Monsanto completes FDA consultation process for Vistive? Gold Soybeans

The U.S. Food and Drug Administration (FDA) notified Monsanto (NYSE: MON) that the biotechnology consultation process for MON 87705, a key component of the company’s Vistive® Gold soybeans that produce a high-oleic, low-saturate, low-trans fat soybean oil, has been completed. Conclusion of the consultation with FDA completes one of the key regulatory steps to allow for full commercial introduction of Vistive Gold soybeans.

Vistive Gold soybeans, which contain the low-saturate, high-oleic trait will enable food companies to produce foods made with soybean oil to have lower saturated fat levels and maintain low levels of trans fat.

Consumers and farmers will benefit from this product, which was developed with input from the food and nutrition communities, said Joe Cornelius, Monsanto’s global technology lead for food quality traits.

"Vistive Gold soybeans will give farmers an opportunity to produce nutritionally improved soybean oil for food companies and consumers,” Cornelius said. “Monsanto is continuing to provide innovations to the soybean oil market and help growers create additional value within the food supply chain.”

Vistive Gold soybeans represent one of the first crops developed through the combination of biotechnology and traditional breeding that enable farmers to help food companies bring direct health benefits to consumers. Vistive Gold soybeans have 85 percent less saturated fat than palm oil, 70 percent less saturated fat than fry shortening and 60 percent less saturated fat than conventional soybean oil.

Vistive Gold soybeans will be commercialized after receipt of appropriate regulatory approvals. The soybeans will be combined with Genuity® Roundup Ready 2 Yield® soybeans, giving farmers an increased yield opportunity in addition to providing the nutritionally improved oil.

"Food companies continue to look for ways to eliminate trans fats and reduce saturated fat, and Vistive Gold soybean oil is an excellent option that is more economical, sustainable and nutritionally desirable than current solutions,” Cornelius added.

Monsanto initiated the biotechnology consultation with FDA in November 2009. In May 2010, FDA issued a positive response letter to Monsanto's Generally Recognized as Safe (GRAS) notification for the oil from these soybeans. The completion of the FDA consultation process supports the use of oil from Vistive Gold soybeans under the intended conditions of use, which enabled food companies to develop and evaluate foods that contain this nutritionally improved oil. Monsanto petitioned the U.S. Department of Agriculture for non-regulated status of high-oleic soybeans in June 2009. The petition is currently under review.

Monsanto has also made submissions for import approval in key export markets. Upon commercialization, food companies will be able to purchase this new food oil from Vistive Gold soybeans and sell food products prepared with this nutritionally improved oil.

To learn more about Vistive Gold, visit www.vistive gold.com.