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Genetically Modified Foods at the Intersection of the Regulatory Landscape and Constitutional Jurisprudence

Published online by Cambridge University Press:  06 January 2021

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An ecosystem … [y]ou can always intervene and change something in it, but there's no way of knowing what all the downstream effects will be or how it might affect the environment. We have such a miserably poor understanding of how the organism develops from its DNA that I would be surprised if we don't get one rude shock after another.

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

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References

1 Michael Pollan, Playing God in the Garden, N.Y. Times, Oct. 25, 1998, (Magazine), at 49 (quoting Harvard Professor Richard Lewontin's discussion about a software metaphor related to DNA and GM foods.).

“From an intellectual-property standpoint, it's exactly right,” he said. “But it's a bad one in terms of biology. It implies you feed a program into a machine and get predictable results. But the genome is very noisy. If my computer made as many mistakes as an organism does” — in interpreting its DNA, he meant — “I'd throw it out.”

Id.

2 Throughout this Article, the expressions GM, GE, or GMO may be used synonymously to refer to foods or consumer products containing ingredients derived from genetic manipulation.

3 See Ghoshray, Saby, Food Safety and Security in the Monsanto Era: Peering Through the Lens of a Rights Paradigm Against an Onslaught of Corporate Domination, 65 Me. L. Rev. 491, 495-96 (2013)Google Scholar (examining food safety and security food throughout human civilization from an American legal perspective, emphasizing human rights, current regulatory schemes, and the current patent framework's contribution to the evolving menace of transgenic pollution).

4 This Article will look at this issue through the prism of Vermont's Act 120, widely known as GMO labeling law. See Niraj Chokshi, Vermont Just Passed the Nation's First GMO Food Labeling Law. Now It Prepares to Get Sued, Wash. Post GovBeat (May 9, 2014), http://www.washingtonpost.com/blogs/govbeat/wp/2014/04/29/how-vermont-plans-to-defend-the-nations-first-gmo-law/ (noting that state officials preemptively created a $1.5 million legal defense fund in anticipation of future constitutional challenges).

5 See Remsen, Nancy, Lawsuit Challenges Vermont's GMO Labeling Law, USA Today (June 12, 2014, 8:58 PM)Google Scholar, http://www.usatoday.com/story/news/nation/2014/06/12/lawsuit-challenges-vermonts-gmo-labeling-law/10402301/ (highlighting the fact that Vermont Attorney General, William Sorrell, openly anticipated constitutional challenges to the statute).

6 See D'Ambrosio, Dan, Nation Watching GMO Labeling Fight in Vermont, Burlington Free Press (Dec. 1, 2014, 5:36 PM)Google Scholar, http://www.burlingtonfreepress.com/story/news/local/vermont/2014/11/29/vermont-gmo-fight-nears-court/19639519/ (explaining that challengers argue that “Act 120, … violates the U.S. Constitution by compelling manufacturers to ‘convey messages they do not want to convey,’” and because “constitutional issues are involved,” if the state loses, it would be liable for the challengers' legal fees, which could easily reach $3 million).

7 See Ghoshray, supra note 3, at 495.

8 See id. at 495 n.15; see also Konig, A. et al., Assessment of the Safety of Foods Derived from Genetically Modified (GM) Crops, 42 Food & Chemical Toxicology 1047, 1048 (2004)CrossRefGoogle ScholarPubMed (summarizing current regulatory frameworks and providing guidance on how to assess any “potential unintended effects” from a genetic modification).

9 See Kristina Hubbard, Out of Hand: Farmers Face the Consequences of a Consolidated Seed Industry, Farmer to Farmer Campaign on Genetic Eng'g 44-45 (Dec. 2009), http://farmertofarmercampaign.com/Out%20of%20Hand.FullReport.pdf (claiming that utility patents have facilitated the downward trend in the number of independent seed companies).

10 Ghoshray, supra note 3, at 495 n.17 (“Genetic engineering … in the context of food production can be defined as crops produced by extracting genes from one species and inserting them into another using recombinant DNA … technology. Genetic [e]ngineering is also referred to as the process to develop transgenic or [GMOs]. Besides the gene or DNA fragments for the desired characteristics, genetic engineering inserts ‘markers’ which are used to determine if the desired characteristic was successfully inserted and ‘promoters’ that force such desired characteristics to express their protein(s) at all times. Genetic [e]ngineering is not the same as conventional breeding and has been in vogue for barely a quarter century.”).

