Calgene Inc. announced Friday that the safety of its geneticallyengineered Flavr Savr tomato will be considered by FDA's FoodAdvisory Committee on March 9 and 10. The Davis, Calif.,company first petitioned FDA for an advisory opinion on thesafety of the tomato in 1991.
Calgene's chairman and chief executive officer, Roger Salquist,called the announcement "a positive and definitive stepforward." Earlier this month, Calgene reported that it expectedto record a significant loss for 1994 associated with FDA's delayin issuing an advisory opinion. The company then predicted alaunch in the second quarter of 1994. A companyrepresentative said the agency's decision to seek the opinion ofan advisory committee does not change Calgene's estimate ofwhen the decay-resistant tomato will be launched.
The advisory committee will not vote, she noted, but ratherwill render an informal advisory opinion to the agencyfollowing examination of Calgene's data. The company said ithas not submitted any new data to FDA on the tomato sinceSeptember 1993.
The advisory committee will also consider Calgene's foodadditive opinion for its APH(3')II selectable marker gene,which is used in its tomato, cotton and rapeseed oil products.Before introducing its herbicide-resistant cotton strain, thecompany is awaiting approval from both FDA and theEnvironmental Protection Agency (EPA). The company stillneeds approval from the U.S. Department of Agriculture, theEPA and FDA before introducing its rapeseed oil products.
Calgene's stock (NASDAQ:CGNE) closed at $13.25 per share onFriday, up 13 cents.
-- Karl A. Thiel Business Editor
(c) 1997 American Health Consultants. All rights reserved.