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FDA ignored own scientists’ warnings about GM foods

By Ken Roseboro
Published: October 1, 2011

Category: GM Food Labeling and Regulations

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The US government’s refusal to label genetically modified foods has been based on a policy that GM foods are “substantially equivalent” to conventional foods that was established by the Food and Drug Administration in 1992. However, internal FDA documents revealed that the agency’s own scientists expressed doubts about the GM food labeling policy when it was being established, while raising questions about GM food safety.

No safety data on GM foods

In a February 1992 memo, Louis J. Pribyl, Ph.D., a scientist in the FDA’s Microbiology Group, critiqued a draft of the policy by writing, “There is a profound difference between the types of unexpected effects from traditional breeding and genetic engineering which is just glanced over in this document.” Dr. Pribyl added that “several aspects of gene insertion may be more hazardous than traditional plant crossbreeding.”

In a January 1992 memo, Linda Kahl, Ph.D., an FDA compliance officer, emphasized the lack of scientific data to recognize the safety of GM foods. “Are we asking the scientific experts to generate the basis for this policy statement in the absence of any data?” she asked. “There is no data that could quantify risk.”

E.J. Matthews, Ph.D., of the FDA’s Toxicology group, warned in an October 1991 memo, “genetically modified plants could also contain unexpected high concentrations of plant toxicants.”

According to Steven M. Druker, J.D., executive director of the Alliance for Bio-Integrity, “Numerous agency experts protested that drafts of the statement of policy were ignoring the recognized potential for genetic engineering to produce unexpected toxins and allergens. But the policy was put into effect despite their scientific judgment that no GM foods can be presumed safe.”

Lawsuit sought mandatory labeling, safety testing

The FDA memos were released in the late 1990s during a lawsuit against the agency led by Druker’s group and a coalition of public interest organizations, scientists, and religious leaders. The suit aimed to force FDA to establish mandatory labeling and safety testing of GM foods.

Druker and the plaintiffs argued that FDA violated the US Food, Drug, and Cosmetic Act, which mandates that new food additives be established safe through testing prior to marketing. Druker says no such tests exist for GM foods.

In 2000 a US District Court ruled against the plaintiffs and upheld FDA’s policy, which remains in effect today.

Druker believes the labeling issue is secondary to the fact that GM foods are on the market illegally. “By merely demanding labeling, it amplifies the impression that these products are legally on the market. As I see it, that’s taking a weaker approach than the facts support and warrant; and it surrenders a lot of leverage.”