The labeling debate in the United States

Abstract

The mandatory labeling of genetically modified (GM) food has become the predominant policy issue concerning biotechnology in the United States. The controversy over GM labeling is being debated at several different levels and branches of government. At the federal level, the Food and Drug Administration, which has primary jurisdiction over food safety and labeling, has steadfastly refused to require labeling of GM foods since 1992 based on its conclusion that GM foods as a category present no unique or higher risks than other foods. Proposed legislation has been repeatedly introduced in the US. Congress over the years to mandate GM labeling, but has made very little progress. With federal labeling requirements apparently stalled, the main activity has switched to the state level, where numerous individual states are considering mandatory GM labeling, either through legislation or proposition. The debate over GM labeling, at both the federal and state levels, has focused on five issues: (1) public opinion; (2) the legality of labeling requirements; (3) the risks and benefits of GM foods; (4) the costs and burdens of GM labeling; and (5) consumer choice. While the pro-labeling forces argue that all of these factors weigh in favor of mandatory GM labeling, a more careful evaluation of the evidence finds that all five factors weigh decisively against mandatory GM labeling requirements.

Keywords: :

• GM foods
• labeling
• FDA
• regulation
• consumer

Introduction

Labeling has become the predominant focus of US policy and public debate on genetically modified (GM) foods in recent years. The labeling issue has cycled on and off the front burner of attention throughout the past 20 years. However, as campaigns to restrict or prohibit GM crops and foods directly have attained very little traction, opponents of GM foods have now settled on labeling as the focus of their efforts. This has triggered controversies and battles at the federal, state and even private industry levels. In this article, we first review the history of the GM labeling issue in the United States, and then examine the current debate over mandatory labeling of GM foods.

History of the GM Labeling Controversy in the United States

The beginning: FDA’s 1992 policy statement

In 1986, the White House Office of Science and Technology Policy put in place the regulatory approach to biotechnology in the United States by publishing its Coordinated Framework for the Regulation of Biotechnology.¹ This Framework rejected the need for any new agencies or statutes to regulate biotechnology, but rather assigned responsibility for regulating the variety of biotechnology products to several different federal agencies under a matrix of existing statutes. The Coordinated Framework did not mention the issue of labeling products produced using biotechnology, but assigned the Food and Drug Administration (FDA) primary responsibility for regulating food products produced using biotechnology.

The FDA has primary responsibility for ensuring the safety of most foods in the United States pursuant to its authority under the Federal Food, Drug and Cosmetic Act (FFDCA). In 1992, the FDA announced its approach to regulation of biotechnology foods, including its policy on GM labeling, in a “Statement of Policy” published in the Federal Register,² and has adhered to the positions announced in that document for the past 20-plus years. FDA announced that it planned to apply the identical approach to GM foods that it had traditionally applied to foods developed by traditional plant breeding: “The regulatory status of a food, irrespective of the method by which it was developed, is dependent upon objective characteristics of the food … [T]he key factors in reviewing safety concerns should be the characteristics of the food product, rather than the fact that the new methods are used.”³ This FDA policy approach of regulating the product rather than the process by which it was made applied both to pre-market approval and labeling of GM foods.

For all foods, under its FFDCA authority, the FDA can only require information on the label that is accurate and “material.” The FDA concluded in its 1992 Statement that the process by which a food is created is usually not a “material” fact that needs to be on the label: “The agency is not aware of any information showing that foods derived by these new methods differ from other foods in any meaningful or uniform way, or that, as a class, foods developed by the new techniques present any different or greater safety concern than foods developed by traditional plant breeding. For this reason, the agency does not believe that the method of development of a new plant variety (including the use of new techniques including recombinant DNA techniques) is normally material information … and would not usually be required to be disclosed in labeling for the food.”⁴

The FDA therefore rejected any requirement for across-the-board labeling of GM foods, but did identify certain circumstances where such a label may be required. Specifically, “if a food derived from a new plant variety differs from its traditional counterpart such that the common or usual name no longer applies, or if a safety or usage issue exists to which consumers must be alerted,” then labeling would be required.⁵ As an example of a potential safety issue, FDA presented a hypothetical whereby a peanut protein was genetically engineered into a tomato, and unless the producer could demonstrate that there was no allergy risk from that peanut gene, the product would need to be labeled to warn individuals allergic to peanuts that the genetically engineered tomato may present an allergenic risk. To date, no such labels for a specific safety or usage issue have been required by FDA for GM foods.

