Labeling of Genetically Engineered Foods: A Constitutional Analysis of California s Proposition 37

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2 I. Introduction Labeling of Genetically Engineered Foods: A Constitutional Analysis of California s Proposition 37 by Lauren E. Handel On November 6, 2012, California voters will decide whether that state will become the first jurisdiction in the nation to require labeling of genetically-engineered foods. The ballot initiative known as The California Right to Know Genetically Engineered Food Act or Proposition 37 (Prop. 37) 1 would require genetically-engineered foods to be labeled with a statement disclosing that fact. Inherent in the initiative is a policy judgment that consumers have a right to know if foods they eat are made from genetically-engineered organisms. 2 Whether or not it is wise policy to provide for such a right to know and the vast majority of Americans seem to think it is there are good reasons to believe that Prop. 37 goes about achieving this policy objective in a manner that is, at least in part, unconstitutional. If Prop. 37 is approved by voters, it is very likely that opponents from the food industry immediately will file a lawsuit that seeks to invalidate the law on constitutional grounds. Two of the claims most likely to be asserted in such a lawsuit are that Prop. 37 violates food companies First Amendment rights to freedom of speech and that Prop. 37 is preempted by federal law governing the labeling of food products. Regardless of whether Prop. 37 is approved by the voters, many of the legal issues it raises will be relevant for other efforts to regulate the labeling of genetically-engineered foods. 3 This article explores the First Amendment and preemption issues with Prop. 37 and assesses the arguments available to both supporters and opponents. Before discussing the constitutional issues, some background on genetically-engineered foods and an overview of what Prop. 37 would require are provided. II. Background on Genetically-Engineered Foods Genetic engineering refers to practices, including recombinant DNA techniques, to modify the genetics of plants or animals in ways that would not be possible with traditional breeding. 4 Genetically-engineered foods have been on the market in the United States since An estimated 75 percent of processed foods sold in this country contain geneticallyengineered ingredients. 6 1

3 While proponents of genetic engineering tout its potential benefits 7 for improving agricultural yields, reducing dependence on chemical pesticides, and improving food quality, many people are concerned about the safety and environmental risks of eating and growing organisms that would not exist in nature. The U.S. Food and Drug Administration (FDA) has determined that foods produced through genetic engineering are safe and effectively no different than their traditional counterparts. 8 Based on this view, FDA has taken the position that the use of genetic engineering in the production of food is not material information that must be disclosed in the products labeling. 9 The American Medical Association (AMA) also has taken the stance that there is no scientific justification for labeling genetically-engineered foods. 10 In contrast to the FDA s and AMA s positions, more than 90 percent of the American public believe genetically-engineered foods should be labeled. 11 The nearly unanimous views of Americans are in line with the precautionary approach to genetically-engineered foods taken by the European Union and about 22 other countries that require labeling of genetically-engineered foods. 12 The same precautionary approach underlies Prop. 37 s labeling requirements. III. What Prop. 37 Would Require Prop would amend California s Health and Safety Code to require that foods offered for retail sale that have been, or that may have been, entirely or partially produced with genetic engineering be labeled with a statement disclosing that fact. 14 As used in the ballot initiative, genetically engineered means that an organism s genetic material has been manipulated through methods such as direct injection of nucleic acid into cells or fusion of cells... in a way that does not occur through natural multiplication or recombination. 15 Thus, the proposed law would not apply to foods produced through traditional plant hybridization techniques. If Prop. 37 is enacted, beginning July 1, 2014, genetically-engineered foods that are sold at retail in California, subject to certain exceptions, will be deemed misbranded unless: For raw agricultural products, the labeling contains the words Genetically Engineered on the front of the package or, for unpackaged food, on a label appearing on the retail display; and For processed foods, the labeling contains the words Partially Produced with Genetic Engineering or May Be Partially Produced with Genetic Engineering on the front or back of the package. 16 In addition, Prop. 37 would prohibit marketers from using the term natural, or any similar language stating or implying that food is naturally made or naturally grown, in the labeling, signage or advertising of genetically-engineered foods and processed foods. 17 The inclusion of processed foods is significant because it is not limited to foods made with genetically-engineered ingredients. As written, the prohibition on natural clams applies if a food meets any of the definitions in subdivision (c) [defining genetically engineered ] or (d) [defining processed food ] of Section Processed food is defined as any food other than a raw agricultural commodity, and includes any food produced from a raw agricultural 2

4 commodity that has been subject to processing such as canning, smoking, pressing, cooking, freezing, dehydration, fermentation, or milling. 19 The definition of processed does not reference genetically-engineered food. To the contrary, it applies to any food that has been processed in any way. Thus, there is no logical reading of the measure that limits the ban on natural claims to genetically-engineered foods. As a consequence, if this provision becomes law, only raw, non-genetically-engineered agricultural products could be called natural in California unless they fit within one of the exemption categories discussed below. The following categories of foods would be exempt from Prop. 37 s labeling requirements and prohibition on natural claims: Foods consisting entirely of, or derived entirely from animals that have not themselves been genetically engineered, even if the animals have been fed genetically-engineered food or injected with genetically-engineered drugs; 2. Foods not knowingly and intentionally grown, raised or produced with genetic engineering, provided that the marketer has documentation of this fact; 3. Alcoholic beverages; 4. Foods certified as organic under federal law; 5. Foods sold in restaurants or otherwise prepared and packaged for immediate consumption; 6. Processed foods that include genetically-engineered processing aids or enzymes, but no other genetically-engineered ingredients; 7. Until July 1, 2019, foods that contain small amounts of genetically-engineered ingredients (i.e., that contain no single genetically-engineered ingredient comprising more than 0.5% of the total weight of the product, as long as the product does not contain more than 10 such ingredients); and 8. Medical food. If Prop. 37 passes and if it is not stayed or struck down by the courts manufacturers, retailers, and distributors of food sold at retail in California will have to make some significant and potentially costly changes to ensure they comply by July 1, The most obvious implication of Prop. 37 is that food labels and retail displays will have to be changed for many foods sold at retail in California. Because an estimated 75 percent of processed foods sold in the U.S. contain at least one genetically-engineered ingredient 21 and because the vast majority of corn and soybeans produced in this country are genetically engineered, 22 chances are that any product made with an ingredient derived from those crops would come within Prop. 37 s labeling requirement. In addition, for all processed foods (except those in one or more of the exempt categories, such as certified organic foods) any language stating or implying that the product is natural would have to be removed from the label and other marketing materials. 23 As of July 1, 2014, if a retailer has products in inventory that are not properly labeled, they would have to be removed from the shelves and could not be offered for sale to consumers. 24 In order to enforce the labeling provisions, Prop. 37 would impose rather extensive recordkeeping obligations. Based on the text of Prop. 37, any food producer or marketer who 3

