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EFAs: This is No Fish Story

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Omega-3s have weathered storms and are still full speed ahead.

Essential fatty acids (EFAs) are today among the most popular and widely used ingredients for finished products and food fortification in the U.S. and globally. They enjoy broad support by consumers, public health agencies and medical bodies.

In 1929, the essentiality of alpha linolenic acid (ALA)—the precursor of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)—was established by Burr and Burr at the University of Minnesota Medical School.

In 1982, the first reported instance of omega-3 deficiency in humans was unveiled, although earlier reports in infants and adults dating back to 1969 laid the foundation for this discovery. And in that 1982 medical case published by Ralph Holman and colleagues from Illinois’ Carle Foundation Hospital, visual complications and sensory loss in a six-year-old girl on total parenteral nutrition were reversed after ALA was added to her nutritional regimen.

Since EPA and DHA can be synthesized by the body from ALA, these two omega-3 polyunsaturated fatty acids (PUFAs) do not strictly meet the definition of essential. Nevertheless, since the dietary levels of omega-3s in the modern era are inadequate, and due to the fact that ALA conversion is not efficient enough to satisfy health requirements, EPA and DHA are considered conditionally essential.

As to studies backing up EFAs, an exhaustive 2015 review of animal, in vivo and clinical research studies over the last 40 years by Karsten Weylandt and colleagues published in BioMed Research International noted, as follows: “Our review of the omega-3 PUFA research literature prompts us to conclude that the animal and in vitro data have been remarkably consistent in showing health benefits, particularly through mechanisms dampening inflammation and proliferation in different tissues,” which have established the protective effects of omega-3s in “diseases ranging from cardiac arrhythmia and inflammatory conditions”—such as atherosclerosis and arthritis—to cancer.

In fact, Duffy MacKay, PhD, senior vice president of scientific and regulatory affairs for the Council for Responsible Nutrition (CRN), noted: “The numerous benefits of omega-3 fatty acids from foods, like salmon and sardines, and dietary supplements are well-established for men and women for all stages of life.” “Hundreds of studies over the past two decades have shown omega-3 fatty acids to have positive effects associated with cardiovascular health, perinatal health, inflammation, cognitive function and cancer,” added MacKay.

So it is with dismay that the industry is challenged by commentaries in the mainstream media dismissing the established benefits of dietary omega-3s, such as the recent New York Times headline, “Fish Oil Claims Not Supported by Research.”

In a response to the Times’ piece, William Harris, PhD, CEO of OmegaQuant Analytics in South Dakota, found a number of problems repeated in meta-analyses and studies that are often the focal point of such articles, one of which involves the statistical methodologies used.

In referring to a meta-analysis by Rizos and colleagues in 2012, Harris said, “They concluded that fish oil capsules offer ‘no benefit’ for heart patients. Unfortunately, Rizos used a highly controversial statistical maneuver. In their actual data, there was a highly statistically significant reduction in cardiac death associated with fish oil use (p<0.01 for the stat-savvy). So, fish oils did reduce risk for cardiac death.”

“Why the ‘no effect’ conclusion?” Harris asked. The researchers “decided to set the statistical bar higher than I’ve ever seen it in meta-analyses. They defined a significant p-value as <0.006, instead of the universally accepted p<0.05. This trick changed a positive finding into a negative one and generated a media storm of ‘fish oils don’t work.’”

Other issues with some of the recent studies, noted Harris, is that they are plagued with such problems as using too low a dose, supplementing for too short a period, and selecting very sick patients who are already being treated with very powerful medications. To this we can add that for populations and study groups already consuming a great deal of fish in their diets, supplemental omega-3s might not show a very significant, added benefit.

The State of the EFA Market

In terms of the EFA omega-3 market, on the one hand there is heavy market saturation and commoditization of traditional fish oil products, with added value segments (such as algae- or krill-sourced products); on the other hand, unique delivery forms, combination products, and unique processing technologies offer disruptive innovation and differentiation in an otherwise crowded category.

