Consumers in the United States have increasingly demanded that manufacturers of foods that are either directly genetically engineered or that contain genetically-engineered (GE) ingredients label their products as such. In general, federal law--in the form of the Food, Drug, and Cosmetic Act (FDCA)--lodges primary authority for approving and regulating the labeling of GE foods in the Food and Drug Administration (FDA), but FDA has been reluctant to mandate labeling of GE foods. In light of this federal regulatory void, states have proposed their own GE food labeling requirements, generating protests from manufacturers and federalism challenges in the form of federal preemption claims.
In July 2016, Congress settled this federalism conflict, mandating that the Secretary of Agriculture promulgate federal regulations to govern GE food labeling and preempting state labeling requirements. This Article explores the history of GE food labeling federalism in the United States, concluding that the 2016 statute leaves the relationship between state and federal authority fairly clear, but creates new ambiguities regarding the relationship of FDA and the FDCA to the United States Department of Agriculture and the new law.
INTRODUCTION 610 II. A BRIEF HISTORY OF GENETICALLY-ENGINEERED FOODS 614 III. THE FOOD AND DRUG ADMINISTRATION'S AUTHORITY OVER GENETICALLY-ENGINEERED FOODS 619 A. The Basics of Food Regulation Under the Federal Food, Drug, and Cosmetic Act 620 B. FDA's Treatment of Plant-Based GE Foods 621 C. The New GE Food in the Market: Animal-Based GE Food 624 IV. STATE ATTEMPTS TO REQUIRE GENETICALLY-ENGINEERED FOOD LABELING, FEDERAL PREEMPTION BATTLES IN COURT, AND CONGRESS'S JULY 2016 RESPONSE 626 A. State Statutes Affecting GE Food Labeling 626 B. Federal Preemption Litigation Before 2016 628 1. State-Law Liability for Bt Com Co-Mingling and Preemption Claims Under the Federal Insecticide, Fungicide, and Rodenticide Act 629 2. State-Law Liability for Labeling GE Foods "Organic" and Preemption Claims Under the Federal Organic Foods Production Act 631 3. State-Law Liability for Labeling GE Foods as "Natural" and Preemption Claims Under the FDCA 632 4. Comprehensive Preemption Challenges to Vermont's 2014 GE Food Labeling Law 633 C. Congress's 2016 Preemption of State Laws 635 V. WE'RE NOT DONE YET: LEGAL ISSUES REMAINING UNDER THE SAFE AND ACCURATE FOOD LABELING ACT 640 A. The Division of Authority Over GE Foods Between the Secretary of Agriculture and FDA 640 B. The Future Role of State Laws in GE Food Labeling 641 VI. CONCLUSION 645 I. INTRODUCTION
Genetically-engineered (GE) plants (1) and, recently, animals (2) are increasingly common components of the human food supply in the United States, resulting in what this Article will refer to as "GE foods"--that is, human foods that are either directly genetically engineered themselves or that contain GE ingredients. As reported in 2016, about 75%-80% of foods in the United States contain GE ingredients, usually derived from genetically modified corn and soybeans. (3)
Especially because genetic modification of foods is often effectively "hidden" in "popular processed food ingredients such as cornstarch, soybean oil or high-fructose corn syrup," (4) consumers in the United States have increasingly demanded that GE foods be labeled as such. (5) Some people object to the whole idea of humans producing genetically modified organisms (GMOs), or worry about the potential environmental impacts of GE crops and other organisms. (6) Others just want to know what they are eating, (7) to avoid potential allergens, (8) to avoid violating religious or medical food restrictions, (9) to adhere to dietary lifestyle choices such as veganism, (10) or, most generally, simply to leave food consumption choices to consumers and not to agribusiness and commercial food mega-industries. (11) In addition, because GE foods implicate food access and quality concerns as well as religious freedoms, the GE food labeling issue is also relevant to human rights discussions. (12)
From these overlapping camps, there has been in the United States an increasing consumer demand for food labeling to include information about GMO content. (13) As Gabriel Rangel summarizes, since the 1990s,
[P]ublic awareness of the existence of GE foods increased, and calls for regulation of GE food grew louder, resulting in labeling requirements for GE food in many countries. Today, 64 countries have mandatory labeling laws for GE food. However, the United States still does not have a mandatory, nationwide labeling law, although many advocacy groups are lobbying to enact one. These groups argue that labeling GE food is important for consumer choice and for monitoring unforeseen problems associated with the technology. In contrast, groups opposing labels claim a law would unnecessarily eliminate consumer demand for current GE crops, causing steep increases in food price and resource utilization. Moreover, despite the United States' lack (until recently) of mandatory GE food labeling laws, the consumer demand for increased information about GE foods has had market effects. (15) For example, "[i]n 2013, Chipotle became the first restaurant chain to label menu items as 'GMO,' and in April of , the company announced the elimination of all ingredients made with GMOs, citing their 'food with integrity journey.'" (16)
