First high-GLA safflower oil on market
The first high-GLA safflower oil has reached the market at commercial scale after six years of research and development work by Arcadia Biosciences, Inc. (Davis, California, USA).
With 44% minimum GLA, SONOVA™ 400 delivers 400 milligrams (mg) of γ-linolenic acid (GLA) per gram (g) of oil. Other sources of GLA deliver considerably less, including borage oil (20%), evening primrose oil (10%), black currant oil (15–20%), and hempseed oil (up to 5%).
“We have significant commercial volumes currently available,” said Frank Flider, Arcadia’s vice president of business develop-ment. “In a short time, we will be able to supply a very substantial portion of the world’s current GLA demand. Additionally, we are ramping up to supply new demand that is expected to develop with the availability of this more concentrated and cost-effective source of GLA.”
The market for GLA has suffered in past years from “very inelastic availability,” Flider noted, adding that sudden increases in de-mand caused wild price swings and made it difficult for formulators of finished products to secure adequate supplies at stable prices.
“As a result,” he said, “new product development and research have suffered and very few new products featuring GLA have been introduced over the past several years.”
Metabolic Pathway and Applications
GLA is an omega-6 fatty acid (18:3n-6), synthesized in the body by the action of the ∆-6 desaturase (D6D) enzyme on linoleic acid (LA; 18:2n-6). Because the activity of D6D diminishes as a result of aging, stress, pollution, diet, smoking, drinking, and other activities of daily living, our bodies may produce suboptimal levels of GLA.
Once synthesized or ingested, GLA quickly is elongated to dihomo-γ-linolenic acid (DGLA; 20:3n-6). DGLA is a precursor to two important anti-inflammatory metabolites: prostaglandin PGE1 and 15-OH-DGLA. Many of the favorable effects of GLA are attributed to increased tissue levels of PGE1, which is known to suppress chronic inflammation. The anti-inflammatory benefits of GLA are recognized in medical foods such as Abbott Nutrition’s Oxepa®, which is used to modulate inflammation in sepsis, ARDS (acute respiratory distress syndrome), and ALI (acute lung injury). Although the body of literature concerning the effects of dietary GLA is sparse compared with the burgeoning body of research on omega-3 fatty acids, there is some indication that GLA combined with omega-3 fatty acids may exhibit synergistic effects.
Animal and human studies suggest that dietary GLA may provide relief from rheumatoid arthritis and other inflammatory disorders. GLA has also been found to be helpful in alleviating the effects of atopic eczema, hyperactivity disorders, cyclical mastalgia (premenstrual breast pain), diabetic neuropathy (pain and loss of peripheral nerve function), and high blood pressure.
Dietary GLA has been shown to reduce low-density lipoprotein cholesterol, plasma triacylglycerols, and smooth muscle prolifera-tion. It may also be helpful in treating dry eye conditions. In vitro studies have characterized GLA’s selective cytotoxic effects on more than 30 types of cancer cells. Others have shown evidence of the suppression of breast cancer genes, tumor growth, and metastasis. A study by Marie A. Schirmer and Stephen D. Phinney of the University of California, Davis, USA, showed that GLA helped maintain weight loss for people who had lost weight (Journal of Nutrition 137:1430–1435, 2007).
Recent studies on evening primrose oil have shown that dietary GLA has a measurable effect on skin softness, moisturization, and wrinkle reduction. This has not gone unnoticed by the personal care and cosmeceutical industries and may represent a significant new market for GLA.
In fact, there is a long, documented history of medicinal use of GLA-containing plants such as evening primrose. The Algonquin Indians chewed the seeds and rubbed the seed oil onto flesh wounds, according to Herbal Medicine in Endocrinology and Metabolic Disease (Food Products Press, Binghamton, New York, USA, 2005). The oil was known in Europe as the “King’s Cure All“because of its beneficial properties.
Although GLA does not have a DRI (Dietary Reference Intake), estimations of the amount that constitutes a therapeutic dose range from 500 to 2,000 mg daily. Given that standard 500-mg capsules of evening primrose oil contain only 50 mg of GLA, the attractions of an oil that contains 44% GLA become immediately apparent.
Development of High-GLA Safflower
The high-GLA safflower plant was developed through a combination of plant breeding and biotechnology.
As Flider previously noted (inform 16:279–282, 2005), Calgene LLC developed transgenic canola oil varieties containing as much as 43% GLA. (Calgene was a biotech research and development company in Davis, California, USA, that Monsanto Co. acquired in 1996.)
“This was accomplished by introducing ∆-6 and ∆-12 desaturase genes from the fungus Mortierella alpina into canola cells,“Flider writes. “. . . Despite the fact that Calgene conducted several generations of field trials on high-GLA canola varieties, for reasons not made public, the product was never commercially produced.“
Why safflower for the next attempt? Most safflower already is produced in defined growing regions throughout North America by contract farmers, making identity preservation easier to achieve. Because safflower is self-pollinating, pollen drift is minimal and identity preservation is improved relative to canola.
A further disadvantage of canola as a platform is the presence of significant quantities of α-linolenic acid (ALA; 18:3n-3). Production of stearidonic acid (18:4n-3) at the expense of GLA is possible in canola because ALA competes with LA for ∆-6 desaturase activity.
Cost and Market
SONOVA 400 is being marketed and distributed by Bioriginal Food & Science Corp., Saskatoon, Saskatchewan, Canada, in partnership with Arcadia.
In support of its commercialization program, Arcadia successfully completed the US Food and Drug Administration (FDA) regulatory process for GLA safflower in December 2009. Following established procedures for New Dietary Ingredients in Dietary Supplements, the FDA reviewed and acknowledged extensive data supporting the safety of GLA safflower, allowing it to be marketed and sold as an ingredient in dietary supplements.
“We have petitioned Canada but have not yet started on other geographies,” said Flider. “We are exploring regulatory requirements for Europe and Japan as well as other Asian and South American countries, but at this point have taken no formal action. We hope to be able to offer SONOVA 400 worldwide within a few years.
“Typically, the cost involved with doubling the concentration of an active component will result in a per-unit price very signifi-cantly higher than two times,” Flider said. “Because it isn’t necessary to fractionate or concentrate the GLA through physico-chemical means, the per-unit GLA price for SONOVA 400 will be reasonably competitive with borage oil GLA.
“SONOVA 400 is the first in what we hope to be a line of nutritional and functional oils developed by Arcadia,” he continued. “As we have lines of GLA safflower producing oil in excess of 65% GLA, more concentrated versions of SONOVA GLA oils can be expected in the foreseeable future.”
Catherine Watkins is associate editor of inform and can be reached at email@example.com.