New research supporting a laundry list of potential health benefits, alongside growing consumer awareness, has propelled an advancing market for essential fatty acids (EFAs), presenting significant product opportunities, and challenges, especially in the functional food and beverage arena.
While the human body cannot produce EFAs naturally, as cellular building blocks, they are critical to general health and must be obtained through the diet.
The three most recognized EFAs-and perhaps the most rigorously studied-include the omega 3s eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) and alpha linolenic acid (ALA). The body partially converts ALA-a short chain omega 3-into EPA and DHA, its long chain derivatives.
Found mainly in oils of cold-water fish like mackerel, halibut, herring, salmon and tuna, industry professionals have also recognized significant EPA and DHA levels in krill, as well as seal oil. Common sources of ALA include flax, algae, hemp, dark green vegetables and nut oils.
Gamma linolenic acid (GLA), a beneficial omega 6 fatty acid derived from evening primrose, borage, black currant and safflower oils, also has noteworthy potential. However, it has had to battle negative press surrounding arachidonic acid (AA), an over-consumed omega 6 that has been shown to lead to inflammation.
Overall, consumers have come to recognize the importance of EFAs, specifically buying into the omega 3 ingredient market, which has increased by 149% since 2001, with an average annual growth rate of 25% over the last six years, according to a recent report from Leatherhead Food International, Surrey, U.K.
"Retail sales of omega 3 supplements, omega 3 enriched foods, drinks and infant formula in the U.S. and EU amounted to over $7.5 billion in the year ending June 2007," said Karen Chen, marketing manager, Health Care, Croda Inc., Edison, NJ, citing the Leatherhead study.
Packaged Facts, Rockville, MD, predicts that U.S. retail sales of foods and beverages enriched with omega 3s will reach more than $7 billion by 2011.
Recently, analysts from Frost & Sullivan, San Antonio, TX, predicted the omega 3 market in Europe would witness a 24% compound annual growth rate (CAGR), topping $1.3 billion by 2014. While dietary supplements are currently the leading application with about 78% market share in Europe, analysts argue functional foods and beverages-which currently retain 13% market share-could grow to the same level, and possibly eclipse supplements in the future.
Experts often cite increased consumer understanding as a principal reason for the skyrocketing EFA market. "Consumer awareness of omega 3 fatty acids is exponentially greater than in years past," said Sarah London, Marketing, Omega Protein, Houston, TX. "The Natural Marketing Institute (Harleysville, PA) published a report in 2008 indicating more consumers felt they were deficient in omega 3 fatty acids than any other nutrient, including fiber and calcium. This feeling of inadequacy will translate into market potential as consumers seek out functional foods rich in EPA and DHA to satisfy their perceived deficiency."
Rob Bailey, marketing manager, Cognis Nutrition & Health, La Grange, IL, agreed, adding that concern about levels of mercury and other contaminants found in fish has left many looking for an alternative. "All market research forecasts indicate consumption rates will continue their double-digit increases," Mr. Bailey said. "Driving that demand is an aging population and consumers eager to take control of their own healthcare. Overall, we believe consumer awareness is high; however, more education is needed on the powerful health benefits of marine-sourced omega 3s."
In a similar vein, Doug Brown, senior marketing manager, DSM Functional Foods Marketing, Parsippany, NJ, said understanding is "approaching saturation levels in the U.S., with awareness nearing 90% and a correspondingly high awareness of cardiovascular and brain health benefits. However, consumer ability to differentiate between the various forms of omega 3s is much lower."
For example, the average end-user doesn't understand the conversion of ALA into EPA and DHA. And this is a basic yet important fact, as Ms. London explains. "During this elongation process, much of the EPA and DHA is compromised leaving only 1-3% for absorption," she said. "Algae sources, while an adequate source of DHA, do not contain any significant amount of the essential nutrient EPA, which is important for reducing inflammation, as well as improving vasodilatation (widening of the lumen of blood vessels) and blood platelet function."
"The most efficient absorption of EPA and DHA is from a direct source like fish oil," she added.
Ian Lucas, executive vice president, Ocean Nutrition Canada, Dartmouth, Nova Scotia, Canada, also said consumers have limited understanding of the differences in the forms of omega 3s and how much they need in their diets on a daily basis. In the North American market, he added, consumer confusion stems from many food products containing ALA, which simply claim on the label that they contain omega 3.
"Since consumers don't fully understand the differences, they are purchasing these products without realizing the full nutritional value of EPA and DHA," Mr. Lucas said. "This is primarily a North American issue because of the large flax industries in western Canada and the U.S. Midwest."
