May 3, 2000 / U.S. Department of Health and Human Services
The Food and Drug Administration (FDA) announced today 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 all foods.
"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 feed. 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.
(posted without permission)
