Grocery Manufacturers Ass'n v. Sorrell (102 F. Supp. 3d 583, 2015)

United States District Court for the District of Vermont 2015-04-27

Food and Drugs Agriculture

Citations

Full opinion text

OPINION AND ORDER GRANTING IN PART AND DENYING IN PART DEFENDANTS’ MOTION TO DISMISS AND DENYING PLAINTIFFS’ MOTION FOR A PRELIMINARY INJUNCTION

CHRISTINA REISS, Chief Judge.

Pending before the court are a motion to dismiss (Doc. 24) filed by Defendants William H. Sorrell, Peter' E. Shumlin, Tracy Dolan, and James B. Reardon (collectively, “the State”) and a motion for a preliminary injunction (Doc. 33) filed by Plaintiffs Grocery Manufacturers-Association (“GMA”), Snack-Food Associátion (“SFA”), International Dairy Foods Association (“IDFA”), and National Association of Manufacturers (“NAM”) (collectively, “Plaintiffs”).

The State’s motion asks the court to dismiss Plaintiffs’ Amended Complaint in its entirety for failure to state a claim for which relief may be granted. Fed.R.Civ.P. 12(b)(6). Plaintiffs’ motion asks the court to enjoin the State’s enforcement of Act 120 in its entirety pending a resolution of the case at trial. Fed.R.Civ.P. 65(a). The court heard oral argument on January 7, 2015, at which point the court took the pending motions under advisement. Because the State’s motion to dismiss winnows the claims for which Plaintiffs may seek a preliminary injunction, the court addresses that motion first. In the course of analyzing the motion to dismiss, the court considers whether Plaintiffs are likely to prevail on the merits of their claims at trial, which is an essential component of their request for preliminary injunctive relief.

Plaintiffs are represented by Catherine E. Stetson, Esq., E. Desmond Hogan, Esq., Mary H. Wimberly, Esq., and Matthew B. Byrne, Esq. The State is represented by Alan D. Strasser, Esq.,' Daniel N. Lerman, Esq., Lawrence S. Robbins, Esq., Lee Turner Friedman, Esq., Vermont Assistant Attorney General (“VTAG”) Megan J. Shafritz, VTAG Jon T. Alexander, VTAG Kate T. Gallagher, VTAG Kyle H. Landis-Marinello, and VTAG Naomi Sheffield.

The following Amicus Curiae have filed briefs in support of Act 120: the Vermont Public Interest Research' Group and the Center for Food Safety, which are represented by Laura B. Murphy, Esq.; The Vermont Community Law Center, which is represented by Jared Kingsbury Carter; Esq. and William B. Peard, Esq.; and the Free Speech For People, Inc., which is represented by Ronald A. Fein, Esq.- and Anthony N.L.. Iarrapino, Esq.

I. Factual and Procedural Background.

A. The Amended Complaint.

Plaintiffs’ Amended Complaint challenges Act 120’s requirement that certain manufacturers and ' retailers identify whether raw and processed food sold in Vermont was produced in whole or in part through genetic engineering (Act' 120’s “GE disclosure requirement”) and which prohibits manufacturers from" labeling or advertising GE foods as “natural,” “naturally made,” “naturally grown,” “all natural,” or “any words of similar import” (Act 120’s “ ‘natural’ restriction”).

Count One of the Amended Complaint alleges Act 120’s GE disclosure requirement violates the First Amendment; Count Two claims Act 120’s “natural” restriction violates the First Amendment; Count Three asserts Act 120’s “natural” restriction is impermissibly vague in violation of the First and Fifth Amendments; Count Four alleges Act 120 violates the Commerce Clause; and Count Five asserts Act 120 is preempted by various federal statutes. With regard to each claim, Plaintiffs allege a violation of the Fourteenth Amendment, as they are suing defendants for their actions under the color of state law. See U.S. Const, amend. XIV, § 1.

B. Act 120.

Act 120 was signed on May 8, 2014 and will be enforceable effective July 1, 2016 (the “effective date”). It requires that “food [intended for human consumption] offered for sale by a retailer” after the Act’s effective date “be labeled as produced entirely or in part from genetic engineering if it is a product: (1) offered for retail sale in Vermont; and (2) entirely or partially produced with genetic engineering.” 9 V.S.A. § 3043(a). Genetic engineering (“GE”) is defined as “a process by which a food is produced from an organism or organisms in which the genetic material has been changed” through the application of:

(A) in vitro nucleic acid techniques, in-' eluding recombinant- deoxyribonucleic acid (DNA) techniques and the direct injection of nucleic acid into cells or organelles; or

(B) fusion of cells (including protoplast fusion) or hybridization techniques that overcome natural physiological, reproductive, or recombination barriers, where the donor cells or protoplasts do not fall within the same taxonomic group, in a way that 'does not occur by natural multiplication or natural recombination.

9 V.S.A. § 3042(4).

Act 120 applies to raw agricultural commodities, which are defined as “any food in its raw or natural state, including any fruit or, vegetable that is washed, colored, or otherwise treated in its unpeeled natural form prior to marketing.” 9 V.S.A. § 3042(10)., It also ’ applies to processed foods, which are defined as “any food other than a raw agricultural commodity and includes any food produced from a raw agricultural commodity that has been subjected to processing such' as canning, smoking, pressing, cooking, freezing, dehydration, fermentation, or milling.” 9 V.S.A. § 3042(8).

A GE manufactureras subject to Act 120 if it:

(A) produces a processed food or raw agricultural commodity under its own bránd or label for sale in or into the Státe;'

(B) sells in or into the Staté under, its own brand or label a processed food or raw agricultural commodity produced by another supplier;

(C) owns a brand that' it licenses or licensed to another person for use oh a processed food or raw commodity sold in or' into the State;

(D) sells in, sells into, or distributes in the State a processed food or raw agricultural commodity that it packaged under a brand or label owned by another person;

(E) imports into the United States for sale in or into the State a processed food or raw agricultural commodity produced , by a person without a presence in the United States; or

(F) produces a processed food or raw agricultural commodity for sale in or into the State without.,affixing a brand name.

9 V.S.A. § 3042(6).

1. Act 120’s GE Disclosure ’ Requirement.

Act 120 requires that a “packaged raw agricultural commodity” be, labeled by GE manufacturers “with the clear and conspicuous words' ‘produced with genetic engineering.’” 9 V.S.A. § 3043(b)(1). If the “raw agricultural commodity” is not sold separately packaged, then a GE retailer must “post a label” - on the shelf or bin “with the clear and conspicuous words ‘produced with genetic engineering.’ ” 9 V.S.A. '§ 3043(b)(2). Packaged processed food must be labeled by a GE manufacturer with the words: “ ‘partially produced with genetic engineering,’ ” or “ ‘may be produced with genetic engineering,’ ” or “ ‘produced with genetic engineering.’ ” 9 V.S.A. § 3043(b)(3). Act 120 states it “shall not be construed to require” either “the listing or identification of any ingredient or ingredients that were genetically engineered” or “the placement of the term ‘genetically engineered’ immediately preceding any common name or primary product descriptor of a food.” 9 V.S.A. § 3043(d).