While consumers may only have a general understanding about EFAs and their health benefits, that has been enough to influence their purchase of omega 3 products.
"Consumption rates have grown dramatically, and over the last five years the market in both North America and Europe has grown over 30%," said Mr. Lucas. "In fact, it is estimated that 8% of Americans are taking fish oil soft gels every day."
With impressive growth comes strong competition, according to Scott Fabro, omega 3s product manager, Cargill, Minneapolis, MN. "Product quality, proper technical knowledge and customer support are keys to the success of new product development," he said. "We see the opportunity to provide our omega 3s to consumers of all ages with a lifetime of healthy eating, adding back the omega 3s that were lost in our diets."
The library of research on the health benefits of omega 3s demonstrates an incredible range of applications for public wellness. In fact, over the course of several decades more than 8000 human clinical trials have been conducted and 14,000 research papers published supporting the positive effects of omega 3 fatty acids.
Consumer research conducted by HealthFocus International (St. Petersburg, FL) in 2004, showed that seven of the top 15 health concerns in the U.S. had associated benefits with omega 3, according to Cognis' Mr. Bailey. "These included cardiovascular, brain/cognitive, arthritis, eye, depression and mood health," he said. "All of these have high consumer awareness and supporting science to provide substantial opportunities for manufacturers."
In 2000, FDA approved a qualified health claim for the reduced risk of heart disease on packaging of dietary supplements. The claim reads: "Supportive but not conclusive research shows that consumption of EPA and DHA omega 3 fatty acids may reduce the risk of coronary heart disease." Sales of fish oil supplements have surged 500% since the claim was approved, according to Nutrition Business Journal (NBJ), Boulder, CO. FDA allowed a similar claim for conventional foods and beverages containing EPA and DHA in 2004, helping to propel that segment as well.
Beyond heart and brain health, Mr. Bailey said, "We can expect to see the science emerge in other areas, including eye health, inflammation, asthma, allergies and rheumatic disorders."
Published research also indicates that EFAs may have a positive influence on children with neurodevelopmental and psychiatric disorders, such as dyslexia and attention deficit hyperactivity disorder (ADHD).
For instance, the landmark 2005 Oxford-Durham study-a randomized, controlled trial-evaluated the dietary supplementation of omega 3 and 6 fatty acids in 117 children (5-12 years of age) with developmental coordination disorder (DCD). Three months of treatment showed significant improvements in reading, spelling and overall behavior.
DHA accounts for about 20% of total brain mass, and is viewed as important throughout the lifecycle, contributing to both brain and eye health. But it is seen as particularly important between birth and five years of age, when the brain increases approximately three-and-a-half times in mass, and DHA content increases from 1 gram to approximately 4.5 grams.
Still, industry executives continue to debate whether or not the various omega 3s should be associated with a specific health benefit.
Ocean Nutrition's Mr. Lucas said there is a "real dietary deficiency for these essential nutrients," at all stages of life. "We believe it's important to position omega 3 EPA and DHA for total wellness so that products don't get niche positioned into disease treatment. Really, these are cradle-to-grave nutrients everyone should have access to, so it is vital that consumers find relevance for all members of the family."
"While Martek is interested in the effect DHA has on health at all ages, we are particularly interested in how DHA may protect cognition in the elderly," said Sheila Gautier, project manager, Martek Biosciences, Columbia, MD. "Currently there are two large clinical trials underway using life'sDHA to test its ability to slow the progression of Alzheimer's disease (AD) and its ability to slow the cognitive decline associated with aging."
According to Baldur Hjaltason, sales manager for North America, Japan and China, EPAX, Aalesund, Norway, a recent survey of U.S. Baby Boomers suggested they worry most about memory loss-even more than having a heart attack or cancer. "There are strong indications that you need DHA all your life to replace the DHA that becomes damaged or destroyed," he said. "EPAX took part in a study to see if DHA-enriched omega 3 concentrate could positively affect the development of cognitive decline in the early stages of AD. This study was done at Karolinska Institute in Sweden where (174) patients were randomly allocated to treatment with EPAX 1050TG (which contains 50% DHA) or placebo for six months. The results have been published and show that the onset of AD can be slowed by adding high DHA sources to your diet."
