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Inappropriate Referral: The Use of Primary Jurisdiction in Food-Labeling Litigation

Published online by Cambridge University Press:  06 January 2021

Diana R. H. Winters*
Indiana University Robert H. McKinney School of Law


Food system regulation must negotiate intensely individual and hyper-local preferences with the national and collective implications of food production and consumption. The regulatory scheme permits the coincidence of multiple sets of regulators, and there is an active interchange between federal and state authorities. This kind of “dynamic” or “polyphonic” federalism entails “the interaction of multiple independent voices” and “the dynamic interaction among states and the national government.”

Copyright © American Society of Law, Medicine and Ethics and Boston University 2015

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1 Schapiro, Robert A., Toward a Theory of Interactive Federalism, 91 Iowa L. Rev. 243, 249, 254 (2005)Google Scholar.

2 Arthur N. Levine, FDA Enforcement Manual: FDA and State and Local Agencies ¶182 (2013), available at 2006 WL 3259307.

3 Laura, Murphy et al., More than Curiosity: The Constitutionality of State Labeling Requirements for Genetically Engineered Foods, 38 Vt. L. Rev. 477, 535-36 (2013)Google Scholar.

4 Winters, Diana R. H., The Magical Thinking of Food Labeling: The NLEA as a Failed Statute, 89 Tul. L. Rev. 815, 866-67 (2015)Google Scholar.

5 Flannery, Diane P., 2013's Key Rulings in Food Mislabeling Litigation, Law 360 (Jan. 7, 2014, 4:38 PM)Google Scholar,

6 Farris, April L., The “Natural” Aversion: The FDA's Reluctance to Define a Leading Food-Industry Marketing Claim, and the Pressing Need for a Workable Rule, 65 Food & Drug L.J. 403, 411-417 (2010)Google ScholarPubMed.

7 See infra Part IV.B.

8 See infra notes 138-141 and accompanying text.

9 Ashley Harrison et al., Shook, Hardy & Bacon, L.L.P., Environmental, Mass Torts & Products Liability Litigation Committees' Joint CLE Seminar: Recent Developments and Case Updates in Food Labeling Class Actions and Advertising Litigation 8-9 (Jan. 29-31, 2015),

10 This piece is a part of a broader project on the history and current use of the primary jurisdiction doctrine that will be available Summer 2015, entitled Beyond Conventional Experience? An Argument for Abandoning Primary Jurisdiction.

11 21 U.S.C. § 343-1 (2012).

12 Id. § 321(k).

13 Id. § 321(m).

14 Barton Hutt, Peter., et alFood and Drug Law Cases and Materials 13 (3d ed. 2007)Google Scholar.

15 United States v. Lane Labs-USA, Inc., 427 F.3d 219, 226 (3d Cir. 2005).

16 Id. § 343.

17 Id. § 343-343(c).

18 Pub. Citizen, Inc. v. Shalala, 932 F. Supp. 13, 14 (D.D.C 1996).

19 21 U.S.C. § 343(q).

20 Id. § 343(q)(1)(A)–(D).

21 Id. § 343(q).

22 Id. § 343(r).

23 See id.

24 Genetically engineered foods (GEs) are produced by altering their genetic composition through a process called “recombinant DNA, or gene splicing, to give the plant a desirable trait.” Linda Bren, Genetic Engineering: The Future of Foods?, FDA Consumer Magazine (Nov.-Dec. 2003), in Lisa Heinzerling, U.S. Food Law: Cases and Materials (2014). Another term used for GEs is genetically modified organisms (GMOs), but the term GMO is broader and encompasses practices, like plant breeding, used by farmers to alter crops for hundreds of years. Rob Endelman, The Difference Between the Terms “GE” and “GMO”, Delicious Truth (Mar. 23, 2012),

25 Infra Part II.C.

26 See H.R. Rep. No. 101-538, at 10-11 (1990), reprinted in 1990 U.S.C.C.A.N. 3336, 3337-39 (explaining that proposed legislation (what would become the NLEA), was “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.”). A Committee Report noted that health claims and nutrient content claims were largely unregulated, and that substantiated claims could assist Americans in maintaining a healthy diet. See id. at 11.