2. Act 120’s “Natural” Restriction.

Act 120 prohibits GE manufacturers from,using labeling, advertising, or signage indicating that a GE food product is “ ‘natural,’ ‘naturally made,’ ' ‘naturally grown,’ ‘all natural,’ or any words of similar import that would have a tendency to mislead a consumer.” 9 V.S.A. § 3043(c). Act 120 does not define the term “natural” or the phrase ’“any words -of similar import.”

3. Act 120’s Exemptions and Penalties.

Act 120 exempts certain products from its embrace, including alcoholic beverages subject to Title 7 of Vermont’s statutory code and food not packaged for retail sale that is “a processed food prepared and intended for immediate human consumption” or that is “served, sold, or otherwise provided in any restaurant or other food establishment.” 9 V.S.A. § 3044(4),- (7)(A)-(B). It also exempts “[flood consisting entirely of or derived entirely from an animal which has not itself been produced with genetic engineering, regardless of whether, the animal has been fed -or injected with any food, drug, or other substance produced with genetic engineering.” 9 V.S.A. § 3044(1).

A GE manufacturer or retailer may obtain an exemption from Act 120 for any food “grown, raised, or produced without the knowing or intentional use of food or seed produced with genetic engineering” by providing its own “sworn statement,” or verification from an independent organization, that the food “has not been knowingly or intentionally produced with genetic engineering and has been segregated from and has not been knowingly or intentionally commingled with food that may have been produced with genetic engineering at any time.” 9 V.S.A. §§ 3044(2), (6); 3045(b). Act 120 provides that a “person” is liable for any “false statement” made in the course of obtaining this exemption. 9 V.S.A. § 3047.

Under Act 120, any “person” who violates its requirements is “liable for a civil penalty of not more than $1,000.00 per day, per product,” which “shall accrue and be assessed per each uniquely named, designated, or marketed product.” 9 V.S.A. § 3048(a).

C. Act 120’s Legislative Findings.

In conjunction with its enactment of Act 120, the Vermont General Assembly promulgated certain “Findings.” One such “Finding” is that federal law does not require the labeling of GE food, as evidenced by the following:

(A) Federal labeling and food and drug laws do not require manufacturers of food produced with genetic engineering to label such food as genetically engineered.

(B) As indicated by the testimony of a U.S. Food and Drug Administration (FDA) Supervisory Consumer Safety Officer, the FDA has statutory authority to require labeling of food products, but does not consider genetically engineered foods to be materially different from their traditional counterparts to require such labeling.

(C) No formal FDA policy on- the labeling of genetically engineered foods has been adopted. Currently, the FDA only provides nonbinding guidance on the labeling of genetically engineered foods, including a 1992 draft guidance regarding labeling of food produced from genetic engineering and a 2001 draft guidance for industry regarding voluntary labeling of food produced from genetic engineering.

2014 Vt. Acts & Resolves No. 120, Sec. 1(1)(A)-(C).

Vermont’s General Assembly’s “Findings” include a finding that “[g]enetically engineered foods are increasingly available for human consumption” in light of estimates “that up to 80 percent of the processed foods sold in the United States” may contain ingredients produced from GE sources. Id. at Sec. 1(3)(A). They also include a “Finding” that federal law does not presently require independent testing of the safety of GE food and that:

(A) In its regulation of food, the FDA does not distinguish genetically engineered foods from foods developed by traditional plant breeding.

(B) Under its regulatory framework, the FDA does not independently test the safety of genetically engineered foods. Instead, manufacturers submit safety research and studies, the majority of which the manufacturers finance or conduct. The FDA reviews the manufacturers’ research and 'reports through a voluntary safety consultation, and issues a letter to the manufacturer acknowledging the manufacturer’s conclusion regarding the safety of the genetically engineered food product being tested.

(C) The FDA does not use meta-studies or other forms of statistical analysis to verify that the studies it reviews are not biased by financial or professional conflicts of interest.

(D) There is a lack of consensus regarding the validity of the research and science surrounding the safety of genetically engineered foods, as indicated by the fact that there are peer-reviewed studies published in international scientific literature showing negative, neutral, and positive health results.

(E)There have been no long-term or epidemiologic studies in the United States that examine the safety of human consumption of genetically engineered foods.

Id. at Sec. 1(2)(A)-(E).

With regard to GE food safety, the General Assembly declared in its “Findings” that GE foods “potentially pose risks to health, safety, agriculture, and the environment,” as evidenced by the following:

(A) There are conflicting studies assessing the health consequences of food produced from genetic engineering.

(B) The genetic engineering of plants and animals may cause unintended consequences.

(C), The use of genetically engineered crops is increasing in commodity agricultural production practices, which contribute to genetic homogeneity, loss of biodiversity, and increased vulnerability of crops to pests, diseases, and variable climate conditions.

(D) Cross-pollination of or cross-contamination ■ by genetically engineered crops may contaminate organic crops and, consequently, affect marketability of those crops.

(E) Cross-pollination from genetically engineered crops may have an adverse effect on native flora and fauna.' The transfer of unnatural deoxyribonucleic acid to wild relatives can lead to displacement of those native plants, and in turn, displacement of the native fauna dependent on those wild varieties. .

Id. at Sec. 1(4)(A)-(E).

Based upon its “Findings,” the General Assembly concluded “that food produced from genetic engineering should be labeled as such,” because “[ljabeling gives consumers information they can use to make decisions about what products they would prefer to purchase,” because public opinion polls indicate labeling is relevant to consumers, and because “[pjersons with certain religious beliefs object to producing foods using genetic engineering [and object] to tampering with the genetic makeup of life forms and the rapid introduction and proliferation of genetically engineered organisms and, therefore, need food to be labeled as genetically engineered.” Id. at Sec. 1(5)(A)-(B), (D)-(E).

In support of Act 120’s “natural” restriction, the General Assembly found:

Because genetic engineering, as regulated by this [A]ct, involves the direct injection of genes into cells, the fusion of cells, or the hybridization of genes that does not occur in nature, labeling foods produced with genetic engineering as “natural,” “naturally made,” “naturally grown/’ “all natural,” or other similar descriptors is inherently misleading, poses a risk of confusing or deceiving consumers, and conflicts with the general perception that “natural” foods are not genetically engineered.

Id. at Sec. 1(5)(C).

“For multiple health, personal, religious, and environmental reasons,” the General Assembly ultimately found that “the State should require food produced with genetic engineering to be labeled as such in order to serve the interests of the State, notwithstanding limited exceptions, to prevent inadvertent consumer deception, prevent potential risks to human health, protect religious practices, and protect the environment.” Id. at Sec. 1(5), (6).

