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1 ¹ Letter from Mark Twain to George Bainton (Oct. 15, 1888), in THE ART OF AUTHORSHIP: LITERARY REMINISCENCES, METHODS OF WORK, AND ADVICE TO YOUNG BEGINNERS 87–8 (George Bainton ed., New York, D. Appleton 1891), http://www.bartleby.com/73/540.html (last visited Sept. 27, 2005).

2 ² 335 U.S. 355 (1948).

3 ³ Id.

4 ⁴ FDA COMPLIANCE POLICY GUIDE NO. 7153.13 (Dec. 1, 1982). The revised version of this compliance policy guide is http://www.fda.gov/ora/compliance:ref/cpg/cpggenl/cpg140‐100.html.

5 ⁵ 52 Stat. 111, 114 (1938), later incorporated into 15 U.S.C. 52658.

6 ⁶ PETER BARTON HUTT & RICHARD A. MERRILL, FOOD AND DRUG LAW 43 (2d ed. 1991).

7 ⁷ 21 C.F.R. § 101.15(c)(2). In addition, the Tariff Act of 1930, 19 U.S.C. 1304, requires all imported articles to be marked with the English name of the country of origin.

8 ⁸ FD&C Act § 403(f).

9 ⁹ 21 C.F.R. § 101.1.

10 ¹⁰ Id.

11 ¹¹ 21 C.F.R. §§ 101.3(a) and 101.105(a).

12 ¹² 21 C.F.R. § 101.2(b) and (d).

13 ¹³ 21 C.F.R. § 101.2.

14 ¹⁴ 21 C.F.R. § 101.3.

15 ¹⁵ FD&C Act § 403(f).

16 ¹⁶ 21 C.F.R. 101.3(d).

17 ¹⁷ 21 C.F.R. 101.3(d).

18 ¹⁸ FD&C Act § 403(g) and 21 C.F.R. § 101.3.

19 ¹⁹ 21 C.F.R. 155.13.

20 ²⁰ 21 C.F.R. 101.3(b).

21 ²¹ 21 C.F.R. § 101.3(b).

22 ²² 21 C.F.R. § 101.3(c).

23 ²³ 21 C.F.R. § 101.3(b)(3).

24 ²⁴ YING HE & JOSEPH G. SEBRANEK, FINELY TEXTURED LEAN BEEF AS AN INGREDIENT FOR PROCESSED MEATS (Beef Research Report, 1996. Paper 39, Iowa State University) (1997).

25 ²⁵ Complaint and Jury Demand, Beef Products, Inc. v. American Broadcasting Companies, Inc., No. CIV12292, 2012 WL 4017340 (S.D. Cir. Sept. 13, 2012).

26 ²⁶ Id.

27 ²⁷ USDA, FSIS, FOOD STANDARDS AND LABELING POLICY BOOK (2005) http://www.fsis.usda.gov/OPPDE/larc/Policies/Labeling_Policy_Book_082005.pdf (last visited Mar. 28, 2015).

28 ²⁸ Specifically, ABC evening news broadcast a segment on March 7, 2012.

29 ²⁹ Rita‐Marie Cain Reid, You Say “Lean Finely Textured Beef,” I Say “Pink Slime,” 69 FOOD & DRUG L. J. 625, 626 (2014).

30 ³⁰ Id.

31 ³¹ For more detailed information, refer to 21 C.F.R. § 101.3(d) and 21 C.F.R. § 101.22.

32 ³² 21 C.F.R. § 101.3(e)(1).

33 ³³ 21 CFR § 101.30.

34 ³⁴ Elizabeth Campbell was then the director of the programs and enforcement policy division in the Office of Food Labeling of FDA's Center for Food Safety and Applied Nutrition.

35 ³⁵ 21 C.F.R. § 101.105.

36 ³⁶ 15 U.S.C. § 1453(a)(2).

37 ³⁷ 15 U.S.C. § 1453(a)(3)(A)(ii).

38 ³⁸ 15 U.S.C. § 1453(a)(6).

