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