11 See Charles M. Benbrook, Genetically Engineered Crops and Pesticide Use in the United States: The First Nine Years, BioTech InfoNet (Oct. 2004), http://organic.insightd.net/reportfiles/Full_first_nine.pdf (finding that since 1996, herbicide tolerant crops have increased herbicide use by 138 million pounds); see also Dennis T. Avery, Saving the Planet with Pesticides and Plastic: The Environmental Triumph of High-Yield Farming 13-19 (2d ed. 2000) (arguing that bio-pesticide agriculture promotes higher yields of farm products which in turn reduces world hunger issues and protects wildlife).

12 See Chao, Eunice & Krewski, Daniel, A Risk-Based Classification Scheme for Genetically Modified Foods III: Evaluation Using a Panel of Reference Foods, 52 Regulatory Toxicology & Pharmacology 235, 241 (2008)Google ScholarPubMed (“[T]he allergenic potential of a food, in contrast with other adverse health effects, cannot be predicted entirely based on the characteristics of a novel gene product. An allergic response is an antigen-specific response in genetically susceptible individuals.”). But see Helm, Ricki M., Food Biotechnology: Is This Good Or Bad?, 90 Annals Allergy Asthma & Immunology 90, 90 (2003)CrossRefGoogle ScholarPubMed (“The estimation that more than two trillion transgenic plants have been grown in 1999 and 2000 alone, with no overt documented adverse food reactions being reported, indicates that genetic modification through biotechnology will not impose immediate significant risks as food allergen sources beyond our daily dietary intake of foods from crop plants.”)

13 See Farquhar, Doug & Meyer, Liz, State Authority to Regulate Biotechnology Under the Federal Coordinated Framework, 12 Drake J. Agric. L. 439, 442-43 (2007)Google Scholar (explaining that criticism of biotechnology stems from the unknown and possible health risks and the potential decrease in genetic diversity).

14 See Jorge Fernandez-Cornejo & Margriet Caswell, U.S. Dep't. of Agric., The First Decade of Genetically Engineered Crops in the United States 3-6 (2006) (reflecting on the first decade of GM crops, from 1996 to 2006).

15 See Hamilton, Neil D., Legal Issues Shaping Society's Acceptance of Biotechnology and Genetically Modified Organisms, 6 Drake J. Agric. L. 81, 97 (2001)Google Scholar (“The United States' position is further reinforced by the FDA's 1992 decision that foods produced using genetic transformation are the substantial equivalent of other foods and do not require labeling.”).

16 See Ghoshray, supra note 3, at 497-98 for a detailed explanation of the current regulatory framework and its inadequacy with respect to food safety.

17 See Fedoroff, Nina V., The Past, Present and Future of Crop Genetic Modification, 27 New Biotech. 461, 464Google Scholar (noting that since GM foods' 1996 introduction into the agricultural industry, only a few of the widely anticipated adverse effects have materialized).

18 See Mairi Anne Mackenzie, Industry Reaps GM Bonanza, but We Will Pay, The Age (Apr. 15, 2006), http://www.theage.com.au/news/business/industry-reaps-gm-bonanza-but-we-will-pay/2006/04/14/1144521507502.html (noting how GM technology has given rise to an environment that has not only changed our way of life but has also created a sense of deep-rooted anxiety of over safety and security of the food we consume); see also Hubbard, supra note 9, at 13 (emphasizing the adverse economic impact of GM food usage on independent farmers).

19 See Hamilton, supra note 15, at 94.

20 See Hubbard, supra note 9, at 20 fig. 4 (showing that in 2008, 85% of corn acreage and 92% of soybean acreage in the United States were planted with GE traits).

21 Bakshi, Anita, Potential Adverse Health Effects of Genetically Modified Crops, 6 J. Toxicology & Envtl. Health 211, 219-20 (2003)Google ScholarPubMed.

