New York City, 54% of adults, and 43% of

elementary school children are overweight or obese and obesity is a contributing factor for heart


       23
          Though it has, we note that to survive rational basis review, New York “has no
obligation to produce evidence, or empirical data to sustain . . . rationality.” Lewis v. Thompson,
252 F.3d 567, 582 (2d Cir. 2001) (quotation marks omitted)).

                                                 31
disease, diabetes, stroke, and cancer, which caused 70% of deaths in New York City in 2005. Id.

at 3. Second, that the obesity epidemic is mainly due to excess calorie consumption, often

resulting from meals eaten away from the home. Americans, including New Yorkers, are eating

out more than in the past and when doing so, typically eat more than they do at home, and in just

one meal ordered in a fast food restaurant, might consume more than the advised daily caloric

intake. Id. at 3-4. Third, that chain restaurants serve food that is associated with excess calorie

consumption and weight gain. Id. at 5. Fourth, that consumers’ distorted perceptions about how

many calories food contained led to unhealthy food choices. Id. Fifth, that providing calorie

information, similar to that provided in the NLEA’s Nutrition Fact panel, at the point-of-decision

would help consumers make informed, healthier food choices. Id. at 6. Finally, it noted that

voluntary activities by restaurants were “woefully inadequate” and failed to inform the vast

majority of customers, only 3.1% of whom in a study, reported noticing calorie information, id.

at 7-8, and that leading health authorities recommend posting calorie information at the point of

purchase, id. at 8.

        New York City was not alone in making these observations. A 2006 FDA-commissioned

report concluded that “obesity has become a public health crisis of epidemic proportions.”

Keystone Report at 4. In addition, a 2005 study by the Centers for Disease Control and

Prevention (the “CDC”) estimated that approximately 112,000 deaths in 2000 were associated

with obesity in the United States. Katherine M. Flegal et al., Excess Deaths Associated with

Underweight, Overweight, and Obesity, 293 J. AM . MED . ASS’N 1861, 1863-64 (2005). Another

study concluded that rising obesity rates led to increasing diabetes rates, finding that as of 2005,

15.8 million Americans had diabetes, almost triple the number from 1980. Ctr. for Disease


                                                 32
Control, Nat’l Ctr. For Health Statistics, Nat’l Diabetes Surveillance Sys., Prevalence of Diabetes

(1980-2005), available at http://www.cdc.gov/diabetes/statistics/prev/national/tablepersons.htm

(last visited Jan. 13, 2009). Yet another study concluded that with these increased rates of

obesity and associated health problems, have come increased health-care costs. See Eric A.

Finkelstein et al., State-Level Estimates of Annual Medical Expenditures Attributable to Obesity,

12 OBESITY RESEARCH 18, 22-23 (2004) (listing increased annual medical expenditures of states

attributable to obesity in several states including New York).

       Further, studies have linked obesity to eating out. The Keystone Report also concluded

that the consumption of high-calorie meals at fast-food restaurants is a significant cause of

obesity, stating that “[e]ating out more frequently is associated with obesity, higher body fatness,

and higher body mass index.” Keystone Report at 27. And, it found, among other things that,

whereas in 1970 American spent just 26% of their food budget on food prepared away from

home, they now spend 46% of their food dollars on such items; and that away-from-home foods

provided 34% of American’s daily total caloric intake in 1995, nearly double the 18% intake in

1977-78. Id. at 30, 122. The United States Department of Agriculture has observed that away-

from-home foods have lower nutritional quality than home foods and found a correlation

between increased caloric intake and eating out. See Biing-Hwan Lin, et al., U.S. Dep’t of

Agric., Econ. Research serv., Agric. Info. Bull. No. 749, Away-From-Home Foods Increasingly

Important to Quality of American Diet (1999), available at

http://www.ers.usda.gov/Publications/AIB749/ (last visited Jan. 13, 2009). Yet another study

found that between 50% and 80% of diabetes cases are associated with obesity, unhealthy eating

and physical inactivity. F.B. Hu, et al., Diet, Lifestyle, and the Risk of Type 2 Diabetes Mellitus


                                                 33
in Women, 345 NEW ENG . J. MED . 790, 790-97 (2001).