Becky Wright, marketing director for Norway-based Aker BioMarine AS, believes that, “The marine omega-3 market—here in North America and abroad—is rebounding from a perception problem, one that severely impacted sales over the past couple of years, especially for fish oil.”

Wright said that there is a lot of encouraging news, too, some of which came out of a physician-focused study sponsored by Aker BioMarine in 2014. “Doctors—the top gatekeepers of health information” continue to recommend omega-3s to their patients.

In research sponsored by Aker BioMarine in 2014, 90 percent of physicians said they continue to recommend omega-3s” to their patients despite the negative media coverage. “In fact,” added Wright, “30 percent of physicians are recommending them more since the first of several negative studies and stories surfaced in mid-2013.”

Gunilla Traberg, marketing and communications manager, health and nutrition for Pennsylvania-based FMC Corporation, the maker of Epax omega-3 concentrates, said that, “Essential fatty acids is still one of the strongest supplement categories; we believe this is due to both the strong science supporting EFAs and also to the unique, tradition-driven place occupied by omega-3s in the minds of many customers.”

Traberg added that, “The drive to develop even more forms of healthy, omega-3 fatty acids through new sources and technologies proves to us that the industry is still experiencing strong demand from consumers around the globe.”

David Hart, vice president of marketing for Texas-based Qualitas Health also points to category growth, however with some changes.

“The omega-3 market has experienced some major shifts since 2013—the overall market has shrunk, but consumers are shifting toward more value-added omega-3s, especially algal sources, krill oil and highly concentrated fish oils.”

Other industry experts see market changes driven by demographic differences.

Tiffany Huenefeldt, corporate development manager at KD Pharma in Germany, observed, “In the U.S. and Europe, we see educated consumers who recognize the importance of higher concentrations and potency in the omega-3s they consume.

“In other countries, the market is primarily lower grade fish oils, but growing steadily, although we do expect a shift to higher-potency concentrates in these markets as consumers become more savvy.”

She attributed “bumps” in growth in the U.S. and China to misguided press coverage in the U.S. and infant formula scandals in China.

Sabrina Di Blasio, marketing director for Neptune Technologies & Bioress-ources in Canada, said the omega-3 slow-down is itself decelerating.

“The decline of omega-3 retail sales in the U.S. seems to be slowing down,” she noted. “According to the latest IRI (Information Resources, Inc.) data, retail sales of omega-3s for the last 12 months are declining at a rate of -2.5 percent whereas they were declining at -7 percent in the previous year.”

The Good Seed (and Plants)

While marine-sourced omega-3s (fish/krill or algal oils) offer the highest levels levels of EPA and DHA, there are also land-based seed oils with respectable levels of omega-3 fats, such as flax (58 percent omega-3s), chia (30 percent omega-3s), hemp (20 percent omega-3s) and pumpkin (up to 15 percent omega-3s). Aker BioMarine’s Wright said, “We are definitely seeing what some are calling ‘The rise of the super seeds,’ like flax and hemp—these omega-3 options are a good choice for consumers who are vegetarian or who have a shellfish allergy.”

She added, however, that many consumers do not realize that not all omega-3s are created equally.

“Some seed omega-3s are trying to ride the coattails of health benefits tied directly to marine-source EPA and DHA,” Wright explained. “While ALA has its own health benefits, and does eventually convert to EPA and DHA in the body, the conversion rate is very low, around 1 percent, which means you would need a lot of it!”

As to seed and marine-plant omega-3s, KD Pharma’s Huenefeldt noted that, “Algae has certainly become an interesting source in recent years, especially for DHA. “Obviously concerns about sustainability may drive some consumers to plant sources for their EFAs, but marine sources remain the best sources for omega-3 EPA and DHA.”

Qualitas Health takes a unique approach to its algae-based Almega PL ingredient. “Algae are the original source of long-chain omega-3s in the marine ecosystem—fish and krill get their omega-3s directly from their diet, ultimately algae,” according to David Hart, vice president of marketing. Qualitas Health’s “Farm-grown algae do not impact fragile marine ecosystems and are a truly renewable and sustainable source of omega-3s.”