22 See Maluszynski, Miroslaw et al., Application of In Vivo and In Vitro Mutation Techniques for Crop Improvement, 85 Euphytica 303, 312 (1995)CrossRefGoogle Scholar (describing the various genetic engineering techniques developed for crop enhancement that rely on changing mutation rates); Nat'l Research Council, Safety of Genetically Engineered Foods: Approaches to Assessing Unintended Health Effects 27-28 (2004) (questioning the adequacy of the safeguard against the astounding development of more than 2300 different crop varieties using radiation-based mutation).

23 See generally Final Report of the Commission on the Evaluation of the EU Legislative Framework in the Field of GM Food and Feed (July 12, 2010) available at http://ec.europa.eu/food/food/biotechnology/evaluation/docs/evaluation_gm_report_en.pdf (providing a detailed overview of the current regulatory frameworks in Europe and compiling opinions from stakeholders and regulatory authorities).

24 See id. at 6-14 for a detailed overview of the European regulatory framework and its objectives. See also McCabe, Heather & Butler, Declan, European Union Tightens GMO Regulations, Nature, July 1, 1999, at 7, 7Google Scholar (describing the European Union's 1999 adoption of increased regulation of GMOs).

25 See Ghoshray, supra note 3, at 496 (noting that I have discussed this area extensively in my earlier work).

26 Mandel, Gregory N., Gaps, Inexperience, Inconsistencies, and Overlaps: Crisis in the Regulation of Genetically Modified Plants and Animals, 45 Wm. & Mary L. Rev. 2167, 2216-17 (2004)Google Scholar.

27 Coordinated Framework for Regulation of Biotechnology, 51 Fed. Reg. 23,302, 23,303 (Exec. Office of the President June 26, 1986); see also Mandel, supra note 26, at 2216-17 (highlighting that once the Coordinated Framework for Regulation of Biotechnology was established in 1986, actual regulation of biotechnology was left to the administrative agencies).

28 See Fernandez-Cornejo & Caswell, supra note 14, at 4 (“[The USDA] plays a central role in regulating field-testing of agricultural biotechnology products … [by determining] whether the release will pose a risk to agriculture or the environment.”).

29 See 51 Fed. Reg. at 23, 303, 23, 313.

30 Id. at 23,303, 23,309; Statement of Policy: Foods Derived from New Plant Varieties, 57 Fed. Reg. 22,984, 22,984 (Food & Drug Admin. May 29, 1992).

31 Statement of Policy: Foods Derived from New Plant Varieties, 57 Fed. Reg. at 22,985.

32 For example, the FDA is authorized to regulate only adulterated foods. Food, Drug, and Cosmetic Act of 1938, 21 U.S.C. § 342 (2012 & Supp. I 2013). The controlling authority of the FDA comes from the statutory provision defining adulterated foods as that which “bears or contains any poisonous or deleterious substance which may render it injurious to health.” Id. at § 342(a)(1).

This language neither compels nor encourages the manufacturers of biotechnology-based food products to research adverse ramifications or potential hazardous implications of genetic modification. Rather, the onus of analyzing any poisonous or deleterious effects is clearly the domain of the agency. By implication, therefore, absent the FDA's intervention, the current regulatory framework does not provide a clear mandate for a biotechnology food producer to be extra vigilant towards consumer food safety.

Ghoshray, supra note 3, at 499-500.

33 Ghoshray, supra note 3, at 499.

34 See Bennett Homer, Michael, Note, Frankenfish … It's What's for Dinner: The FDA, Genetically Engineered Salmon, and the Flawed Regulation of Biotechnology, 45 Colum. J.L. & Soc. Probs. 83, 97-99 (2011)Google Scholar (arguing that the FDA's regulation of GE animals is inadequate due to the risk of loss of biodiversity in ecological environments).

35 See Chao & Krewski, supra note 12, at 241 (suggesting that because the allergenic potential of a food product cannot be accurately predicted from gene characteristics, the potential for unintended adverse health effects is higher than non-GM food products); see also Konig et al., supra note 8, at 1048 (providing analysis of pesticide safety assessment methodologies and suggesting how to adapt these methods to GM food safety evaluations).

36 21 U.S.C. § 321(s).

