How the Food and Drug Administration is Misrepresenting the Facts About Risks of Genetically Engineered Foods and Violating the Laws Meant to Regulate Them
Statement by Steven M. Druker, JD, executive director of the Alliance for Bio-Integrity, coordinator of the lawsuit against the FDA to obtain mandatory safety testing and labeling of GE foods, and an attorney on the case (in collaboration with the legal department of the Center for Food Safety).
Overview: Uncovering FDA's Misbehavior Through Litigation
In May 1998, the Alliance for Bio-Integrity led an unprecedented coalition of public interest groups, scientists, and religious leaders in filing a landmark lawsuit against the U.S. Food and Drug Administration to obtain mandatory safety testing and labeling of all genetically engineered (GE) foods. In an unprecedented step, nine eminent life scientists joined as plaintiffs in order to emphasize the degree to which they think FDA policy is scientifically unsound and morally irresponsible. Now, the FDA's own files confirm how well founded their concerns are. The FDA was required to deliver copies of these files—totaling over 44,000 pages—to the plaintiffs' attorneys. (Key documents from these files are in a numbered list at www.biointegrity.org Numbers following quotations below refer to the corresponding document's place on this list. Also on our website are fuller discussions of FDA misbehavior.)
The FDA's records reveal it declared GE foods to be safe in the face of broad disagreement from its own experts—all the while claiming an overwhelming scientific consensus supported its stance. Besides contradicting the FDA's claim that its policy is science-based, this evidence shows the agency violated the U.S. Food, Drug and Cosmetic Act in allowing genetically engineered foods to be marketed without first being proven safe, on the premise that they are generally recognized as safe by experts.
FDA's Admitted Agenda to Promote the Biotech Industry
The FDA acknowledges it has been operating under a government policy "to foster" the U.S. biotechnology industry. ("Genetically Engineered Foods," FDA Consumer, Jan.-Feb. 1993, p. 14.) This policy was initiated by the Reagan/Bush administration and has continued through Clinton/Gore. Further, when in 1991 the FDA created a new position of Deputy Commissioner for Policy to supervise the formulation of its policy on GE foods, it appointed Michael Taylor, a Washington, D.C. lawyer who had been representing Monsanto and other members of the biotech industry on regulatory issues. During Mr. Taylor's tenure as Deputy Commissioner, warnings from FDA scientists were persistently overridden and drafts of the policy statement increasingly contradicted their assertions about the hazards of bioengineering. (Subsequently, Mr. Taylor was hired by Monsanto as Vice-President for Public Policy.) Moreover, when Vice-President Dan Quayle introduced FDA's final policy in 1992, he referred to it as "regulatory relief" for the industry.