GE Foods: To Label or Not to Label - That is the Question (Again)

Right or wrong, scientifically-based or not, the labeling of genetically engineered foods (GE foods) - often, and erroneously, referred to as GMO foods - remains a topic on the mind of activists and legislatures across the country.

In October 2011, the Center for Food Safety (not to be confused with FDA's Center for Food Safety and Applied Nutrition), and other nonprofit organizations, filed a citizens' petition with the US Food and Drug Administration seeking mandatory labeling for foods made from genetically engineered crops. Similar groups launched a "Just Label It" campaign to garner support for the petition, and many nonprofit organizations asked their members to submit comments to FDA in support. Comments closed last month, and FDA recently stated that it hopes to complete its review and respond to the petition in the near future.

For nearly twenty years, FDA has repeatedly asserted that there is "no basis for concluding that bioengineered foods differ from other foods in any meaningful or uniform way, or that, as a class, foods developed by the new techniques present any different or greater safety concern than foods developed by traditional plant breeding." The petition, yet again, seeks a new policy and labeling requirements. The FDA's long-held position is that GE foods are not materially different from their conventional counterparts.

The petitioners repeat two often-used arguments in support of the labeling requirement. First, they argue that the failure to label GE foods renders the labeling "false or misleading" under the Food, Drug, and Cosmetic Act, even if the presence of GE ingredients is not a "material" fact. Second, the petitioners argue that FDA should amend its 1992 policy to state that the presence of GE ingredients is a material fact.

Whether an ingredient is "material" for purposes of food labeling depends on whether the presence or absence of it changes the nutritional content or alters the organoleptic properties (taste, smell, texture, etc.) of the food. If the presence or absence of an ingredient has no material impact on the food, then to label for it is to suggest a difference where none exists - which is the very heart of misleading label statements. FDA has argued as recently as September 2010 that the process by which a food is made is not, in and of itself, material to the food. The petitioners argue, however, that FDA has the authority to consider processes "material" based on FDA's past regulation of certain foods, including irradiated foods.

It is notable that the petitioners do not cite any new science that would justify a change in FDA's approach to GE foods. Instead, the petitioners argue that the presence of GE ingredients is a material fact because a majority of polled consumers had a desire to know which foods contain GE ingredients. They also contend that the risk of GE foods is uncertain because they are a relatively new addition to the food supply.

Of course, just because a poll of consumers suggests a "desire to know" does not mean that consumers are currently misled by labeling. The petitioners state over a half-dozen times that consumers purchase foods with the reasonable expectation that the foods do not contain GE ingredients, or that consumers are deceived by the failure to disclose, but the petition does not cite a single source supporting the idea that non-disclosure of GE ingredients has resulted in consumer deception.

While the petition has been under review at FDA, various groups in California have gained support for a ballot initiative, entitled the "California Right to Know Genetically Engineered Food Act," which would require labeling of GE foods and would prohibit any marketing of GE foods as "natural." The initiative also provides for a private right of action under California's Consumer Legal Remedies Act, which would allow a consumer to bring an action for failure to disclose GE ingredients without establishing any specific damage from, or reliance on, the lack of a disclosure. Notably, the Environmental Law Foundation, a longtime Proposition 65 enforcer, is one of the main promoters of the initiative. The deadline to collect signatures in support of the initiative was April 22nd, and the initiative's proponents recently reported that they successfully gathered the requisite number of signatures to place the initiative on the ballot in November 2012. The local county recorders will process and review the signatures before making any official announcement regarding the initiative.

Twenty-two states (recently, Vermont) have proposed similar laws that would require labeling of GE foods. Yet, to date, even with a broad and concerted effort on the part of groups such as CFS, no such state law has been enacted. At the same time, GE foods are becoming more prevalent, with around 85% of all corn, soy, and wheat in the US coming from GE seeds.

Whether it is noble for these opposition groups to take arms against GE foods (and by opposing end them), remains, alas, an open question. We will continue to monitor these issues and keep you updated as they progress.

© Arnold & Porter Kaye Scholer LLP 2012 All Rights Reserved. This blog post is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.