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GMO Labeling Archive

Making Sense of Seals of Approval

October 20, 2014

by Michele Simon

These days health-conscious consumers are increasingly seeking out food products not only with fewer ingredients and a “clean label”, but also foods produced in a manner that minimizes harm to the environment, among other ethical business practices. And it’s not enough to claim your product is healthy or sustainable with just words; to get that much-needed boost in a highly competitive marketplace, many food companies are spending the extra money to obtain third-party certification for various claims.

But before jumping on the “seal of approval” bandwagon, it’s important to understand the legal implications of various types of certification. For example, some seals are legally defined and require third-party certification while others are just voluntary.

Organic Seal: Federally Defined, Certification Required

Let’s start with the most rigorously-defined seal under federal law: organic. The U.S. Department of Agriculture requires strict adherence to various production practices for a farm or food product to obtain USDA organic certification. While the USDA itself does not certify, the agency maintains a list of approved third-parties. You must choose a certifier from this list to obtain organic approval.

USDA organic logoIn addition, USDA only allows its official organic seal for products that are either “100 percent organic” or for products containing 95 percent organic ingredients, in which case the product can be labeled simply “organic”. Also, the name of the third-party certifier must appear on the label. Products containing at least 70 percent organic ingredients can say, “made with organic ingredients”, but are not allowed to use the official USDA seal – an important distinction for marketing purposes.

Gluten-Free: Federally Defined, No Certification Required

Another popular claim being made on food products is “gluten-free.” Until recently, this claim had no legal definition. Then in August, the U.S. Food and Drug Administration began requiring food companies making gluten-free claims to adhere to specific federal regulations. However, in contrast to the USDA organic program, the FDA does not approve third parties for gluten-free certification, nor is certification required to make the gluten-free claim. Food companies are free to obtain gluten-free certification from a reliable third-party of their choosing, as long as that certifier uses the FDA definition at a minimum. (Some certifiers go further.)

Non-GMO: Not Legally Defined, Rapidly Changing

A good example of a seal program that is neither defined nor overseen by a government agency is the non-GMO label. Despite—or perhaps because of—recent controversy over genetically-engineered ingredients, the FDA has so far not required the labeling of foods containing GMOs. A significant response to this federal void in the wake of rising consumer demand has been an explosion of products on the market seeking to make “non-GMO” claims. The popular third-party certifier, the Non-GMO Project, claims to be “North America’s only independent verification for products made according to best practices for GMO avoidance.”

With several states (see the list here) already enacting GMO labeling bills and more being considered, along with ongoing litigation over “natural” labels on products containing GMO ingredients, pressure on the feds to act is mounting. In other words, this issue continues to be legally volatile. Also, remember that even though the federal government has not expressly defined “non-GMO”, such claims (along with any advertising) must still meet general federal rules to be truthful and non-misleading.

Additional certification programs cover kosher, vegan, and labor practices. I also recently wrote about “benefit corporations”. Some states allow a corporation to include ethical business practices in its legal charter. Companies can also obtain a related private certification by becoming a “B Corp”, and use that symbol as a marketing tool.

However you want to stand out in the marketplace with a seal of approval, it’s important to choose only legally-defensible claims and reliable third-party certifiers that adhere to current federal and state laws, as well as best marketing practices.

(This article has also been published at circleup.com)

Will Vermont’s GMO Labeling Law Survive Legal Challenge?

May 5, 2014

by Lauren Handel

Vermont’s GMO labeling bill is expected to be challenged in the courts soon after it is signed by the Governor. In an opinion piece for Food Safety News,  Shelley Powers predicts “Vermont Will Triumph Against Court Challenges to New Labeling Legislation.” My prediction more lawyerly and less sanguine: Vermont’s GMO labeling law might survive constitutional challenge, in part, or it could be entirely struck down. The two biggest constitutional hurdles for Vermont’s law are federal preemption and the First Amendment guarantee of free speech.