5 wants to avoid labeling their products as genetically engineered (or as potentially containing genetically-engineered ingredients) would have to generate and maintain extensive records to document that their products have not been intentionally produced with genetic engineering. That is because the law would presume that foods have been produced with genetic engineering unless the manufacturer and everyone else responsible for complying with Prop. 37 i.e., everyone in the supply chain from the manufacturer to the retailer obtains a sworn statement from their direct supplier attesting that the food or ingredient has not been knowingly or intentionally genetically engineered and that it has been segregated from food that may have been genetically engineered. 25 So, even if a manufacturer has no reason to believe that its product is made with genetically engineered ingredients, to avoid labeling the product, May Be Partially Produced with Genetic Engineering, the manufacturer would have to obtain an affidavit from each of its ingredient suppliers, maintain those records with some tracking system linking affidavits for particular lots of ingredients to the batches of finished products produced with those ingredients, and provide a similar affidavit to its customer, which would have to do the same thing until the product reaches the retailer. Although violations of Prop. 37 would be difficult to police, the consequences for noncompliance would be serious. Foods offered for retail sale in California that do not comply would be deemed misbranded. It is illegal to manufacture, sell, offer for sale, store or deliver misbranded food. 26 Violators are subject to criminal or civil prosecution, and the product may be seized or embargoed by the state. 27 Violations of Prop. 37 s requirements also would be deemed unfair or deceptive acts in violation of California s Consumer Legal Remedies Act, which permits private citizens to sue individually or through a class action for compensatory damages, injunctions, and punitive damages. 28 Significantly, to bring such a suit, plaintiffs would not have to show that they had been damaged by or relied on the defendant s allegedly deceptive label. 29 Prop. 37 also would allow private citizens to sue violators under the Health and Safety Code for injunctions and, if successful, for their costs incurred in investigating and prosecuting the action. 30 IV. Potential First Amendment Challenges to Prop. 37 Prop. 37 implicates the First Amendment free speech rights of food manufacturers and marketers in two ways: (1) by prohibiting certain speech i.e., natural claims; and (2) by compelling certain speech i.e., a disclosure that a product is Genetically Engineered, Partially Produced with Genetic Engineering or May Be Partially Produced with Genetic Engineering. The First Amendment protects the interest in speaking, as well as the interest in not speaking. 31 Yet, not all speech is protected equally under the First Amendment. Commercial speech, like the labeling and marketing speech targeted by Prop. 37, is protected under the First Amendment; however, it is less protected than other kinds of speech. 32 The degree to which commercial speech is protected depends on the nature of the government s regulation. 4

6 A. Applicable First Amendment Standards Three different standards might govern a court s First Amendment review of Prop 37. In order from most to least protective of speech rights (or, alternatively, from least to most regulation friendly), they are: (1) heightened scrutiny for content-based regulations under Sorrell v. IMS Health Inc.; 33 (2) intermediate scrutiny for commercial speech restrictions under Central Hudson Gas and Electric Corp. v. Public Service Commission of New York; 34 and (3) rational basis review for compelled commercial speech under Zauderer v. Office of Disciplinary Counsel of the Supreme Court of Ohio Heightened Scrutiny for Content-Based Regulations In IMS Health, which was decided just last year, the Supreme Court made clear that regulations of commercial speech are subject to heightened scrutiny under the First Amendment if they target commercial speech based on its content. Although, in general, regulations of commercial speech are scrutinized less strictly than regulations of other types of expression, the Court held in IMS Health that, [t]he First Amendment requires heightened scrutiny whenever the government creates a regulation of speech because of disagreement with the message it conveys.... Commercial speech is no exception. 36 When the government regulates speech because of disagreement with the message it conveys, the regulation is considered contentbased and subjected to heightened judicial scrutiny. 37 In contrast, the government is given more leeway to impose content-neutral regulations on speech i.e., regulations that are justified without reference to the content of the regulated speech. 38 The justification for the regulation is the most important consideration. Thus, a regulation that targets commercial speech of a particular content is permissible if it is has the content-neutral purpose of preventing consumer fraud or deception. However, if a content-based regulation is based on nothing more than a difference of opinion between the state and the speaker, it is impermissible. 39 Content-based regulations are presumptively invalid 40 and, therefore, the conclusion that a law is content-based generally ends the First Amendment inquiry Intermediate Scrutiny for Content-Neutral Commercial Speech Regulations If a regulation of commercial speech has a content-neutral purpose, 42 it will be analyzed under the four-part intermediate scrutiny 43 test of Central Hudson: At the outset, we must determine [1] whether the expression is protected by the First Amendment. For commercial speech to come within that provision, it at least must concern lawful activity and not be misleading. Next, we ask [2] whether the asserted governmental interest is substantial. If both inquiries yield positive answers, we must determine [3] whether the regulation directly advances the governmental interest asserted, and [4] whether it is not more extensive than is necessary to serve that interest. 44 5

7 The government has the burden of establishing each of these factors. 45 Under the first Central Hudson factor, if speech is inherently misleading or illegal, it is entitled to no First Amendment protection and may be banned outright. 46 But, if speech is only potentially misleading, it may be banned only if the deception cannot be cured by requiring a disclosure or some other means. 47 Potentially misleading and other lawful commercial speech may be restricted only if the government satisfies the remaining Central Hudson factors. 48 To establish the second factor a substantial interest the government must show that the harms it recites are real. 49 In general, the government s interest in preventing false or misleading labeling is considered substantial. 50 But the state may not paternalistically assume that consumers are unthinking and likely to be misled. 51 Rather, the state needs sufficient evidence showing that the speech it seeks to suppress is likely to deceive or confuse. 52 With regard to the third factor, the government must demonstrate that the regulation directly advances its interest by presenting evidence that the speech restriction will in fact alleviate [the harms] to a material degree. 53 Again, the state must have evidence and cannot rely on mere speculation or conjecture. 54 Finally, to establish the fourth factor, the government must show that it could not achieve its interests in a manner that does not restrict speech, or that restricts less speech. 55 Although it need not show that the regulation is the least restrictive means possible to achieve its purposes, 56 the state must demonstrate that there is a reasonable fit between the regulation and the government s interests. 57 This means that the government may not disregard[] far less restrictive and precise means, 58 such as requiring disclosures that could prevent consumer confusion. Because there is a preference in the First Amendment for more disclosure, rather than less, 59 where additional speech would cure the potential deception, suppression of potentially misleading speech is unconstitutional Rational Basis Review for Compelled Commercial Speech Because of the First Amendment s preference for more, rather than less information, the Supreme Court has applied a more relaxed rational basis standard of First Amendment scrutiny to regulations that compel commercial speech for the purpose of preventing consumer deception. 61 In Zauderer, the Court held that government may require commercial speakers to make purely factual and uncontroversial disclosures that are reasonably related to the State s interest in preventing deception of consumers, as long as the requirements are not unjustified or unduly burdensome. 62 This more lenient, regulation-friendly standard is justified on the ground that a commercial speaker has only a minimal constitutionally-protected interest in not providing a factual disclosure. 63 Although the First and Second Circuits have applied the Zauderer standard where the asserted state interest was unrelated to preventing consumer deception, 64 the Supreme Court has since reaffirmed that the Zauderer s less exacting scrutiny applies when a state s disclosure requirement is directed at misleading commercial speech. 65 6