27 21 C.F.R. § 101.13(b) (2014) (“An expressed nutrient content claim is any direct statement about the level (or range) of a nutrient in the food, e.g., ‘low sodium’ or ‘contains 100 calories …. An implied nutrient content claim is any claim that: (i) [d]escribes 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) [s]uggests 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’).”).

28 Id. § 101.56(d)(2)(i).

29 Id. § 101.14(a)(1) (emphasis omitted).

30 See id.

31 Id. § 101.13, 101.54, 101.56, 101.60, 101.61, 101.62.

32 See FDA, Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims-Final (2009), [hereinafter Guidance for Industry]; FDA, Questions and Answers: Qualified Health Claims in Food Labeling, (2005), [hereinafter Qualified Health Claims].

33 21 C.F.R. § 101.14(c).

34 Pearson v. Shalala, 164 F.3d 650, 658 (D.C. Cir. 1999); Guidance for Industry, supra note 32.

35 Qualified Health Claims, supra note 32.

36 Mel Drozen & Eve Pelonis, Food Labeling, in Food and Drug Law and Regulation 115-117 (David G. Adams et al. eds., 2d ed. 2011).

37 Derr, Laura E., When Food is Poison: The History, Consequences, and Limitations of the Food Allergen Labeling and Consumer Protection Act of 2004, 61 Food & Drug L.J. 65, 101 n.210 (2006)Google ScholarPubMed.

38 21 U.S.C. § 343-1 (2012); Burros, Marian, Eating Well; Nutrition Labeling: To Be or Not to Be?, N.Y. Times, Mar. 14, 1990Google Scholar,; Hilts, Philip J., Congress Votes Bill on Labeling of Food and Health Claims, N.Y. Times, Oct. 25, 1990Google Scholar,

39 See infra notes 40, 43 and accompanying text.

40 In re Farm Raised Salmon Cases, 175 P.3d 1170, 1179 (Cal. 2008).

41 See, e.g., 21 U.S.C. § 360k (2012) (“[T]he Secretary may … exempt from subsection (a) of this section … a device intended for human use”); id. § 360ss (“Nothing in this part shall be construed to prevent the Federal [or State] Government … from establishing a requirement with respect to emission of radiation ….”); In re Farm Raised Salmon Cases, 175 P.3d at 1179 (“Congress enacted numerous specific express preemption provisions in the FDCA … [including] §§ 360k (medical devices), [and] 360ss (radiation emissions) ….”).

42 Koenig v. Boulder Brands, Inc., 995 F. Supp. 2d 274, 280 (S.D.N.Y. 2014).

43 21 U.S.C. § 337(a) (“[A]ll such proceedings for the enforcement, or to restrain violations, of this chapter shall be by and in the name of the United States”); Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 349 n.4 (2001) (“The FDCA leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance with … medical device provisions[, here]”).

44 Merrell Dow Pharms., Inc. v. Thompson, 478 U.S. 804, 806-07 (1986); see, e.g., Bryan G. Scott & Elizabeth K. Strickland, Recent Developments in Federal Preemption of Pharmaceutical Drug and Medical Device Product Liability Claims, Defender (N.C. Ass'n of Def. Attorney), Fall 2009, 3, 7, available at

45 21 U.S.C. § 343-1(a) to (a)(4).

[N]o State or political subdivision of a State may directly or indirectly establish under any authority or continue in effect as to any food in interstate commerce … any requirement for the labeling of food of the type required by section 343(c), 343(e), 343(i)(2), 343(w), or 343(x) of this title that is not identical to the requirement of such section … [or] any requirement for the labeling of food of the type required by section 343(b), 343(d), 343(f), 343(h), 343(i)(1), or 343(k) of this title that is not identical to the requirement of such section … [or] any requirement for nutrition labeling of food that is not identical to the requirement of section 343(q) of this title.


46 Id. § 343-1(a)(4) to (5).

47 In re Farm Raised Salmon Cases, 175 P.3d 1170, 1178 (Cal. 2008) (“The words of Section 343-1 clearly and unmistakably evince Congress's intent to authorize states to establish laws that are ‘identical to’ federal law.”).