Regarding preemption, Ms. Powers says that the “Supremacy Clause doesn’t apply to Vermont’s law” because FDA does not formally regulate GMO labeling. It is true that FDA has issued only informal guidance regarding labeling of GMO products. For that reason, I agree with Ms. Powers that Vermont’s law is not likely preempted with respect to the labeling of food products within FDA’s jurisdiction. However, I believe that Vermont’s law is preempted to the extent that it requires labeling of foods within USDA’s authority. While the law has an exemption for “food consisting entirely of or derived entirely from an animal which has not itself been produced with genetic engineering,” foods made in part with meat or poultry would be subject to the labeling requirement. The labeling of such foods is governed by USDA under the Federal Meat Inspection Act and Poultry Products Inspection Act. Both of those statutes expressly preempt state laws imposing labeling requirements “in addition to, or different than” federal law. Vermont’s law requires labeling in addition to and different than that required by USDA and, thus, it likely is preempted with respect to foods containing meat or poultry.

The First Amendment analysis could go either way, largely depending on what test the court decides to use. Ordinarily, laws regulating commercial speech are analyzed under the test articulated by the US Supreme Court in Central Hudson Gas and Electric Corp. v. Public Service Commission of New York. That is the four-part test Ms. Powers references. If the court applies Central Hudson, the State of Vermont will have the difficult burden of proving (not merely claiming, as Ms. Powers states) that it has a substantial interest in requiring GMO labeling and that the law materially alleviates the problems. Although the Vermont bill declares that it has an interest in preventing consumer deception, preventing potential risks to human health, protecting religious practices, and protecting the environment, it is not clear that the State has evidence sufficient to prove that these are legitimate concerns or that labeling of GMO foods would materially advance any of these interests. 

Ms. Powers quotes from an analysis of the Vermont bill by the law firm Emord & Associates, which opines that the law is constitutional under the First Amendment. The authors of that memo anticipate that a court reviewing the Vermont law will apply a fairly lax (regulation-friendly) First Amendment test from the Supreme Court’s decision in Zauderer v. Office of Disciplinary Counsel of the Supreme Court of Ohio. In that case, 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.” The Supreme Court never has applied this test in circumstances where the government did not have an interest in preventing consumer deception. However, the US Court of Appeals for the Second Circuit (Vermont is within the Second Circuit) has held that the Zauderer test is appropriate where the state requires a purely factual disclosure, even if its interest is unrelated to preventing deception.

Even where Zauderer applies, the Second Circuit has said that the state’s interest has to be something more than satisfying consumer curiosity. In the mid-1990s, the same court found that a Vermont law that would have required labeling of dairy products produced with the synthetic growth hormone rBST violated the First Amendment because the State’s only interest was in satisfying consumer curiosity. Vermont will have a difficult time, I think, in distinguishing its present interest in informing consumers about the presence of GMOs from its earlier interest in disclosure of rBST. Thus, even if the court applies the easier test, Vermont’s “triumph” is far from a sure thing.



GMO Labeling and Food Prices

September 12, 2013

– by Lauren Handel

Proponents of GMO labeling laws, such as Washington State’s Initiative 522, are touting a new study finding that mandatory labeling will have no effect on retail food prices. The study, which was commissioned by the advocacy group Just Label It, undoubtedly is intended to counter claims by labeling opponents that mandatory GMO labeling will result in higher prices. However, the study overlooks key consequences of labeling laws that are likely to drive up costs for food manufacturers, wholesalers, retailers and – at least to some degree – consumers.

The study’s author, corporate sustainability consultant Kai Robertson, looked at research on the factors influencing supermarket prices, as well as literature on the impact of food label changes on retail prices and drew two conclusions. First, that demand-related factors – such as consumer demographics and competitors’ pricing behavior – affect the prices set by grocery stores more than wholesale costs. The unstated implication of this is that, even if a labeling law increases wholesale costs, retailers might not pass those costs on to their customers. That could be true, but it defies common sense to think that grocers – which typically operate on slim margins – won’t pass on at least some of their increased costs to consumers. Moreover, the study says nothing about how retail prices will be affected by retailers’ increased compliance costs, such as increased recordkeeping costs.

"Welcome back, Doctor. We missed you."

“Welcome back, Doctor. We missed you.”