Sam Wright IV, CEO of The Wright Group, Crowley, LA, offered words of caution for those connecting clinical science with health claims. "Marketers must be careful not to treat EFAs and omega 3 specifically as cure-alls. A recent survey we conducted at a number of health food stores in the Chicago area yielded a list of 34 separate conditions that could be prevented or treated using omega 3s," he said. "In marketing, if you stand for too much, you do not stand for anything. Credibility must not be sacrificed on the altar of market growth."
Cause for Concern?
Not all the news surrounding the EFA market has been glowing. Recently, Muller Dairy, Shropshire, U.K., removed the marine-sourced omega 3 ingredient from its Vitality yogurt line-which also contained pre- and probiotics-citing consumer skepticism.
Specifically, they didn't trust the product's efficacy, believing dose levels were inadequate and health claims were misleading or not science-based, according to the company.
Unilever, London, U.K., has also discontinued drinkable and regular yogurt products from its Omega-3 Plus line in European markets and removed omega 3 from its plant sterol-infused, cholesterol-lowering Flora/Becel Pro.activ products.
For a company like Martek, which has already laid its claim on the infant formula market, the functional food and beverage category continues to offer significant growth opportunities.
However, a recent article in the Chicago Tribune, headlined "Martek's Brain Food Suffers Arrested Development," questioned the company's progress in this segment-despite impressive growth overall-noting that many of Martek's customers are smaller health-food companies, meaning lower return per product sold.
Martek spokesperson Cassie France-Kelly responded to the article, saying, "While this story summarizes some of Martek's challenges of expanding into the food and beverage business, we believe that our customers represent some of the most respected names in the industry," including Coca-Cola, General Mills and Dean Foods.
In 2005, Martek announced a supply deal with Kellogg Co., Battle Creek, MI, which agreed to explore the use of DHA in its products, but without committing to a minimum purchase requirement. As of yet no products have emerged from the deal.
"We enjoy a good relationship with Kellogg and continue to work with them, as we do with all of our food and beverage partners," Ms. France-Kelly said.
"In 2006, our food and beverage revenues were $1.4 million," she added. "In FY 2007 they were $5.5 million-a more than 200% increase. So far in the first half of FY 2008, we've reported $5.3 million in food and beverage and we are optimistic about our continued growth in this category. As we approach the launch of the 100th product with life'sDHA, we believe that the numbers and the continued product launches speak for themselves. We now have products in multiple categories-yogurt, bread, cheese, milk, soymilk, baby food, baby cereal, juices, bars, eggs, chocolate, cooking oil-and are constantly improving our processes and products and developing new food formulation technologies."
While dietary supplements remain a highly sought after application for EFAs, omega 3-enriched foods and beverages are emerging from a natural food niche and entering a more mainstream market.
With regard to the latter, Jan Haakonsen, vice president, Sales & Marketing, Denomega Nutritional Oils, Gamle Fredrikstad, Norway, commented, "I am a strong believer in the rapid adjustments American consumers make when they digest new news. They want to do the right thing and taking omega 3 as part of the meal is quickly becoming the right thing to do. I suspect data over the next few years will support significantly faster growth for this delivery method over the more established supplement formats."
Mary Ann Siciliano, national sales manager, Arista Industries, Wilton, CT, offered another perspective. "There is great potential for EFAs to be used in food, but stability, odor and taste continue to be a problem. The best form for consumption continues to be encapsulated products, as in these closed systems the EFAs remain stable. "
Manufacturers are making strides to overcome formulation challenges, according to Mark Brudnak, PhD, executive vice president, Technology, MAK Wood, Inc., Grafton WI. "Microencapsulation is the buzz word for EFAs," he said. "The issues of stability and flavor can both be addressed with this technique. Further, companies such as ours have done a large amount of work on making various EFA products water-soluble. The old dogma of oil and water not mixing is no longer true. We can easily mix the two and do so with long-term stability and with great flavor profiles customized to each company."
The array of different technologies available has created a ripe market for EFA fortification, said The Wright Group's Mr. Wright. "The range of foods and beverages containing EFAs is expanding at many times the rate of supplements since the possible vehicles are so numerous in comparison," he said. "As the supplement and functional food/beverage categories continue to converge, however, we will see more products such as 'shots,' bars, tonics, confections and chews that have one foot in each industry. The products will be categorized by their intended use more than by the product form. There is a growing trend toward more food-like products to achieve supplementary nutritional benefits."
"From the customers we deal with, we've seen popularity rise in drinks, smoothies and snack bars and products geared toward adults," said Kat Frey, marketing director, AHD International, Atlanta, GA.
