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1 ¹ See, e.g., HHS, The President's Council on Physical Fitness and Sports, Steps to Preventing Overweight and Obesity (2003).

2 ² John Cawley & Chad Meyerhoefer, The Medical Care Costs of Obesity: an Instrumental Variables Approach, 31 J. HEALTH ECON. 219–30 (2012).

3 ³ At 21 U.S.C. §§ 343(Q), (R) [§§ 403(Q), (R) FD&C Act].

4 ⁴ 21 C.F.R. § 101.9(c).

5 ⁵ 21 C.F.R. 101.9(a), 21 C.F.R. 101.9(c), 21 C.F.R. 101.9(c)(8)(ii).

6 ⁶ Adapted from The Food Label, FDA BACKGROUNDER (May 1999).

7 ⁷ 21 C.F.R. § 101.9(d).

8 ⁸ 21 C.F.R. § 101.9(e).

9 ⁹ 21 C.F.R. § 101.9(b)(10).

10 ¹⁰ 21 C.F.R. § 101.9(j)(13).

11 ¹¹ 21 C.F.R. § 101.9(c).

12 ¹² 21 C.F.R. § 101.12.

13 ¹³ 21 C.F.R. § 101.9(b)(2)(i)(A).

14 ¹⁴ 21 C.F.R. § 101.9(b)(2)(i)(B).

15 ¹⁵ 21 C.F.R. § 101.9(b)(2)(i)(C).

16 ¹⁶ 21 C.F.R. § 101.9(b)(2)(i)(D).

17 ¹⁷ 21 C.F.R. § 101.9(b)(2)(ii).

18 ¹⁸ 21 C.F.R. § 101.9(b)(2)(iii).

19 ¹⁹ 21 C.F.R. § 101.9(b)(3).

20 ²⁰ 21 C.F.R. § 101.9(b)(2)(i)(E).

21 ²¹ 21 C.F.R. § 101.9(b)(6).

22 ²² 21 C.F.R. § 101.9(b)(5).

23 ²³ 21 C.F.R. § 101.9(b)(8).

24 ²⁴ 21 C.F.R. § 101.9(j)(1).

25 ²⁵ 21 C.F.R. § 101.9(j)(18).

26 ²⁶ 21 C.F.R. § 101.9(j)(4).

27 ²⁷ 21 C.F.R. § 101.9(j)(5).

28 ²⁸ 21 C.F.R. § 101.9(j)(8).

29 ²⁹ 21 C.F.R. § 101.9(j)(9).

30 ³⁰ 21 C.F.R. § 101.9(j)(10).

31 ³¹ 21 C.F.R. § 101.9(j)(13).

32 ³² 21 C.F.R. § 101.9(j)(16).

33 ³³ Also http://www.fda.gov/fdac/special/foodlabel/ingred.html (May 1993).

34 ³⁴ Ed Scarbrough, Ph.D., director of the Office of Food Labeling in FDA's Center for Food Safety and Applied Nutrition, when NLEA was enacted.

35 ³⁵ Amanda Spake, The Truth on Foods and Fats, 124, 126, U.S. NEWS & WORLD REPORTS (2004).

36 ³⁶ Robert L. Wolke, Trans Fat Translation, Washingtonpost.com, Page F01 (Aug. 20, 2003).

37 ³⁷ CSPI petitions FDA to ban hydrogenated vegetable oil, FOOD CHEMICAL NEWS DAILY, Vol. 6, No. 96 (May 19, 2004).

38 ³⁸ CSPI's entire petition to FDA is www.cspi.org.

39 ³⁹ Id.

40 ⁴⁰ Id. (quoting Regina Hildwine).

41 ⁴¹ See Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health Claims, 68 Fed. Reg. 41433–1506 (July 11, 2003).

42 ⁴² FDA, Final Determination Regarding Partially Hydrogenated Oils, 80 Fed. Reg. 34650–46790 (June 17, 2015).

43 ⁴³ Because PHOs are no longer GRAS, PHOs are subject to the food additive requirements under Food, Drug, and Cosmetic Act § 409. See Chapter 10.

44 ⁴⁴ 61 Fed. Reg. 40332 (Aug. 2, 1996).

45 ⁴⁵ Section 4205 of the ACA amends section 403(q) of the Food, Drug, and Cosmetic Act, which governs nutrition labeling requirements, and section 403A of the FD&C Act, which governs federal preemption of state and local food labeling requirements.

46 ⁴⁶ FDA, Food Labeling; Calorie Labeling of Articles of Food in Vending Machines. Final Rule, 79 Fed. Reg. 71259 (Dec. 1, 2014)(explaining the purpose of the final rule).

47 ⁴⁷ 79 Fed. Reg. 71156 (Dec. 1, 2014).

48 ⁴⁸ 76 Fed. Reg. 19237‐19255 (Apr. 6, 2011).

49 ⁴⁹ FD&C Act § (q)(5)(H)(i).

50 ⁵⁰ 21 C.F.R. § 101.11(a).

51 ⁵¹ 21 C.F.R. § 101.11(b)(2)(i)(A).

52 ⁵² Menus and menu boards targeting children may substitute an alternative statement. See 21 C.F.R. § 101.11(b)(2)(i)(B).

53 ⁵³ 21 C.F.R. § 101.11(b)(2)(i)(C).

54 ⁵⁴ 21 C.F.R. § 101.11(b)(2)(ii).

55 ⁵⁵ FD&C Act 403(q).