8 Where it applies, the Zauderer standard is more permissive of speech regulations than Central Hudson in two significant respects. First, the state need not come forward with evidence proving consumers are likely to be deceived by the targeted speech, as long as the possibility of deception is self-evident. 66 Second, there is no requirement for the government to establish that the regulation is no more extensive than necessary. Rather, it need only show that there is a reasonable relationship between the government s purpose and the means employed to achieve it. 67 B. First Amendment Analysis of Prop. 37 s Prohibition on Natural Claims From a First Amendment standpoint, Prop. 37 s prohibition on natural claims is its most problematic provision. Because the provision bans rather than compels commercial speech, it would have to survive at least intermediate scrutiny under Central Hudson. There is an argument, however, that Prop. 37 s ban on natural claims is content-based and, therefore, must meet the heightened scrutiny of IMS Health. Under either test, the provision is unlikely to survive a First Amendment challenge. The prohibition on natural claims clearly targets a particular content of speech i.e., that which states or implies that a product is natural, naturally made, naturally grown, all natural, or any words of similar import that would have a tendency to mislead any consumer. 68 What is important, however, is not whether measure targets speech of a particular content, but rather whether it has a content-neutral justification. As evidenced by the quoted language of the provision, the justification for the prohibition on natural claims is that such claims have a tendency to mislead consumers. 69 Prop. 37 also contains the finding that labeling, advertising and marketing of genetically engineered foods using terms such as natural, naturally made, naturally grown, or all natural is misleading to California consumers. 70 Presumably, the concern is that natural claims will cause consumers to believe mistakenly that a food product has not been genetically engineered. If the state could prove that it has a legitimate interest in preventing such deception perhaps consumer surveys would show that consumers are likely to believe that foods labeled natural have not been genetically engineered that might provide a content-neutral justification for prohibiting natural claims with regard to genetically-engineered foods. But, as already discussed, the ban does not apply only to genetically-engineered foods; it also applies to processed foods. It is implausible that the state could prove that it has a real interest in preventing consumers from being deceived by natural claims on processed foods of all kinds, including minimally-processed, non-genetically-engineered foods (for example, frozen fruits and vegetables, or milled non-genetically-engineered grains). The purpose for prohibiting natural claims for processed foods would seem to be that the state disagrees with food manufacturers about whether such processed foods are, in fact, natural. Thus, at least with regard to processed foods, the prohibition on natural claims likely would be characterized as contentbased and presumptively invalid. 7

9 Even if the ban on natural claims is not deemed content-based, it is unlikely to survive the Central Hudson test. With regard to the first prong of Central Hudson, it is unlikely that California could establish that natural claims are inherently deceptive for all foods to which the prohibition would apply. At most, natural claims might be potentially misleading in that they might cause consumers to believe that genetically-engineered foods or highly-processed foods were produced with traditional, natural methods or ingredients. Because natural claims are not inherently misleading, the state would have to satisfy the remaining Central Hudson factors by proving: (1) that it has a substantial interest; (2) that the prohibition directly serves that interest; and (3) that the prohibition is not more restrictive of speech than necessary. 71 The analysis of whether the state has a substantial interest and whether the prohibition directly serves that interest is essentially the same as the issue of whether the state has a contentneutral justification for prohibiting natural claims. The state might be able to show (assuming it has evidence) that that there is a problem with consumers being misled by claims that genetically-engineered foods are natural and that eliminating such claims would prevent the confusion. But, it is unlikely to show that there is a real problem with consumers being misled by natural claims on processed foods that are obviously processed or that with regard to minimally processed, traditional foods that people commonly would think of as natural. The idea that consumers need to be protected from natural claims because they cannot tell whether or not a processed food is processed or natural, particularly given the ingredients listing required to be included on food labels, reeks of paternalism that the First Amendment forbids. 72 Moreover, even if California could establish that the prohibition on natural claims directly serves a substantial interest, it likely cannot show that the ban does not restrict speech more than necessary. As already discussed, the government may not suppress commercial speech if its interests can be served by requiring a disclosure. 73 Assuming for the moment that the state has a substantial interest in preventing consumer confusion about genetically-engineered or processed foods labeled as natural, the state would have great difficulty demonstrating that such interest could not be served by a mandatory disclosure identifying the food as genetically engineered or processed, to the extent that such disclosures might be justified and constitutional. C. First Amendment Analysis of Prop. 37 s Compelled Disclosure of Genetic Engineering In analyzing whether Prop. 37 s disclosure requirement is constitutional under the First Amendment, the central issue will be whether the labeling of genetically-engineered foods serves a legitimate interest in preventing consumer deception. If so, the disclosure requirement likely will be reviewed under the more lenient Zauderer rational basis test. 74 If not, it will be reviewed under the intermediate scrutiny of Central Hudson. Moreover, if intermediate scrutiny applies, whether labeling of genetically-engineered foods serves an interest in preventing consumer deception or, relatedly, whether it serves a legitimate interest in satisfying the consumers 8

10 right to know will be relevant to deciding whether the regulation satisfies the substantial interest prong of Central Hudson. There is room for debate as to whether there is a legitimate state interest in preventing consumer deception about whether foods have been genetically engineered. Opponents of Prop. 37 will argue that consumers cannot be deceived by the absence of a genetically engineered label because FDA has deemed genetically-engineered foods to be not materially different than their traditional counterparts. 75 If there is no material difference between genetically-engineered foods and traditionally-produced foods, the opponents of Prop. 37 will argue, the law would serve only an interest in satisfying consumer curiosity. The interest in satisfying consumer curiosity has been held insufficient to support a law compelling commercial speech. In International Dairy Foods Association v. Amestoy, the Second Circuit struck down a Vermont law requiring labeling of dairy products that were or might have been produced with the synthetic growth hormone recombinant Bovine Somatotropin ( rbst ). 76 Vermont s stated interest in requiring the disclosure was strong consumer interest and the public s right to know. 77 According to the court, Vermont did not assert an interest in the health or safety of the dairy products. Characterizing the state s interest as one in satisfying mere consumer curiosity, the court held that Vermont failed to meet the substantial interest element of Central Hudson. 78 In so holding, the court relied on the fact that FDA had conducted exhaustive studies and determined that rbst has no appreciable effect on the composition of milk produced by treated cows, and that there are no human safety or health concerns associated with food products derived from cows treated with rbst. 79 Based on its finding that the record in this case contains no scientific evidence from which an objective observer could conclude that rbst has any impact at all on dairy products, the court held that Vermont could not justify the statute on the basis of real harms. 80 The court also noted that it was aware of no case in which consumer interest alone was sufficient to justify requiring a product s manufacturers to publish the functional equivalent of a warning about a production method that has no discernible impact on a final product. 81 Although the Amestoy decision will not be binding precedent on a California court considering the constitutionality of Prop. 37, its reasoning may be persuasive because of the factual parallels between the cases. As it did with rbst, FDA has determined that labeling of genetically-engineered foods is not required because they are safe and not materially different than foods produced without genetic engineering. 82 Like the Vermont law at issue in Amestoy, Prop. 37 is motivated primarily by an interest in the consumers right to know how their food was produced so that they can decide what they want to buy and eat. Although Prop. 37 contains findings that suggest an interest in human health, so far the weight of scientific evidence for genetically-engineered foods on the market indicates that they are safe. 83 Therefore, it will be difficult to demonstrate a real concern with the safety of genetically-engineered foods. Prop. 37 also contains findings about harms for the environment and for the organic foods industry associated with cultivating genetically-engineered plants. 84 However, the main thrust of those 9