48 See, e.g. Ivie v. Kraft Foods Global, Inc., No. C–12–02554-RMW, 2013 WL 685372, at *8 (N.D. Cal. Feb. 25, 2013) (“California courts generally hold that there is no bar to bring suits to enforce California laws,” even if claims are predicated on identical requirements to those in the FDCA or NLEA).

49 21 U.S.C. § 343(q).

50 Chacanaca v. Quaker Oats Co., 752 F. Supp. 2d 1111, 1123-1124 (N.D. Cal. 2010).

51 Mutual Pharm. Co., v. Bartlett, 133 S. Ct. 2466, 2473 (2013) (citing English v. Gen. Elec. Co., 496 U.S. 72, 79 (1990)).

52 Wyeth v. Levine, 555 U.S. 555, 589 (2009) (citing Hines v. Davidowitz, 312 U.S. 52, 67 (1941)).

53 Chacanaca, 752 F. Supp. 2d at 1118, 1123-1124.

54 In re Farm Raised Salmon Cases, 175 P.3d 1170, 1173, 1175 (Cal. 2008).

55 What is the Meaning of ‘Natural’ on the Label of Food?, FDA, (last visited Mar. 13, 2015); see FDA, DRAFT Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering; Draft Guidance (2001), [hereinafter Draft Guidance].

56 Food Labeling: Nutrient Content Claims, General Principles, Petitions, Definition of Terms; Definitions of Nutrient Content Claims for the Fat, Fatty Acid, and Cholesterol Content of Food, 58 Fed. Reg. 2,302, 2,407 (Jan. 6, 1993) (to be codified at 21 C.F.R. pts. 5, 101); Draft Guidance, supra note 55.

57 Beck, James M., Food Fight: FDA Preemption and Food Labeling Claims, Law 360 (Jan. 27, 2011, 2:14 PM)Google Scholar,

58 Statement of Policy: Foods Derived from New Plant Varieties, 57 Fed. Reg. 22,984, 22,984-85 (May 29, 1992).

59 Id. at 22,984, 22,989-90.

60 Id. at 22,984.

61 Id.

62 21 U.S.C. § 342(a)(1) (2012).

63 Statement of Policy: Foods Derived from New Plant Varieties, 57 Fed. Reg. at 22,989-90.

64 Id. at 22,991.

65 21 U.S.C. § 348.

66 21 U.S.C. § 321(s).

67 See Neltner, Thomas G. et al., Navigating the U.S. Food Additive Regulatory Program, 10 Comprehensive Revs. in Food Sci. & Food Safety, 342, 351, 360 (2011)Google Scholar.

68 See id. at 347, 360.

69 Id. at 360.

70 See, e.g., Kindy, Kimberly, Food Additives on the Rise as FDA Scrutiny Wanes, Wash. Post, Aug. 17, 2014Google Scholar, (showing that “[e]ven when the FDA approves a new additive or signs off on a company's GRAS determination … the agency has little way of monitoring this threat after the initial introduction of the additive”).

71 Food Labeling: Nutrient Content Claims, General Principles, Petitions, Definition of Terms; Definitions of Nutrient Content Claims for the Fat, Fatty Acid, and Cholesterol Content of Food, 58 Fed. Reg. 2,302, 2,407 (Jan. 6, 1993); Cf. Meat and Poultry Labeling Terms, USDA Food Safety & Inspection Serv., (last visited Mar. 13, 2015) (formally defining “natural” as “[a] product containing no artificial ingredient or added color and is only minimally processed. Minimal processing means that the product was processed in a manner that does not fundamentally alter the product. The label must include a statement explaining the meaning of the term natural (such as ‘no artificial ingredients; minimally processed.’)”.

72 Food Labeling: Nutrient Content Claims, General Principles, Petitions, Definition of Terms, 56 Fed. Reg. 60,421, 60,467 (Nov. 27, 1991) (to be codified at 21 C.F.R. pts. 5, 101, 105).

73 Id. at 60,466.

74 Food Labeling: Nutrient Content Claims, General Principles, Petitions, Definition of Terms; Definitions of Nutrient Content Claims for the Fat, Fatty Acid, and Cholesterol Content of Food, 58 Fed. Reg. at 2,407.