       Stating that “calorie information is most relevant to obesity prevention,” Keystone Report

at 80, the Keystone Report concluded that “restaurants should provide consumers with calorie

information in a standard format that is easily accessible and easy to use,” id. at 76, allowing

consumers to view the information “when standing at a counter, while reviewing a menu board,

in a car when reading a drive-through menu, or when sitting down at a table reviewing a menu,”

id. at 77.24 In arriving at this conclusion the Keystone Report stated that “[w]ithout nutrition

information, consumers typically are unable to assess the caloric content of foods,” id. at 68, a

statement which we do not doubt upon being informed, counter-intuitively, that a smoked turkey

sandwich at Chili’s contains 930 calories, more than a sirloin steak, which contains 540, or that 2

jelly-filled doughnuts at Dunkin’ Donuts have fewer calories than a sesame bagel with cream

cheese. City and County of San Francisco, CA et al. Amicus Br. 13-14; see also Scot Burton et

al., Attacking the Obesity Epidemic: The Potential Health Benefits of Providing Nutrition

Information in Restaurants, 96 AM . J. PUB. HEALTH 1669, 1669-75 (2006) (finding that calories


       24
          The American Medical Association, the American Heart Association, the American
Association of Retired Persons (AARP), and the American Public Health Association (APHA),
have all endorsed nutrition labeling at fast food and chain restaurants as well. See Am. Med.
Ass’n, Press Release, AMA Adopts Policies to Promote Healthier Food Options to Fight Obesity
in America (June 27, 2007), available at
http://www.ama-assn.org/ama/pub/category/print/17768.html (last visited Jan. 13, 2009); Am.
Heart Ass’n, Position Statement on Menu Labeling (Mar. 4, 2008), available at
http://www.americanheart.org/downloadable/heart/I204661406112Policy%20Posit
ion%20Statement%200n%20Menu%20Labeling.pdf; AARP, Nutrition Labeling At Fast-Food
And Other Chain Restaurants (July 2004), available at
http://www.aarp.org/research/health/healthquality/aresearch-import-882-IB71.html (last visited
Jan. 13, 2009); Am. Public Health Ass’n, Support for Nutrition Labeling in Fast-Food and Other
Chain Restaurants (Nov. 9, 2004), available at
http://www.apha.org/advocacy/policy/policysearch/default.htm?id= 1300 (last visited Jan. 13,
2009).

                                                 34
in restaurant items were almost two times more than what consumers expected). Indeed,

NYSRA’s expert does not assert that provision of information about the calorie content of food

at the point of purchase in restaurants will not be beneficial in reducing obesity levels, and only

states that it might not.

        In view of all the above findings, Regulation 81.50’s calorie disclosure rules are clearly

reasonably related to its goal of reducing obesity.25 We thus conclude that NYSRA has not

demonstrated a likelihood of success on its First Amendment claims and affirm the district

court’s denial of an injunction.

III.    Conclusion

        For the reasons stated above, we reject NYSRA’s challenge to Regulation 81.50 because

we conclude that it is not preempted by the NLEA and does not violate NYSRA’s member

restaurants’ First Amendment rights. Because this panel did not grant a stay of enforcement of

the district court’s order and NYSRA and its member restaurants are complying with Regulation

81.50, or facing fines for non-compliance, no further action is required by this Court.




        25
           As requested in City and County of San Francisco, CA et al. Amici Curiae’s Request
for Judicial Notice, we take judicial notice of the fact that numerous other states and or localities
have passed or introduced similar nutrition disclosure legislation. See County of Suffolk v. First
Am. Real Estate Solutions, 261 F.3d 179, 190 n.5 (2d Cir. 2001) (“[W]e take judicial notice of
the introduction of a similar bill seeking to amend [New York State’s Freedom of Information
Law] now before the 224th Legislature.”).

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