Preserving the Safety of Our Food, the Health of Our Environment,
and the Harmony of Our Relationship with Nature2040 Pearl Lane #2, Fairfield, Iowa 52556
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|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
FDA Scientists Protested the Attempt to Equate Bioengineering 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
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.
Moreover, the government consistently distorts the fact that in 1989 a GE food killed dozens of Americans and permanently crippled over 1,500 others. That product (a supplement of the amino acid L-Tryptophan) contained at least one unusual toxin never found in conventionally produced batches. Many experts think the bioengineering process was the most likely cause of the toxicity, and the FDA’s biotech coordinator admits it cannot be ruled out. (FDA Administrative Record 22923) But in public statements, FDA officials have hidden the fact the fatal product was bioengineered and instead blamed risks of health supplements; and other government spokespersons persistently claim that no GE food has ever harmed a consumer.
Violating Federal Law
Consequently, every genetically engineered food in the U.S. is on the market illegally and should be recalled for rigorous safety testing. The FDA has deliberately unleashed a host of potentially harmful foods onto American dinner tables in blatant violation of U.S. law.
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