Arcadia Biosciences Release: Biotech Obtains FDA GRAS Status For SONOVA GLA Safflower Oil
Published: Jan 10, 2017
-- GRAS Notification Expands Application Options for Nutritional Oil Rich in Gamma-linolenic acid (GLA) for Uses in Nutritional Beverages and Medical Foods --
DAVIS, Calif.--(BUSINESS WIRE)--Arcadia Biosciences, Inc. (Nasdaq: RKDA), an agricultural technology company, announced today that the U.S. Food and Drug Administration (FDA) has accepted Arcadia’s conclusion that its SONOVA® GLA safflower oil is “generally recognized as safe” (GRAS) for use in nutritional beverages and medical foods.
Arcadia produces GLA safflower nutritional oils with high concentrations of gamma-linolenic acid (GLA). These oils are marketed by Arcadia under the SONOVA® brand and are currently used in nutritional supplement products. GLA is a nutritionally important omega-6 fatty acid that helps support the body’s anti-inflammatory response and is especially useful for managing weight, improving skin health and maintaining hormonal balance for women. When used in combination with the omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), GLA has been shown to support heart and eye health.
“This FDA GRAS notification expands the application options for Arcadia’s SONOVA® GLA safflower oil, opening adjacent markets for our customers in nutritional beverages and medical foods,” said Raj Ketkar, president and CEO of Arcadia Biosciences. “By providing our customers with oil containing two to three times the concentration of other sources of GLA, we expect our proprietary SONOVA® GLA safflower oil to provide important health benefits at a superior cost position.”
Arcadia followed FDA-proposed procedures to establish its SONOVA® GLA safflower oil as GRAS under the intended conditions of use. This process included convening an expert panel to review the necessary product safety data and then submitting a notification to the FDA.
SONOVA® GLA safflower oil is produced in the United States under strict identity preservation protocols and is currently available in several forms, including bulk oil, soft gels and powder. SONOVA® 400 GLA Safflower Oil contains 40 percent GLA, four times the concentration of evening primrose oil and twice the concentration of borage oil. SONOVA® ULTRA GLA Safflower Oil contains 55 percent GLA.
For samples and more information, visit www.SonovaGLA.com.
About Arcadia Biosciences, Inc.
Based in Davis, Calif., Arcadia Biosciences (Nasdaq: RKDA) develops agricultural products that create added value for farmers while benefitting the environment and enhancing human health. Arcadia’s agronomic performance traits, including Nitrogen Use Efficiency, Water Use Efficiency, Salinity Tolerance, Heat Tolerance and Herbicide Tolerance, are all aimed at making agricultural production more economically efficient and environmentally sound. Arcadia’s nutrition traits and products are aimed at creating healthier ingredients and whole foods with lower production costs.
Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the company’s traits and the regulatory process for such traits. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: the company’s and its partners’ and affiliates’ ability to identify and isolate desired traits; the company’s and its partners’ ability to develop commercial products incorporating its traits, and complete the regulatory review process for such products; the company’s compliance with laws and regulations that impact the company’s business, and changes to such laws and regulations; the company’s future capital requirements and ability to satisfy its capital needs; and the other risks set forth in the company’s filings with the Securities and Exchange Commission from time to time, including the risks set forth in the company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2016 and other filings. These forward-looking statements speak only as of the date hereof, and Arcadia Biosciences, Inc. disclaims any obligation to update these forward-looking statements.
Arcadia Biosciences, Inc.