Innovate or Fade Away?

Facing that crowded marketplace, one marked by proliferation of me-too brands and by some products that do not offer a compelling “reason to buy” in the minds of either finished product manufacturers or end-user consumers, ingredient companies that have powerful and innovative brand stories attempt to focus on what sets them apart from an ocean of choices.

When asked, “What do you do differently or better than other brands?”—Aker BioMarine’s Wright pointed out that, “Aker developed eco-friendly harvesting technology (i.e., Eco-Harvesting), which helps protect the integrity of krill as well as minimize environmental impacts and eliminate by-catch.”

According to Wright, what helps is that Aker BioMarine is “the only vertically integrated krill supplier, meaning that we have full control of the supply chain, from sea to shelf.”

Wright explained that Aker BioMarine partners with several outside institutions to research and monitor the krill biomass in the Southern Ocean and to check on the animal populations that depend on krill as a food source. The company maintains close relationships with the World Wildlife Fund for Nature (WWF-Norway), which helps Aker to establish best practices that go above and beyond traditional sustainability requirements, she said.

Some firms aim to exceed standard practices in terms of quality and purity.

KD Pharma’s Huenefeldt explained that, “As markets mature, there is an increasing demand for higher potency and purity in concentrates.”

“You certainly can’t handle 95 percent omega-3 oils in the same manner as you handle 18/12 or low fish oil concentrates,” added Huenefeldt. “For example, we may be the only manufacturer that flushes our systems and drums with argon gas, rather than nitrogen, thus ensuring the best quality product.”

Other firms develop or implement novel methods of analysis to assess the stability, purity and efficacy of its products, which is what Israel-based Enzymotec aimed to do for its K•Real krill oil brand.

Normally, the quality of krill oil is measured by chemical markers that are tested during shelf life, however these parameters do not reflect changes in krill oil’s biological activity after consumption.

“By using a simulation model for measuring the biochemical quality of the krill oil in the digestive system, Enzymotec has established [new] biological quality parameters,” the company noted.

According to Jeffrey Blumberg, PhD of Tufts University, “Utilizing a validated in vitro gastric model, K•Real krill oil proved more resistant to oxidation reactions and to degradation of its DHA and EPA content than other krill oil samples tested.”

KD Pharma’s Huenefeldt noted that, since its founding 25 years ago, the company has specialized in what it refers to as kd-pur Technology, a combination of supercritical CO2 fluid extraction (SFE) and supercritical fluid chromatography (SFC), in order to produce its ultra-high fish oil concentrates.

“Today, we still continue to be at the forefront of innovation in separation technologies,” Huenefeldt added. “The benefits of ultra-high concentrates for our customers and end users are immense—smaller soft gel size, fewer sof gels per serving, higher omega-3 daily dose, less pro-inflammatory molecules, less gelatin, etc.—and we are happy to provide cutting-edge solutions to this exciting market.”

Qualitas Health’s Hart said that sustainability and the unique algal product itself sets them apart.

“By definition, Almega PL, and our nutrition ingredients from farm-grown algae are sustainable—in addition to using sunlight for photosynthesis as the main energy source, we have purchased renewable energy credits so that our Texas algae farm is complexly powered by renewable energy.”

Hart added, “Almega-PL is the only omega-3 with both glycolipids and phospholipids—a unique molecular structure that provides improved bioavailability and digestibility.”

Innovation is critical to the FMC Corporation, according to Traberg.

“Purity, quality and innovation form the basis for everything we do with the Epax brand, which has been proven again and again over the years,” explained Traberg. “Our continued innovation is key to maintaining our market leadership, and our new EPAX 4535 TGN omega-3 triglyceride oil, which we debuted in September, is a testament to that as it is, to our knowledge, the highest concentration of EPA and DHA fatty acids in a 90 percent triglyceride form on the market today.”

In addition to innovation, FMC attempts to focus on purity and quality, as well, starting at the fishing ground level.