Alliance for bio-integrity case

A coalition of organizations and individuals, called the Alliance for Bio-Integrity (hereinafter “Alliance”), filed a lawsuit challenging the FDA’s refusal to require mandatory labels on all GM foods and other policies regarding the regulation of GM foods contained in the 1992 Statement of Policy. The case, decided in 2000 by the federal district court for the District of Columbia, upheld the FDA on all procedural and substantive claims.⁶ The court rejected the claims of the Alliance that consumer demand should be a relevant factor in determining whether a change to food is “material.” The court held that not only was the FDA’s interpretation reasonable, but that it was likely compelled by the FFDCA itself: “without a determination that, as a class, rDNA derived food pose inherent risks or safety consequences to consumers, or differ in some material way from their traditional counterparts, the FDA is without authority to mandate labeling.”⁷

The court also rejected the Alliance’s argument that labeling of GM foods was required to protect the free exercise of religion by some members of the public. The Alliance argued that some religions prohibit the consumption of GM foods, and thus the lack of labels prevented people holding such religious beliefs from exercising their religion, in violation of the Constitution and the Religious Freedom Restoration Act. The court held that even for the sake of argument if there were religions that prohibited the consumption of GM foods (no such religion was identified), the government had not “substantially burdened” the exercise of those religious beliefs by failing to take action to mandate labeling of GM foods. The Alliance never appealed these adverse decisions to the Court of Appeals or Supreme Court, and so the district court decision remains the final decision on the legality of the FDA policy to not label GM foods.

Subsequent FDA activities

The FDA has steadfastly adhered to its position against mandatory GM labeling in the 20 plus years since its 1992 Statement of Policy was published, through both Republican and Democratic administrations. Public concern and attention regarding GM foods and their labeling has waxed and waned over the years, with little action by the agency. In 1999, the FDA announced and conducted a series of three public hearings across the nation (in Washington, DC, Oakland and Chicago) to solicit public comment on the FDA’s biotechnology regulatory program, including its labeling policy.⁸ These hearings produced conflicting testimony by various interest groups, and the submission of over 50,000 written comments, but led to no immediate changes in the FDA policy.

Nevertheless, in response to the widespread view expressed in the 1999 public hearings and comments that the FDA should explore additional mechanisms for communicating information about the genetic modification of foods, the FDA issued a draft guidance in 2001 on voluntary labeling of GM foods and non-GM foods. In its notice of this draft guidance, the FDA noted that while many of the comments in the 1999 proceedings favored mandatory labeling of GM foods, they failed to provide any data demonstrating that genetic engineering of food resulted in a “material” change, and thus the FDA reaffirmed its decision one decade earlier not to mandate special labeling of GM foods.⁹ Instead, FDA favored voluntary mechanisms for disclosing whether foods were GM or not.

The 2001 draft guidance therefore set forth requirements for a food producer which wanted to label its product as not containing any non-GM ingredients. While permitting such claims, the draft guidance imposed fairly strict criteria to prevent companies from misleading consumers. For example, the draft guidance prohibits claims that a food is GM “free,” since it is not possible to demonstrate a zero level of GM ingredients. The draft guidance also concluded that “a label statement that expresses or implies that a food is superior (e.g., safer or of higher quality) because it is not bioengineered would be misleading” given the lack of evidence that GM foods are materially different than non-GM foods.¹⁰ Further, a statement may be misleading if it suggests that a food or ingredient itself is not bioengineered, when there are no marketed bioengineered varieties of that same category of foods or ingredients. The FDA draft guidance has never been finalized, so it remains an unofficial statement of the agency’s approach to non-GM labeling.

For the next decade, GM food labeling was not a major issue at FDA. In October 2011, a new Citizen Petition drafted by the Center for Food Safety on behalf of a number of organic and other activist organizations was filed with the FDA calling for the compulsory labeling of all GM foods in the United States. The petition would require that all foods containing any amount of GM ingredients would include the following label: “UNITED STATES GOVERNMENT NOTICE: THIS PRODUCT WAS PRODUCED USING GENETIC ENGINEERING.” Unlike GM labeling requirements in other countries, no threshold for adventitious presence was specified below which labeling would not be required. The FDA has not responded to this citizen petition as of the date of this writing, other than to acknowledge receipt and to state that the agency would require more time to provide an official response. A coalition of supporters of GM labeling called “Just Label It,” funded and organized primarily by organic food interests and endorsed by over 600 organizations, has organized a grassroots campaign to support the GM labeling petition at FDA, which as of May 2013 claimed to have collected 1.2 million signatures in support of mandatory GM labeling.