39 ³⁹ Metric Labeling; Quantity of Contents Labeling Requirement for Foods, Human and Animal Drugs, Animal Foods, Cosmetics, and Medical Devices, 58 Fed. Reg. 67444 (Dec. 21, 1993) (Docket nos. 92N‐0406 and 93N‐0226).

40 ⁴⁰ FDA withdrew the proposed metric regulations, but the withdrawn proposal still provides guidance and offers a sound position. 68 Fed. Reg. 19766 (Apr. 22, 2003).

41 ⁴¹ The Gould Amendment of 1913 to the 1906 Act, 37 Stat. 732 (1913).

42 ⁴² See NIST HANDBOOK 133, CHECKING THE NET CONTENTS OF PACKAGED GOODS, www.nist.gov (last visited Feb. 10, 2016.) (This publication includes procedures for testing packages labeled by weight, volume, measure, and count.)

43 ⁴³ The word “ingredients” does not refer to the chemical composition, but means the individual food and food additive components of a mixed food.

44 ⁴⁴ 21 C.F.R. § 101.4(a)(2).

45 ⁴⁵ 21 C.F.R. § 102.5(b).

46 ⁴⁶ Id.

47 ⁴⁷ 21 CFR § 101.30.

48 ⁴⁸ 21 C.F.R. § 101.4(e).

49 ⁴⁹ FD&C Act § 403(k) and 21 C.F.R. § 102(k)(3).

50 ⁵⁰ Id.

51 ⁵¹ 21 C.F.R. § 102(k)(2).

52 ⁵² FD&C Act § 403(k).

53 ⁵³ 21 C.F.R. § 102.22 on protein hydrolysates applies to FDA regulated foods. “The common or usual name of a protein hydrolysate shall be specific to the ingredient and shall include the identity of the food source from which the protein was derived. (a) “Hydrolyzed wheat gluten,” “hydrolyzed soy protein,” and “autolyzed yeast extract” are examples of acceptable names. “Hydrolyzed casein” is also an example of an acceptable name, whereas “hydrolyzed milk protein” is not an acceptable name for this ingredient because it is not specific to the ingredient (hydrolysates can be prepared from other milk proteins). The names “hydrolyzed vegetable protein” and “hydrolyzed protein” are not acceptable because they do not identify the food source of the protein. (b) [Reserved]” At this time, USDA regulations still allow listing protein hydrolysate as “flavoring.” For example, see 9 C.F.R. § 381.118 for the ingredients statement on poultry.

54 ⁵⁴ 21 CFR § 101.100(a)(3).

55 ⁵⁵ 21 C.F.R. § 101.100(a)(3).

56 ⁵⁶ 21 C.F.R §. 101.5

57 ⁵⁷ Some states have specific date labeling requirements.

58 ⁵⁸ 9 C.F.R. § 381.126 and 9 C.F.R. § 431.2(e), respectively.

59 ⁵⁹ 21 C.F.R. § 113.60(c).

60 ⁶⁰ S 1944, 73d Cong. (1st Sess § 6(a) 1933) from JAMES T. O'REILLY, FOOD AND DRUG ADMINISTRATION (2d ed. § 10‐05).

61 ⁶¹ This case predates the FD&C Act (1938), but the standard was the same under the Pure Food and Drug Act of 1906.

62 ⁶² See Chapter 12 for more detail on cell‐cultured meat.

63 ⁶³ National Milk Producers Federation, FDA Should Stop Imitation Products from Milking Dairy Terms, Says NMPF, https://www.nmpf.org/latest‐news/articles/fda‐should‐stop‐imitation‐products‐milking‐dairy‐terms‐says‐nmpf (last visited Nov. 8, 2018).

64 ⁶⁴ Emily Atkin, The War of Soy Milk, NEW REPUB LIC (Jul. 20, 2018) https://newrepublic.com/article/150006/war‐soy‐milk (last visited Oct 8, 2020).

65 ⁶⁵ 21 C.F.R. § 131.110(a).