D. Act 120’s Legislative Purpose..

Act 120’s “Purpose,” as declared by the General Assembly, is to:

(1) Establish a system by which persons may make informed decisions regarding the potential health effects of the food •they purchase and consume and by which, if they choose, persons may avoid potential health risks of food produced from genetic engineering;

(2) Inform the purchasing decisions of consumers who are concerned about the potential environmental effects of the production of food from genetic engineering;

(3) Reduce and prevent consumer confusion and deception by prohibiting the labeling of products produced from genetic engineering as “natural” and by promoting the disclosure of factual information bn food labels to allow consumers to make informed decisions; and

(4) Provide consumers with data from which they may make informed decisions for religious reasons.

9 V.S.A. § 3041(l)-(4).

E. Evidence In Support of the Pending Motions.

The parties have submitted competing expert witness declarations and reports, examining the science, safety, efficacy, economics, and impacts of GE food production. They nonetheless acknowledge that their submissions cannot be considered in adjudicating the State’s motion to dismiss Plaintiffs’ Amended Complaint pursuant to Fed.R.Civ.P. 12(b)(6).

The parties further acknowledge that because Plaintiffs do not seek either an evidentiary hearing or a consolidation with the merits for their preliminary injunction motion, the court cannot rely on contested evidence to resolve any factual disputes. See Kern v. Clark, 331 F.3d 9, 12 (2d Cir.2003) (“ ‘The existence of factual disputes necessitates an evidentiary hearing ... before a motion for a preliminary injunction may be decided.’ ”) (alteration in original) (quoting Commodity Futures Trading Comm’n v. Incomco, Inc., 649 F.2d 128, 131 (2d Cir.1981)).

For purposes of adjudicating the pending motions, the court is therefore confined to the factual and procedural background set forth herein and does not determine whether the General Assembly erred in its “Finding” that “[gjenetically engineered foods potentially pose risks to health, safety, agriculture, and the. environment.” 2014 Vt. Acts & Resolves No. 120, Sec. 1(4).

In support of their motion for a preliminary injunction, Plaintiffs ■ submitted the declarations of the Coca-Cola Company (“Coke”), PepsiCo, Inc. (“Pepsi”), General Mills, ConAgra Foods, Inc. (“ConAgra”), and Kraft Foods Group, Inc. (“Kraft”), as well as declarations from the SFA, Michaud Distributors (“Michaud”), and the Council of Supply Chain Management Professionals (“CSCMP”). The court refers to these entities -as “Plaintiffs’ GE manufacturers.”

The State submitted competing declarations from Ben & Jerry’s, Clif Bar and Company (“Clif Bar”), and Beanfields Snacks (“Beanfields”). These entities are referred to as “the State’s declarants.”

1. The Costs of Compliance with Act 120.

Generally, food manufacturers .offer items for retail sale by identifying them through a “stock-keeping unit” (“SKU”), which is a unique number for purposes of manufacturing, packaging, storage, sales, and distribution. - A single product can have several SKUs that reflect each size of the-product offered for sale; such as a six-' pack or a twelve-pack, as well as the type of packaging used, such as a cardboard box or plastic. A SKU is typically not state-specific because manufacturers often do not have separate product lines for individual states, but, rather, distribute their products nationwide.

Plaintiffs’ GE manufacturers distribute a large number of SKUs, ranging from approximately 1,700 SKUs (Pepsi) to tens of thousands of SKUs (ConAgra). None of Plaintiffs’ GE manufacturers currently label their products in accordance with Act 120’s GE disclosure requirement. They have considered whether to “reformulate” their products to be GE-free and have concluded that it is virtually impossible to manufacture many foods with non-GE sources for several reasons, including the prevalence of GE crops nationwide and the unavailability of non-GE ingredients in relation to demand, as well as an inability to change existing planting patterns, crops cycles, and contracts for production before Act 120’s effective date. (See, e.g., Doc. 33-4 at 6-7, ¶¶ 20-23.) Plaintiffs’ GE manufacturers therefore represent that if they continue to distribute nonexempt food products in Vermont, they will have to relabel the “vast majority” of their products. (See, e.g., Doc. 33-8 at 4, ¶ 12; Doc. 33-10 at 5, ¶ 16.) They contend that relabeling will require “a costly, time and resource-intensive effort” because they source from hundreds of ingredients that are made from or with GE crops in order to produce and distribute a large number of products. (Doc. 33-8 at 5, ¶ 15; see also Doc. 33-7 at 3-4, ¶¶ 11,15.)

To comply with Act 120’s GE disclosure requirement, Plaintiffs’ GE manufacturers represent that they will incur “significant” costs, although the total costs of compliance are “difficult or impossible to quantify.” (Doc. 33-10 at 10, ¶¶ 33-34.) They explain that compliance will require them to evaluate whether their products contain or likely contain GE ingredients, including an investigation of all “upstream components,” (Doc. 33-10 at 5, ¶ 18), which will be followed by an evaluation of “the feasibility of designing, producing!),] and implementing Vermont-specific labels for all affected products.” (Doc. 33-8 at 5, ¶ 17; see also Doc. 33-9 at 7, ¶¶ 22-24.)

In addition to the impacts of designing new packages and/or labels for Vermont-bound products, Plaintiffs’ GE manufacturers assert they will need to expend resources for dual-inventory, production, and distribution systems for Vermont-bound products, which will require' additional plant and storage space for producing and handling separate inventories of Vermont-specific labels and products. They point out that while larger manufacturers will have more SKUs to change, smaller manufacturers may not be able to incur the expense of designing, reviewing, and creating new labels for their Vermont-bound products. They contend that this, in turn, may reduce competition in Vermont to a few multi-category, multinational companies that can afford product segregation.

2. The Timing of Compliance with Act 120.

Plaintiffs’ GE manufacturers claim that they may not be able to implement product changes in time to comply with Act 120’s effective date because the process of “designing the packaging, conducting a compliance review, and making new plates would take 20 to 26 weeks,” without accounting for additional lead times for production of new labels and newly-labeled products, distribution, and to “clear non-compliant products from commerce.” (Doc. 33^1 at 4,10, ¶¶ 14, 33; see also Doc. 33-3 at 12-13, ¶¶ 40-41.) The lead times required for Plaintiffs’ GE manufacturers vary based on the number of GE products that must be re-labeled and on the shelf lives' of those products, which range from “months, if not up to two years.” (Doc. 33-8 at 7, ¶ 22; see also Doc. 33-6 at 6-7, ¶¶ 20-22.) Some of Plaintiffs’ GE manufacturers estimate they will have to begin distribution by at least July 1, 2015 to comply with Act 120’s GE disclosure requirement. (See Doc. 33-10 at 11-12, ¶¶ 40-41.)

