The Food and Drug Administration (FDA) announced on 03 May 2000 plans to
refine its regulatory approach regarding foods derived through the use of
modern biotechnology. The initiatives unveiled stem in part from input
received during FDA's public outreach meetings held late last year and
build upon programs already underway at FDA to help ensure the safety of
"FDA's scientific review continues to show that all bioengineered
foods sold here in the United States today are as safe as their non-
bioengineered counterparts, "said Jane E. Henney, MD, Commissioner of
Food and Drugs. "We believe our initiatives will provide the public with
continued confidence in the safety of these foods."
FDA will publish a proposed rule mandating that developers of
bioengineered foods and animal feeds notify the agency when they intend
to market such products. FDA also will require that specific information
be submitted to help determine whether the foods or animal feeds pose any
potential safety, labeling or adulteration issues.
Although the current consultative process has worked well, and the agency believes it has been consulted on all bioengineered foods and
feeds currently on the market, FDA will propose to strengthen this
process by specifically requiring developers to notify the agency of
their intent to market a food or animal feed from a bioengineered plant
at least 120 days before marketing. After reviewing the company's
submission, FDA will issue a letter to the firm describing its conclusion
about the regulatory status of the food or animal feed. To make sure
that consumers also have access to product information, FDA will propose
that submitted information and the agency's conclusions be made available
to the public, consistent with applicable disclosure laws, by posting
them on the FDA Web site for easy viewing.
In a related step, the agency will augment its food and veterinary
medicine advisory committees by adding scientists with agricultural
biotechnology expertise. FDA will use these committees to address over-
arching scientific questions pertaining to bioengineered foods and animal
FDA also announced today plans to draft labeling guidance to assist
manufacturers who wish to voluntarily label their foods being made with
or without the use of bioengineered ingredients. The guidelines will
help ensure that labeling is truthful and informative. To receive
maximum consumer input, FDA will develop the guidelines with the use of
focus groups and will seek public comment on the draft guidance.
For more information, visit the FDA's Web site at www.fda.gov. Watch the site for future information for the public regarding bioengineered foods.