Over the past few years, there has been a virtual onslaught of lawsuits directed to the food and beverage industry, principally relating to claims that certain marketing efforts of food and beverage producers falsely advertise their products and encourage consumers to purchase them based upon fraudulent representations.  Likely due to California’s expansive consumer protection statutes and perceived “green” nature, the U.S. District Court for the Northern District of California has become the venue of choice for many of these lawsuits and, as a result, has been dubbed by some as the “Food Court.”

Recently, the Food Court received another complaint directed to a human food product. Rather than a labeling or false advertising claim, this suit contends that the U.S. Food and Drug Administration’s (FDA) recent approval of a genetically modified (GM) animal intended for human consumption was unsound and further challenges the FDA’s authority to even approve genetically modified animals used for food.  At issue is a GM salmon offered by AquaBounty Technologies, Inc, which claims its now-FDA approved salmon grow twice as fast as wild versions of Atlantic salmon while consuming 25% less feed in the process.  In November, the FDA approved AquaBounty’s GM salmon finding the product “safe for human consumption” and equally nutritious as non-genetically engineered Atlantic salmon.  The AquaBounty salmon is the first GM animal cleared for human consumption in the United States.

The suit suggests that FDA violated federal law by making its decision “without  considering or fully disclosing the environmental and other risks” including the possibility that GM salmon released into the wild may damage existing fisheries and pose a health threat to wild salmon. The central issue in the suit appears to be whether the FDA, in creating a GM animal program, was required to analyze the program’s impacts on the environment as required by the National Environmental Policy Act, including preparing a full Environmental Impact Statement.  The suit concedes that an environmental assessment was performed, resulting in a finding of no significant impact to the environment. Nonetheless, plaintiffs contend the FDA’s study failed to evaluate “myriad scientific questions” regarding risks to the environment and ecology as well as “intertwined socioeconomic harms” that could come from AquaBounty’s GM fish.

The plaintiffs in this suit consist of a coalition of fishing, food safety and environmental groups including the Friends of the Earth, a well-known anti-GMO activist.  Although principally geared toward environmental issues, the plaintiffs also contend that the FDA’s action of approving a GM organism, through provisions covering the evaluation and approval of animal drugs, exceeds the FDA’s authority under the Food, Drug and Cosmetics Act.  Interestingly, the present lawsuit does not address the FDA’s specific findings that the AquaBounty GM salmon is actually safe for human consumption.  According to plaintiffs, the action will serve as a precedent for the assessment and regulation of all potential future genetically engineered or modified animals intended for human consumption.

This lawsuit serves as the latest skirmish line in the ongoing debate over GMO intended for human consumption, and the case will undoubtedly resolve question relating to FDA’s jurisdiction over genetically modified animals offered as food. We have previously provided information on the FDA guidelines here.  Rest assured that our Animal Health team will careful watch this case and report to you on important developments as they occur.