DSM's Mr. Brown said high quality formats such as oils and powders that have excellent stability and sensory characteristics can be easily folded into existing consumer products. "DSM produces extremely high quality ROPUFA 30 food oil and ROPUFA food powders and emulsions that allow manufacturers to easily incorporate omega 3s into nearly any food product without influencing taste or stability of the existing product," he said.
Companies have also started developing products that combine omega 3s with complementary ingredients to offer a synergistic health impact.
Researchers at Hormel Specialty Products, a division of Hormel Foods, Austin, MN, have recently developed a patented formulation that combines omega 3 fish oils and natural plant phytosterols. It is designed to lower "bad" LDL cholesterol, according to Chet Rao, PhD, sales and marketing manager. The company's Eterna omega 3 fish oils can be incorporated into a variety of food products at "efficacious levels," he said.
Things are also looking up on the quality front. In late July, the omega 3 market got a vote of approval from ConsumerLab.com, White Plains, NY, which conducted tests of 50 fish oil supplements, fortified foods and beverages, concluding that all were free of contaminants often found in fish, such as mercury, lead and PCBs.
Amounts of EPA and DHA ranged from as little as 16 mg in a container of yogurt to 1000 mg in a single pill. All products contained their claimed amounts of EPA and DHA without signs of spoilage, according to the analysis.
Krill & Other Sources
While industry professionals continue to debate the benefits and failings of various EFA sources, one tiny sea creature is beginning to make a big splash: krill.
"Speaking as a scientist, I believe krill is the best source of omega 3 EPA and DHA," said Tina Sampalis, MD, PhD, CSO, Neptune Technologies & Bioressources, Laval, Quebec, Canada, which manufacturers Neptune Krill Oil (NKO). "Looking specifically at the biomass itself, krill is at the bottom of the food chain. Nutrients in krill have retained many biological properties lost if you go higher up the food chain."
Toni Rinow, PhD, corporate development and investor relations with Neptune, said consumers are showing greater interest in "premium products" with higher concentrations of omega 3s. "They are becoming more educated and you need to develop targeted products with specific benefits."
After laying the groundwork over the last decade, Dr. Sampalis said, "We have overcome the barriers that other companies are still trying to solve. And we offer a therapeutic dose that is backed up by clinical research."
With U.S. GRAS (Generally Recognized as Safe) status in hand, the company awaits Novel Food approval in Europe. Having signed research collaborations with Yoplait and Nestlé, commercial food and beverage products containing NKO should be forthcoming. Ultimately, Dr. Sampalis is pushing toward the development of a more potent product that will go all the way to the pharmaceutical market.
As interest in krill continues to expand, researchers at Memorial University of Newfoundland in Canada may have also unlocked potential in seal oil. While human testing is not yet underway, scientists claim seal oil contains fewer unwanted saturated fats and is more easily absorbed by the body than fish oil. However, as the sealskin trade remains a source of controversy, the jury is still out on how big an impact, if any, seal oil supplements can make in the global EFA industry.
Still, some companies stress that vegetarian-sourced omega 3 ingredients offer additional benefits for food and beverage formulators. Richard Staack, PhD, vice president, Product Development & Research, Avatar Corporation, University Park, IL, said the company's ProEssential omega 3 flax ingredients are produced by proprietary processes, which yield fully-fatted, highly-stable powders and highly-concentrated oils. Its flaxseed powder has a non-refrigerated shelf-life of more than 22 months and also provides a source of dietary fiber and natural lignans.
Taking another approach to market, AHD recently introduced Luravida, a branded cranberry omega 3 oil, which is extruded from the oil found in cranberry seeds. It has an equal ratio of omega 3 and omega 6, according to AHD's Ms. Frey, and can be applied to supplements, foods and beverages. The company also offers a chia seed oil. With some questions lingering about the current health of fisheries, supplying ingredients that are renewable and sustainable "puts us a step ahead," she said.
Manufacturers have demonstrated interest in oils that have high levels of omega 3, 6 and 9, according to MAK Wood's Mr. Brudnak, which also offers cranberry and chia seed oils. "The issue of stability seems to be solved by these two oils in a two-fold manner. First, they both come from small, round seeds that are not subject to crushing and hence oxidation during growth, harvest, storage or processing. Second, products such as cranberry seed oil are naturally high in all eight isomers of vitamin E, thus enabling manufacturers to avoid adding compounds to stabilize the products. Refrigeration and/or freezing are no longer required."
