Monday, April 11, 1994
HERNDON, Va. - Generally convinced that Calgene Inc.'s mountain of data has proven the safety of its genetically engineered tomato, an FDA food advisory committee last week focused on the regulatory implications for future food products and the likelihood that a mandatory premarket notification process will be imposed on companies.
While the committee concluded on Friday that CGNE's tomato is safe for marketing, some committee members worried that Flavr Savr's thoroughly documented safety record will encourage lax regulation of future food products that could be more hazardous or less carefully studied than CGNE's product.
At the conclusion of the three-day meeting, FDA Commissioner David Kessler noted that committee members and witnesses expressed concern that companies following Calgene could decide not to notify the FDA nor submit data about their genetically engineered products. To address this concern, the FDA is "doing a lot of thinking" about mandating premarket notification for genetically engineered foods, Kessler said.