Second, Robertson reports that there are no existing studies on the link between product labeling changes and prices charged to consumers. From this, she concludes, “this study finds no evidence that changes to a food processor’s product labels affect the prices paid by shoppers.” Again, that may be true, but a lack of “evidence” when no studies have been done tells us nothing about what those studies would find, if they were done. More importantly, though, the cost of labeling changes is not the factor likely to drive price increases, although the costs of having to use special labels just for products sold in Washington could be substantial (a point Robertson does not address).

To put it as simply as possible, we are systemically incapable of making GMO labeling an inexpensive proposition. It is not possible to avoid GMOs without increasing costs, given our existing food distribution infrastructure. The most significant costs of mandatory GMO labeling likely will result not from manufacturers having to add “genetically engineered” to their product labels, but rather, from the steps that food businesses will have to take to avoid the label. Obviously, producers would rather not brand their products as containing something consumers view negatively. Yet, even if a product contains trace amounts of GMO material, and even if GMOs are not intentionally added to the product, Washington’s Initiative 522 would require the product to be labeled as “partially produced with genetic engineering” or “may be partially produced with genetic engineering.” To avoid using those labels, food manufacturers will have to implement measures to ensure that non-GMO and GMO ingredients are not commingled and do quality control testing to confirm that GMO materials are not present. Furthermore, everyone in the supply chain from farmer to retailer will have to obtain affidavits from their suppliers stating that the ingredients were not intentionally produced with genetic engineering and were segregated from GMOs. A study relied on by the “No on 37” campaign – the industry group that lobbied against California’s Prop 37 – estimated that such increased operational and recordkeeping costs would add $400 per year to the average California family’s grocery bills. Even if that number is inflated, the cost is not realistically zero. Robertson’s study does not consider these costs.

New Meat Labeling Claims Available to Non-GMO Livestock Farmers

July 3, 2013

As the New York Times reported recently, USDA recently approved the use of the third-party Non-GMO Project verification seal on labels for meat raised on a GMO-free diet. If a product contains meat or poultry, the label must be pre-approved by USDA. And this is the first time that USDA has approved a “non-GMO” label claim. USDA initially rejected the label submitted by Mindful Meats, which included the Non-GMO Project seal, because the agency had no rule in place for handling “GMO-free” claims. However, after reviewing the Non-GMO Project’s certification procedures, USDA changed its mind.

UnknownThis story highlights the complications food producers can face in trying to market their products as GMO free. Like Mindful Meats’ products, foods increasingly are labeled with  statements that they are made without genetically engineered ingredients, and many carry the seal of the Non-GMO Project. But, in many circumstances, USDA and FDA do not consider such claims to be appropriate.

Importantly, USDA’s decision to allow the Non-GMO Project seal reflects only a determination that the seal is accurate and not misleading for products that have been verified by the Non-GMO Project. The decision does not reflect a broader policy change on “no GMO” claims.  In fact, USDA has no regulation or policy defining when “no GMO” claims are permissible. And, without a regulatory definition in place, USDA does not allow such labeling claims, even for certified organic products, unless they can be verified. Thus, manufacturers of USDA-regulated products who have not gone through Non-GMO Project’s verification process are likely to have GMO-free labeling claims rejected.

Furthermore, manufacturers of FDA-regulated foods must be careful to ensure that their “no GMO” claims are verifiable and not misleading. In 2001, FDA issued guidance to industry in which it warned that “no GMO” type claims may be misleading and, therefore, illegal. For example, FDA stated that “GMO free” claims would be misleading because trace amounts of bioengineered material may be present. FDA also said that “non-GMO” statements would be misleading if they imply that the product is superior to ones that contain genetically engineered ingredients. Even though FDA’s guidance does not have the force of law, it signals the position the agency may take in enforcement proceedings.

Thus, USDA’s decision does not clear regulatory hurdles for most manufacturers to use “non-GMO” type claims. However, it may cause more meat and poultry processors to seek the Non-GMO Project verification.