75 Negowetti, Nicole E., A National “Natural” Standard for Food Labeling, 65 Me. L. Rev. 581, 587-588 (2013)Google Scholar.

76 See, e.g. Holk v. Snapple Beverage Corp., 575 F.3d 329, 340-341 (3d Cir. 2009) (concluding “that the FDA's policy statement regarding use of the term ‘natural’ is not entitled to preemptive effect”); In re Frito-Lay N. Am., Inc. All Natural Litig., No. 12–MD–2413 (RRM)(RLM), 2013 WL 4647512, *10 (E.D.N.Y. Aug. 29, 2013) (noting that the “[c]omplaint w[ould] not be dismissed on the basis of obstacle preemption”).

77 See infra notes 87-101 and accompanying text (discussing cases referred to FDA to determine whether “natural” could include GE ingredients).

78 Negowetti, Nicole E., Food Labeling Litigation: Exposing Gaps in the FDA's Resources and Regulatory Authority, Governance Studies at Brookings 1, 7-8 (2014)Google Scholar, available at (comprehensively laying out the history of food labeling litigation).

79 Id.

80 Id.

81 Id. at 7.

82 Id.

83 Jessica Dye, Food Companies Confront Spike in Consumer Fraud Lawsuits, Thomson Reuters (June 13, 2013),

84 Vanessa Blum, Welcome to Food Court, Recorder, Mar. 1, 2013,; Dye, supra note 83; Glenn G. Lammi, Who's Filling the ‘Food Court’ with Lawsuits: Consumers or Lawyers?, Forbes, July 22, 2013,; Press Release, Edgeworth Economics, Trends in Food Labeling Class Action Litigation (Sept. 16, 2013),; Beisner, John H. et al., The New Lawsuit Ecosystem: Targets, Trends, Players, U.S. Chamber Inst. for L. Reform, 1, 91-92 (2013)Google Scholar,

85 See Blum, supra note 84; Beisner et al., supra note 84, at 91; infra note 125. Indeed, advocates for tort reform point to the California courts as excessively plaintiff friendly: “The business-funded American Tort Reform Association currently ranks the Northern District of California atop its list of ‘Judicial Hellholes’—jurisdictions it calls particularly hostile to corporate interests.” Paul M. Barrett, California's Food Court: Where Lawyers Never Go Hungry, Bloomberg Bus. Wk., Aug. 22, 2013,

86 See Negowetti, supra note 78, at 1; Glenn Lammi, Food Court Delivers Plaintiffs'-Lawyer Consortium Mixed Results in Four January Rulings, WLF Legal Pulse (Jan. 31, 2014),

87 See 21 U.S.C. § 337(a) (2012).

88 See id. § 343-1.

89 Ivie v. Kraft Foods Global, Inc., 961 F. Supp. 2d 1033, 1043 (N.D. Cal. 2013).

90 See, e.g. Pelayo v. Nestle U.S., Inc., 989 F. Supp. 2d 973 (C.D. Cal. 2013) (analyzing defendant pasta seller's use of the phrase “all natural” and holding that it was “not deceptive”).

91 See 21 U.S.C. § 343.

92 Biderman, David et al., What's Trending? Food Litigation Class Actions: A Look at Preemption and Class Certification, 2012 A.B.A. Sec. of Litig. Food & Supplements Subcommittee and the Products Liability Committee 4Google Scholar, available at

93 See Julie A. Steinberg, Courts in Ninth Circuit Diverge on Ascertainability in Food Label Suits, but ConAgra, Jones v. Foods May Offer Clear Direction on Class Certification, 83 U.S.L.W. 635, 635 (2014)Google Scholar (“[C]ourts view [ascertainability] as an implicit requirement for certification.”).

94 Ivie v. Kraft Foods Global, Inc., No. C-12-02554-RMW, 2013 WL 685372, at *5 (N.D. Cal. Feb. 25, 2013) (finding that plaintiff lacked standing to sue for products she did not purchase).

95 See supra Part II.B.

96 Astiana v. Ben & Jerry's Homemade, Inc., Nos. C 10–4387 PJH, C 10–4937 PJH, at *10 (N.D. Cal. May 26, 2011) (“[T]he court must consider whether the requirements [of the California Unfair Competition Law] … are identical to the requirements in the NLEA.”).

