FDA Expands Use of Voluntary Labeling Statements for GE Foods, Approves GE Salmon

On November 19, the Food and Drug Administration (FDA) released a Final Guidance on the permitted use of voluntary labeling to indicate whether foods have been derived from genetically engineered (GE) plants. In a significant shift, the Final Guidance allows for a wide array of permissible GE-related claims, even as it confirms FDA’s long-held position that such labeling is not mandatory under the Federal Food, Drug, and Cosmetic Act (FDCA). On the same day, FDA also denied two Citizen Petitions demanding mandatory labeling, took the significant step of approving AquaBounty Technologies’ GE salmon (after nearly 20 years of consideration), and issued a Draft Guidance regarding voluntary labeling indicating whether foods have been derived from GE salmon. This array of agency actions comes amidst battles in Congress and several states regarding GE labeling, and may indicate that FDA felt it necessary to stake out a clear position.

The Final Guidance significantly broadens the scope of GE-related statements that are not considered misleading. Newly permissible claims include:

• “Not bioengineered.”
• “Not genetically engineered.”
• “Not genetically modified through the use of modern biotechnology.”

In contrast, in FDA’s 2001 Draft Guidance, “Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering” (2001 Draft Guidance), FDA permitted only limited claims, such as “We do not use ingredients that were produced using biotechnology” and “Our tomato growers do not plant seeds developed using biotechnology.” Moreover, the agency only considered such claims acceptable if the labeling as a whole did not imply superiority to bioengineered foods and was not otherwise misleading.

In addition, the Final Guidance leaves out FDA’s prior admonition that statements may be misleading if they suggest that a food or ingredient is non-GE when there are no marketed GE varieties of that food. Thus, it appears that in FDA’s view it is now theoretically possible to make such a claim, potentially opening the door to a greater number of “non-GE” claims on foods (provided that such foods are capable of being GE).

FDA is careful to reiterate its view that there are generally no “material” differences in GE foods that would compel labeling (except where the GE-derived food has different nutritional properties, contains an unexpected allergen, behaves differently under some circumstances, or no longer fits within the common or usual name or existing statement of identity). Further, as in the 2001 Draft Guidance, the agency continues to discourage the use of “GMO” and similar terms as confusing; despite this, the agency states that it will not take enforcement action based on the use of such terms, as long as the labeling is not false or misleading.

Just as in the 2001 Draft Guidance, FDA makes clear that any label claims regarding GE must be adequately substantiated. The Final Guidance sets forth several possible methods, including documentation of handling practices and procedures, the use of food certified as organic under the U.S. Department of Agriculture’s (USDA) organic regulations, and the use of validated test methods. FDA notes that tests may be inadequate to demonstrate that GE materials are absent from a food, and if such methods are not available or reliable, documentation of handling practices may be a more practical method of substantiation.

Consistent with the Final Guidance, FDA denied two Citizen Petitions requesting mandatory labeling of GE foods. Filed in 2011, a Petition by the Center for Food Safety (CFS) asked FDA to require labeling of GE foods on the basis that the use of genetic engineering results in changes in foods and is therefore material under the FDCA. Similarly, a 2010 Petition by the Truth in Labeling Coalition (TILC) contended that GE foods present greater safety concerns than their traditional counterparts and that mandatory labeling should be required for such foods. In its responses to CFS and TILC, FDA reiterates its position—first articulated in its 1992 "Statement of Policy: Foods Derived from New Plant Varieties" and affirmed in the Final Guidance—that there is insufficient evidence to show that GE foods differ from non-GE foods in a meaningful way, or that the method of production of GE foods is material under the FDCA.

FDA’s November 19 approval of the animal drug application for the GE AquAdvantage salmon further affirms the agency’s position that there is no evidence that GE foods are any less safe than non-GE foods. The approval was grounded in FDA’s conclusion that the salmon is safe for humans to eat, the technology is not harmful to the fish, and the sponsor presented sufficient evidence to show the fish grows faster than non-GE salmon (the desired characteristic). In the accompanying Draft Guidance regarding voluntary labeling of foods derived from GE or non-GE salmon, FDA advises that, as with foods derived from GE plants, the AquAdvantage salmon and any food products derived from it will not be required to bear GE labeling, but that voluntary labeling is permitted if truthful, not misleading, and adequately substantiated. FDA will accept comments on the Draft Guidance.

In recent years, consumer demand has led several states to mandate disclosure of GE ingredients. Vermont’s passage of Act 120, the labeling provisions of which are set to take effect on July 1, 2016, requires labeling of GE foods offered for retail sale in the state. Maine and Connecticut have also passed laws requiring GE foods to be labeled, with effective dates that are contingent upon other states adopting similar laws. Ongoing litigation over Vermont’s GE labeling law and the use of the term "natural" in the labeling of foods produced with GE ingredients have raised additional First Amendment and federal preemption questions. Notably, in its Notice of Availability for the Final Guidance, FDA takes the position that state GE food labeling requirements may be preempted insofar as such requirements are inconsistent with applicable federal requirements or otherwise expressly preempted.

Meanwhile, in July 2015, the House of Representatives passed the Safe and Accurate Food Labeling Act, which would: clarify that mandatory labeling of GE foods is not required; establish criteria for voluntary labeling of GE and non-GE foods; and preempt state laws requiring labeling of GE foods. Since House passage, the bill has been referred to the Senate Agriculture Committee, which has not taken further action. In addition, the White House announced in July 2015 that the federal government was undertaking a reevaluation of the 1986 Coordinated Framework on Biotechnology, which describes how FDA, USDA and the Environmental Protection Agency (EPA) will regulate products developed from biotechnology.

While FDA’s November 19 actions mark the conclusion of a long-awaited and multi-layered process within the agency, consideration of GE-related issues is far from over, as is apparent from state and federal legislative activity as well as ongoing and threatened litigation. A number of groups, including the CFS, are already preparing to challenge the agency’s approval of AquAdvantage in court and litigation on labeling of GE-foods is likely to continue.


If you have any questions regarding this Sidley Update, please contact the Sidley lawyer with whom you usually work, or

Diane C. McEnroe Partner dmcenroe@sidley.com +1 212 839 5621

Emily Marden Counsel emarden@sidley.com  +1 650 565 7099

Deepti A. Kulkarni Associate dkulkarni@sidley.com  +1 202 736 8805

Sarah M. Goldstein Staff Attorney smgoldstein@sidley.com  +1 212 839 5703

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