11 findings is that California consumers should have the choice to avoid purchasing foods the production of which can lead to such harms. 85 For these reasons, a court considering Prop. 37 could find that the state s only interest is in satisfying consumer curiosity and, therefore, that it has no substantial interest in preventing consumer deception or otherwise. Thus, if a court is to find that mandatory labeling of genetically-engineered foods is constitutional, it will have to reject the Second Circuit s view that the public s right to know is based merely on curiosity about immaterial facts. That more than 9 out of 10 Americans believe genetically-engineered foods should be labeled 86 strongly suggests that the public disagrees with FDA s position that the manner in which food is produced is immaterial. The survey data suggest that consumers care deeply about how their food was produced and want to be able to make purchasing decisions that reflect their personal values, even if those values are not supported by existing science or federal policy. In defending the governmental interest in supporting consumers right to know, the state might argue that requiring disclosure of genetic engineering is consistent with the First Amendment. The First Amendment protects not only the right to speak, but also the right to receive information. The Supreme Court has held that the right to receive information and ideas, regardless of their social worth,... is fundamental to our free society. 87 Moreover, a regulation compelling labeling of genetically-engineered foods is consistent with the First Amendment preference for more information, rather than less, and the principle that commercial speakers have only minimally protected constitutional rights in not providing factual information about their products. 88 Finally, a law that facilitates consumer decision-making based on individual views about what information is material is consistent with the First Amendment s rejection of government paternalism 89 i.e., the government should not decide for consumers what information is material to their purchasing decisions. Whether or not a court would accept these arguments and find that consumers right to know may trump the commercial speech rights of food companies remains to be seen. V. Potential Federal Preemption Challenges to Prop. 37 In addition to the First Amendment challenges Prop. 37 likely will face if it is passed by voters, opponents of the measure will seek to invalidate the measure on the ground that it is preempted by federal food labeling laws. Specifically with regard to food labeling, the Food, Drug, and Cosmetic Act (FDCA), 90 the Federal Meat Inspection Act (FMIA) 91 and the Poultry Products Inspection Act (PPIA) 92 all contain provisions expressly preempting conflicting state requirements. Under the FMIA and the PPIA, the U.S. Department of Agriculture s (USDA) Food Safety Inspection Service has primary authority for regulating labeling of meat and poultry products, 93 including products containing more than three percent raw meat, at least two percent cooked meat or poultry, or at least 10 percent cooked poultry skins, giblets or fat. 94 All other food products fall within the jurisdiction of FDA pursuant to its authority under the FDCA. 95 Because of differences in these federal laws, Prop. 37 is likely preempted to the extent that it 10

12 would regulate the labeling of meat and poultry products; but it is likely not preempted with respect to labeling of other foods. Federal preemption doctrine is based on the Supremacy Clause of the U.S. Constitution, 96 which invalidates state laws that interfere with, or are contrary to, federal law. 97 State law may be preempted by federal law in three ways: (1) express preemption stated in a federal statute; (2) implied preemption where federal law fully occupies a regulatory field leaving no room for state regulation; 98 or (3) implied conflict preemption where it would be impossible for a private party to comply with both the state and federal requirements, 99 or where state law stands as an obstacle to the accomplishment and execution of Congress s objectives. 100 In determining whether federal law preempts state law, courts start with the assumption that the historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress. 101 Where the federal government regulates an area traditionally within the states police powers, the presumption against preemption requires a narrow reading of express preemption statutes. 102 Regulation of food marketing and labeling historically have been the province of the states and, therefore, are assumed not to be preempted unless Congress clearly intends otherwise. 103 Preemption issues with respect to food labeling most often arise in the context of private claims brought under state statutes and common law causes of action alleging that labeling of food products is fraudulent or deceptive. Federal law preempts state law requirements arising from such claims the same as it preempts state law requirements codified in statutes or regulations. 104 A state law requirement may be preempted whether it imposes an affirmative obligation or prohibits certain conduct. 105 A. Preemption Analysis under the Federal Meat Inspection Act and Poultry Products Inspection Act The preemption provisions in the FMIA and PPIA state, in relevant part: Marking, labeling, packaging, or ingredient requirements in addition to, or different than, those made under this chapter may not be imposed by any State In deciding whether state law imposes a requirement for meat or poultry product labeling in addition to, or different than federal law, courts have found state requirements preempted even when the subject matter of the state requirements is not addressed in any provision of the FMIA or PPIA or USDA regulations. 107 The rationale for federal preemption of state labeling requirements for meat and poultry products is especially strong because USDA must pre-approve labels for such products. 108 Because the labels must be approved by USDA, courts have found that state law claims challenging the labels are necessarily preempted. 109 In particular, [b]ecause the [USDA] pre-approval process includes a determination of whether the labeling is false and misleading, state law claims alleging that USDA-approved labels are false or misleading are preempted. 110 The pre-approval of labels by USDA is a significant difference in the federal labeling regime for meat and poultry products compared to other food products, for which no approval is required. 11

13 Given the broad federal control of labeling for meat and poultry products, Prop. 37 challengers would have a strong argument that the law would be preempted by the FMIA and PPIA to the extent it would regulate the labeling of such products. Although Prop. 37 exempts from its labeling requirements [f]ood consisting entirely of, or derived entirely from, an animal that has not itself been genetically engineered, 111 that exemption would not apply to a great many products regulated by USDA that are not entirely from an animal because they contain other, non-animal-based ingredients. Prop. 37 would impose requirements in addition to [and] different from federal requirements 112 because it would require labeling of geneticallyengineered meat or poultry products whereas no such requirement exists in federal law. In addition, Prop. 37 would impose different requirements in direct conflict with federal law in that it would prohibit natural claims on minimally-processed meat and poultry products that would be permitted and pre-approved by USDA. For these reasons, Prop. 37 likely is preempted by the FMIA and PPIA to the extent it imposes labeling requirements for meat and poultry products. B. Preemption Analysis under the Food, Drug, and Cosmetic Act The Nutrition Labeling and Education Act of 1990 (NLEA) amended the FDCA with the intent to establish uniform national standards for the nutritional claims and the required nutrient information displayed on food labels. 113 The NLEA added an express preemption provision, codified at 21 U.S.C (a), prohibiting state requirements that are not identical to 114 several enumerated labeling provisions of the FDCA. The NLEA also provided that it shall not be construed to preempt any provision of State law, unless such provision is expressly preempted under section [343-1(a)]. 115 This savings language has been interpreted to mean that courts may not find implied preemption based on any provision of NLEA ; however, state law may be impliedly preempted by other parts of the FDCA. 116 Courts have found the FDCA to preempt state law only where the state law would require different labeling than that permitted or prohibited by the FDCA or its implementing regulations. 117 In contrast, where state law would impose requirements identical to the FDCA i.e., where a plaintiff s claims effectively seek to enforce the FDCA courts find no preemption. 118 And, where no provision in the FDCA or FDA regulations addresses the subject matter of a state law requirement, courts have held that the state law is not preempted. 119 In this last respect, the courts have construed the express preemption provision of the NLEA much more narrowly than those of the FMIA and PPIA. Of particular relevance to Prop. 37, several courts have held that because FDA has not regulated the use of natural claims, states are not preempted from doing so. 120 Because the labeling of genetically-engineered foods and natural claims are not addressed in the FDCA or formal FDA regulations, Prop. 37 s requirements for labeling foods within the ambit of the FDCA (everything other than meat and poultry) probably are not preempted. 121 That Congress, in the NLEA, specifically enumerated the statutory provisions having preemptive effect strongly suggests that state requirements not falling within the 12