However, a more basic legal question also arose in the GE food labeling debate: Who, exactly, should oversee GE food labeling? Traditionally, most food labeling requirements have come from the United States Food and Drug Administration (FDA) pursuant to the Federal Food, Drug, and Cosmetic Act (17) (FDCA), and FDA has taken the lead in approving GE foods for marketing. (18) However, FDA has also eschewed mandatory labeling requirements for GE foods, concluding that their GE content is not a material enough fact to require labeling. (19) Nevertheless, in November 2015, it promulgated new guidelines for voluntary labeling of GE foods, including both the more common plant-based GE foods and the recently approved GE Atlantic salmon (Salmo salar). (20)
In light of this rather light-handed federal approach to GE food labeling, some states--especially Vermont--began to enact their own GE food labeling requirements. (21) In response, GE food producers protested that they faced the prospect of a fifty-state patchwork of labeling requirements, a potentially costly food distribution nightmare. (22) They and various biotech companies spent about $100 million in 2015 alone to fight state GE food labeling requirements. (23)
Thus, state GE food labeling laws presented a classic federalism conundrum: The federal government refused to act in ways that at least some citizens desired in a situation where national uniformity in the law, given the realities of pervasive interstate commerce in GE foods, is arguably the most efficient result for all concerned. Moreover, state intervention into the GE food labeling arena prompted classic federalism litigation in favor of federal supremacy--namely, claims of federal preemption. (24)
However, and particularly in response to Vermont's 2014 GE food labeling law, food companies also began to capitulate to individual states' laws. (25) As the New York Times reported, "Campbell Soup was the first to break ranks, announcing in January  that it would put G.M.O. labels on all its products nationally. General Mills, ConAgra and others quickly followed suit, and now many food packages contain tiny print affirming the presence of [GE] ingredients." (26)
After federal preemption claims failed in the courts, Congress, in late July 2016, expressly preempted state GE food labeling laws. (27) In doing so, Congress also ordered the Secretary of Agriculture to promulgate regulations to govern GE food labeling, (28) leaving FDA's residual authority regarding GE food labeling in some doubt.
This Article explores the federalism battle over GE food labeling and Congress's resolution of it--although the exact contours of that resolution will depend on the regulations that the Secretary of Agriculture decides to issue by July 29, 2018. It begins in Part II with a brief history of the genetic modification of organisms and their current presence in human foods. Part III then surveys FDA's authority over food labeling under the FDCA and its pre-2016 application of that authority to GE foods. Part IV provides an overview of the multi-year drama among states, the courts, and Congress regarding the viability of state GE food labeling requirements, culminating in a comprehensive federal court decision upholding Vermont's GE food labeling law and Congress's July 2016 preemptive legislation. As noted, what Congress's preemption of state GE food labeling laws actually means will not be completely clear until the Secretary of Agriculture issues its new regulations. In the meantime, however, the new legislation has created other legal issues regarding the continued viability of state consumer protection laws when applied to GE foods and FDA's continuing role in GE food regulation, which this Article explores in Part V. This Article concludes that FDA retains its role as the primary regulator of GE foods seeking entry into consumer markets. However, the exact contours of FDA's and the states' continuing abilities to influence GE food labeling through, respectively, the FDCA's misbranding requirements and state consumer protection laws will require further interpretation and development.
A BRIEF HISTORY OF GENETICALLY-ENGINEERED FOODS
Humans have been genetically modifying their foods through plant and animal breeding for over 30,000 years. (29) Artificial selection in animal breeding occurred before plant breeding; scientists and historians believe that the dog was the first organism that humans genetically manipulated through artificial selection, starting about 32,000 years ago. (30) Controlled...