Another recent flare-up in the GM labeling issue at FDA resulted from the agency’s regulatory review of the AquAdvantage salmon, the first genetically engineered animal to be considered by the FDA. The agency held a public hearing on September 21, 2010 and invited public comments on whether this genetically engineered salmon, if approved for commercialization by FDA, should be required to be labeled as genetically engineered.¹¹ Although the FDA has not announced any final regulatory decisions on the AquAdvantage salmon as of the date of this writing, the materials it has produced suggest that if the agency approves the salmon for release, it will not require special labeling given that the process by which it was engineered is not “material.” Nevertheless, the AquAdvantage salmon precedent has stirred up pro-labeling activity by activist groups and some members of Congress who have been exerting pressure on the FDA to change its position, without any success to date.

Congressional activity

Legislation has been introduced in each Congress since at least 2000 to mandate the labeling of GM foods, but these proposed bills have never even reached the floor of either house of Congress for a vote, never mind being enacted. Senator Barbara Boxer of California introduced the first GM labeling bill in the Senate in 2000, and from 2003 to 2011 Congressman Kucinich introduced a bill in the House in every Congress. Although these bills always included a number of co-sponsors, they never had any serious chance of passage and made little if any progress through the legislative process. In 2013, the Genetically Engineered Food Right-to-Know Act was introduced simultaneously in the Senate (S. 809) and House (H.R. 1699) by Senator Boxer and Representative Peter DeFazio to require the FDA to mandate GM labeling. The bills have nine co-sponsors in the Senate and 22 co-sponsors in the House, including one Republican in each chamber, allowing proponents to argue it is the first bipartisan, bicameral GM labeling legislation in the United States Congress. Senator Boxer has also introduced two related amendments into the 2013 Farm Bill (S.954). Amendment # 1025, while it does not mandate labeling of GMOs, requests that the Senate demonstrate support for mandatory GMO labeling, and Amendment #1026 requests that the FDA and USDA make a study of the 64 countries around the world that currently require labeling.

State activities

As proponents of GM labeling became frustrated by their lack of progress in both Congress and the FDA, they have recently shifted much of their focus to state governments. At least 25 states have considered proposed legislation to require mandatory GM labeling over the past decade, but none of the bills have been enacted to put into effect mandatory labeling as of the date of this writing with the exception of a law enacted by the State of Alaska that requires labeling of genetically engineered salmon sold in the State. Many of the bills progressed through the legislative process to hearings or even committee or floor votes in some cases, but were eventually defeated or watered down, often by fairly narrow margins. States that have come closest to adopting labeling through the legislative process include Vermont, Maine and Hawaii.

Perhaps the closest that states have come to mandating labeling to date have been through the proposition mechanism. Oregon was the first state to put mandatory GM labeling on the state-wide ballot (Measure 27) in the general election of November 2002, and although the proposition had overwhelming support (of 3:1 or more) in initial polls, it ultimately was soundly defeated by a vote of 886,806 votes (70%) against and only 371,851 votes (30%) in favor.¹² California put forward a similar measure (Prop 37) one decade later in November 2012, and again notwithstanding strongly favorable initial poll results, this proposition also went down to defeat, but this time by the much narrower margin of 6,442,371 in favor (51.4%) and 6,088,714 against (48.6%).¹³ In both States, companies opposing GM labeling outspent proponents of GM labeling many-fold, although these official expenditures did not include most of the substantial grassroots campaigns in favor of the labeling propositions. Another important issue in both states was information provided through universities and the media on the significant costs associated with compulsory GM labeling. In California, for example, all major newspapers in the state ended up opposing the GM labeling proposition. Finally, California’s Prop 37 included some sloppy language that suggested it would prohibit all processed foods from using the term “natural” on its label, which alienated some natural food interests that would have likely been otherwise supportive of the proposition, and given the close result may therefore have affected the outcome.

Washington State has approved a proposition question on mandatory GM labeling for its state-wide election in November 2013, and once again early public opinion polls are showing strong initial support for requiring labeling. Washington State also has some additional factors pushing the pro-labeling side, including strong apple and fishing industries which are concerned about the trade implications of new genetically engineered salmon and apple products approaching the market without any current labeling requirement. Other States are likewise moving forward with their own legislation to require labeling. The Vermont House of Representatives passed by a vote of 107–37 a mandatory GM labeling bill in May 2013; the proposed legislation must now be voted on by the Vermont Senate, likely not until early 2014. In June 2013, Connecticut became the first state to enact broad GM food labeling legislation, but the legislation will only take effect if four other states in the Northeast (one of which must border Connecticut) adopt a similar requirement. If and when a state does succeed in implementing a mandatory GM labeling requirement, it will almost certainly be subject to a legal challenge, under one of several legal theories discussed further below.