The State’s declarants challenge Plaintiffs’ GE manufacturers’ contentions regarding the costs of creating new packaging, as well as the timing and feasibility of compliance with Act 120. They point out that using stickers, adding labels, or using separate packaging for products requiring a GE disclosure present alternative methods of compliance that would be less costly and time-consuming than the methods suggested by Plaintiffs’ GE manufacturers. Regardless of how a, manufacturer chooses to .comply, the State’s declarants point out that compliance costs could be passed on to consumers or absorbed by the manufacturer, that “[c]hanging labels is simply part of the business,” and that it is “common” to change a product’s packaging or labeling for a host of reasons, including to further marketing objectives. (Doc. 63-9 at 4, ¶ 7; see also Doc. 63-8 at 4, ¶¶ 6-8.) They contend that most food manufacturers manage their inventory “in weeks, not months,” (Doc. 63-7 at 4, ¶,7), and maintain no greater than a 90 day supply of “packaging inventory.” (Doc. 63-8 at 6, ¶ 13.) Accordingly, they assert that GE manufacturers will have the ability to use non-compliant packaging before Act 120’s effective date and to use any non-compliant inventory thereafter for distribution outside of Vermont. (See Doc. 63-8 at 6, ¶ 13.)

F. The Final Rule.

Act 120 provides that the Attorney General “may adopt by rule requirements for the implementation” of Act 120 that include: (1) “a requirement that the label required for food produced from genetic engineering include a disclaimer that the Food and Drug Administration does not consider foods produced from genetic engineering -to be materially different from other foods”; and (2) “a requirement that a label required under [Act 120] identify food produced entirely or in part from genetic engineering in a manner consistent with requirements in other jurisdictions for the labeling of food, including the labeling of food produced with genetic engineering.” 2014. Vt. Acts & Resolves No. 120, Sec. 3(1), (2); see' also 9 V.SA. § 3048(b) (“The Attorney General shall have the same authority to make rules ... as provided under subchapter 1 of chapter 63 of this title.").

During the pendency of this case, 'the Office of the Attorney General filed a Final Rule on April 20, 2015. See Consumer Protection Rule 121 [hereinafter Final Rule] (Doc. 93-1). According to the State, the Final Rule is intended “to clarify the reach of the statute,” (Doc. 63 at 27), and provides several definitions for terms used in Act 120, including that “[t]he term ‘genetic engineering’ does not encompass a change of genetic material through the application of traditional breeding techniques, conjugation, fermentation, traditional hybridization, in vitro fertilization, or tissue culture.” Final Rule § 121.01(6). The Final Rule also provides definitions for “Clear and conspicuous,” “Know,” and “Knowingly.” See Final Rule § 121.01(1), (9X10).

The Final Rule purports to “clariffy] the scope” of Act 120’s “natural” restriction, (Doc. 63 at 28), by stating that the phrase “ ‘[n]atural or any words of similar import’ means the words nature, natural, or naturally.” Final Rule § 121.01(14). It limits Act 120’s, “natural” restriction on advertising or signage to a “retail premises” in Vermont:

The manufacturer of a food that is produced entirely or partially with genetic engineering and offered for retail sale in Vermont shall not make any statement about the food that contains the word natural or any words of similar import: (1) in advertising at or in the retail premises, (2) on signs identifying the product at the point of display in the retail premises, or (3) on the label of the food. This prohibition does not apply to a food’s trade, brand, or product name, or any information required by the [FDA],- as referenced in 21- C.F.R. § 101.2(b).

Final Rule § 121.02(c)©; see also Final Rule § 121.01(22)-(23) (defining “Retail Premises” to mean “the physical location in Vermont where a retailer offers food for retail sale to consumers” and “Retailer” to mean “a person located in Vermont offering any raw agricultural commodity or processed food for retail sale”).

The Final Rule confirms that Act 120 does not prohibit “a person” from disclaiming on a food’s “packaging” that the FDA “does not consider food produced with genetic engineering to be materially different from other foods,” and it affirmatively provides that “a person may, in connection with offering food, produced with genetic engineering for retail sale in Vermont, make other disclosures about the food on its packaging.” Final Rule § 121.02(c)(ii).

The Final Rule provides that Act 120 shall not be construed to:

require the listing or identification of any ingredient or ingredients that were genetically engineered; or require the placement' of the term “genetically engineered” or a similar phrase immediately preceding or following any common name or primary product descriptor of a food; or require the placement of any disclosure required under section 121.02 of this rule as “intervening material” under 21 C.F.R. § 101.2(e); or otherwise require adding to or amending the information required by the [FDA], as referenced in 21 C.F.R. § 101.2(b).

Final Rule § 121.02(d).'

The Final Rule purports to limit when a GE manufacturer may use “partially” and “may be” produced with genetic engineering in conjunction with a GE food. Under the Final .Rule, “ ‘[plartially5 may be used to modify ‘Produced with Genetic Engineering’ only when a processed food contains less than 75% genetically engineered material by weight,” and “ ‘[m]ay be’ may be used to modify ‘Produced with Genetic Engineering* only when the food’s manufacturer does not know, after reasonable inquiry, whether the food is, or contains a component that is,.produced with genetic engineering.” Final Rule § 121.02(b).

The Final Rule provides a safe harbor for GE retailers that requires notice and an opportunity for “corrective action” before an enforcement action takes place. Final Rule § 121.04(c)(i). It also sets forth a “presumption of manufacturer compliance,” which provides that:

Any packaged, processed food subject to the, provisions of this rule and offered for retail sale in Vermont before January 1, 2017, that does not comply with this rule, is presumed to have been packaged and distributed prior to July 1, 2016, and the manufacturer shall not be liable for failure to comply with this rule unless there is evidence that the food was distributed on or after July 1, 2016.

Final Rule § 121.04(d)®.

Plaintiffs contend that Act 120 cannot lawfully be amended by either a 'Draft Rule or a Final Rule and that only the General Assembly may “correct” Act 120’s alleged constitutional deficiencies. The parties have not fully briefed this issue as only a Draft Rule existed when their motions and related papers were filed. The court thus considers the Final Rule in conjunction with the pending motions, but will provide the parties with an opportunity to address its import in supplemental briefing.

II. Conclusions of Law and Analysis.

A. Motion to Dismiss.

Under Fed.R,Civ.P. 12(b)(6), when deciding a motion to dismiss for failure to state a claim, a court assumes “all well-pleaded, nonconelusory factual allegations in the complaint to be true,” Kiobel v. Royal Dutch Petroleum Co., 621 F.3d 111, 124 (2d Cir.2010), and determines “whether they plausibly give rise to an entitlement to relief.” Ashcroft v. Iqbal, 556 U.S. 662; 679, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009). The court also draws “all reasonable inferences in the plaintiffs .favor.” Holmes v. Grubman, 568 F.3d 329, 335 (2d Cir.2009) (internal quotation marks omitted). The court will not credit “legal conclusions” or “[tjhreadbare recitals of the elements of a'cause of action, supported by mere conclusory statements.” Iqbal, 556 U.S. at 678, 129 S.Ct. 1937.

In its evaluation of a motion to dismiss, “a district court may consider the facts alleged in the complaint, documents attached to the complaint as exhibits, and documents incorporated by reference in the complaint.” DiFolco v. MSNBC Cable L.L.C., 622 F.3d 104, 111 (2d Cir.2010). A district court may also consider any “materials” that are “integral to” the complaint, Global Network Commc’ns, Inc. v. City of New York, 458 F.3d 150, 156 (2d Cir.2006), as well as those matters of which the court took judicial notice. See Tellabs, Inc. v. Makor Issues & Rights, Ltd., 551 U.S. 308, 322, 127 S.Ct. 2499, 168 L.Ed.2d 179 (2007).