14 enumerated categories are not impliedly preempted. 122 The listed sections of the FDCA that expressly preempt state and local law and their associated regulations say nothing about labeling of genetically-engineered foods or the use of natural claims. 123 FDA has issued nonbinding guidance on these topics, but has not promulgated any formal regulations. Thus, the same analysis that courts have used in finding state law requirements for natural claims are not preempted should apply to state requirements for labeling of genetically-engineered food. Because FDA has not required nor prohibited labeling of genetically-engineered foods, Prop. 37 s disclosure requirement (with respect to foods other than meat and poultry) should not be preempted. Only one court has addressed the issue of whether the FDCA preempts state law requirements for labeling of genetically-engineered foods. In that case, the U.S. District Court for the Central District of California considered whether the plaintiff s claim seeking to require disclosure of genetically-engineered ingredients was preempted by federal law. 124 In an unreported decision, the court held that the claim was preempted because: Congress and the FDA have thoroughly regulated the manner in which ingredients must be listed on packages, including specifying how oil products must be labeled. See, e.g., 21 U.S.C. 343(i)(2); 21 CFR 101.4(b)(14). Entering an order of the type [plaintiff] seeks would impose a requirement that is not identical to federal law, and his prayer for such relief is thus preempted. 125 That decision is inapplicable to Prop. 37 because Prop. 37 would not require manufacturers to identify ingredients that were genetically engineered. Rather, Prop. 37 would require only a statement on the front or back of a package stating that a food is genetically engineered or that it has been (or may have been) partially produced with genetic engineering. A somewhat better preemption argument under the FDCA might be that, in requiring manufacturers to identify products as genetically engineered, Prop. 37 would cause them to violate the FDCA s prohibition against misleading claims. It could be argued Prop. 37 is impliedly preempted because the state law requirement is in direct conflict with federal law. The argument would be that a genetically engineered label would mislead consumers by causing them to believe that the food is materially different than and inferior to a comparable product containing only traditional ingredients. While this argument may have some appeal in light of FDA s position that genetically-engineered foods are no different than their traditional counterparts, FDA has stated (albeit in its draft guidance document) that a simple, factual statement of the type Prop. 37 would require i.e., that a food is genetically engineered is not likely to be misleading. 126 Although FDA s guidance on this issue would not be binding on a court, it is some evidence that the agency would not consider the disclosure required by Prop. 37 to run afoul of the FDCA s prohibition against misleading claims. 13

15 VI. Conclusion Whether California voters approve Prop. 37 or not, the policy and constitutional issues it raises will continue to be debated and certainly will affect other jurisdictions efforts to require labeling of genetically-engineered foods and, perhaps, to limit the use of natural claims. Leaving aside the issue of whether requiring labeling of genetically-engineered foods makes good policy sense, there are significant constitutional obstacles in the way of legislation like Prop. 37. In particular, laws compelling labeling of genetically-engineered foods may violate the First Amendment free speech rights of food manufacturers unless the government can establish that they serve a substantial government interest in preventing consumer deception. In addition, Prop. 37 s prohibition on claims that genetically-engineered and processed foods are natural likely violates the First Amendment. Finally, Prop. 37 and other potential state efforts to regulate the labeling of genetically-engineered foods are likely preempted by federal law to the extent they reach meat and poultry product labels. 1 The California Right to Know Genetically Engineered Food Act, Proposition 37 (2012), in CAL. SEC Y OF STATE, CALIFORNIA GENERAL ELECTION TUESDAY, NOVEMBER 6, 2012 OFFICIAL VOTER INFORMATION GUIDE, at 110, available at (last visited Oct. 20, 2012) [hereinafter Prop. 37]. 2 The stated purpose of Prop. 37 is to create and enforce the fundamental right of the people of California to be fully informed about whether the food they purchase and eat is genetically engineered and not misbranded as natural so that they can choose for themselves whether to purchase and eat such foods. Prop. 37, supra note 1, 2. 3 For example, a group in Washington State is presently collecting signatures for a petition to place an initiative similar to Prop. 37 on Washington s ballot. See LABEL IT WA, (last visited Oct. 20, 2012). 4 Genetic engineering is a specific subset of genetic modification. Genetic modification has been accomplished in traditional agriculture through a variety of methods by which plants and animals are bred for desirable traits including selection, cross-breeding and hybridization. In contrast to these traditional techniques, genetic engineering involves the isolation and introduction of specific genes from one organism into another organism in order to produce desired traits. For example, genes from bacteria that produce proteins toxic to certain insects have been introduced into crops in order to improve their resistance to insects. See Statement of Policy: Foods Derived from New Plant Varieties, 57 Fed. Reg (May 29, 1992) (discussing recombinant DNA techniques and related FDA policy). 5 Debra M. Strauss, The International Regulation of Genetically Modified Organisms: Importing Caution into the U.S. Food Supply, 61 FOOD & DRUG L.J. 167, 167 (2006) (stating that the first genetically-modified food was introduced to the market in 1994). 14

16 6 ASSOCIATED PRESS, Americans Clueless About Gene-Altered Foods, NBCNEWS.COM (Mar. 23, 2005, 6:13 PM), (statement of Stephanie Childs, Grocery Manufacturers of America). 7 See FOOD SAFETY DEP T, WORLD HEALTH ORG., MODERN FOOD BIOTECHNOLOGY, HUMAN HEALTH AND DEVELOPMENT: AN EVIDENCE-BASED STUDY, at iii (2005), available at ( The development of GM organisms (GMOs) offers the potential for increased agricultural productivity or improved nutritional value that can contribute directly to enhancing human health and development. From a health perspective, there may also be indirect benefits, such as reduced agricultural chemical usage and enhanced farm income, and improved crop sustainability and food security, particularly in developing countries. ). 8 See Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering; Draft Guidance (Jan. 2001), available at elingnutrition/ucm htm [hereinafter FDA Draft Guidance]; see also 66 Fed. Reg. 4839, 4839 (Jan. 18, 2001) (announcing availability of Draft Guidance and restating a 1992 policy that the FDA has no basis for concluding that bioengineered foods differ from other foods in any meaningful or uniform way, or that, as a class, food developed by the new techniques present any different or greater safety concern than foods developed by traditional plant breeding (citing 57 Fed. Reg )). 9 Id. at COUNCIL ON SCI. & PUB. HEALTH, AM. MED. ASS N, LABELING OF BIOENGINEERED FOODS 7 (2012), available at bioengineeredfoods.pdf. 11 Gary Langer, Poll: Skepticism of Genetically Modified Foods, ABC NEWS (June 19), (last visited Oct. 20, 2012) (discussing results of a 2001 poll). The ABC News findings closely match those of a recent Thomson Reuters poll. See THOMSON REUTERS, NATIONAL SURVEY OF HEALTHCARE CONSUMERS: GENETICALLY ENGINEERED FOOD (Oct. 2010), available at (question 3). Support for Prop. 37 among California voters is not nearly as strong as national support for labeling of genetically-engineered foods generally. According to poll results released on October 11, 2012, 48.3 percent of California voters surveyed favor Prop. 37, while 40.2 percent were against it. California Business Roundtable and Pepperdine University Release Statewide Initiative Survey Results, PEPPERDINE UNIV. SCH. OF PUB. POLICY (October 11, 2012), Those findings represented a nearly 19 percent decrease in support for the initiative compared to a poll conducted just two weeks earlier. See California Business Roundtable and Pepperdine University Release Statewide Initiative Survey Results, PEPPERDINE 15

