By Colin O'Neil

Americans cherish their freedom of choice. If you want to choose food that doesn’t contain gluten, aspartame, high fructose corn syrup, transfats or MSG, you simply read the ingredients label. But one choice Americans are not free to make is whether their food contains genetically engineered ingredients. Unlike most other developed countries—including 15 European Union nations, Japan, Australia, Brazil, Russia and China—the U.S. has no laws requiring labeling of genetically engineered foods. Yet polls have repeatedly shown that the overwhelming majority of Americans—over 90% in most polls— believe GE foods should be labeled.

Citing this overwhelming support, last month the Center for Food Safety (CFS) filed a groundbreaking legal petition with the U.S. Food and Drug Administration (FDA) demanding that the agency require the labeling of all food produced using genetic engineering. CFS prepared the legal action on behalf of the Just Label It campaign and a number of health, consumer, environmental and farming organizations, and food companies are also signatories to the petition.

A Choice Deferred

In 1992, the FDA issued a policy statement that GE foods were not 'materially' different from non-GE foods and thus did not need to be labeled. The agency severely constricted what it called 'material,' limiting it to changes that could be tasted, smelled, or detected through the other human senses. Because GE foods cannot be 'sensed' in this way, FDA declared them to be 'substantially equivalent' to conventionally produced foods, and no labeling was required.

FDA adopted this stance despite a lack of scientific studies and data to support their underlying assumption that genetically engineered foods were 'substantially equivalent' to conventional foods. It was a political, not scientific, decision to apply 19th century logic to a 20st century food technology, and in the process left all consumers in the dark to hidden changes to their food. We as consumers no longer base our decisions solely on what we can see or taste or smell, so why should the FDA continue to do so?

FDA Should Prevent Consumer Deception – Not Create It

FDA’s authority to require labeling goes well beyond the agency’s outdated definition of 'material.' Rather, the law authorizes FDA to require labeling for GE foods in order to prevent consumer deception. Because FDA allows these facts to go unlabeled, consumers believe they are purchasing something different than what they actually are.

To be patentable, a genetically engineered food must be 'new' and 'novel.' Thus, a product or process that is patentable cannot be both 'novel' for patent purposes yet 'substantially equivalent' to existing technology in other contexts. Continuing to treat GE foods as novel for patenting purposes but traditional for labeling purposes is a clear error in judgment by the FDA and abuse of the public’s trust.

Polls consistently show1 that more than 90 percent of Americans want GE foods to be labeled and consumers do not expect food to be genetically engineered absent labeling. FDA’s continued failure to mandate labeling is an abdication of its duty to protect consumers from deception.

Unlabeled, Untested and You’re Eating It

Unlabeled GE foods are misleading not only because they contain unperceivable genetic and molecular changes to food, but also because they have unknown and undisclosed risks. FDA has never conducted a single safety assessment for GE foods and does not affirm their safety. There have been very few independent, peer-reviewed, comprehensive studies of their long-term human health and environmental impacts, and the few that exist give cause for concern. In fact, scientists both within FDA and outside the agency agreed that there are profound differences between genetically engineered foods and those produced through traditional breeding practices.

Yet, rather than requiring the necessary safety assessment, FDA explicitly places responsibility for determining the safety of GE foods and crops back in the hands of their makers the biotechnology companies, and uses what it calls a 'voluntary consultation' process. Companies that develop a GE crop are encouraged, but not required, to share the conclusions (but not the raw data or methodology) of any studies they may have conducted on their GE crop. This system does not favor health, safety or transparency.

A recent independent Canadian study found that a toxin from the soil bacterium Bacillus thuringiensis (Bt), which has been engineered into Bt corn, was present in the bloodstream of 93% of pregnant women, as well as in the fetal cord blood of 80% of the pregnant women.2 These findings cast grave doubt on the biotechnology industry’s assurances—accepted at face value by federal agencies, including FDA—that the genetically engineered Bt toxin would be broken down by human digestive systems before entering the bloodstream. This study not only underscores the scientific uncertainty surrounding the health impacts of GE crops, but also casts doubt on the wisdom of federal agencies’ practice of relying excessively on crop developers’ own safety assessments rather than on independent studies.

FDA’s Looming Decision on GE Salmon Labeling

One issue related to GE food labeling currently sitting at the FDA is the pending approval of AquAdvantage transgenic salmon, the first GE animal intended for human consumption. The genetically engineered Atlantic salmon was developed by AquaBounty Technologies, which artificially combined growth hormone genes from an unrelated Pacific salmon, (Oncorhynchus tshawytscha) with DNA from the anti-freeze genes of an eelpout (Zoarces americanus).

This genetic modification causes the AquAdvantage salmon to produce growth-hormone year-round, creating a fish the company claims grows at twice the normal rate. This GE salmon poses a number of health, environmental, economic and animal welfare concerns and is only made worse by FDA’s acknowledgment that it would likely not require labeling despite these concerns. Yet a careful look at this fish reveals that it is not the safe and healthy fish that its proponents would lead you to believe [See GE Salmon Nutrition Facts].

According to the company’s own data, its GE salmon contains less healthy fatty acids than other farmed salmon and far less healthy fatty acids than wild salmon. FDA claims that the omega-3 to omega-6 fatty acid ratio in the AquAdvantage salmon is similar to the ratios found in scientific literature for farmed Atlantic salmon. In fact, the ratio for the AquAdvantage salmon is nearly 15% less than the recorded ratio for conventionally farmed Atlantic salmon and 65% less than wild salmon.

GE salmon also contain levels of healthy vitamins and minerals inferior to the levels present in other farmed salmon. The company study provided to the FDA identified a number of vitamins and essential nutrients for which the levels present in the AquAdvantage salmon differed from non-GE salmon by more than 10%. The AquAdvantage salmon has lower levels of every essential amino acid tested and nearly 25% less folic acid and vitamin C. As a result of the genetic modification, this fish is fattier, less nutritious and at higher risk for physical deformities than other salmon.

With regard to food allergies, FDA stated: 'the technical flaws in this [AquaBounty’s allergy] study so limit its interpretation that we cannot rely on its results.' It’s no wonder a 2008 Consumers Union nationwide poll found that 95 percent of respondents said they thought food from genetically engineered animals should be labeled. 3 And while you’re not going to see this type of comparison on a nutrition label, absent mandatory labeling for GE foods, you will not be able to choose between a GE fish and regular farmed salmon.

In the U.S., we pride ourselves on having choices and making informed decisions. The longer the U.S. clings to its antiquated policy on GE food labeling, the more its standing as a leader in scientific integrity will be compromised. It is long overdue that FDA acknowledges the myriad reasons GE foods should be labeled and rewrites its outdated policy, lest it continue to foster consumer deception.


Colin O’Neil is Regulatory Policy Analyst at the Center for Food Safety.



2 See Aris A., Leblanc S., “Maternal and fetal exposure to pesticides associated to genetically modified foods in Eastern Townships of Quebec, Canada,” (Feb. 18, 2011) available at (last visited May 25, 2011). In approving Bt corn, FDA had previously relied on the industry’s assurances that the Bt toxin would be broken down during digestion. 


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