Connecticut GMO Labeling Bill Introduces New Rules for “Natural” Labeling

June 24, 2013

– by Lauren Handel

As covered in an earlier post, this month, Connecticut became the first state in the nation to pass a bill requiring labeling of genetically-modified (GMO) foods. If signed by the Governor, as expected, the law’s GMO labeling requirements will not take effect until at least four more states, including Northeast states with a total population of at least 20 million people, enact similar legislation. Although the Maine Legislature quickly passed a similar GMO labeling bill, it is anyone’s guess as to whether or when another three states with sufficient population will do likewise. However, a significant part of Connecticut’s bill, which has received little to no attention in the press, will take effect on October 1, 2013, even if no other states adopt GMO labeling laws.

Starting October 1, persons who advertise, distribute, or sell food in Connecticut are prohibited from using the term “natural” or similar language to describe food produced with genetic engineering. Unlike federal law and that of all other states except Massachusetts, Connecticut law already limits the use of the “natural” descriptor in food labeling and advertising. Under existing Connecticut law, food may be marketed as “natural” only if it has not been treated with preservatives, antibiotics, synthetic additives, artificial flavoring, or artificial coloring; and if it has not been processed in a manner that makes it significantly less nutritive. Connecticut’s GMO labeling law adds genetically-engineered foods to the list of foods that may not be called “natural.”

Like California’s failed Proposition 37, which also included a very broad ban on natural claims, Connecticut’s bill seems to go further than lawmakers may have intended. While the bill exempts several categories of food from its requirement to label foods produced with genetic engineering – including, alcoholic beverages, food sold for immediate consumption, farm products sold directly to consumers, and food derived from non-genetically engineered animals – those exemptions do not apply to the prohibition on natural claims. Furthermore, while the GMO labeling requirement applies only to food for human consumption, the prohibition on natural claims applies to all “food,” including food for animals. In addition, whereas the bill exempts processed foods containing not more than 0.9% GMO ingredients from the GMO labeling requirement until July 1, 2019, there is no similar tolerance in the restriction on natural claims.

Given the prevalence of GMO ingredients in the marketplace, Connecticut’s law could pose significant practical difficulties for many businesses that sell food in the state. For example, unless and until goods containing GMO ingredients are labeled as such, how will retailers know whether products labeled with natural claims are misbranded? A retailer would have to assume that all processed foods without organic or other non-GMO certification contain GMOs.

Moreover, the law is problematic from a legal standpoint because it conflicts with – and, therefore, likely is preempted by – federal law. In particular, Connecticut’s prohibition on the use of “natural” may directly conflict with decisions of the US Department of Agriculture (USDA) and the federal Alcohol and Tobacco Tax and Trade Bureau (TTB) in carrying out their responsibilities to pre-approve labels for meat products and alcoholic beverages, respectively. Neither USDA nor TTB prohibit the use of the term “natural” in labeling of products made with genetic engineering. Unless some action is taken to limit the Connecticut bill’s prohibition on natural claims, we can expect these preemption issues, among other legal challenges, to be raised in the courts.

The Legal Consequences of GMO Crop Drift

June 6, 2013

–  by Lauren Handel, Esq.

Last week’s report that unapproved genetically-engineered (GE) wheat unexpectedly was found growing in an Oregon farmer’s field has brought renewed attention to the issue of genetic crop contamination. The unintended transfer of engineered DNA to non-GE crops could cause economic harm, as evidenced by the fact that Japan – one of the largest importers of US wheat – has temporarily banned imports of US Western White wheat in response to the reported finding in Oregon. At least one lawsuit has already been filed against Monsanto alleging that the Oregon incident has damaged the market for US wheat.

The Oregon finding comes on the heels of the US Court of Appeals for the Ninth Circuit’s recent decision not to overturn USDA’s approval of genetically-engineered alfalfa. That decision is particularly important for its holding that, in determining whether to allow commercialization of new biotech plants, USDA may consider only whether the new plant is likely to be a plant pest, such as by spreading disease to other plants. According to the Ninth Circuit, USDA has no power to consider the potential environmental impact of a GE crop (such as, increased resistance of weeds to herbicide) or the potential economic harms that might result from genetic contamination of organic or other non-GE crops.