17 UNIV. SCH. OF PUB. POLICY (September 27, 2012), 12 See Strauss, supra note 5, at Prop. 37 provides that it may be amended by the Legislature, but only to further its intent and purpose, by a statute passed by a two-thirds vote in each house. Prop. 37, supra note 1, 10. The discussion in this Article of what Prop. 37 would require is based on the measure as currently drafted and does not consider any potential amendments that could be made by the California Legislature. 14 Id. 3 (to be codified at CAL. HEALTH & SAFETY CODE (a)). 15 Id. (to be codified at CAL. HEALTH & SAFETY CODE (c)(1)). 16 Id. (to be codified at CAL. HEALTH & SAFETY CODE (a)). 17 Id. (to be codified at CAL. HEALTH & SAFETY CODE ). 18 Id. (to be codified at CAL. HEALTH & SAFETY CODE ). 19 Id. (to be codified at CAL. HEALTH & SAFETY CODE (d)). 20 Id. (to be codified at CAL. HEALTH & SAFETY CODE ); see also id. (to be codified at CAL. HEALTH & SAFETY CODE ) (providing that prohibition on natural claims applies to a food meeting the definitions of genetically engineered or processed food and not otherwise exempted from labeling under Section ). 21 See ASSOCIATED PRESS, supra note Adoption of Genetically Engineered Crops in the U.S., U.S. DEP T OF AGRIC. (July 12, 2012), (follow Genetically engineered varieties of corn, upland cotton, and soybeans, by State and for the United States, hyperlink). 23 Prop. 37, supra note 1, 3 (to be codified at CAL. HEALTH & SAFETY CODE ). 24 Id. (to be codified at CAL. HEALTH & SAFETY CODE 11809(a)). 25 See id. (to be codified at CAL. HEALTH & SAFETY CODE (b)). 26 CAL. HEALTH & SAFETY CODE (West 2012). 27 Id , , , See Prop. 37, supra note 1, 3 (to be codified at CAL. HEALTH & SAFETY CODE ) (providing that violations of Prop. 37 are also violations of CAL. CIV. CODE 1770(a)(5) (West 16

18 2012), which defines unfair and deceptive trade practices, and providing a cause of action under the Consumers Legal Remedies Act, CAL. CIV. CODE ). 29 Id. 30 Id. 4 (amending CAL. HEALTH & SAFETY CODE ). 31 Wooley v. Maynard, 430 U.S. 705, 714 (1977) ( [T]he right of freedom of thought protected by the First Amendment against state action includes both the right to speak freely and the right to refrain from speaking at all. ). 32 See Ohralik v. Ohio State Bar Ass n, 436 U.S. 447, (1978) (stating that commercial speech is speech proposing a commercial transaction ); Va. State Bd. of Pharm. v. Va. Citizens Consumer Council, 425 U.S. 748, (1976) (stating similar principles) S. Ct. 2653, (2011) U.S. 557, 573 (1980) (Blackmun, J., dissenting) (describing the Court s rule as an intermediate level of scrutiny ) U.S. 626, 651 (1985) (holding First Amendment rights not violated by disclosure requirements that are reasonably related to the State s interest ). 36 IMS Health, 131 S. Ct. at 2664 (internal quotation marks omitted); see also id. at 2667 ( [When a law] imposes a speaker- and content-based burden on protected expression,... that circumstance is sufficient to justify application of heightened scrutiny. ). Although, in IMS Health, the Court announced that heightened judicial review is appropriate for content-based regulations of commercial speech, the Court went on to analyze the Vermont law at issue using the lesser standard generally applied in commercial speech cases, finding the outcome is the same whether a special commercial speech inquiry or a stricter form of judicial scrutiny is applied. Id. 37 Ward v. Rock Against Racism, 491 U.S. 781, 791 (1989). 38 Id. (quoting Clark v. Cmty. for Creative Non-Violence, 468 U.S. 288, 293 (1984)). 39 IMS Health, 131 S. Ct. at R.A.V. v. City of St. Paul, Minn., 505 U.S. 377, 382 (1992). 41 IMS Health, 131 S. Ct. at Id. (discussing commercial speech analysis applicable where heightened scrutiny required for content-based regulations does not apply). 43 Milavetz, Gallop & Milavetz, P.A. v. United States, 130 S.Ct. 1324, 1339 (2010). 44 Cent. Hudson Gas & Elec. Corp. v. Pub. Serv. Comm'n of N.Y., 447 U.S. 557, 566 (1980). 17

19 45 IMS Health, 131 S. Ct. at See In re R.M.J., 455 U.S. 191, 203 (1982). 47 See id. at 203, See Int l Dairy Foods Ass n v. Boggs, 622 F.3d 628, 638 (6th Cir. 2010). 49 Ibanez v. Fla. Dep t of Bus. & Prof l Regulation, 512 U.S. 136, 146 (1994) (quoting Edenfield v. Fane, 507 U.S. 761, 771 (1993)). 50 See, e.g., Int l Dairy Foods Ass n, 622 F.3d at IMS Health, 131 S. Ct. at 2671 ( The First Amendment directs us to be especially skeptical of regulations that seek to keep people in the dark for what the government perceives to be their own good. (quoting 44 Liquormart, Inc. v. Rhode Island, 517 U.S. 484, 503 (1996) (opinion of Stevens, J.)); Peel v. Attorney Registration & Disciplinary Comm'n of Ill., 496 U.S. 91, 105 (1990) ( We reject the paternalistic assumption that the recipients of petitioner s letterhead are no more discriminating than the audience for children s television. ); Bates v. State Bar of Ariz., 433 U.S. 350, (1977) (rejecting idea that the public is not sophisticated enough to realize the limitations of advertising, and that the public is better kept in ignorance than trusted with correct but incomplete information ); Pearson v. Shalala, 164 F.3d 650, 655 (D.C. Cir. 1999) (characterizing and rejecting FDA s view that health claims lacking significant scientific agreement are inherently misleading as if the consumers were asked to buy something while hypnotized, and therefore they are bound to be misled ). 52 Int l Dairy Foods Ass n, 622 F.3d at (citing Ibanez, 512 U.S. at ). 53 Edenfield, 507 U.S. at Id. 55 Thompson v. W. States Med. Ctr., 535 U.S. 357, 371 (2002). 56 See Bd. of Trustees of the State Univ. of N.Y. v. Fox, 492 U.S. 469, 478 (1989) ( [W]e have not insisted that there be no conceivable alternative.... ). 57 City of Cincinnati v. Discovery Network, Inc., 507 U.S. 410, 416 (1993). 58 Fox, 492 U.S. at 479 (internal quotation marks omitted). 59 Bates v. State Bar of Ariz., 433 U.S. 350, 375 (1977). 60 Pearson v. Shalala, 164 F.3d 650, 658 (D.C. Cir. 1999) ( It is clear, then, that when government chooses a policy of suppression over disclosure at least where there is no showing that disclosure would not suffice to cure misleadingness government disregards as far less restrictive means. ); see also Int l Dairy Foods Ass n v. Boggs, 622 F.3d 628, (6th Cir. 18

