Write a 8-10 page paper, APA format. The paper should follow conventional structure for academic writing.Include an Introduction, Body, and Conclusion. The body of the paper should include subheadings that either adheres to the following outline, or subheadings of the students own choosing. The conclusion should restate the main points and tie together all the concepts presented in the body of the paper.Topic: Food and Drug Administration (FDA) Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food EstablishmentsI will attach six articles down below. Please make sure to include all 6 articles in the paper.
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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)
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).
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).
HARVARD LAW REVIEW
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–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
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
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.
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
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
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,
HARVARD LAW REVIEW
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
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.
41 See 21 U.S.C. § 343(q)(5)(H)(x)(I).
42 549 U.S. 497 (2007).
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
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. …
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