37 Id. § 348(a)(2).

38 Statement of Policy: Foods Derived from New Plant Varieties, 57 Fed. Reg. 22, 984, 22,985 (Food & Drug Admin. May 29, 1992).

39 21 U.S.C. § 321(s).

40 Statement of Policy: Foods Derived from New Plant Varieties, 57 Fed. Reg. at 22,990.

41 21 U.S.C. §§ 321, 348; see Statement of Policy: Foods Derived from New Plant Varieties, 57 Fed. Reg. at 22,990.

42 Ghoshray, supra note 3, at 500-01 (“According to the FDA, genetically engineered crops containing only nucleic acids as the active additional components are kept outside of the agency's regulatory ambit. By extolling the virtues of nucleic acid as essential to human existence, the FDA attempted to allay any safety concerns consumers might have. This misapplied interpretation of human biology is a result of faulty understanding of nucleic acid functionality, regardless of whether nucleic acid is taken in isolation or in collaboration with other elements. The scientific details of this analysis are beyond the scope of this essay, and I shall not belabor this argument further except to note that the FDA's argument is inconsistent with scientific viewpoints that have support in the literature.”)

43 See infra Part IV.

44 See sources cited supra note 24.

45 See Rebekah Wilce, GMO Lobby Works Tirelessly Against Mandatory Labeling, PR Watch (Apr. 10, 2014), http://www.prwatch.org/news/2014/03/12431/gmo-lobby-works-tirelessly-against-mandatory-labeling (noting that a corporate trade group lobbying for voluntary GMO labeling recently found a Congressional sponsor for a bill that would preempt any state's mandatory labeling law).

46 See Statement of Policy: Foods Derived from New Plant Varieties, 57 Fed. Reg. at 22,991 (“Ultimately, it is the food producer that is responsible for assuring food safety.”).

47 FDA Food Safety Modernization Act of 2011, Pub. L. No. 111-353, 124 Stat. 3885 (codified as amended in scattered sections of 21 U.S.C.); see also Helena Bottemiller, The Food Safety Modernization Act – One Year Later, Food Safety News (Jan. 20, 2012), http://www.foodsafetynews.com/2012/01/the-food-safety-modernization-act-one-year-later (discussing the FDA's failure to meet evaluative and regulatory deadlines promulgated by the statute).

48 Coordinated Framework for Regulation of Biotechnology, 51 Fed. Reg. 23,303 (Exec. Office of the President June 26, 1986); Statement of Policy: Foods Derived from New Plant Varieties, 57 Fed. Reg. at 22,985; see also Biotechnology, Food & Drug Admin., http://www.fda.gov/Food/FoodScienceResearch/Biotechnology/ (last updated Dec. 9, 2014) (clarifying that the FDA's statement of policy applied to “all foods derived from all new plant varieties,” including varieties that are developed from bioengineered foods).

49 Food, Drug, and Cosmetic Act, 21 U.S.C. § 393 (2012) (creating the FDA and explaining its purpose and authority).

50 See Mike Zelina et al., The Health Effects of Genetically Engineered Crops on San Luis Obispo County: A Citizen Response to the SLO Health Commission GMO Task Force Report, San Luis Obispo Cnty. Cal. (May 2006), http://www.slocounty.ca.gov/Assets/PH/HealthCommission/GMOTaskForce/Citizen+Response+on+the+Health+Effects+of+GE+Crops.pdf.

51 See sources cited supra note 24.

52 Ghoshray, supra note 3, at 501.

53 See Mandel, supra note 26, at 2194-96 (highlighting the potential for gene flow into unintended environments and the risk of wild species extinction through hybridization); see also John Tuxill, Worldwatch Inst., Nature's Cornucopia: Our Stake in Plant Diversity 12 tbl.1 (1999) (arguing that bio-uniformity is rising as plant species' extinction-risk rates increase).

54 See Tuxill, supra note 53, at 62 (noting that environmental degradation has already occurred in Guatemala, “where non-traditional vegetable production expanded … and displaced subsistence cultivation”).

