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Historic Lawsuit Against the Food and Drug Administration to Force Labeling and Safety Testing of Genetically Engineered Foods Continues

June 17, 1999

On May 27, 1998, an unprecedented coalition of scientists, religious leaders, health professionals, consumers and chefs filed suit against the Food and Drug Administration (FDA). The suit, filed in Federal District Court, challenged the FDA’s current policy on genetically engineered foods, specifically its failure to require labeling or any safety testing for genetically engineered foods. The plaintiffs have charged that the FDA policy violates the agency’s statutory mandate to protect public health and provide consumers with relevant information about the foods they eat. The suit also alleges that the FDA policy is a violation of religious freedom.

In the suit, plaintiffs challenge the marketing of 36 different genetically engineered whole foods which are currently being sold (or commercially developed) without labeling or safety testing. These include potatoes, tomatoes, soy, corn, squash and many other fruits and vegetables to which a variety of new genes from different species have been added. These genetically engineered whole foods are also used as ingredients in processed foods, and have been reported to be present in a number of mass consumed food products from major soy-based baby formulas to some of the most popular corn chip brands. Because of FDA’s failure to require labeling, millions of American infants, children and adults are consuming genetically engineered food products each day without their knowledge.

A central issue in the case involves the consumer’s right to know about the new genetic material being engineered into their food. Labeling and testing are also vital given the health risks that scientists have associated with gene modified foods. The most pressing health concern involves the impact of inserting novel genes into fruits, vegetables and other food products. With each gene insertion there is the possibility that a nontoxic element in the food could become toxic and create a human health hazard. This remains the most probable explanation for the dozens of deaths and hundreds of serious illness caused by the genetically engineered food supplement L-tryptophan several years ago.

Food allergies are another major health concern with genetically engineered foods. Those with food allergies will have no way of knowing what foods to avoid. The problem of food allergies was outlined in a recent study reported in the New England Journal of Medicine. In the study a gene from a Brazil nut was introduced into a soybean. The genetically engineered soybean was then tested on people who were allergic to the nuts, and it was found that they had an allergic reaction to the engineered soybeans but not the natural variety. Health professionals are also concerned that the mass consumption of genetically engineered foods could make treating infections more difficult in that some genetically modified foods contain antibiotic resistant genes.

In addition to health concerns, millions of Americans feel obligated to refrain from consuming some or all genetically engineered foods based on their ethical and religious principles. Many Jews and Muslims need to avoid foods with substances from specific animals, while devout vegetarians want to avoid substances from any animal. Additionally, a considerable portion of the population is religiously motivated to avoid genetically engineered foods because they view the production of these foods to be incompatible with proper stewardship of the biological integrity of creation. The religious plaintiffs allege that by refusing to label genetically engineered foods, the FDA is significantly infringing their free exercise of religion as guaranteed by the Constitution and the Religious Freedom Restoration Act (RFRA).

On June 1, 1999, both the plaintiffs and FDA filed cross-motions for summary judgment in the case. Under the court’s order, the parties will complete briefing of the case by July 12, 1999. After completion of the briefing, a decision in the case will rest with United States District Court Judge Colleen Kollar-Kotelly.

“The FDA has ignored the law and placed the interest of a handful of biotechnology companies ahead of their responsibility to protect public health,” stated Joseph Mendelson, Legal Director of the Center for Food Safety and lead attorney on the case. “By failing to require testing and labeling of genetically engineered foods, the agency has made consumers unknowing guinea pigs for potentially harmful, unregulated food substances.”

To view the petition, click HERE.