Private labeling mechanisms

The United States has had a de facto non-GM label ever since the United States Department of Agriculture (USDA) responded to pressure from organic food activists and excluded GM foods from being included as organic foods under the National Organic Program. Thus, a consumer could generally avoid most GM ingredients by buying only products certified as organic. Notwithstanding this available mechanism for avoiding GM foods, the “Non-GMO Project” was launched to provide third-party verification and labeling of non-GM foods. The website for this non-profit organization states that it is dedicated “to preserving and building sources of non-GMO products, educating consumers, and providing verified non-GMO choices.”¹⁴ Over 6000 food products have reportedly been certified as meeting the Non-GMO Project's standard for non-GM.

Another potentially important development in the US GM labeling debate was the announcement of the health and organic grocery chain Whole Foods that it will require all foods-containing GM ingredients that it stocks to be labeled by 2018. While this decision on the part of Whole Foods has been touted as a “game changer” by Gary Hirshberg, chairman of Just Label It, the Grocery Manufacturers Association, which is a trade group representing major food companies and retailers, appears to see it differently. Louis Finkel, Executive Director of Government Affairs for the Association, in referring to the FDA, the World Health Organization and the American Medical Association deeming genetically modified products safe, issued a statement that, “These labels could mislead consumers into believing that these food products are somehow different or present a special risk or a potential risk.”¹⁵ Some other smaller health and organic food stores have joined the Whole Foods policy. It remains to be seen how food manufacturers and processors will respond to this requirement, but it clearly puts additional pressure on companies with regard to GM labeling.

The GM Labeling Debate in the United States

Following the above review of the major events and developments with regard to GM labeling in the United States over the past 20 years, we now turn to the central points of contention and argument in the GM labeling debate in the United States. These issues are: (1) public opinion; (2) risks and benefits of GM foods; (3) legality of mandatory GM labeling requirements; (4) costs and burdens of GM labeling; and (5) consumer choice. Each of these points of contention is summarized below in the context of how that issue is playing out in the US GM labeling debate.

Public opinion

The first argument generally put forward in favor of compulsory GM labeling is that public opinion polls consistently show that 90 percent or more of Americans want GM foods labeled, and thus politicians in a democracy should heed this overwhelming public support for GM labeling. It is true that polls that ask respondents if they would prefer to have GM foods labeled consistently produce very strong majority responses (in the range of 80–90 percent). Yet, asking the public if they would prefer to have any type of information available, especially while implying that such information would not cost them anything, will almost always produce an overwhelming positive response. Why wouldn’t someone want more information if it was costless and did not involve anything personal or potentially damaging? So, for example, polls that ask if consumers would like information on food labels about pesticide use also receive overwhelming support, and interestedly, if people are asked if they prefer information on pesticides vs. genetic modification, they prefer the pesticide information by a 2–1 margin.¹⁶

There is other evidence that the public support for mandatory GM labeling is “soft.” For example, if respondents are asked the more neutral question of whether there is any additional information they would favor being included on food labels, without specifically listing any options (including GM labeling), less than two percent of respondents volunteer anything about biotechnology or genetic modification. Moreover, when respondents are read the FDA’s current policy that rejects mandatory across-the-board labeling of GM foods, and then asked if they approve or disapprove of that FDA policy, 66 percent of the public supports the FDA policy while only 14 percent are against.¹⁷

The most realistic and relevant question is whether consumers support compulsory GM labeling and are willing to pay for it, since any additional costs from GM labeling will be passed on to consumers in whole or in part. As discussed further below, the costs of mandatory GM labeling are disputed, but are likely to be non-trivial since mandatory GM labeling will require segregating GM from non-GM food ingredients at every step of the food production process from farm to fork. According to the USDA Economic Research Service, as of July 2012 the adoption of GM corn was at about 88% of all US corn and GM soybean at 93% of the total soybean crop production in the US,¹⁸ which suggests that the vast majority of foods that contain any ingredients from corn or soybean are derived from GMO plants. Beyond simply indicating if a product contains ingredients derived from GMO plants, if identification of the actual trait were also required for traceability, the costs associated would be compounded. The only public opinion poll that we are aware of that asked respondents how much they would be willing to pay for mandatory GM labeling was conducted by the Center for Science in the Public Interest in 2001. That survey found that only 12 percent of the population would be willing to pay $250 or more per household per year for such labeling, while 61% would only be willing to pay $10 or less^.[9] Since mandatory GM labeling is certain to impose costs significantly higher than $10 per household per year, this poll suggests that the majority of Americans are not in favor of paying for mandatory GM labels, and thus the democracy argument actually weighs against mandatory GM labeling. This is also apparent in the defeat of both the Oregon (2002) and California (2012) propositions to require GM labeling. Unfortunately, most of the media and advocacy discussion of GM labeling does not go beyond the simplistic and misleading poll results that simply ask people if they want GM labeling without any mention of the costs involved.