97 Id. at *8.

98 See, e.g. Chacanaca v. Quaker Oats Co., 752 F. Supp. 2d 1111, 1121, 1123-1124, 1127 (N.D. Cal. 2010) (allegations regarding trans fats listing were expressly preempted; allegations regarding word “wholesome” were not impliedly preempted).

99 See Beck, supra note 57.

100 See Struve, Catherine T., Greater and Lesser Powers of Tort Reform: The Primary Jurisdiction Doctrine and State-Law Claims Concerning FDA-Approved Products, 93 Cornell L. Rev. 1039, 1042-43 (2008)Google ScholarPubMed (citing Peters v. Astrazeneca, LP, 417 F. Supp. 2d 1051, 1053 (W.D. Wis. 2006)) (“While it is hard to predict the ultimate scope of the preemption defense, it is quite possible that some types of claims will escape it. Consequently, defendants, continuing their search for ways to privilege FDA determinations over those of lay juries, have turned to the primary jurisdiction doctrine as an alternative.”); see generally Winters, supra note 4 for a discussion of the difficulty, and the inefficiency, of the preemption inquiry in the food-labeling context.

101 Jaffe, Louis L., Primary Jurisdiction, 77 Harv. L. Rev. 1037, 1037 (1964)CrossRefGoogle Scholar.

102 United States v. W. Pac. R.R. Co., 352 U.S. 59, 64 (1956).

103 Tex. & Pac. Ry. Co. v. Abilene Cotton Oil Co., 204 U.S. 426 (1907) (holding “that a shipper seeking reparation predicated upon the unreasonableness of [an] established rate must … primarily invoke redress through the Interstate Commerce Commission”).

104 United States v. Radio Corp. of Am., 358 U.S. 334, 346 (1959) (“The doctrine [of primary jurisdiction] originated with Mr. Justice (later Chief Justice) White in Texas & Pacific R. Co. v. Abilene”); Texas & Pac. Ry. Co., 204 U.S. at 441-42 (1907).

105 United States v. Radio Corp. of Am., 358 U.S. 334, 346-347 (1959).

106 See id. at 347-48.

107 Far E. Conference v. United States, 342 U.S. 570, 575 (1952) (quoting United States v. Morgan, 307 U.S. 183, 191 (1939)).

108 United States v. W. Pac. R.R. Co., 352 U.S. 59, 63-64 (1956); see Knippa, Paula K., Note, Primary Jurisdiction Doctrine and the Circumforaneous Litigant, 85 Tex. L. Rev. 1289, 1298 n.50 (2007)Google Scholar (collecting cases).

109 See Davel Commc'ns, Inc. v. Qwest Corp., 460 F.3d 1075, 1086-87 (9th Cir. 2006); Nat'l Comm'n Ass'n, Inc. v. Am. Tel. & Tel. Co., 46 F.3d 220, 222-23 (2d Cir. 1995).

110 Nat'l Comm'n Ass'n, Inc., 46 F.3d at 222 (quoting Nat'l Comm'ns Ass'n, Inc. v. Am. Tel. & Tel. Co., 813 F. Supp. 259, 262-63 (1993)).

111 Davel Commc'ns, Inc., 460 F.3d at 1086-1087 (quoting United States v. Gen. Dynamics Corp., 828 F.2d 1356, 1362 (9th Cir. 1987) (internal quotation marks omitted)).

112 Compare Pharm. Research & Mfrs. of Am. v. Walsh, 538 U.S. 644, 674 (2003) (Breyer, J., concurring) (“Where such conditions [to satisfy primary jurisdiction doctrine] are satisfied … courts may raise the doctrine on their own motion … A court may then stay its proceedings”), with Davel Commc'ns, Inc., 460 F.3d at 1089 (“primary jurisdiction doctrine requires referral of the threshold issue”).

113 See Hilliard, James W., Tapping Agency Expertise: The Doctrine of Primary Jurisdiction, 96 Ill. B.J. 256, 258-259 (2008)Google Scholar.