“FMC requires that all crude fish oil suppliers to Epax omega-3 concentrates adhere to strict FMC procurement standards and unalterable specification requirements in order to be a business partner,” Traberg added. “FMC only receives human-grade-certified Epax raw materials from Friend of the Sea-certified strategic partners and exercises strict quality control over the entire process, from the fishing ground through ingredient manufacturing.”

Quality depends on multiple factors, which all need to be satisfied before a product can be released, observed Neptune’s Di Blasio.

“Neptune’s unique extraction process allows for the company to have the purest krill oil product on the market—our krill oil has 98 percent fat content compared to competitors’ krill oils, which have around 92 percent,” Di Blasio added.

“Neptune’s products also have less than 0.001 percent solvent residue compared to 3 percent in other krill products. Impurities are the main cause of oil degradation—our krill oil contains more fat, less residual solvent, no protein, a bright red color and a better odor, superior levels of EPA and DHA, and seven times more antioxidant astaxanthin.”

More bang for the buck is important to New York-based BASF, as well, in its recent roll-out of an ultra-high EPA-DHA omega-3 concentrate and other innovations.

“We carefully concentrate the beneficial omega-3s to a high level of 90 percent to ensure optimal delivery of EPA and DHA,” said Anne van Gastel, business director of BASF Human Nutrition. “The new 46:38 EPA:DHA product composition is the most clinically studied, so it gives our customers a solid foundation to market their products.”

The Future of EFAs

So what does the future hold for this category?

“The Baby Boomers are no longer babies,” said Qualitas Health’s Hart. “They are living longer and more active lives, may have chronic health issues, and have more discretionary income.”

“The well-proven health benefits of EFAs, especially the cardiovascular benefits, make these an important component of ‘do-it-yourself’ nutrition and health care—the combination of an aging population which seeks its own solutions to maintain a healthy lifestyle will fuel future demand for EFAs.”

FMC Corporation’s Huenefeldt sees growth and market change on the immediate horizon.

“EFA supplementation will continue to grow in 2016 and beyond, albeit with some regional markets slowing—immature markets will gradually shift to higher concentrates of omega-3s as consumers and health care providers become more educated on the benefits and are provided alternatives to traditional fish oil.”

Aker BioMarine’s Wright also predicts that knowledgeable end-users will drive market changes and product offerings. “Consumers are becoming more savvy and educated, and that will help dictate how companies evolve to meet those needs,” she said. “Sustainability will also become a prerequisite for companies operating in the marine omega-3 market—third-party certification will be deemed necessary to help ensure that everyone is taking the appropriate steps to protect our world’s oceans and species.”

Some experts, such as FMC Corporation’s Traberg, see particularly robust growth ahead for condition-focused formulations.

“We see strong growth in condition-specific omega-3 formulas for both sports nutrition and healthy aging,” Traberg noted. “Additionally, recent U.S. market research showed double-digit omega-3 growth in what we call ultra concentrates, meaning 700-plus mg/g of EPA:DHA, suggesting that consumers are looking for more convenient, more potent products.”

Neptune’s Di Blasio also forecasts increased consumer interest in condition-oriented products.

“As more and more unique benefits are clinically proven and accepted, consumers will continue to look for omega-3 products for overall health and for antioxidant properties, but they also will become increasingly interested in targeted, specific formulas to meet their individual health needs.”

Other omega-3 market watchers, such as BASF’s van Gastel, believe that improved, and more varied, delivery options will open up untapped market potential. “Form and function will increasingly drive demand for dietary supplements,” predicted van Gastel. “While consumers are increasingly wellness-oriented, we do know that about 30 percent do not regularly take their supplements, so there’s a tremendous opportunity to reach this group with products that better fit their lifestyle and are more pleasant to take.” NIE

For More Information:
Aker BioMarine AS, www.akerbiomarine.com
BASF Human Nutrition, (800) 527-9881
Enzymotec, +972 74 717 7177
FMC Corporation, +47 70 13 59 60
KD Pharma, +49 (0) 6826 979700
Neptune Technologies & Bioressources, (450) 687-2262
OmegaOne Analytics, (800) 949-0632
Qualitas Health, www.qualitas-health.com

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