20 2010) (holding that Ohio rule prohibiting claims that dairy products were free of added hormones did not directly advance the State s interest in preventing consumer confusion and was more extensive than necessary to serve the interest because an added disclaimer would cure any confusion). 61 See Int l Dairy Foods Ass n, 622 F.3d at (characterizing Zauderer test as rational basis ); N.Y. State Rest. Ass n v. N.Y.C. Bd. of Health, 556 F.3d 114, 132 (2d Cir. 2009) (same). 62 Zauderer v. Office of Disciplinary Counsel, 471 U.S. 626, 651 (1985). 63 Id. 64 See Pharm. Care Mgmt. Ass n v. Rowe, 429 F.3d 294, 310 n. 8 (1st Cir. 2005); N.Y. State Rest. Ass n, 556 F.3d at Milavetz, Gallop & Milavetz, P.A. v. United States, 130 S.Ct. 1324, 1339 (2010); see also Int l Dairy Foods Ass n, 622 F.3d at 641 (holding that Zauderer standard applies when commercial speech at issue is inherently or potentially misleading and regulation requires disclosure); R.J. Reynolds Tobacco Co. v. Food & Drug Admin., Nos , , 2012 WL , at *5 (D.C. Cir. Aug. 24, 2012) ( The Supreme Court has never applied Zauderer to disclosure requirements not designed to correct misleading commercial speech. ). 66 Zauderer, 471 U.S. at See N.Y. State Res. Ass n, 556 F.3d at Prop. 37, supra note 1, 3 (to be codified at CAL. HEALTH & SAFETY CODE ). 69 Id. 70 Id. 1(k). 71 See Int l Dairy Foods Ass n v. Boggs, 622 F.3d 628, 638 (6th Cir. 2010). 72 See, e.g., IMS Health, 131 S. Ct. at See discussion supra Part IV.A See discussion supra Part IV.A See FDA Draft Guidance, supra note F.3d 67, (2d Cir. 1996). 77 Id. at 73 (internal quotation marks omitted). 78 Id. at 73 n.1. 19

21 79 Id. at 73 (internal quotation marks omitted). 80 Id. 81 Id. 82 See FDA Draft Guidance, supra note See, e.g., COUNCIL ON SCI. & PUB. HEALTH, AM. MED. ASS N, supra note Prop. 37, supra note 1, 1(h)-(j). 85 Id. 1(h), (j). 86 See sources cited supra note Stanley v. Georgia, 394 U.S. 557, 564 (1969) (citation omitted). 88 See Zauderer, 471 U.S. at See IMS Health, 131 S. Ct. at U.S.C.A f (West 2012). 91 Id Id U.S.C.A. 451, 603 (West 2012) C.F.R (a) (2012) (poultry); FOOD SAFETY & INSPECTION SERV., U.S. DEP T OF AGRIC., FOOD STANDARDS AND LABELING POLICY BOOK (August 2005) ( amenability ), available at 95 See 21 U.S.C.A See U.S. CONST. art. VI, cl Hillsborough Cnty., Fla. v. Automated Med. Labs., Inc., 471 U.S. 707, 712 (1985) (quoting Gibbons v. Ogden, 22 U.S. (9 Wheat.) 1, 211 (1824)). 98 See United States v. Locke, 529 U.S. 89, 111 (2000) (applying field preemption). 99 English v. Gen. Elec. Co., 496 U.S. 72, (1990). 100 Hines v. Davidowitz, 312 U.S. 52, 67 (1941). 101 Medtronic, Inc. v. Lohr, 518 U.S. 470, 485 (1996) (internal quotation marks omitted). 20

22 102 Id. 103 Fla. Lime & Avocado Growers v. Paul, 373 U.S. 132, (1963); Holk v. Snapple Beverage Corp., 575 F.3d 329, (3d Cir. 2009); In re Farm Raised Salmon Cases, 175 P.3d 1170, 1176 (Cal. 2008). 104 Bates v. Dow Agrosciences LLC, 544 U.S. 431, 443 (2005). 105 Nat l Broiler Council v. Voss, 44 F.3d 740, (9th Cir. 1994) U.S.C.A. 678 (West 2012) (emphasis added); see also id. 467e (substantially identical). 107 See Nat l Broiler Council, 44 F.3d at 747 (holding state requirement limiting use of fresh in poultry labeling preempted by PPIA even though USDA regulations did not address the definition of fresh ); Am. Meat Inst. v. Leeman, 102 Cal. Rptr. 3d 759, , 785 n.38 (Cal. Ct. App. 2009) (holding that FMIA preempted plaintiff s claim to enforce Proposition 65 warning requirements for dioxins and PCBs with regard to beef products where no federal rule addressed the issue); Boulahanis v. Prevo s Family Mkt., Inc., 583 N.W.2d 509, 512 (Mich. Ct. App. 1998) (rejecting plaintiff s argument that state law claim was not preempted by FMIA because USDA had not regulated E. coli as an adulterant at the relevant time based on finding that USDA s intentional decision not to regulate had preemptive force). 108 The FMIA and PPIA both provide that no food article shall be sold or offered for sale by any person in commerce, under any name or other marking or labeling... but established trade names and other marking and labeling and containers which are not false or misleading and which are approved by the Secretary. 21 U.S.C.A. 457(c) (PPIA); see 21 U.S.C.A. 607(d) (substantially similar language in FMIA); see also Labeling Approval, 9 C.F.R (a) (2012); False or Misleading Labeling Practices Generally, id (a). 109 E.g., Meaunrit v. ConAgra Foods Inc., No. C CRB, 2010 WL , at *7 (N.D. Cal. July 20, 2010) (distinguishing USDA pre-approved label from labeling requirements under the jurisdiction of FDA, which does not require pre-approval, and reasoning that the USDA and FSIS pre-approved ConAgra s labeling, which means that any liability Plaintiff seeks to attach based on a state law would impose requirements on ConAgra additional to, or different than federal law ); Meaunrit v. The Pinnacle Foods Group, LLC, No. C CW, 2010 WL , at *7 (N.D. Cal. May 5, 2010) ( To allow a jury to pass judgment on Defendant's labels, notwithstanding the USDA s approval, would disrupt the federal regulatory scheme. ). 110 ConAgra Foods Inc., 2010 WL , at * Prop. 37, supra note 1, 3 (to be codified at CAL. HEALTH & SAFETY CODE (a)) U.S.C.A. 678; id. 467e. 113 H.R. REP. NO , at (1990), reprinted in 1990 U.S.C.C.A.N. 3336,