55 Frequently Asked Questions on Genetically Modified Foods, World Health Org. http://www.who.int/foodsafety/publications/biotech/20questions/en (last visited Mar. 10, 2015) (“Issues of concern include: the capability of the GMO to escape and potentially introduce the engineered genes into wild populations; … the susceptibility of non-target organisms … to the gene product; … [and] the reduction in the spectrum of other pants including loss of biodiversity.”); see also Relyea, Rick A., The Impact of Insecticides and Herbicides on the Biodiversity and Productivity of Aquatic Communities, 15 Ecological Applications 618, 626 (2005)CrossRefGoogle Scholar (finding that insecticides and herbicides had varying positive and adverse effects on ecological communities, with the most influential negative effect being reduction in biological diversity).

56 See Donegan, Katherine K. & Seidler, Ramon J., Effects of Transgenic Plants on Soil and Plant Microorganisms, in 3 Recent Research Developments in Microbiology 415, 424 (S. G. Pandalai ed., 1999)Google Scholar (“The repeated use of transgenic plants in an area may also result in the accumulation of antimicrobial compounds in the ecosystem.”).

57 But see Coordinated Framework for Regulation of Biotechnology, 51 Fed. Reg. 23,302 (Exec. Office of the President June 26, 1986) (“These agency policies build upon experience with agricultural, pharmaceutical, and other commercial products developed by traditional genetic modification techniques.”).

58 Id.

59 See Guide to U.S. Regulation of Genetically Modified Foods and Agricultural Biotechnology Products, Pew Initiative on Food & Biotech. 5-6 (Sept. 2001), http://www.pewtrusts.org/~/media/legacy/uploadedfiles/wwwpewtrustsorg/reports/food_and_biotechnology/hhsbiotech0901pdf.pdf (explaining that in the 1980s, because of the existence of several statutes that promulgated multiple agency jurisdictions over the biotechnology industry, the Reagan Administration offered the Coordinated Framework policy statement to clarify any confusion over the multi-jurisdictional structure).

60 See id. at 6-7 (noting that the Coordinated Framework indicated the need for future periodic review of policies as technology developed).

61 See Homer, supra note 34, at 101 (“In deciding that existing laws are sufficient for biotechnology regulation, [the OSTP, through] the Coordinated Framework[,] instructs the agencies to rely on laws for their regulatory authority that were enacted decades earlier, long before rDNA genetic engineering was even scientifically conceivable.”).

62 See id. at 100 (“Despite enormous advances in the GE field over the past few decades, the twenty-five year old Framework [which was promulgated by the OSTP] remains the cornerstone of the biotechnology regulatory scheme today.”).

63 See Issues in the Regulation of Genetically Engineered Plants and Animals, Pew Initiative on Food & Biotech. 10–11 (2004), http://www.pewtrusts.org/~/media/legacy/uploadedfiles/phg/content_level_pages/reports/foodbiotechregulation0404pdf.pdf.

64 See id.

65 Vt. Stat. Ann. tit. 9, §§ 3041-3048 (2014) (requiring labeling of food produced with genetic engineering, effective July 1, 2016).

66 See 2014 Vt. Acts & Resolves 348 (codified as amended at Vt. Stat. Ann. tit. 9, §§ 3041-3048 (2014)).

67 Id. sec. 1(2).

68 Id. sec. 1(1).

69 Id. Because the Act was the 120th bill to be signed into law in 2014, Vermont officials and the public have nicknamed the statute “Act 120.” See, e.g., Press Release, Vt. Att'y Gen. William H. Sorrell, Attorney General Announces Public Meetings to Introduce Draft Rules for Act 120 GE Food Labeling (Oct. 10, 2014), http://ago.vermont.gov/focus/news/attorney-general-announces-public-meetings-to-introduce-draft-rules-for-act-120-ge-food-labeling.php.

70 Vt. Stat. Ann. tit. 9, §§ 3041-3048.

71 Id. §§ 3041, 3043.

72 Id. § 3043(c).

73 See Gary Langer, Poll: Skepticism of Genetically Modified Foods, ABC News (June 19, 2014), http://abcnews.go.com/Technology/story?id=97567 (“[N]early everyone, moreover — 93 percent — says the federal government should require labels on food saying whether it's been genetically modified, or ‘bioengineered’ (this poll used both phrases). Such near-unanimity in public opinion is rare.”). These results were part of an ABCNEWS.com telephone survey that was conducted during June 2014. A random sample of approximately 1000 adults were contacted. The results were collected and verified by the Pennsylvania group, TNS Intersearch. Id.