To survive a motion to dismiss, a complaint must contain sufficient factual allegations “to raise a right to relief above the speculative level.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007). “The plausibility standard is not akin to a probability requirement, but it asks for more than a sheer possibility that a defendant has acted unlawfully. Where a complaint pleads facts that are merely consistent with a defendant’s liability, it stops short of the line between possibility and plausibility of entitlement to relief.” Iqbal, 556 U.S. at 678, 129 S.Ct. 1937 (citations and internal quotation marks omitted).,

The district court’s role “is merely to assess the legal feasibility of the complaint, not to assay the weight of the evidence which might be offered in support thereof.” DiFolco, 622 F.3d at 113 (internal quotation marks omitted); see also Global Network Commc’ns, Inc., 458 F.3d at 155 (“The purpose of Rule 12(b)(6) is to test, in a streamlined fashion, the formal sufficiency of the plaintiffs statement of a claim for relief without resolving a contest regarding its substantive merits.”). For this reason, the court does not evaluate the credibility of the Amended Complaint’s factual allegations. See Wright v. Metro-Health Med. Ctr., 58 F.3d 1130, 1138 (6th Cir.1995) (“In considering a motion under Fed.R.Civ.P. 12(b)(6), it is not the function of the court to weigh the evidence or evaluate the credibility of witnesses!)]”) (citation omitted).

B. Count Four: Plaintiffs’ Commerce Clause Challenge.

In adjudicating the motion to dismiss, the court turns first to Count Four, the only count of the Amended Complaint with regard to which Plaintiffs do not seek á preliminary injunction. In Count Four, Plaintiffs allege Act 120 violates the dormant Commerce Clause, and on that basis they ask that the Act be declared invalid in its entirety. The Commerce Clause authorizes Congress “[t]o regulate Commerce with foreign Nations, and among the several States, and with the Indians Tribes.” U.S. Const, art. I, § 8, cl. 3. Although the Commerce Clause does not “expressly restrain the several States in any way, [the Supreme Court has] sensed a .negative implication” within the Clause, “called the dormant Commerce Clause.” Dep’t of Revenue of Ky. v. Davis, 553 U.S. 328, 337, 128 S.Ct. 1801, 170 L.Ed.2d 685 (2008) (internal quotation marks, omitted).

“The limitation imposed by the Commerce Clause on state regulatory power ‘is by no means absolute,’ and ‘the States retain authority under their general police powers to regulate matters of legitimate local concern, even though, interstate commerce may be affected.’” Maine v. Taylor, 477 U.S. 131, 138, 106 S.Ct. 2440, 91 L.Ed.2d 110 (1986) (quoting Lewis v. BT Inv. Managers, Inc., 447 U.S. 27, 36, 100 S.Ct. 2009, 64 L.Ed.2d 702 (1980)). “[B]ecause consumer protection is a field traditionally subject to state regulation,” courts are “ ‘particularly hesitant to interfere with the [state’s consumer protection] efforts under the guise of the Commerce Clause.’” SPGGC, LLC v. Blumenthal, 505 F.3d 183, 194 (2d Cir.2007) (quoting United Haulers Ass’n, Inc. v. Oneidar-Herkimer Solid Waste Mgmt. Auth., 550 U.S. 330, 344, 127 S.Ct. 1786, 167 L.Ed.2d 655 (2007)).'

A law may “clearly discriminat[e]” against interstate commerce “in three ways: (1) by discriminating against interstate commerce on its face; (2) by harboring a discriminatory purpose; or (3) by discriminating in its effect.” Town of Southold v. Town of E. Hampton, 477 F.3d 38, 48 (2d Cir.2007) (citations omitted).

In seeking dismissal of Count Four, the State argues that Act 120 does not discriminate against interstate commerce because it treats in-state and out-of-state GE manufacturers in the same manner and because the burdens of Act 120 are not excessive in relation to its benefits under Pike v. Bruce Church, Inc., 397 U.S. 137, 90 S.Ct. 844, 25 L.Ed.2d 174 (1970) [hereinafter Pike ]. Plaintiffs respond that they have alleged sufficient facts at the pleading stage to survive a motion to dismiss, and they urge the court to await the development of the record before undertaking the fact-intensive inquiry required by Pike. As explained below, because of the manner in which Plaintiffs have framed their Commerce Clause challenges, the court does not reach a Pike analysis.

.1. Whether Plaintiffs Assert a Facial Challenge to Act 120 and Whether They Allege It Reflects a Discriminatory Purpose.

Plaintiffs’ allegations all address Act 120’s probable impacts on GE manufacturers and interstate commerce. They do not identify any distinction found within Act 120, itself, that discriminates between instate and out-of-state GE manufacturers. Where courts have struck down a statute based on a facial challenge under the Commerce Clause, the law in question has generally distinguished between in-state and out-of-state commerce. Here, no such distinctions within Act 120 exist “on its face.” Town of Southold, 477 F.3d at 48. Accordingly, the court assumes Plaintiffs are not making a facial challenge.

Plaintiffs also do not appear to claim that Act 120 reflects a' discriminatory purpose. In order to advance a discriminatory purpose challenge under the Commerce Clause, Plaintiffs must plausibly allege that the Vermont General Assembly enacted Act 120 in order to favor Vermont products over the same or similar products from other states. See, e.g., Bacchus Imps., Ltd. v. Dias, 468 U.S. 263, 265, 273, 104 S.Ct. 3049, 82 L.Ed.2d 200 (1984) (striking down facially-neutral statute exempting certain locally-produced alcoholic beverages from Hawaii’s excise tax because legislative history showed it was intended to foster local industry and “favor” local products); Hunt v. Wash. State Apple Adver. Comm’n, 432 U.S. 333, 335-36, 352-54, 97 S.Ct. 2434, 53 L.Ed.2d 383 (1977) (striking down facially-neutral statute prohibiting any state grading on certain apple boxes and noting evidence that it was intended to discriminate against out-of-state apples carrying state grades, while favoring in-state apples). Plaintiffs do not allege that Act 120 was passed'to favor Vermont GE manufacturers over GE manufacturers from other states,- nor do they point to anything in the legislative history that would make such a claim plausible.

2. Whether Plaintiffs Plausibly Allege a Discriminatory Effects Challenge to Act 120 Under the Commerce Clause.

Plaintiffs’ Commerce Clause challenge to Act 120 is- thus confined to a claim that the Act discriminates against interstate commerce “in its effect.” Town of Southold, 477 F.3d at 48. A discriminatory effects challenge does not always lend itself to neat categorization;' but instead often reflects a sliding scale of state-imposed burdens on interstate commerce:

Regulations that clearly discriminate against interstate commerce [are] virtually invalid per se, while those that incidentally burden interstate commerce will be struck down only if the burden imposed on such commerce is clearly excessive in relation to the putative local benefits. The Supreme Court has acknowledged, however, that there is no clear line separating the category of state regulation that is virtually per se invalid under the Commerce Clause, and the category subject to the Pike v. Bruce Church balancing approach. In order to determine whether [a law] should be analyzed under the Pike balancing test or as a per se violation, [a court must] examine the nature of the burden on interstate commerce. , Under either analysis, the critical consideration is the overall effect of the statute on both local and interstate activity.