Unresolved legal issues create a host of problems for non-GMO farmers

These latest developments suggest that concerns about GE contamination of non-GE crops will only increase. Biotech companies will continue developing GE crops, and absent a change in law, USDA’s power to regulate them will be limited. It is not seriously disputed that incidents of contamination will occur and cause some amount of harm. Rather, the current debate is mostly about who – as between the farmers who use GE technology and the biotechnology companies, on the one hand, and the non-GE farmers, on the other hand – should bear the responsibility and costs of preventing contamination as well as the economic losses resulting from contamination.

In cases involving contamination from unapproved GE crops like the wheat found in Oregon, courts have found that plaintiffs suffered real harms and allowed them to assert negligence and nuisance claims. The plaintiffs harmed by contamination from unapproved StarLink corn and Liberty Link rice recovered large settlements and damage awards. However, such cases represent a departure from the default position that has emerged in the law, which generally imposes the costs of prevention and contamination on the farmers who choose not to use GE technology, rather than on the biotech companies and growers of GE crops.

As explained by University of Illinois law professor A. Bryan Endres the default allocation of costs can be thought of as a rule requiring non-GE farmers to “fence out” GE contamination, rather than requiring GE producers to “fence in” the engineered genes. For example, certified organic producers must take “reasonable” steps, through implementation of their approved organic system plans, to prevent contact with GE material. Such steps may include the use of buffer zones to separate organic from GE crops, testing seeds for GE, timing planting to stagger flowering of organic and GE crops, forming agreements with neighbors to avoid planting GE crops adjacent to organic crops, cutting or mowing alfalfa prior to flowering, and posting signs to notify neighbors of the location of organic fields. The costs of taking such preventive measures ordinarily cannot be recovered through litigation unless a farmer also suffers actual contamination resulting in harm. As demonstrated in the Organic Seed Growers & Trade Association v. Monsanto case, which was decided by the US District Court for the Southern District of New York last year, unless plaintiffs suffer actual contamination resulting in harm, courts are unlikely to find a controversy to be decided.

Similarly, the November 2012 report of USDA’s Advisory Committee on Biotechnology and 21st Century Agriculture (AC21) reflects the default position that non-GE farmers should bear the costs of GE contamination. The report proposes to allow organic and other non-GE farmers to buy a new type of insurance to protect against the economic risks of GE contamination. The report was harshly criticized by the National Organic Coalition (NOC) as allowing “USDA and the agricultural biotechnology industry to abdicate responsibility for preventing GE contamination while making the victim of GE pollution pay for damages resulting from transgenic contamination.”

The lesson here for producers of organic and specialty crops and seeds is that GE contamination is a real risk and, importantly, the law cannot be counted on to protect against such risk. While it may be possible to sue neighboring farmers after GE contamination has already caused harm, litigation is costly, time-consuming, and unpredictable. Farmers of premium-priced, non-GE crops must, therefore, take all feasible precautions to protect themselves from contamination and to insure against risks.

Lauren Handel and Proposition 37, Now In Culinaria

October 24, 2012

I am happy to report that Lauren Handel’s series of posts on Proposition 37 and GMO labeling in California has been picked up by  Culinaria, a new publication of the Southern Food and Beverage Museum. Lauren’s series on Prop 37 appeared on this blog a few weeks back, and I am delighted to see that it got the further attention it deserved from another publication. Well done, my friend.

You can find Lauren’s article as it appears in Culinaria at this link. Give it a read even if you’ve read the entire series here – she’s put even more work into it since it first appeared here.

California’s Prop 37, GMO Labeling, Part 4

September 28, 2012

Lauren Handel is back to conclude her series on California’s Proposition 37, today addressing the real logistical challenges businesses will face when the time comes to comply with this law.

If Prop 37 passes (which, according to a recent poll, seems likely), 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, 2014.

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. It has been reported that 60 to 70 percent of processed foods sold in U.S. grocery stores contain at least one genetically-engineered ingredient. Because the vast majority of corn, soybeans, and sugar beets produced in this country are genetically engineered, chances are that any product made with an ingredient derived from those crops would come within Prop 37’s labeling requirement.