Risks and benefits of GM foods

In Europe and other jurisdictions where GM labeling has been implemented, the official justification for such labeling is not based on any additional health risks of GM foods, but rather on factors such as consumer preferences and choice. In the United States, however, proponents of GM labeling make the claim that GM crops and foods do likely present unique risks, and therefore labeling is necessary both to allow consumers to avoid such health risks and to track and investigate health problems that may result from the consumption of GM foods. For example, Proposition 37, the unsuccessful 2012 state-wide ballot measure in California, begins with the following statement in the first section of the official proposition:

“Genetic engineering of plants and animals often causes unintended consequences. Manipulating genes and inserting them into organisms is an imprecise process. The results are not always predictable or controllable, and they can lead to adverse health or environmental consequences. … Government scientists have stated that the artificial insertion of DNA into plants, a technique unique to genetic engineering, can cause a variety of significant problems with plant foods. Such genetic engineering can increase the levels of known toxicants in foods and introduce new toxicants and health concerns.”¹⁹

Michael Hansen, of Consumer’s Union (publisher of Consumer Reports), likewise argues that states “have a compelling state interest in labeling of genetically engineered foods … due to the potential human health and environmental impacts of genetically engineered foods.”²⁰ Organizations like Just Label It have even developed anti-GMO labels that are effectively a skull and crossed ears of corn, which they encourage consumers to download and place on products in the supermarket.²¹

The claims that GM foods present unique risks are contrary to, and deliberately ignore, the conclusions of the most authoritative scientific organizations in the United States. Examples include:

US Food and Drug Administration: “FDA has no basis for concluding that bioengineered foods differ from other foods in any meaningful or uniform way, or that, as a class, foods developed by the new techniques present any different or greater safety concern than foods developed by traditional plant breeding.”²

National Research Council: “There is no strict dichotomy between, or new categories of, the health and environmental risks that might be posed by transgenic and conventional pest-protected plants.”²²

American Medical Association: “There is no evidence that unique hazards exist either in the use of rDNA techniques or in the movement of genes between unrelated organisms … The risks associated with the introduction of rDNA-engineered organisms are the same in kind as those associated with the introduction of unmodified organisms ... [T]here is no scientific justification for special labeling of bioengineered foods, as a class ….”²³

American Association for the Advancement of Science: “There are several current efforts to require labeling of foods containing products derived from genetically modified crop plants, commonly known as GM crops or GMOs. These efforts are not driven by evidence that GM foods are actually dangerous. Indeed, the science is quite clear: crop improvement by the modern molecular techniques of biotechnology is safe. Rather, these initiatives are driven by a variety of factors, ranging from the persistent perception that such foods are somehow “unnatural” and potentially dangerous to the desire to gain competitive advantage by legislating attachment of a label meant to alarm. Another misconception used as a rationale for labeling is that GM crops are untested.”²⁴

The proponents and proposals to mandate labeling of GM foods never cite or refer to these scientific assessments, even though they have been issued by the most authoritative and credible scientific organizations in the nation. Instead, they rely primarily on analyses conducted by a small number of individuals with scientific degrees employed or paid by anti-GM organizations, along with a series of small, obscure and poorly-designed studies published by scientists who usually have a long-standing and public ideological opposition to GM foods. These studies invariably cannot be replicated and are discredited, but quickly replaced by a new study with many of the same flaws. The most recent example is a French study by the anti-GM activist Gilles-Eric Seralini,²⁵ whose recent study is frequently cited by GM labeling supporters but has been criticized by multiple governmental and scientific organizations²⁶ and independent plant scientists.²⁷ The GM labeling proponents thus tend to cherry-pick single studies that support their pre-existing position, while failing to consider the much more substantial and authoritative body of consistent data and findings that GM foods are at least as safe as non-GM foods, or to conduct any sort of weight of evidence balancing. The New York Times writer Andrew Revkin refers to this selective use of science “single study syndrome,”²⁸ a tendency shared by other fringe science campaigns such as the anti-vaccination and creationism movements.