Am. Booksellers Found. v. Dean, 342 F.3d 96, 102 (2d Cir.2003) (citations and internal quotation marks omitted).

The State seeks dismissal of Plaintiffs’ discriminatory effects claim, arguing that Act 120’s effect on interstate commerce is either non-existent or de minimus and is therefore not excessive in relation to Act 120’s benefits. In opposing dismissal, Plaintiffs assert, among other things, that they have “stated a claim that the natural ban’s regulation of national media is a per se violation of the Commerce Clause.” (Doc. 36 at 23.) Although the Amended Complaint does not contain this specific claim, Plaintiffs’ allegations are sufficient to be characterized as a per se challenge. In essence, Plaintiffs allege that Act 120’s “natural” restriction reaches national and Internet communications that cannot lawfully be regulated by a single state.

Act 120 prohibits GE manufacturers from, among other things, labeling a product “in signage, or in advertising as ‘natural,’ ‘naturally made,’ ‘naturally grown,’ ‘all natural,-’ or any words of similar import that would have a tendency to mislead a consumer.” 9 V.S.A. § 3043(c) (emphasis supplied). The Act. does not define either “signage” or “advertising,” and therefore these restrictions apply to any non-exempt “Manufacturer” who produces, sells, distributes, or licenses GE products that are sold in or into- Vermont. 9 V.S.A. § 3042(6). There is, however, no corresponding requirement that the signage and advertising occur in Vermont. By its terms, Act 120 purports to restrict a GE manufacturer’s use of “natural” terminology in signage and advertising nationwide and on the Internet.

Act 120’s “Findings” and “Purpose” contain no mention of any putative benefit that could be tied to Vermont’s regulation of GE manufacturers’ advertising and signage,activities in other states. “A state law may burden interstate commerce when it ‘has the practical effect of requiring out-of-state commerce to be conducted at the regulating state’s direction.’” Entergy Nuclear Vt. Yankee, LLC v. Shumlin, 733 F.3d 393, 429 (2d Cir.2013) (quoting Am. Booksellers Found., 342 F.3d at 102); cf. SPGGC, LLC, 505 F.3d at 194 (holding that a statute prohibiting the in-state sale of certain types of gift cards did not violate the dormant Commerce Clause because it did not, “by its terms or its effects, directly regulate sales of ‘gift cards in other states ... [or] prevent other states from regulating gift card sales differently within their own territories”).

In American Booksellers Foundation, the Second Circuit struck down portions of a Vermont statute that prohibited the transfer of sexually explicit material to a minor. The Second Circuit noted that the Vermont statute reached distribution of sexually explicit material via the Internet and explained that, “[b]ecause the [Internet does not recognize geographic boundaries, it is difficult, if not impossible, for a state to regulate [I]nternet activities without ‘projecting] its legislation into other States.’” Am. Booksellers Found., 342 F.3d at 103 (quoting Healy v. Beer Inst., Inc., 491 U.S. 324, 334, 109 S.Ct. 2491, 105 L.Ed.2d 275 (1989)). The Vermont' statute’s regulation of such activities therefore had “‘the practical effect of regulating commerce occurring wholly outside that State’s borders,’” and,' “[although Vermont aim[ed]' to protect Only Vermont minors, the rest of the nation [was] forced to comply with its regulation or risk prosecution.” Id. at 103 (quoting Healy, 491 U.S. at 332, 109 S.Ct. 2491). Because “Vermont ha[d] projected its legislation into other States, and directly regulated commerce therein, in violation of the dormant Com-' merce Clause,” id. at 104 (internal quotation marks omitted), the Second Circuit affirmed this court’s permanent injunction prohibiting enforcement of the Vermont statute insofar as it “applied to the [Internet speech upon which plaintiffs based their suit.” Id. at 105.

A similar conclusion is warranted here. Without limitation and for no stated purpose, Act 120 purports t.o prohibit GE manufacturers’ use of “natural” terminology in signage and advertising regardless of where or how those activities take place. These allegations are sufficient to state a plausible per se violation of the Commerce Clause based upon- its discriminatory effects. The State’s motion to dismiss this aspect of Plaintiffs’ Commerce Clause claim is therefore DENIED.

The State is more persuasive in arguing that Plaintiffs’ remaining discriminatory effects Commerce Clause claims should be dismissed. In their- Amended Complaint, Plaintiffs allege that the effects of Act 120 fall disproportionately on out-of-state food manufacturers because “the vast majority” of Plaintiffs’ members are located outside Vermont, there are allegedly “no major food manufacturers” based in Vermont, and that, as a result, “the cost of implementing [Act 120] falls largely, if not entirely, on out-of-state companies.” (Doc. 37-1 at 21, ¶ 73.)

Plaintiffs further allege that Act 120 forces their members, who sell food in interstate commerce .through national and regional distribution chains, to establish Vermont-specific distribution channels, which cannot be established in a commercially reasonable manner before Act 120’s effective date. They assert that they will effectively be compelled to change their regional or national labeling, regardless of where their products may be sold, as this will be the only cost-efficient means of achieving compliance with Act 120’s GE disclosure requirement. In light of GE labeling legislation in other states, Plaintiffs represent that this task will be complicated by the need to comply with conflicting GE regulations which will only further impede the flow of interstate commerce. For purposes of ruling on the motion to dismiss, the court must accept Plaintiffs’ factual allegations as true. See Mastafa v. Chevron Corp., 770 F.3d 170, 177 (2d Cir.2014). However, even after Plaintiffs’ allegations are fully credited, dismissal of their remaining Commerce Clause claims is appropriate under National Electrical Manufacturers Association v. Sorrell, 272 F.3d 104 (2d Cir.2001) [hereinafter NEMA ].

In NEMA the Second Circuit explained that in order to “run afoul” of the Commerce Clause, a statute “must impose a burden on interstate commerce that is qualitatively or quantitatively different from that imposed on intrastate commerce.” NEMA 272 F.3d at 109. Provided Act 120 does not “require manufacturers to label all [products] wherever distributed,” there is thus no Commerce Clause violation because “[t]he Vermont statute, by its terms, is indifferent to whether [products] sold anywhere else in the United States are labeled or not.” Id. at 110 (internal quotation marks omitted). ’ “To the extent the statute may be said to ‘require’ labels on [products] sold outside Vermont, then, it is only because the manufacturers are unwilling to modify their production and distribution systems to differentiate between Vermont-bound and non-Vermont-bound [products].” Id.