These are the basic components of virtually every food there is to eat on supermarket shelves. Almost all products would have to be re-labeled on the front or back of the package with the required language, “Partially Produced with Genetic Engineering” or, to the extent the manufacturer is uncertain about whether the product contains genetically-engineered ingredients (or cannot document that it does not contain genetically-engineered ingredients), with the words “May be Partially Produced with Genetic Engineering.”

Food makers will have create special labels for those products destined for the California market, or make California-compliant labels for all products meant for nation-wide distribution.

In addition, for all processed foods—except those that are certified organic, that are derived entirely from a non-genetically-engineered animal, and alcoholic beverages—any language stating or implying that the product is “natural” would have to be removed from the label. 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.

In order to enforce the labeling provisions, Prop 37 would impose extensive recordkeeping obligations. Based on the text of Prop 37, any food producer or marketer who 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. 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.

Presumably, by regulation, the California Department of Health could limit some of the recordkeeping burdens by carving out entire categories of foods that would not have to comply with Prop 37’s labeling requirements because no genetically-engineered variety exists in the marketplace (for example, most whole fruits and vegetables) or because the ingredients used in the food (perhaps, as defined by a regulated standard of identity) are not genetically engineered. However, such exemptions would not apply to products made with ingredients derived from corn, soybeans, sugar beets, canola or other crops that are likely to have been genetically engineered or commingled with genetically engineered crops.

Although violations of Prop 37’s requirements 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. Violators are subject to criminal or civil prosecution, and the product may be seized or embargoed by the state. 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. 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. 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.

– by Lauren Handel

California’s Prop 37, GMO Labeling, Part 3

September 27, 2012

Lauren Handel is back today with further insight into the possible legal objections to California’s Proposition 37, the popular referendum on mandatory GMO labeling of food products. Once again, she puts policy and science debates to the side and examines just how challenging it will be for Prop 37 to successfully navigate our constellation of existing food laws. 

In addition to the First Amendment challenges Prop 37 that we covered yesterday, the opponents of the measure will seek to invalidate the law on the grounds that it is preempted by federal food labeling requirements.  Preemption is the constitutional principle that federal law trumps state law.  State laws may not conflict with federal laws.  Specifically with regard to food labeling, the Food, Drug, and Cosmetic Act (“FDCA”), Federal Meat Inspection Act (“FMIA”) and the Poultry Products Inspection Act (“PPIA”) all contain provisions expressly stating that they preempt conflicting state laws.

Opponents of Prop 37 have a strong argument that the law would be preempted by FMIA and PPIA to the extent it would regulate the labeling of meat and poultry products.  That is because FMIA and PPIA prohibit state labeling requirements for meat and poultry products  “in addition to, or different than” federal requirements.  Prop 37 would impose requirements “in addition to [and] different” from federal requirements because it would require labeling of genetically-engineered 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 could even be pre-approved by USDA—under federal law.

In contrast, Prop 37’s requirements for labeling foods within the ambit of FDCA (nearly everything other than meat and poultry) probably are not preempted.  FDCA’s preemption language prohibits state labeling requirements that are “not identical to” federal requirements.  In interpreting this provision, courts have held that states may impose labeling requirements addressing issues not regulated by FDA.  Because FDA has not regulated the use of “natural” claims, many courts have held that states are free to do so.  The same analysis should apply to regulation of genetically-engineered food labels.  Because FDA policy does not require nor prohibit disclosures that foods are genetically engineered, Prop 37’s disclosure requirement (with respect to foods other than meat and poultry) should not be preempted.

Nevertheless, challengers may argue that Prop 37 is preempted because it would conflict with FDA ingredient labeling requirements.  A  recent decision of a federal court in California held that state requirements to disclose of genetically-engineered ingredients are preempted by FDA’s exhaustive regulation of ingredient listings.  That decision, however, does not apply 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 has been produced with genetic engineering.