Legality of mandatory GM labeling

Another issue of contention is whether mandatory labeling of GM foods would be legal, especially at the state level. A state requirement for mandatory GM labeling could face three different legal challenges. First, such a measure could be preempted by federal law, and specifically the FDA’s determination not to require mandatory GM labeling. Federal preemption of state laws is based on the Supremacy Clause of the Constitution, which states that the “Constitution and the laws of the United States...shall be the supreme law of the land...anything in the constitutions or laws of any State to the contrary notwithstanding.” This means that a federal law, including a regulatory action by a federal agency, trumps conflicting state laws. Preemption can be either express or implied. Express preemption is where Congress or a federal agency explicitly states it intends to displace state laws in a certain area, which is not the case here.

Rather, the preemption question for state GM labeling laws is whether they are implicitly preempted by the FDA decision not to mandate GM labeling. Implied preemption applies when (1) the federal government has “occupied the field” in which the state has regulated, (2) a state law directly conflicts with federal law, or (3) where the state law might frustrate federal purposes. In deciding whether there is such implied preemption, courts consider the pervasiveness of the federal regulatory scheme, the federal interest at stake, and the likelihood that the federal goals would be frustrated by the state regulation. Arguably, the FDA decision to not label GM foods “occupied the field” or would be frustrated by state labeling requirements, and thus would preempt the state mandate. However, given that the FDA’s action was a decision simply not to act rather than an affirmative step to put in place a federal regulatory program, and moreover that the FDA action consisted of only a statement of policy rather than an official rulemaking, it is not clear whether a state labeling requirement would be preempted by FDA’s GM labeling policy. However, in May 2013, a proposed amendment by Senator Bernie Sanders (D-VT) that sought to clarify that state GM labeling requirements would not be preempted was soundly defeated by the Senate by a vote of 71–27, providing further evidence to support federal preemption.

A second potential legal challenge to any state labeling requirement would be a claim under the dormant commerce clause. This doctrine holds that even when the federal government has not taken regulatory action under the commerce clause of the Constitution, a state regulation may still be prohibited if it discriminates or unduly burdens interstate commerce. While the doctrine applies most strongly to state laws that discriminate against out-of-state products or activities, it also prohibits state actions that under a balancing test impose burdens on interstate commerce that outweigh the benefits of the state statute. For example, Iowa’s state statute limiting the length of trucks on the state highways for safety reasons was held to violate the dormant commerce clause by the United States Supreme Court which found that inconsistent state-level restrictions on truck length would restrict interstate trucking and would not provide significant safety benefits.²⁹ In the same way, opponents of state GM labeling requirements would argue that such mandates disrupt interstate commerce by imposing patchwork requirements for food products sold nationally and are not justified by the scientific evidence on GM foods.

The third and final legal argument against compulsory GM labeling, which unlike the arguments above would apply to both state and federal GM labeling requirements, are that such mandates violate the commercial free speech doctrine under the US Constitution. This doctrine prohibits government from forcing companies to make statements on its product labels without a legitimate government rationale. Unlike the other two theories described above, this legal claim has been applied successfully in the biotechnology context in the past, so there is precedent indicating that government cannot require labeling without a credible finding of risk, and may not mandate labeling based solely on consumer demand or preferences. For example, a federal court of appeals struck down a Vermont law requiring labeling of milk produced from cows treated with recombinant bovine somatotrophin (rBST) under the commercial free speech doctrine: consumer “desire is insufficient to permit the State of Vermont to compel the dairy manufacturers to speak against their will. Were consumer interest alone sufficient, there is no end to the information that states could require manufacturers to disclose about their production methods. . . . Absent, however, some indication that this information bears on a reasonable concern for human health or safety or some other sufficiently substantial governmental concern, the manufacturers cannot be compelled to disclose it.”³⁰

Moreover, as discussed above, a different federal court likewise held in the Alliance for Bio-Integrity case that consumer choice is not a legally sufficient reason for the FDA to require companies to label GM foods.⁶ A state could make a finding that it believes GM foods do present a significant risk to support its labeling mandate, but such a finding would likely be treated skeptically by a reviewing court given the contrary conclusions reached by much more experienced and authoritative scientific bodies such as the FDA and National Research Council of the National Academy of Sciences. So at least with the current factual record, any mandatory GM labeling requirement would be legally suspect under the commercial free speech doctrine, and possibly also the dormant commerce clause and federal preemption for a state law.