NEMA also dispenses with Plaintiffs’ argument that Act 120 violates the Commerce Clause because the costs of compliance fall disproportionately on larger, out-of-state GE manufacturers:

Although a regulation might violate the Commerce Clause by creating market incentives that encourage out-of-state manufacturers to abandon a state market while encouraging in-state manufacturers to pick up the slack, the instant regulation is evenhanded such that ... producers both inside and outside Vermont would face the same putative need to develop separate production and distribution systems to accommodate simultaneously the Vermont market and other state markets.

Id. at 111. The NEMA court observed that “the manufacturers, .remain free to charge higher prices only to Vermonters without risking violation of the statute” and that, even if the full costs could not be passed on to the consumer, the possibility that “manufacturers must bear some of the costs of the Vermont regulation in the form of lower profits does not cause the statute to violate the Commerce Clause.” Id. at 110-11.

NEMA also forecloses Plaintiffs’ claim that there will be a “patchwork of state labeling requirements” because the few states that have enacted GE labeling requirements have not done so in a uniform manner. (Doc. 37-1 at 23, ¶ 78.) The Amended Complaint alleges no actual conflict between Act 120 and any mandatory GE labeling law elsewhere, and a potential statutory conflict will not suffice:

A state regulation might impose a disproportionate burden on interstate commerce if the regulation is in substantial conflict with a common regulatory scheme in place in other states. It is not enough to point to a risk of conflicting regulatory regimes in multiple states; there must be an actual conflict between the challenged regulation and those in place in other states.

NEMA 272 F.3d at 112 (citations omitted). As the Amended Complaint all but concedes, “[n]o such conflict has been shown here” because “no other state [currently] regulates the labeling of [GE products], much less does so in conflict with Vermont’s approach.” Id. Accordingly, “[w]hile the scope of conflict required to state a dormant Commerce Clause claim is somewhat unclear, it is clear that the present case involves no conflict whatsoever.” Id.

In accordance with NEMA’s controlling precedent, the court must dismiss Plaintiffs’ remaining claims that Act 120 is discriminatory in its effects. Act 120 does not require GE manufacturers to alter their labeling, production, and distribution practices nationwide, and it is indifferent regarding whether and how GE products are labeled in other states. See Parkcentral Global Hub Ltd. v. Porsche Auto. Holdings SE, 763 F.3d 198, 208-09 (2d Cir.2014) (noting dismissal is appropriate when it is “clear” that “plaintiffs claims are barred as a matter of law”) (internal quotation marks omitted); D.P. ex rel. E.P. v. Sch. Bd. of Broward County, 483 F.3d 725, 728-29 (11th Cir.2007) (noting dismissal is appropriate “when, on the basis of a dispositive issue of law, no construction of the factual allegations will support the cause of action”) (internal quotation marks omitted).

In the absence of a plausible claim that Act 120 in its effects “clearly discriminates against interstate commerce,” Wyoming v. Oklahoma, 502 U.S. 437, 454, 112 S.Ct. 789, 117 L.Ed.2d 1 (1992), the court need not consider whether Act1 120 is “ ‘demonstrably justified by a valid factor unrelated to economic protectionism.’ ” Automated Salvage Transp., Inc. v. Wheelabrator Envtl. Sys., Inc., 155 F.3d 59, 74 (2d Cir.1998) (quoting Wyoming, 502 U.S. at 454, 112 S.Ct. 789). This is because Plaintiffs must first allege discriminatory effects before “the burden shifts to the government to show that the local benefits of the law outweigh its discriminatory effects and that the government lacked a nondiseriminatory alternative by which it could protect the local interests.” Town of Southold, 477 F.3d at 47 (citing USA Recycling, Inc. v. Town of Babylon, 66 F.3d 1272, 1281-82 (2d Cir.1995)). “[I]f no such unequal burden [is] shown, a reviewing court need not proceed further” with Pike’s complex factual inquiry. NEMA, 272 F.3d at 109.

Because Plaintiffs’ remaining Commerce Clause challenges fail to.state a plausible claim for relief under'the dormant Commerce Clause, they are hereby DISMISSED under Fed.R.Civ,P. 12(b)(6). The State’s motion to dismiss Count Four of' the Amended Complaint is thus GRANTED IN PART and DENIED IN PART.

C. Count Five: Plaintiffs’ Preemption Claims.

In Count Five of their Amended- Complaint, Plaintiffs allege that Act 120 is expressly preempted or conflict preempted, in whole or in part, by various federal laws and thus violates Article VI, Clause 2 of the U.S. Constitution (the “Supremacy Clause”). The Supremacy Clause provides that the laws of the United States are “the supreme Law of the Land; ... any Thing in the Constitution or Laws of any State to the Contrary notwithstanding.” U.S: Const, art. VI, cl. 2.

Under the Supremacy Clause, a state law may be preempted by federal law in. three ways: express preemption, field preemption, and conflict preemption. See Hillsborough County, Fla. v. Automated Med. Labs., Inc., 471 U.S. 707, 713, 105 S.Ct. 2371, 85 L.Ed.2d 714 (1985). In analyzing whether the Amended Complaint states a claim under the Supremacy Clause, the court is “guided by the rule that ‘[t]he purpose of Congress is the ultimate touchstone in every pre-emption case.’ ” Altria Grp., Inc. v. Good, 555 U.S. 70, 76, 129 S.Ct. 538, 172 L.Ed.2d 398 (2008) (quoting Medtronic, Inc. v. Lohr, 518 U.S. 470, 485, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996)). It must also adhere to the" presumption against preemption, which dictates that “[i]n areas of traditional state regulation, [the court] assume[s] that a federal statute has not supplanted state law unless Congress has made such an intention clear and manifest.” Bates v. Dow Agrosciences LLC, 544 U.S. 431, 449, 125 S.Ct. 1788, 161 L.Ed.2d 687 (2005) (internal quotation marks omitted). For this reason, “where the text of a preemption clause is ambiguous or open to more than one plausible reading, courts ‘have a duty to accept the reading that disfavors pre-emption.’ ” N.Y. State Rest. Ass’n v. N.Y.C. Bd. of Health, 556 F.3d 114, 123 (2d Cir.2009) [hereinafter NYSRA ] (quoting Bates, 544 U.S. at 449, 125 S.Ct. 1788).

Plaintiffs allege express preemption and conflict preemption pursuant to four federal statutes regulating the, labeling of food and beverages. They do not allege, nor could they reasonably allege, field preemption, which would require the court to find that Congress has regulated so comprehensively, and the federal interest is so dominant, in the field of food and beverage labeling that Congress “left no room for state regulation of these matters.” United States v. Locke, 529 U.S. 89, 111, 120 S.Ct. 1135, 146 L.Ed.2d 69 (2000); see also Holk v. Snapple Beverage Corp., 575 F.3d 329, 337 (3d Cir.2009) (“It does not appear that Congress has regulated so comprehensively in either the food and beverage or juice fields that there is no role for the states.”); Fellner v. Tri-Union Seafoods, L.L.C., 539 F.3d 237, 243 & n. 3 (3d Cir.2008) (noting defendants could not assert a field preemption claim in case involving labeling requirements because “[c]ourts rarely find field preemption, especially in areas traditionally-regulated by the states, unless the structure of a regulatory program leaves little doubt that Congress intended federal law to be exclusive in a particular field”) (citing Hillsborough County, Fla., 471 U.S. at 717, 105 S.Ct. 2371).

