Solae and Monsanto Reach Regulatory Milestone on Omega-3 Soybean Oil

The U.S. Food and Drug Administration (FDA) issued a Generally Recognized as Safe (GRAS) notice confirming that the SDA omega-3 soybean oil could be used under the intended conditions of use.

27 Oct 2009 --- In keeping with a commitment to deliver innovations for agriculture, food companies and consumers, Monsanto Company and Solae, LLC have announced that the companies have reached an important regulatory milestone that advances the development of foods containing the world’s first stearidonic acid (SDA) omega-3 soybean oil product.

The U.S. Food and Drug Administration (FDA) issued a Generally Recognized as Safe (GRAS) notice confirming that the SDA omega-3 soybean oil could be used under the intended conditions of use. 

The confirmation of GRAS status enables food companies to develop and test foods containing the new omega-3 oil, which are important steps towards consumers being able to benefit from this omega-3 product in a variety of food products with an acceptable taste experience. 

Consumer demand for omega-3 fatty acids is growing as research continues to demonstrate that diets rich in omega-3 fatty acids help play an important role in maintaining health, including heart health.

“Consumers are increasingly looking for ways to improve health through better nutrition,” said Al Gallegos, marketing and sales director for omega-3 – Solae.  “One approach food companies are taking is incorporating omega-3s into food and beverage products.  The development of this new, plant-based omega-3 soybean oil can play an important role in helping food companies achieve this objective.”

Monsanto developed the soybean product that produces oil containing SDA, an omega-3 fatty acid.  Earlier this year, the company completed U.S. regulatory submissions to the U.S. Department of Agriculture (USDA) and FDA for the product that produces a sustainable, land-based source of SDA omega-3 soybean oil.  Upon completion of the regulatory process, food companies will be able to purchase this new food oil and deliver its benefits to consumers.

“As the population expands and consumer demand for healthier foods grows, this product could offer farmers and the food industry an opportunity to help meet this growing demand in a sustainable manner,” said Roy Fuchs, Monsanto’s global technology lead for oilseeds. “This soybean trait will be one of several value-added traits Monsanto is working hard to launch that will directly benefit consumers and the food industry.”

Currently, the only significant source of long-chain, omega-3 fatty acids are fish and algal oils, which are expensive and difficult to incorporate into food products.  The new omega-3 soybean oil would enable food manufacturers to enhance the nutritional benefits of a broad range of food products because of its preferred sensory qualities and functional performance in familiar food and beverage applications.  Monsanto and Solae are actively seeking food application partnerships with companies interested in delivering food products to consumers with this improved oil.

“Evidence strongly suggests that increased consumption of dietary omega-3 fatty acids could have major health benefits,” said Eric Decker, Ph.D., Professor and Department Head of Food Science at the University of Massachusetts Amherst.  “The availability of a new high quality, sustainable source of nutritionally active omega-3 fatty acids would be a useful food ingredient that could be extremely beneficial to consumers.”

Monsanto and Solae announced in 2007 an agreement to develop and market Omega-3 products for a rapidly growing market. The agreement combines each company's unique strengths to deliver innovation to consumers.