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.

FDA Scientists Protested the Attempt to Equate Bioengineering with Conventional Breeding

The White House directive to foster biotechnology advocates the premise that GE foods are essentially the same as others. However, the agency's attempts to bend its policy to conform to this premise met with strong resistance from its own scientists. Numerous agency experts protested that the proposed policy was ignoring the recognized potential for bioengineering to produce unexpected and unpredictable toxins, carcinogens and allergens -- hazards not ordinarily involved with conventional breeding.

For instance, Dr. Louis Pribyl of the FDA Microbiology Group wrote, "There is a profound difference between the types of unexpected effects from traditional breeding and genetic engineering ..." He added that some aspects of gene splicing "...may be more hazardous." (4) Dr. E.J. Matthews of the FDA's Toxicology Group warned that GE plants could contain unexpected toxins that could "...be uniquely different chemicals that are usually expressed in unrelated plants." (2) Citing the potential for such unintended dangers, the Director of FDA's Center for Veterinary Medicine (CVM) called for GE products to be demonstrated safe prior to marketing. He stated: "... CVM believes that animal feeds derived from genetically modified plants present unique animal and food safety concerns." (10) He explained that residues of unexpected substances could make meat and milk products harmful to humans.

The numerous in-house critiques are summed up by Dr. Linda Kahl, who protested the agency was "... trying to fit a square peg into a round hole . . . [by] trying to force an ultimate conclusion that there is no difference between foods modified by genetic engineering and foods modified by traditional breeding practices." She declared: "The processes of genetic engineering and traditional breeding are different, and according to the technical experts in the agency, they lead to different risks." (1)

Moreover, Dr. James Maryanski, FDA's Biotechnology Coordinator, acknowledged in a letter to a Canadian official that there is no consensus about the safety of genetically engineered foods in the scientific community at large (8); and FDA scientists advised they should undergo special testing.

Misrepresenting the Facts in Order to Approve the Foods

Nonetheless, so strong was the FDA's motivation to promote the biotech industry that it not only disregarded the warnings of its own scientists about the unique risks of gene-spliced foods, it covered them up and claimed that no such input had been received. Its official policy asserts: "The agency is not aware of any information showing that foods derived by these new methods differ from other foods in any meaningful or uniform way...." Thus, although agency experts advised that GE foods should be subjected to special testing, the bureaucrats in charge of the policy proclaimed these foods require no testing at all.

Further, the FDA misrepresents the tests that have been done. For instance, although not required to do so, the developer of the "Flavr Savr" tomato, the first GE whole food brought to market, voluntarily put it through feeding studies and asked the FDA to review the data. FDA scientists noted a pattern of stomach lesions that raised a safety issue and repeatedly requested more testing. None was performed. Consequently, FDA experts concluded "... the data fall short of 'a demonstration of safety'…" (15) and said "... unresolved questions still remain." (16) Yet, the FDA not only approved the tomato, it claimed that all relevant safety issues had been satisfactorily resolved – and that because the Flavr Savr did so well, it would be unnecessary for any subsequent GE food to go through the same rigorous testing. To date, there is no reliable evidence showing that any has successfully met the standard the Flavr Savr failed to meet.

Violating Federal Law

Besides violating basic canons of ethics, the FDA's behavior flagrantly violates the U.S. Food, Drug and Cosmetic Act, which mandates that new food additives be demonstrated safe through testing before they are marketed. While the FDA admits that bioengineered organisms fall under this provision, it claims they are exempt from testing because they are "generally recognized as safe" (GRAS), even though it knows they are not recognized as safe even by its own scientists, let alone by a consensus in the scientific community.

Further, the statute prescribes that additives like those in GE foods can only be recognized as safe on the basis of tests that have established their harmlessness. But no such tests exist for GE foods. So, although the GRAS exemption was intended to permit the sale of substances whose safety has already been demonstrated through testing, the FDA is using it to circumvent testing and to approve novel substances based largely on conjecture--conjecture that is dubious in the eyes of its own and many other experts.