With regard to Act 120’s GE disclosure requirement, Plaintiffs allege both express and - conflict preemption claims under the Federal Food, Drug, and Cosmetic Act (the “FDCA”), 21 U.S.C. §§ 301-399f; and the Nutrition Labeling and Education -Act (the “NLEA”), 21 U.S.C. §§ 343-1-343-3; and express preemption claims under the Federal Meat Inspection Act ' (the “FMIA”), 21 U.S.C. §§ 601-695; and the Poultry Products Inspection Act- (the “PPIA”), 21 U.S.C. §§ 451-472. With regard to Act 120’s “natural” restriction, Plaintiffs assert preemption only under the FMIA and PPIA.

The State seeks dismissal of Plaintiffs’ claims, arguing that preemption is not mandated by the identified federal statutes, Plaintiffs lack standing to assert a Supremacy Clause claim to the FMIA and PPIA, and the State’s, Final Rule rectifies any remaining conflicts between Act 120 and preemptive federal law,

1. The FDCA and NLEA.

The FDCA prohibits' the misbranding of food -and drink, see 21 U.S.C. § 343, and its “statutory regime is designed-primarily to- protect the health and safety of the public at large.” POM Wonderful LLC v. Coca-Cola Co., — U.S. -, 134 S.Ct. 2228, 2234, 189 L.Ed.2d 141 (2014). Because the FDCA does not contain any express preemption language, it does not, itself, provide a basis for Plaintiffs’ express preemption claims. See Grocery Mfrs. of Am., Inc. v. Gerace, 755 F.2d 993, 997 (2d Cir.), aff'd, 474 U.S. 801, 106 S.Ct. 36, 88 L.Ed.2d 29 (1985) (mem.).

The NLEA, which amends the FDCA, is intended “ ‘to . clarify and to strengthen the [FDA’s] legal authority to require nutrition labeling on foods, and to establish, the circumstances under which claims may be made about nutrients in foods.’ ” NYSRA, 556 F.3d at 118 (quoting H.R.Rep. No. 101-538, at 7 (1990), reprinted in 1990 U.S.C.C.A.N. 3336, 3337). The NLEA contains five express preemption clauses that prohibit states from enacting food labeling requirements that are “not identical” to certain mandatory food labeling requirements set forth in the FDCA. 21 U.S.C. § 343-l(a)(l)-(5).

In order .to state a claim that Act 120’s GE disclosure requirement violates the Supremacy Clause, Plaintiffs’ burden is twofold. They must first plausibly allege that Act 120’s GE disclosure requirement is “not identical” to a mandatory requirement of the FDCA. And second, they must plausibly allege that under the NLEA the identified mandatory FDCA requirement is clearly entitled to preemptive effect. See 21 U.S.C. § 343-l(a)(l)-(5); see also NYSRA; 556 F.3d at 123 (holding “the NLEA is clear on preemption, stating that it ‘shall not be construed to preempt any provision of State law, unless such provision is expressly preempted’ under [21 U.S.C. § 343 — 1(a) ]”) (alterations in original) (quoting Pub.L. No. 101-535, § 6(c)(1), 104 Stat. 2353, 2364, 21 U.S.C. § 343-1 note).

Plaintiffs acknowledge that the FDA has promulgated no formal standards for GE labeling. They thus point to no federal statute or regulation that prohibits Act 120’s GE disclosure requirement. Plaintiffs further concede that the FDA provides guidance for the voluntary disclosure of GE ingredients. This clearly implies that, at least from the FDA’s perspective, GE ingredient information may be provided without violating federal law or misbranding a food product. See U.S. Food & Drug Admin., Draft Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering, at 6-7 (2001) [hereinafter FDA Draft Guidance] (noting that manufacturers may label their food and beverage products as “genetically engineered” or containing ingredients that were - “produced using biotechnology”). Plaintiffs also recognize that pending federal legislation, if enacted, is intended to expressly preempt state law GE disclosure requirements. This, of course, begs the question of why 'such legislative measures would be necessary if Act 120’s 'GE disclosure requirement was already preempted. See Safe and Accurate Food Labeling Act of 2014, H.R. 4432, 113th Cong. (2014) (proposing an amendment to the FDCA that would include express preemption of state mandatory labeling requirements for food and beverages produced with bioengineered organisms). It is in the midst of this .unpromising environment that, Plaintiffs claim they can overcome the presumption against preemption with regard to Act 120’s GE disclosure requirement,

a. Whether Act 120’s GE Disclosure Requirement Is Expressly Preempted by the FDCA and NLEA.

Plaintiffs cite Act 120’s “ingredient labeling” and “product labeling” requirements as the focus of their Supremacy Clause challenge under the FDCA and the NLEA. They assert that Act 120’s GE disclosure requirement forces them to modify the “standard of identity” for some products, “the common or usual name” for other products, and the “list of ingredients” for all products. The State counters that Act 120 does not reach that far and must “be interpreted to avoid constitutional difficulties,” Frisby v. Schultz, 487 U.S. 474, 483, 108 S.Ct. 2495, 101 L.Ed.2d 420 (1988), as “courts ‘have a duty to accept the reading that disfavors preemption.’” NYSRA, 556 F.3d at 123 (quoting Bates, 544 U.S. at 449, 125 S.Ct. 1788).

In order for Act 120’s GE disclosure requirement to be found “not identical” to the FDCA’s mandatory labeling requirements, Plaintiffs argue that the court need only find that Act 120 requires disclosure of additional or different labeling information from the FDCA. Plaintiffs rely heavily on a federal regulation that appears to interpret “not identical” in this manner. See 21 C.F.R. § 100.1(c)(4) (defining “not identical” as “directly or indirectly imposes obligations or contains provisions concerning the ... labeling of food” that are “not imposed by” or that “[d]iffer from those specifically imposed by” federal law). Courts, however, have rejected the proposition that a federal regulation may extend preemption beyond NLEA’s express preemption provisions. See Reid v. Johnson & Johnson, 780 F.3d 952, 959 (9th Cir. 20Í5) (observing that the NLEA “does not preempt any state law unless the law is expressly preempted,” notwithstanding 21 C.F.R. § 100.1(c)(4)) (internal quotation marks omitted); In re Farm Raised Salmon Cases, 42 Cal.4th 1077, 72 Cal.Rptr.3d 112, 175 P.3d 1170, 1179 (Cal.2008) (holding that “Congress made clear that the preemptive scope of section 343-1 was to sweep no further than the plain language of the statute itself’); see also NYSRA, 556 F.3d at 126 (noting the court would “owe deference to the FDA’s reading” of a statute embodied