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The Flavr Savr Arrives

Brad Stone
(202) 205-4144
Food and Drug Administration
May 18, 1994

On May 18, 1994, the Food and Drug Administration announced that the Flavr Savr, a new tomato developed through biotechnology, is as safe as tomatoes bred by conventional means. This is the first time the FDA has evaluated a whole food produced by biotechnology, a science that can make plant improvements with more precision than traditional cross-breeding.

The finding that Flavr Savr tomatoes are as safe as their traditionally developed counterparts follows FDA approval in 1990 of the first biotechnology food products, chymosin, a milk-clotting agent for making cheese.

"We have approached our review of this product with scientific rigor and a commitment to full, public disclosure of that science," said FDA Commissioner David A. Kessler, M.D. "Consumers can be confident that we remain committed to assuring that foods produced by genetic engineering are as safe as food in our grocery stores today."

The finding was accompanied by a new food additive regulation allowing the use of an enzyme encoded by a marker gene called the kanamycin resistance or kan-r gene. The kan-r gene confers resistance to the antibiotic kanamycin, allowing early identification of plant cells successfully modified with a new trait. The FDA is publishing in the Federal Register a food additive regulation allowing the use of the enzyme encoded by the kan-r gene in new varieties of these plants.

The FDA's review of the Flavr Savr was requested by the tomato's developer, Calgene Inc. of Davis, California, in August, 1991. The company later submitted a food additive petition on the use of the kan-r gene in the development of new varieties of tomato, cotton, and rapeseed. In 1992, the U.S. Department of Agriculture granted Calgene permission to begin large-scale production of the new tomato.

Last month, FDA's approach to evaluating the safety of the Flavr Savr was discussed in a public meeting by outside experts of the agency's Food Advisory Committee. Members of the panel concurred with the FDA's preliminary assessment that all relevant safety questions about the new tomato had been resolved.

The FDA has not found it necessary to require special labeling for Flavr Savr tomatoes, since it maintains the essential characteristics of traditionally developed tomatoes. However, the company has notified the agency that it plans to provide point-of-sale information for consumers about the development of the new product through genetic engineering.

The FDA is one of eight Public Health Service agencies in the Department of Health and Human Services.


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