74 While GM laws continue to be the exception, various states are calling for more regulations on such GE foods. For example:

[V]oters in both California and Hawaii adopted measures in early November that ban the production of GMOs at the county level. In California, a ballot initiative prohibiting the propagation, cultivation, raising or growing of such products in Humboldt County passed with a vote of 59% to 41%, and in Hawaii, a similar measure prohibiting the cultivation or reproduction of GMOs within Maui County was approved by a vote of 51% to 49%.

Currently, three US states require GMO labeling. Connecticut and Maine have both passed such laws, but they contain provisions stating that they can't be implemented unless several other states approve similar labeling laws. Vermont, meanwhile, has passed a labeling law that is slated to go into effect in 2016.

See Rebecca Trager, U.S. States Reject GM Labeling Laws, Chemistry World (Nov. 10, 2014), http://www.rsc.org/chemistryworld/2014/11/us-states-reject-genetically-modified-food-labeling.

75 Elaine Watson, GMA et al Seek Injunction to Stop Vermont Implementing GMO Labeling Law Until Legal Dispute Is Resolved, FoodNavigator-USA.com (Sept. 15, 2014), http://www.foodnavigator-usa.com/Regulation/GMA-seeks-injunction-to-stop-Vermont-implementing-GMO-labeling-law.

76 Complaint at 1, Grocery Mfgrs. Ass'n. v. Sorrell, No. 5:14-CV-117 (D. Vt. filed June 12, 2014).

77 See id. at 13-21.

78 Id. at 13.

79 Nutrition Labeling and Education Act of 1990, Pub. L. No. 101-535, sec. 6, 104 Stat. 2353 (codified as amended in 21 U.S.C. § 343-1).

80 Food, Drug, and Cosmetic Act, 21 U.S.C. § 343(a)(1) (2012).

81 Complaint, supra note 76, at 20.

82 Id. at 18.

83 See generally, Winters, Diana R. H., The Magical Thinking of Food Labeling: The NLEA as a Failed Statute, 89 Tul. L. Rev. (forthcoming 2015)Google Scholar available at http://ssrn.com/abstract=2394250 (discussing the failure of NLEA to improve the quality of information available to consumers and arguing for its partial repeal).

84 Id. at 46 (arguing against NLEA's preemption provisions because labeling laws are motivated by consumer interests and state law “can be tailored in response to the interests of the state's populace”).

85 See Ghoshray, supra note 3, at 494-496.

86 U.S. Const. art. I, § 8, cl. 3.

87 See Ghoshray, Saby, From Wheat to Marijuana: Revisiting the Federalism Debate Post-Gonzales v. Raich, 58 Wayne L. Rev. 63 (2012)Google Scholar for an overview of recent Supreme Court jurisprudence with respect to federal conflict preemption of state laws. See also Gonzalez v. Raich, 545 U.S. 1, 29 (2005) (holding that if a conflict exists between state and federal laws, the “Supremacy Clause unambiguously provides that … federal law shall prevail”).

88 Although the Commerce Clause enables Congress to regulate interstate commerce, the Tenth Amendment limits that inherent power by prohibiting the federal government from coercing states to enact laws that enforce federal regulatory initiatives. See Saby Ghoshray, Brandeisian Experiment Meets Federal Preemption: Is Cooperative Federalism a Panacea for Marijuana Regulation, N. Ill. U. L. Rev. (forthcoming 2015) (manuscript at 11) (on file with author) (“[W]hile states are constitutionally prevented from stopping the federal government from enforcing federal law within their territory, the federal government cannot compel the state to enact laws criminalizing such conduct.”).

89 See Ghoshray, supra note 87, at 68-70.

90 Compare U.S. Const. art. I, § 8, cl. 3 (stating that Congress shall have the power to “regulate Commerce with foreign Nations, and among the several States, and with the Indian Tribes”), with U.S. Const. amend. X (“The powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States respectively, or to the people.”).