114 See generally Lucchetti, Nicholas A., Note, One Hundred Years of the Doctrine of Primary Jurisdiction: But What Standard of Review is Appropriate for It?, 59 Admin. L. Rev. 849 (2007)Google Scholar (examining “the circuit split over whether to use a de novo or an abuse of discretion standard of review upon appeal from a district court's decision of whether an issue is within an agency's primary jurisdiction”); Santaguida, Bryson, Note, The Primary Jurisdiction Two-Step, 74 U. Chi. L. Rev. 1517 (2007)CrossRefGoogle Scholar (explaining how circuit courts must decide “whether to review primary jurisdictions decisions de novo or for abuse of discretion”).

115 Davel Commc'ns, Inc., 460 F.3d at 1087 (quoting Syntek Semiconductor Co. Ltd. v. Microchip Tech. Inc., 307 F.3d 775, 782 n.3 (9th Cir. 2002)).

116 See id. at 1091 (citing Reiter v. Cooper, 507 U.S. 258, 268-69 (1993) (“Whether to stay or dismiss without prejudice a case within an administrative agency's primary jurisdiction is a decision within the discretion of the district court.”).

117 Id.

118 Hilliard, supra note 113, at 261; Negowetti, supra note 78, at 12 (discussing Cox v. Gruma Corp., 12–CV–6502 YGR, 2013 WL 3828800 (N.D. Cal. July 11, 2013), where court addressed question regarding GMOs and the “natural” label to FDA).

119 United States. v. Radio Corp. of Am., 358 U.S. 334, 348 (1959).

120 See, e.g. Davel Commc'ns, Inc., 460 F.3d at 1087 (9th Cir. 2006) (arguing that reimbursements due to payphone providers should be referred to the FCC); Am. Auto. Mfrs. Ass'n. v. Mass. Dep't of Env't. Prot., 163 F.3d 74 (1st Cir. 1998) (referring regulation of automobile emissions to EPA). The doctrine is also used by state courts. See, e.g., Cohen, Craig A. et al., Using the Primary Jurisdiction Doctrine in Insurance Litigation, 36 The Brief 12, 15 (2007)Google Scholar (discussing extension of primary jurisdiction doctrine to state courts); Nelson, Brent, Users Beware: Primary Jurisdiction May Abdicate Another's Right to a Jury Trial, 10 Tex. Tech. Admin. L.J. 291, 294-99 (2008)Google Scholar (discussing line of Texas state primary jurisdiction cases).

121 Struve, supra note 100, at 1044-46.

122 See Harrison et al., supra note 9, at 2-3, 8-12.

123 See supra notes 3, 4 and accompanying text.

124 See Frank, Richard L., Food Labeling – The Case for National Uniformity, 34 Food Drug Cosmetic L.J. 512, 513 (1979)Google Scholar.

125 See, e.g., Gustavson v. Mars, Inc., No.: 13-CV-04537, 2014 WL 2604774, at *1 (N.D. Cal. June 10, 2014) (determining whether plaintiff's claims that Defendant's labeling claims are “unlawful and misleading … [and] should be dismissed under the doctrine of primary jurisdiction”); Avila v. Redwood Hill Farm and Creamery, Inc., No. 5:13–CV–00335–EJD, 2014 WL 2090045, at *1 (N.D. Cal. May 19, 2014) (determining “whether Plaintiff's ECJ [labeling] claims are barred by the doctrine of primary jurisdiction”); Figy v. Lifeway Foods, Inc., No. 13-cv-04828-TEH, 2014 WL 1779251, at *1 (N.D. Cal. May 5, 2014) (determining “whether ECJ is the ‘common or usual name’ of the ingredient used in Defendant's product and whether the use of that ingredient name is misleading and prohibited under the FDCA”); Reese v. Odwalla, Inc., 30 F. Supp. 935 (N.D. Cal. 2014) (determining “whether ECJ is the ‘common and usual name’ of any ingredient or if use of that ingredient name is misleading and prohibited under the FDCA”). I have compiled a list of cases addressing the doctrine of primary jurisdiction in the context of food labeling. Research addressing food labeling and primary jurisdiction compiled by Diana R. H. Winters (on file with author).