56 ⁵⁶ Effective date: Dec. 1, 2016. FDA, Food labeling; calorie labeling of articles of food in vending machines. Final rule. 79 Fed Reg. 71259 (Dec. 1, 2014).

57 ⁵⁷ FD&C Act § 403A(a)(4).

58 ⁵⁸ 21 C.F.R. § 100.

59 ⁵⁹ That is, subject to FD&C Act § 403(q)(5)(H)(viii).

60 ⁶⁰ FD&C Act § 403(q)(5)(H)(ix) and 75 Fed. Reg. 43182 (July 23, 2010).

61 ⁶¹ FD&C Act § 403(r)(1)(A) (emphasis added).

62 ⁶² FD&C Act § 403(r)(2).

63 ⁶³ FD&C Act § 403(r)(2)(C).

64 ⁶⁴ 21 C.F.R. § 101.13(b).

65 ⁶⁵ The FDCA regulates a claim that, “characterizes the level of any nutrient” on the label or labeling of the food. FD&C Act § 403(r)(2). Neither “nutrient content claims” nor “nutrient descriptors” precisely convey the language in the Act. Nutrient content claims that only indicate the factual quantity of a nutrient without characterizing the level (high, low, and so forth) are outside the scope of § 403(r)(1)(A). Nutrient descriptors that only indicate the function of a nutrient without characterizing the level are also outside the scope of § 403(r)(1)(A). Therefore, I use the terminology “nutrient level descriptor.”

66 ⁶⁶ 21 C.F.R. § 101.54.

67 ⁶⁷ 21 C.F.R. § 101.54.

68 ⁶⁸ 21 C.F.R. § 101.65(d)(2).

69 ⁶⁹ 21 C.F.R. § 101.65(d)(2)(i).

70 ⁷⁰ 21 C.F.R. § 101.65(d)(2)(iv).

71 ⁷¹ 81 Fed. Reg. 66527‐66529 (Sept. 28, 2016).

72 ⁷² 21 C.F.R. § 101.65(d).

73 ⁷³ 21 C.F.R. § 101.65(d)(2)(ii).

74 ⁷⁴ Daily Values (DVs) are label reference value. Daily Values encompass both the Reference Daily Intakes (RDIs) for vitamins and minerals and the Daily Reference Values (DRVs) for macronutrients, such as fat, protein, and sodium. FDA determined that a single DV would be less confusing on the label than two references values.

75 ⁷⁵ 21 C.F.R. § 101.54.

76 ⁷⁶ Id.

77 ⁷⁷ 21 C.F.R. § 101.62(e).

78 ⁷⁸ 21 C.F.R. § 101.62(b).

79 ⁷⁹ 21 C.F.R. § 101.61(b).

80 ⁸⁰ 21 C.F.R. § 101.62(d).

81 ⁸¹ 21 C.F.R. § 101.60(b).

82 ⁸² 21 C.F.R. § 101.54.

83 ⁸³ 21 C.F.R. § 101.13(j).

84 ⁸⁴ 21 C.F.R. § 101.60(c).

85 ⁸⁵ 21 C.F.R. § 101.13(e).

86 ⁸⁶ FD&C Act § 403(r)(2).

87 ⁸⁷ 21 C.F.R. § 130.10.

88 ⁸⁸ 21 C.F.R. § 101.13(d).

89 ⁸⁹ 21 C.F.R. § 101.3(e)(4). With a reduction in the caloric or fat content, the food must labeled pursuant to the provisions of 21 C.F.R. § 101.9, and the labeling with respect to any reduction in caloric content must comply with the provisions applicable to caloric content in 21 C.F.R. § 105.

90 ⁹⁰ 21 C.F.R. § 101.13(h).

91 ⁹¹ 21 C.F.R. § 101.13(q)(3).

92 ⁹² 21 C.F.R. § 101.13(b)(3).

93 ⁹³ 21 C.F.R. § 101.13(q)(1).

94 ⁹⁴ 21 C.F.R. § 101.13(q)(2).

95 ⁹⁵ 21 C.F.R. §§ 101.65, 130.10.

96 ⁹⁶ 21 C.F.R. § 101.65(b).

97 ⁹⁷ See FD&C Act § 403(r)(4)(A).

98 ⁹⁸ FD&C Act § 403(r)(2)(C).

99 ⁹⁹ FDA, “Nutrient Content Claims Notification for Choline Containing Foods,” http://www.fda.gov/Food/IngredientsPackagingLabeling/LabelingNutrition/ucm073599.htm (last visited Sept. 20, 2015).

100 ¹⁰⁰ FDA, Food Labeling: Nutrient Content Claims; Alpha‐Linolenic Acid, Eicosapentaenoic Acid, and Docosahexaenoic Acid Omega‐3 Fatty Acids; Guidance for Industry Small Entity Compliance Guide (Feb. 2016).

101 ¹⁰¹ Nutrient content claims must comply with all applicable FDA regulations regarding the making of such claims.

102 ¹⁰² 21 C.F.R. § 104.20; 45 Fed. Reg. 6323 (Jan. 25, 1980), and 58 Fed. Reg. 2228 (Jan. 6, 1993).

103 ¹⁰³ Id.

104 ¹⁰⁴ See 21 C.F.R. § 104.20(d)(3) for the list of nutrients.

105 ¹⁰⁵ 2003 WL 22052778 (S.D.N.Y. 2003) (not reported in F.Supp.2d).