66 ⁶⁶ Central Hudson Gas & Electric v. Public Service Commission of New York, 447 U.S. 557 (1980) (see Chapter 5 infra for more discussion of this case).

67 ⁶⁷ Citizen Petition, Recognized the Term “Soymilk” as the Established Common of [sic] Usual Name, FDA‐1997‐P‐0016 (Feb. 28, 1997), https://www.regulations.gov/docket?D=FDA‐1997‐P‐0016 (last visited Oct. 8, 2020).

68 ⁶⁸ FD&C Act § 403(i) [21 U.S.C. § 343(i)].

69 ⁶⁹ 21 C.F.R. § 101.3(b).

70 ⁷⁰ Ang v. Whitewave Foods Co., No. 13‐CV‐1953, 2013 WL 6492353, at 4 (N.D. Cal. Dec. 1, 2015) (finding as a matter of law no customer could confuse soymilk or almond milk for dairy milk); Gitson v. Trader Joe's, No. 13–cv–01333–VC, 2015 WL 9121232, at 7 (N.D. Cal. Dec. 1, 2015) (finding that no reasonable consumer would believe that a product labeled Organic Soy Milk, including the explicit statement that it is “LACTOSE & DAIRY FREE,” has the same qualities as cow's milk); Painter v. Blue Diamond Growers, CV 17‐02235‐SVW‐AJW at 2, 2017 WL 4766510 (C.D. Cal. May 24, 2017) (“Almond milk” accurately describes “the basic nature of the food or its characterizing properties or ingredients.”)

71 ⁷¹ Central Hudson, supra note 66 at 1239.

72 ⁷² Pub. L. No 108‐282 of 2004.

73 ⁷³ FD&C Act § 403(w)(1).

74 ⁷⁴ 21 U.S.C. § 343(w)(6).

75 ⁷⁵ 21 U.S.C. § 343(w)(7).

76 ⁷⁶ 21 C.F.R. § 101.91(a)(2) (grains from the genera Triticum, Secale, or Hordeum).

77 ⁷⁷ 21 C.F.R. § 101.91 Gluten‐free labeling of food.

78 ⁷⁸ Id.

79 ⁷⁹ TTB, Major Food Allergen Labeling for Wines, Distilled Spirits, and Malt Beverages, Notice of Proposed Rulemaking, Notice No. 62, 71 Fed. Reg. 42329 (July 26, 2006) (the agency had not proposed final rules as of October 2014).

80 ⁸⁰ TTB, Major Food Allergen Labeling for Wines, Distilled Spirits, and Malt Beverages, Interim Rule, 71 Fed. Reg. 42260 (July 26, 2006) codified at 27 C.F.R. parts 4, 5, and 7.

81 ⁸¹ 27 C.F.R. § 4.33.

82 ⁸² 27 C.F.R. § 4.34.

83 ⁸³ 27 C.F.R. § 4.35.

84 ⁸⁴ 27 C.F.R. § 4.37.

85 ⁸⁵ 27 C.F.R. § 4.32(e).

86 ⁸⁶ 27 C.F.R. § 4.36.

87 ⁸⁷ 27 C.F.R. § 4.34.

88 ⁸⁸ Id.

89 ⁸⁹ 27 C.F.R. § 16.21.

90 ⁹⁰ 58 Fed. Reg. 2899 (Jan. 6, 1993).

91 ⁹¹ Id.

92 ⁹² 9 C.F.R. § 412.2.

93 ⁹³ 9 C.F.R. § 412.1(c) (1).

94 ⁹⁴ 9 C.F.R. § 412.1(c) (2).

95 ⁹⁵ 9 C.F.R. § 412.1(c) (3).

96 ⁹⁶ 9 C.F.R. § 412.1(c) (4).

97 ⁹⁷ 9 C.F.R. §§ 317.2(l) and 381.125

98 ⁹⁸ 7 C.F.R. § 317.2(e)(3).

99 ⁹⁹ 80 Fed. Reg. 28153 (May 18, 2015).

100 ¹⁰⁰ Id.

101 ¹⁰¹ 7 C.F.R. § 317.2(e)(3).