126 See, e.g., Smedt v. Hain Celestial Grp., Inc., No. 5:12-CV-03029-EJD, 2014 WL 2466881, at *5 (N.D. Cal. May 30, 2014) (holding that “the Court finds it appropriate to dismiss the ECJ claims without prejudice pursuant to the doctrine of primary jurisdiction”); Swearingen v. Yucatan Foods, L.P., No. C 13-3544 RS, 2014 WL 2115790, at *3 (N.D. Cal. May 20, 2014) (“dismiss[ing] [the claim] … pursuant to the doctrine of primary jurisdiction”); Avila, 2014 WL 2090045, at *3 (“applying the doctrine of primary jurisdiction … to defer to the FDA's expertise on food labeling”); Haggag v. Welch Foods, Inc., No. CV 13–00341–JGB (OPx), 2014 WL 1246299, at *7 (C.D. Cal. Mar. 24, 2014) (holding “that the doctrine of primary jurisdiction applies to the issue of whether the Heart Health Label constitutes an implied health claim”); see also supra note 125 (discussing research by Diana R. H. Winters).

127 See, e.g., Haggag, 2014 WL 1246299, at *7; Watkins v. Vital Pharm., Inc., No. CV 12–09374 SJO (JCx), 2013 WL 5972174, at *1, *2, *5 (C.D. Cal. Nov. 7, 2013) (granting defendant's motion to dismiss plaintiff's claim that product is “falsely labeled” as “zero impact”); The cases regarding “natural” claims were stayed for six months while the issue was appealed to FDA. In re General Mills, Inc. Kix Cereal Litig., No. 12–249(KM), 2013 WL 5943972, at *1 (D. N.J. Nov. 1, 2013); Barnes v. Campbell Soup Co., No. C 12–05185 JSW, 2013 WL 5530017, at *9 (N.D. Cal. July 25, 2013); Cox v. Gruma Corp., 12–CV–6502 YGR, 2013 WL 3828800, at *2 (N.D. Cal. July 11, 2013). The FDA then declined the invitation to rule on this issue. Letter from Leslie Kux, FDA Assistant Commissioner for Policy, to Honorable Judges Gonzalez Rogers, White, McNulty (Jan. 6, 2014), available at [hereinafter FDA Letter].

128 David Schultz, Evaporated Cane Juice: Sugar in Disguise?, NPR The Salt (Oct. 18, 2012, 2:06 PM),

129 Swearingen v. Santa Cruz Natural Inc., No. C 13–04291 SI, 2014 WL 1339775, *1 (N.D. Cal. Apr. 2, 2014) (judgment set aside on different grounds by No. C 13–04291 SI, 2014 WL 2967585 (N.D. Cal.)).

130 Id. at *2 (internal quotation marks omitted).

131 Id. at *2-*3.

132 See e.g., Hood v. Wholesoy & Co, Modesto Wholesoy Co. LLC, No.: 12–cv–5550–YGR, 2013 WL 3553979, at *6 (N.D. Cal. July 12, 2013) (“defer[ring] to the authority and expertise of the FDA”); Kane v. Chobani, Inc., No.: 12–CV–02425–LHK, 2013 WL 3703981, at *17-*19 (N.D. Cal. July 12, 2013) (granting “[m]otion to [d]ismiss on primary jurisdiction grounds with respect to Plaintiffs'” evaporated cane juice claim).

133 See Archis A. Parasharami & Andrea Weiss, Primary Jurisdiction is Gaining Some Weight in the Food Court, Mayer Brown's Class Defense Blog (June 2, 2014),

134 See, e.g., Garcia v. Kashi Co., 43 F. Supp. 3d 1359, 1380-81 (S.D. Fla. 2014) (refusing to apply primary jurisdiction to claims concerning the labeling “all natural” and “nothing artificial”).

135 See Parasharami & Weiss, supra note 133 (noting that “a[s] if a light had been switched on, virtually every court to consider the issue since … March … has ruled in favor of deferring to the FDA's primary jurisdiction in [ECJ] cases”).

136 See, e.g., Garcia, 2014 WL 4392163, at *6 (explaining that defendant's implied preemption “argument fails because the FDA does not have a policy permitting food containing GMOs to be described as ‘natural,’ nor has it regulated the term ‘all natural.’”).