23 114 According to FDA: Not identical to does not refer to the specific words in the requirement but instead means that the State requirement directly or indirectly imposes obligations or contains provisions concerning the composition or labeling of food, or concerning a food container, that: (i) Are not imposed by or contained in the applicable provision (including any implementing regulation) of section 401 or 403 of the act; or (ii) Differ from those specifically imposed by or contained in the applicable provision (including any implementing regulation) of section 401 or 403 of the act. 21 C.F.R (c)(4) (2012); see also Nat l Broiler Council, 44 F.3d at 747 (stating that [n]ot identical and in addition to, or different than are not distinguishable under any fair construction of the phrases, and holding that the PPIA preempted state requirements limiting use of fresh claims even though no USDA regulation existed for the use fresh ). But see 60 Fed. Reg. 57,076, 57,120 (Nov. 13, 1995) ( [T]he only State requirements that are subject to preemption are those that are affirmatively different from the Federal requirements on matters that are covered by the Section 403A(a) of the [NLEA]. (emphasis added)). 115 Pub. L. No , 6(c)(1), 104 Stat. 2353, 2364 (1990). 116 Holk v. Snapple Beverage Corp., 575 F.3d 329, 336 (3d Cir. 2009). 117 Lam v. Gen. Mills, Inc., No SC, 2012 WL , at *3-4 (N.D. Cal. May 10, 2012) (holding that state law claims that fruit flavored and naturally flavored labels are false and misleading were preempted by 21 U.S.C.A. 343(k) and 21 C.F.R (i), which expressly permitted the labeling at issue); Yumul v. Smart Balance, Inc., No. CV MMM (AJWx), 2011 WL , at *9-10 (C.D. Cal. March 14, 2011) (holding state law claims to enjoin no cholesterol and healthy labeling preempted because such labeling is permitted by the NLEA and its accompanying regulations ); In re Pepsico, Inc., Bottled Water Mktg. & Sales Practices Litig., 588 F. Supp. 2d 527, 537 (S.D.N.Y. 2008) (finding preemption of state law claims that Aquafina bottled water was labeled to mislead consumers into believing the water came from a source other than a municipal water supply because (1) federal law is not silent on the subject of implied labeling misrepresentations regarding the municipal source of bottled water; and (2) given that the Aquafina label fits within the exception for purified water and thus complies with the FDCA s requirements, Plaintiff s state law claims by necessity are premised on requirements that are not parallel to those imposed by federal law ). 118 Stewart v. Smart Balance, Inc., No (JLL), 2012 WL , at *6 (D.N.J. June 26, 2012) (holding plaintiffs claims regarding fat free labeling were not preempted where the gravamen of Plaintiffs complaint is precisely that Defendants products are misleading because they fail to comply with [the FDCA and regulations] ); Smajlaj v. Campbell Soup Co., 782 F. Supp. 2d 84, 97 (D.N.J. 2011) (holding plaintiffs claims that less sodium claims were misleading not preempted because they mirrored federal requirements, but claims that labels 22

24 omitted material information were preempted because they would impose a requirement inconsistent with federal regulations); In re Farm Raised Salmon Cases, 175 P.3d 1170, 1175 (Cal. 2008) ( [S]tates may establish their own requirements pertaining to the labeling of artificially colored food so long as their requirements are identical to those contained in the FDCA.... ). 119 E.g., Holk, 575 F.3d at (holding that a state law consumer fraud claim regarding natural labeling was not preempted because FDA had not formally regulated natural claims); Fellner v. Tri-Union Seafoods, L.L.C., 539 F.3d 237, (3d Cir. 2008) (holding that a state law claim that would require mercury warnings not preempted because FDA had not taken formal action regarding mercury warnings); Guerrero v. Target Corp., No CIV, 2012 WL , at *10 (S.D. Fla. Sept. 4, 2012) (holding that a state law deceptive trade practices claim for labeling as honey products that did not comply with Florida Honey Standard held not to be preempted by FDCA because there is no federal standard of identity for honey); Astiana v. Ben & Jerry's Homemade, Inc., Nos. C PJH, C PJH, 2011 WL , at *10 (N.D. Cal. May 26, 2011) (holding that a state law claim about the phrase all natural was not preempted because there is no federal regulation about the word natural ); Chacanaca v. Quaker Oats Co., 752 F. Supp. 2d 1111, (N.D. Cal. 2010) (finding a claim that labeling product as wholesome was misleading not preempted because wholesome not regulated by FDA); Lockwood v. ConAgra Foods, Inc., 597 F. Supp. 2d 1028, 1034 (N.D. Cal. 2009) (finding no federal field preemption in context of labeling foods as natural ); cf. In re Pepsico, 588 F. Supp. 2d at 538 ( Where federal requirements address the subject matter that is being challenged through state law claims, such state law claims are preempted to the extent they do not impose identical requirements. ). 120 See, e.g., Holk, 575 F.3d at (regulation of the term natural not preempted); Briseno v. ConAgra Foods, Inc., 2011 U.S. Dist. LEXIS , at *14-16 (C.D. Cal. Nov. 23, 2011) (genetically engineered canola oil); Astiana, 2011 WL , at *1 (ice cream containing alkalized cocoa processed with potassium carbonate); Wright v. Gen. Mills, Inc., No. 08cv1532 L(NLS), 2009 WL , at *1 (S.D. Cal. Sept. 30, 2009) (granola bars containing high fructose corn syrup); Lockwood, 597 F. Supp. 2d at 1034 (Snapple, which contains high fructose corn syrup); see also Chacanaca, 752 F. Supp. 2d at (finding that state law claims regarding use of the term wholesome are not preempted because FDA has not regulated the use of wholesome. ). 121 In any event, if a court were to find that the FDCA expressly preempts Prop. 37, California could petition FDA for a waiver. Under Section 403A(b) of the Act, FDA may exempt a state or political subdivision from the express preemption provisions upon a petition and FDA s finding that the state or local requirement: (1) would not cause any food to be in violation of any applicable requirement under Federal law, (2) would not unduly burden interstate commerce, and 23

25 (3) is designed to address a particular need for information which need is not met by the requirements of the sections referred to in subsection (a) of this section. 21 U.S.C.A (b); see also Petitions Requesting Exemption from Preemption for State or Local Requirements, 21 C.F.R See In re Farm Raised Salmon Cases, 175 P.3d at 1179 ( The inference to be drawn from [the specific express preemption provisions in FDCA] is that Congress, in light of the dual statefederal cooperation in this area, did not intend to limit states options in a broad fashion. ). 123 The statutory sections listed in the FDCA at 21 U.S.C.A as preempting non-identical state and local laws deal with the topics of: representations as to definition and standard of identity of foods, id. 341, 343(g), imitation food, id. 343(c), name and address of manufacturer and contents weight, id. 343(e), common and usual name of ingredients, id. 343(i)(2), major food allergens, id. 343(w), nonmajor food allergens, id. 343(x), food offered for sale under the name of another food, id. 343(b), misleading containers, id. 343(d), prominence of information on label, id. 343(f), representation as to standard of quality or fill, id. 343(h), common or usual name, id. 343(i)(1), artificial coloring, flavoring and chemical preservatives, id. 343(k), nutrition information i.e., the information required on the nutrition fact panel, id. 343(q), and nutrient content and health claims, id. 343(r). 124 Briseno, 2011 U.S. Dist. LEXIS , * Id. 126 See FDA Draft Guidance, supra note 8 (stating that voluntary labeling using phrase Genetically engineered is not likely to be misleading. ). 24

26 Lauren E. Handel is an attorney in private practice with a focus on representing and counseling food, beverage, and farming entrepreneurs. After receiving her law degree from Georgetown University Law Center cum laude in 2002, she practiced for nearly ten years at McDermott Will & Emery LLP in New York City and Washington, DC where she concentrated on product liability and environmental litigation, as well as workplace safety regulation. Ms. Handel presently is enrolled in the LL.M. Program in Agricultural and Food Law at the University of Arkansas School of Law. She is admitted to practice in New York, the District of Columbia, Maryland, the U.S. Supreme Court, and the U.S. District Courts for the Southern, Eastern and Western Districts of New York. 25