Costs and burdens of GM labeling

Another contested issue about mandatory GM labeling is the cost and burdens of GM labeling. Proponents of GM labeling contend that the costs of GM labeling are negligible. They make two arguments in support of this contention. First, they argue that the costs of labeling only involve changing the text on food product labels, and then argue that because product manufacturers update the labels of food products several times per year anyways, the costs of adding the term “genetically modified” to the next version of the product label is only pennies per product. Second, GM labeling proponents argue that costs associated with labeling in the European Union did not noticeably increase food prices, and thus they claim this empirical evidence demonstrates that the biotechnology industry is “crying wolf” when it claims GM labeling would be expensive and burdensome.

Both of these arguments are demonstrably simplistic and flawed. The major cost of GM labeling is not the relatively minor cost of printing new labels, but rather the cost of segregating GM from non GM foods from farm to fork.³¹ Failure to carefully segregate GM ingredients at the farm level, during transportation and storage, during food processing, and during distribution can result in enormous penalties under proposed GM labeling programs.³² This involves costs far beyond those encountered by organic and non-GMO certified foods (which do usually cost much more in part because of the need to segregate such foods during the entire production chain), both because of the volume of genetically modified commodity crops currently on the market, and because organic and non-GMO certified foods are not subject to the strict enforcement regimes that GM foods would be subject to under the proposed labeling provisions. Tests of organic foods do find significant GM contamination, which would result in major fines under the proposed labeling laws for foods with similar co-mixing not labeled as GM. Studies that provide realistic estimates of the costs of segregating GM and non-GM foods estimate that costs of GM labeling will exceed $100 per family per year.³³ As discussed above, there are few consumers who are willing to pay this price for labeling of GM foods.

The claim that Europe’s experience demonstrates that GM labeling is essentially costless ignores the key fact that the strict labeling and traceability requirements for GM products imposed by the EU in 2004 have virtually eliminated GM foods from the EU market. The costs of tracking and segregating GM foods from farm to fork are the equivalent of a burdensome tax selectively imposed on GM ingredients, and make such products non-viable in the European market. Since virtually no GM products are being grown or sold in the EU, except for Spain, there are no costs associated with tracking and labeling such non-existent products. Thus, from the perspective of GM crops, which are effectively eliminated in Europe, mandatory labeling would make growing and using GM ingredients economically infeasible.

Consumer choice

Finally, the issue of consumer choice is critical to the GM labeling controversy in the United States. The campaigns for mandatory GM labeling frequently refer to the goal of giving consumers “choice” through GM labeling. For example, Just Label It, the coalition pushing federal GM labeling, states in their campaign fact sheet “We consumers have a right to know what’s in our food so we can make informed choices about what we buy, eat and feed our families.”³⁴ But as we have seen in Europe and other jurisdictions that have adopted GM labeling, the effect of GM labeling is to force GM foods from the market, and thus to prevent consumers from having the choice to buy GM foods or not. The extra costs of segregating, tracking and labeling GM foods effectively price such products out of the highly competitive, low margin food markets. Moreover, consumers will interpret the government-mandated label as a warning, suggesting that there is something different and worrisome about GM foods, thus stigmatizing such products.³³ Food processors, distributors and retailers will source non-GM ingredients to avoid the costs, burdens, stigma and potential liability of using GM ingredients.

The purported objective of GM labeling to promote consumer choice is perplexing given the clear record that such labeling reduces rather than expands consumer choices in food purchases, and that existing alternatives already exist for consumers who wish to avoid GM foods to do so. Specifically, foods carrying the term “organic” in the United States are not permitted to use genetic engineering, and as discussed above, there are vibrant non-GM voluntary labeling programs in effect. So, US consumers can already avoid GM foods, obviating the need for mandatory GM labeling. Why then is so much effort being given to GM labeling campaigns?

The GM labeling campaign is really a “Trojan Horse” that, unbeknownst to many in the public who innocently support what they believe will be more choice though labeling, is intended to eliminate GM foods altogether.³⁵ It is a campaign funded almost entirely by the organic food industry, which realizes its future growth is limited by the strong preference for GM crops by farmers. As long as most commodity crops are GM, as they currently are in the United States, most processed foods will not be organic, and thus organic foods will be restricted to a relatively small segment of the total food market, and provides very little room for future growth. Realizing this, the organizers and funders of the GM labeling campaigns have developed a strategy to leverage GM labeling to eliminate GM crops from the United States.