137 Far E. Conference v. United States, 342 U.S. 570, 575 (1952).

138 Pharm. Research & Mfrs. of Am. v. Walsh, 538 U.S. 644, 673-74 (2003) (Breyer, J., concurring).

139 Id. at 673.

140 Catherine M. Sharkey, Tort-Agency Partnerships in an Age of Preemption 385 (N.Y.U. Sch. of Law Pub. Law & Legal Theory Research Paper Series, Working Paper No. 14-24, 2014). Sharkey qualifies her statement by noting that “delay” and “the capacity of agencies” are important factors. Id. at 385 n.110.

141 See, e.g., Far E. Conference, 342 U.S. at 578-79 (Douglas, J., dissenting).

142 Id. at 578.

143 Id. at 579.

144 Struve, supra note 100, at 1048-72; see also Nelson, supra note 120, at 313 (arguing that the use of primary jurisdiction in Texas cases may, under certain circumstances, “violate[] citizens' right to a civil jury trial.”). See generally Knippa, supra note 108, at 1289-92 (discussing primary jurisdiction).

145 Struve, supra note 100 at 1049, 1059.

146 See Knippa, supra note 108 at 1291.

147 See generally Winters, Diana R. H., Intractable Delay and the Need to Amend the Petition Provisions of the FDCA, 90 Ind. L.J. __ (forthcoming 2015)Google Scholar (discussing “the failure of agencies, the Food and Drug Administration in particular, to respond to rulemaking petitions and the denial of rulemaking petitions”).

148 See id.

149 See, e.g., Heinzerling, Lisa, Undue Process at the FDA: Antibiotics, Animal Feed, and Agency Intransigence, 37 Vt. L. Rev. 1007, 1029 (2013)Google Scholar (describing the FDA's “extreme insouciance about delay”); Winters, supra note 147 (discussing the FDA's delay in “respond[ing] to rulemaking petitions”).

150 See Swearingen v. Santa Cruz Natural Inc., No. C 13–04291 SI, 2014 WL 1339775, *3 (N.D. Cal. Apr. 2, 2014).

151 Tsekerides, Theodore E. & Akhavan, Melody E., FDA's Primary Jurisdiction Won't Save Food Manufacturers, Law 360 (July 17, 2014, 10:39 AM)Google Scholar,

152 See cases cited regarding six month stay supra note 127.

153 See Becker, Josh L., To Stay or Not to Stay GMO Labeling Cases?, Law 360 (Dec. 5, 2013, 4:16 PM)Google Scholar, (comparing the court's holding in Cox v. Gruma Corp. that primary jurisdiction doctrine applied, to its holding in Bohac v. General Mills Inc. that the doctrine did not apply).

154 Nor was the doctrine meant to apply to suits like these. I discuss the doctrine's historical background in much more detail in a second piece, available Summer 2015, entitled Beyond Conventional Experience? An Argument for Abandoning Primary Jurisdiction.

155 See Biber, Eric, The Importance of Resource Allocation in Administrative Law, 60 Admin. L. Rev. 1, 4 (2008)Google Scholar.

156 See supra note 74 and accompanying text.

157 See Heinzerling, supra note 149, at 1013.

158 For example, FDA declined to determine whether GE foods could be labeled as “natural.” See FDA Letter, supra note 127 and accompanying text.

159 See, e.g., id. (noting that the FDA would use “a public process, such as issuing a regulation or formal guidance” if it decides to amend its policy regarding the use of the term “natural”).

160 See Biber, supra note 155, at 43-44.

161 Silverman, Cary, State Consumer Protection Laws Run Rampant Without Reform, Law 360 (Jan. 7, 2014, 5:04PM)Google Scholar,

162 See, e.g., Garcia v. Kashi Co., 43 F. Supp. 3d 1359, 1380-81 (S.D. Fla. 2014) (“[T]his is not a technical area in which the FDA has greater technical expertise than the courts—[as] everyday courts decide whether conduct is misleading.”)

163 See Winters, supra note 4, at 859-60.

164 See, e.g., Negowetti, Nicole E., Defining Natural Foods: The Search for a Natural Law, 26 Regent U. L. Rev. 329, 334-35 (2013)Google Scholar.