A somewhat better argument for preemption might be that, in requiring manufacturers to identify products as genetically engineered, Prop 37 would cause them to violate FDCA’s prohibition against making misleading claims.  The argument would be that a “genetically-engineered” label would mislead consumers into believing that the food is materially different than (and inferior to) a comparable product containing 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 a draft guidance document) that simple, factual statements of the type Prop 37 would require—that a food is genetically engineered or contains genetically-engineered ingredients—are not likely to be misleading.  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 claims required by Prop 37 to run afoul of FDCA’s prohibitions against misleading claims.

–by Lauren Handel

California’s Prop 37, GMO Labeling, Part 2

September 26, 2012

Regulating food is never simple. Here again with some insight on California’s Proposition 37 is Lauren Handel, our newest contributing food law attorney. Without regard to the policy arguments for or against GMO labeling, which are approaching hyperbole on either side of the debate, Lauren addresses the policy-neutral issues this law may face if passed by the people of California. Today, it’s Free Speech (didn’t see that coming?), and tomorrow it’ll be doctrine of Federal Preemption. 

Regardless of the policy merits of their position, opponents of Proposition 37 have a valid point that the referendum will be unconstitutional on the grounds that it infringes on freedom of speech protected by the First Amendment.

The First Amendment not only limits government’s power to prohibit speech; it also limits government’s power to compel speech.  Prop 37 would regulate speech both by prohibiting certain statements—that foods are “natural” if they have been produced with genetic engineering or processed in any way—and by compelling certain statements—that products are “Genetically Engineered,” “Partially Produced with Genetic Engineering” or “May Be Partially Produced with Genetic Engineering.”

From a First Amendment standpoint, Prop 37’s prohibition on “natural” claims is its most problematic provision.  To defend that part of the law, California would have to establish that it has a substantial interest in protecting consumers from being deceived by “natural” claims and that the prohibition directly serves the state’s interest without overly infringing on speech.  With regard to genetically-engineered products, there is at least some reason to think that “natural” claims confuse consumers and cause them to believe products are not genetically engineered.  (Remember the Kashi story?)  And many lawsuits have been brought (for example, against Snapple and General Mills) alleging that “natural” claims are deceptive when products contain highly processed ingredients, such as high fructose corn syrup.  However, it is utterly implausible that a ban on “natural” claims is necessary to prevent consumer confusion with regard to minimally processed, traditional foods that most people would think of as natural—including non-genetically-engineered canned, cooked, or frozen foods containing no artificial ingredients.  In that regard, Prop 37 goes too far.

Prop 37’s requirement to compel disclosure statements identifying genetically-engineered foods has a somewhat better chance of withstanding a First Amendment attack.  The government may compel purely factual  disclosures to consumers for purposes of preventing consumer deception.  The disclosures required by Prop 37—simple statements indicating that the product is genetically engineered—are factual in nature.  But there is room for debate as to whether the disclosures serve the state’s interest in preventing consumer deception.

Opponents of Prop 37 will argue that consumers cannot be deceived by the absence of a “genetically engineered” label because genetically-engineered foods are deemed not materially different than their traditional counterparts.  In fact, it is the policy of the federal government, as determined by FDA, that genetically-engineered foods are not materially different than traditional foods and, therefore, labeling  is not needed to prevent consumer deception.  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.  But the interest in consumer curiosity, by itself, has been held by one federal appeals court to be insufficient to support a law compelling commercial speech—in that case, a Vermont law requiring labeling of dairy products produced with synthetic hormones.

To defend Prop 37’s disclosure requirement, California will have to convince the court that the provision is related to the government’s interest in preventing consumer deception (as opposed to merely gratifying curiosity) or that it directly serves another substantial state interest, such as an interest in protecting human health or the environment.  Given that science has not proven genetically-engineered foods to be dangerous, it may be difficult for California to establish that Prop 37’s disclosure requirement serves a legally-recognized, substantial state interest.  At the heart of the matter will be a dispute about whether the state has a legitimate interest in protecting consumers’ “right to know” how their food has been produced.  That Americans overwhelmingly support labeling of genetically-engineered foods indicates that they believe they should have such a right; but, so far, it has not been recognized by the courts.

I predict that if Prop 37 passes, the lawsuit challenging it will contain a First Amendment Element.

by Lauren Handel