Agbiotech companies are applauding Calgene Inc.'s decision tobecome the first company to ask for Food and DrugAdministration marketing approval of a biotechnology-derivedfood.
How the FDA treats Calgene's Flavr Savr tomato, whichcontains an antisense polygalacturonase (PG) gene to extendshelf life and a marker gene for kanamycin resistance, coulddetermine how long it takes to get genetically engineeredfoods to market and influence consumer acceptance of thoseproducts.
Although there are no specific regulations for biotech foods,Roger Salquist, chief executive officer, told BioWorld thatCalgene had no choice about submitting its tomato for approvalon Monday. "The FDA's authority under the Food, Drug andCosmetics Act is very broad," he said.
"I think they're doing the appropriate thing, going through theproper regulatory channels and engendering the trust of thepublic," said Margaret McGeorge, a biotech analyst at Sutro &Co. in San Francisco.
"The kanamycin gene is the single most important issue andthe one the FDA will grapple with the most," McGeorge said. "Ifthey get the FDA to sign off on the kanamycin resistance gene,that could pave the way for that aspect of the approval process(for other companies)."
Ag biotech executives said they are pleased that Calgene, onthe advice of the FDA, asked for an advisory opinion from theagency.
Calgene's other choices would have been to ask forconsideration of its tomato as a food additive or seek approvalunder GRAS (generally recognized as safe) regulations, whichare used for substances that have been in long-term use.
"Most of us feel that many of these products don't raise manyissues that would require food additive or GRAS," said RodTownsend, director of regulatory affairs at Pioneer Hi-Bred inJohnston, Iowa. "The fact that the FDA has directed Calgene totake this course suggests the FDA sees it this way. They couldhave directed Calgene to apply for a food additive petitionstraight off. The fact that they didn't is a good sign."
"Whatever happens in the first or second case will beprecedent-setting," said David Evans, vice president ofbusiness development at DNA Plant Technology in Cinnaminson,N.J. "It will help to clear the situation up in terms of what'snecessary for the regulatory process. Right now, we don't knowif a (review) will take three weeks or three years."
Salquist said it's likely that the FDA will require some sort oflabeling for the tomato. "I could argue very strongly that wewant to label it to show it has added value," Salquist said.
But will consumers eat the tomatoes if they're labeled forkanamycin genes? "People went out in droves to buy softdrinks with NutraSweet in them, and that's a chemical,"Salquist said.
-- Karen Bernstein BioWorld Staff
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