GLA: The Good Omega 6
While omega 3s have dominated the EFA market, omega 6 sourced from a new variety of safflower is in a unique position. Arcadia Biosciences, Davis, CA, an agricultural technology company, and Bioriginal Food and Science Corp., Saskatoon, Saskatchewan, Canada, a global provider of EFA solutions, recently partnered to develop and market "High GLA safflower oil" that contains 40% GLA; it is the first genetically modified oil developed specifically as a human nutritional product. Under the agreement, Arcadia will produce high GLA safflower oil and Bioriginal will have exclusive marketing and sales rights.
Clinically validated benefits of GLA include anti-inflammatory effects and improved skin health and appearance. Recent research indicates GLA supplementation may also play a key role in maintaining weight loss.
Currently, evening primrose oil and borage oil are the two main sources of dietary GLA, but only contain 10% and 20-23% GLA respectively.
Arcadia's product is in late commercialization stages, according to Ken Ardisson, business manager, Specialty Nutritionals. He said he expects the product to be commercially available early in the first quarter of 2009.
"GLA has very much been a boutique type of ingredient," he said. "But we have the ability to bring a consistently reliable source of GLA to the market-and in a significantly higher concentration."
Cam Kupper, vice president of sales, North America, Bioriginal, said there is significant potential in the synergy between GLA and EPA. "That will drive a lot more product development and interest from the research community," he predicted. "There are dozens of clinical research studies that have put GLA and EPA together."
Mr. Ardisson said his company's focus early on will be the supplement market, but in the long-term (three to five years) GLA's advantages will become more apparent for functional food and beverage applications.
"I see significant potential in personal care and cosmetic applications," he noted. "There is substantial data that show the efficacy of GLA in reduction of transdermal water loss and improvement in elasticity of the skin. There's big market potential and it fits very nicely into marketing-'beauty from within and without, topically and orally.'"
GOED Fights for Intake Levels
Despite a rapidly advancing EFA market and a host of clinical trials validating the importance of these nutrients, there are no authoritatively recognized daily intake levels for EPA and DHA in the U.S.
On top of this, FDA has proposed a final rule to prohibit nutrient content claims on products containing omega 3s on the basis that the Institute of Medicine (IOM) has not identified a daily required or recommended nutrient level for EPA and DHA. Currently, companies can claim a product is an "excellent source" of omega 3s if it contains at least 32 mg EPA/DHA.
In response to FDA's proposal, the Global Organization for EPA and DHA Omega 3 (GOED)-a trade association of more than 50 companies united in growing the omega 3 market-submitted legal arguments defending the use of nutrient content claims. GOED is also urging the agency and the IOM to review the clinical research on omega 3s and make appropriate intake recommendations.
The last such IOM assessment cited research through 2001, according to Adam Ismail, GOED executive director. Information published since that time would better inform the evaluation, he noted. "There is a significant body of scientific evidence that hasn't even been assessed yet," he said.
According to a written statement from GOED, the group said it "strongly believes the best path forward, and to allow consumers to make the informed choices intended under NLEA (Nutrition Labeling and Education Act of 1990), is for the FDA and/or the IOM to make a determination about the required levels of these two vital nutrients for consumers to help prevent chronic diseases."
Formally petitioning IOM to review the matter is one option, but realistically, the institute's staff is limited, making a review unlikely, Mr. Ismail said. Alongside advocacy of omega 3s in the context of global regulatory affairs, which includes unqualifying the current health claim in the U.S., one of GOED's missions is to educate consumers.
Meanwhile, the lack of recognized daily intake levels has led to criticism of foods and beverages fortified with omega 3s-spurring consumer skepticism about whether or not these products actually contain efficacious doses.
While opinions vary on appropriate omega 3 levels, according to Omega Protein's Ms. London, research has shown the dietary intake of 400-1000 mg of EPA and DHA daily will positively impact an individual's health. "Most functional foods containing omega 3 have 32-50 mg of EPA and DHA per 100 gram serving," she said. "By consuming three to four servings of omega 3 rich foods as well as a dietary supplement, consumers will meet this daily guideline."
For the future, many argue that establishing clear guidelines for consumers, based on clinical evidence, is in everyone's best interest. "The current U.S consumption of omega 3s via the typical U.S diet is only 80-100 mg per day compared to 1200 mg in the typical Japanese diet," said The Wright Group's Mr. Wright. "We believe the American population, as over-nourished as we are in many ways, is seriously deficient in these important nutrients. We spend over $2 trillion per year on healthcare-98% of which is for treating, not preventing illness. It's time to take prevention more seriously from a purely economic standpoint."