The game plan can be seen from what happened in Europe, where the very same groups who campaigned for mandatory GM labeling, once successful in imposing such labeling requirements, then turned to pressuring (through boycotts if necessary) food brands and food retailers to commit to not carrying any labeled GM products, now easily identified by the mandatory labels.³³ Given the small margins in the food industry, food producers and retailers cannot afford to lose even five percent of their customers through such boycotts. These threatened boycotts, combined with the extra costs and liability risks associated with GM foods under the labeling regulations, forced GM foods off the market in Europe. Thus, rather than giving European consumers more choice, GM labeling has restricted the choice to buy only non-GM foods.

While the organic food industry interests and their allies that are the primary funders and organizers of the GM labeling campaigns in the United States frame their public statements in terms of providing greater consumer choice, their true intention to prohibit rather than just label GM foods is not hard to discern. David Bronner, President of Dr Bronner’s Magic Soaps, and one of the leading funders and organizers of the campaign to label GM foods, stated: “Labeling is something everyone can get behind… We could march for a ban on GM foods, but a ban won’t happen. Labeling is the only way to win. We have the Non-GMO Project, and can carve out our non-GMO niche, but if we want to win we have to have a labeling law. With labeling we have a fighting chance. We saw what happened in Europe (when labeling was introduced it killed the market for GM foods)… A labeling law would be the death of GMOs in the US.”³⁶

Another leading organizer of the GM labeling efforts, Ronnie Cummins of the Organic Consumers Association, likewise wrote that “[t]he burning question for us all then becomes how—and how quickly—can we move healthy, organic products from a 4.2% market niche, to the dominant force in American food and farming? The first step is to change our labeling laws.”³⁷ In another letter seeking donations in support of the California GM labeling initiative, he made clear that the objective and consequence of mandatory GM labeling is to remove GM foods from the US market completely: “If we pass this initiative—which will require food manufacturers and retail stores in California to label genetically engineered (GE) foods—we will be on our way to getting GE-tainted foods out of our nation's food supply for good… If a company like Kellogg’s has to print a label stating that their famous Corn Flakes have been genetically engineered, it will be the kiss of death for their iconic brand in California—the eighth-largest economy in the world—and everywhere else.”³⁸ This “kiss of death” for GM foods will directly benefit his organic food industry: “In the wake of this development American farmers will convert millions of acres of GE crops to non-GMO or organic varieties.”³⁹

Thus, the GM labeling issue in the United States is not about choice. Rather, it is about whether the organic food industry can succeed in putting in place unnecessary and burdensome requirements on its GM competitors in order to advance its own economic and ideological interests, while actually depriving consumers of real food choices.

Conclusion

In the past couple years, significant grassroots mobilization and momentum has built for compulsory GM labeling laws at both the federal and state levels. Federal action to require labeling does not seem imminent at either the FDA or Congress, notwithstanding significant pressure being exerted on these institutions. Legislation and voter propositions at the state level have been introduced in numerous states, to date with little success, although given the number and unpredictability of such state level initiatives, there could be a breakthrough at any time and one or more states could enact a mandatory labeling requirement. Such an action would almost surely trigger a legal challenge, that is likely (although not certain) to be successful. A uniform national approach to the labeling of foods sold in the nation-wide market for most foods would make the most sense; Congress could make this happen by expressly preempting state GM labeling requirements that are inconsistent with the FDA’s national policy on GM labeling.

The GM labeling controversy in the United States presents an interesting case study of the increasing collision between evidence-based policy and populist believes and biases empowered by unreliable internet and social media information. While the case for GM labeling seems compelling on first appearance, a closer examination of the scientific, legal, economic and policy arguments and evidence demonstrates that compulsory GM labeling is unwarranted, unnecessary and being manipulated by a cynical and self-serving campaign funded and organized by the organic food industry. This campaign is driven by popular websites and social media that produce a torrent of scientifically unsupported and alarmist information about GM foods. A good example is Mercola.com, which claims to be the most visited “natural health” website in the world with several million visitors per day, was the largest funder of the GM labeling initiative in California, is a strong proponent and purveyor of alternative medicines and organic products that have received numerous FDA warnings, and opposes childhood vaccination, water fluoridation and many other scientifically supported products and technologies in addition to GM foods. The GM labeling debate is one of the most important battlefields in the country pitting science- and evidence-based public policy against a populist social movement funded and manipulated by pseudoscientific, unaccountable and self-interested forces. The outcome of this battle will not only determine the future of GM foods in the United States (and likely worldwide), but also the strength and soundness of American democracy.

Disclosure of Potential Conflicts of Interest

The authors declare no conflicts of interest.