91 Vt. Stat. Ann. tit. 9, § 3043 (2014).

92 Complaint, supra note 76, at 13.

93 See Caryn Connolly, Lawsuits Against Kashi and Naked Juice for Falsely Mislabeling “Natural” Products Continue, Organic Consumers Ass'n (Jan. 10, 2013), https://www.organicconsumers.org/news/lawsuits-against-kashi-and-naked-juice-falsely-mislabeling-natural-products-continue.

94 Ass'n of Private Sector Colls. & Univs. v. Duncan, 681 F.3d 427, 457 (D.C. Cir. 2012) (holding that “deceptive” commercial speech is not protected under the Constitution).

95 Cent. Hudson Gas & Elec. Co. v. Pub. Serv. Comm'n of N.Y., 447 U.S. 557, 566 (1980) (“At the outset, we must determine whether the expression is protected by the First Amendment. For commercial speech to come within that provision, it at least must concern lawful activity and not be misleading. Next, we ask whether the asserted governmental interest is substantial. If both inquiries yield positive answers, we must determine whether the regulation directly advances the governmental interest asserted, and whether it is not more extensive than is necessary to serve that interest.”).

96 Id. at 563.

97 Complaint, supra note 76, at 13 (arguing that Act 120 places both content and speaker based restrictions on speech); see also, e.g., United States v. Edge Broad. Co., 509 U.S. 418, 426 (1993) (“The Constitution … affords a lesser protection to commercial speech than to other constitutionally guaranteed expression.” (citing Cent. Hudson Gas & Elec, Co., 447 U.S. at 563)). But see Sorrell v. IMS Health, Inc., 131 S. Ct. 2653, 2664 (2011) (holding that when a state law is designed to impose “content-based” restrictions on speech, “heightened judicial scrutiny” is warranted).

98 See Keighley, Jennifer M, Can You Handle the Truth? Compelled Commercial Speech and the First Amendment, 15 J. Const. L. 539, 554 (2012)Google Scholar (“The First Amendment protects commercial speech because of its informational value to consumers, not because the commercial speaker has a right to promote his products in whatever manner he see fit.”)

99 See id. at 555-56 (explaining that when regulation compels disclosure of information that a commercial speaker would otherwise choose to not disclose, the speaker's First Amendment interest “in not providing any particular factual information in his advertising is minimal” (quoting Zauderer v. Office of Disciplinary Counsel, 471 U.S. 626, 651 (1985))).

100 E.g., Edge Broad. Co., 509 U.S. at 426; Cent. Hudson Gas & Elec. Co., 447 U.S. at 566.

101 Vt. Stat. Ann. tit. 9, § 3043 (2014).

102 2014 Vt. Acts & Resolves 348, sec. 1(5).

103 See Administrative Law Panel at the American Journal of Law & Medicine Symposium: The Iron Triangle of Food Policy (Feb. 9, 2015) (noting the discussion challenging the validity of consumer interest premised on health impact of GMO foods).

104 See sources cited supra note 24.

105 See, e.g., Aris, Aziz & Leblanc, Samuel, Maternal and Fetal Exposure to Pesticides Associated to Genetically Modified Foods in Eastern Townships of Quebec, Canada, 31 Reprod. Toxicology 528, 532 (2011)CrossRefGoogle ScholarPubMed (revealing the presence of pesticides associated with GM foods in pregnant and non-pregnant women's blood); Spisak, Sandor et al., Complete Genes May Pass from Food to Human Blood, 8 PLOS ONE, July 2013, at 9CrossRefGoogle ScholarPubMed (reporting evidence of DNA fragments' ability to carry complete genes into the human circulatory system); Thongprakaisang, Siriporn et al., Glyphosate Induces Human Breast Cancer Cells Growth Via Estrogen Receptors, 59 Food & Chemical Toxicology 129, 135 (2013)CrossRefGoogle ScholarPubMed (revealing additive effects of glyphosate contamination in GM soybeans); GMOs Linked to Gluten Disorders Plaguing 18 Million Americans, RT.com (Nov. 28, 2013, 8:20 PM), http://rt.com/usa/gmo-gluten-sensitivity-trigger-343/ (observing the possibility of maladies from GM foods).

106 Cent. Hudson Gas & Elect. Co. v. Pub. Serv. Comm'n of New York, 447 U.S. 557, 566 (1980).