Ingredients in our industry are referred to as "snake oil" again and again, primarily by the mainstream media exploiting another unbelievable claim or quality-related problem. But one segment of the business, omega 3 fatty acids, can actually almost claim to be "snake oil" as it truly can be many things to many people with the variety of health benefits attached to it.

The words used to describe the market are varied, most of them an alphabet soup of acronyms-PUFA's, LCPUFA's, EPA, DHA and the list goes on-but the bottom line is that here is an industry segment with strong science behind it, a qualified health claim in its pocket, consumer awareness above the 50% mark and a committee of competitors working together as a group to move the industry even farther forward.

While this sounds like a sure recipe for success, there are still issues that must be addressed-fishy taste and odor problems (or perceptions) still plague the business, confusion about the "long chain" component of the product abounds and the need for a stronger health claim-and even more science-continue to remain obstacles.

The Health Claim
Perhaps the most exciting news on the omega 3 front has been the qualified health claim approved by FDA late in 2000 for long chain omega 3 fatty acids. The suggested claim, which is currently only available for dietary supplements, states, "The scientific evidence about whether omega 3 fatty acids may reduce the risk of coronary heart disease (CHD) is suggestive but not conclusive. Studies in the general population have looked at diets containing fish and it is not known whether diets or omega 3 fatty acids in fish may have a possible effect on a reduced risk of CHD. It is not known what effect omega 3 fatty acids may not have on risk of CHD in the general population."

While any type of health claim is a step in the right direction, with wording so awkward and confusing, the question is, will the industry benefit by using it? The answer is no, according to many suppliers.

"The qualified health claim is useless," said Marian McClure, director of marketing, Omega Tech, Boulder, CO, manufacturer of DHA Gold¨ brand DHA and Gold Circle Farms fortified eggs. "No one is using it to my knowledge and we are trying to get FDA to revise it to make it a little more reasonable."
While the qualified health claim may not be the answer, suppliers do see this as positive. "We need a stronger health claim," said Karen Todd, senior marketing manager, new ingredients & business development, Roche Vitamins, Parsippany, NJ, which manufactures ROPUFA¨ omega 3 products, "but the fact that it is recommended at all is a big step forward."

Espen Thomassen, area sales manager at omega 3 supplier Denofa, Oslo, Norway, concurred. "Long chain omega 3's (EPA & DHA) from fish were already documented to be good for your health but it is very positive that the FDA have reviewed the evidence and reached the same conclusion. I would say that the health claim has not really had that much impact, perhaps because the wording is so long and complicated. But we see that consumers are becoming more aware of long chain omega 3 and a stronger health claim might give a positive push to the entire category."

There are several next steps, say industry suppliers. One is to achieve a full health claim without all the qualifiers and the way to do this is through more science. Herb Woolf, technical marketing manager, nutraceuticals at omega 3 manufacturer BASF, Mt. Olive, NJ-talked about one way to accomplish this. "An industry group, chaired by BASF, has been working through their legislative liaisons to achieve language in a Senate bill to assign resources for initiating a major clinical study of omega 3's in the general population," commented Mr. Woolf. "The intention is to put in motion some activity to begin addressing the need for a large clinical trial assessing the value of omega 3's in preventing sudden cardiac death." The trial would include up to 10,000 people, said Mr. Woolf, and would last for five or more years. Currently, he said, the House and Senate are in discussions to develop the final bill. "After it passes, a group will then administer a workshop to determine how to set up a budget for this, who should be responsible for administering the trial, etc. At this point," he said, "the industry could begin campaigning for a true health claim."

Additionally, the industry is awaiting the issuance of a recommended intake figure for omega 3's, which is expected early this year. The number will reportedly be an AI (adequate intake) figure rather than an RDI (recommended daily intake) but will go a long way toward raising awareness. As Rick Becker, area sales manager at omega 3 distributor GCI Nutrients, Redondo Beach, CA, put it, "We need to get to the point of being able to say 'fortified with DHA.'"


Consumer Awareness: 55% And Growing
In looking at the spectrum of nutraceutical products and levels of consumer awareness, omega 3's are high on the scale. "No ingredient has better backup in terms of clinical studies and consumer awareness," commented Helmut Reuscher, Ph.D., market development manager at omega 3 supplier Wacker Biochem, Adrian, MI. According to market research done by HealthFocus, Atlanta, GA, for Roche Vitamins, 55% of consumers are aware of the term omega 3's. According to Omega Tech, awareness of omega 3's has risen 40% since 1996. And according to the Natural Marketing Institute, Harleysville, PA, use of omega 3's increased 100% from 2000 to 2001 (% of general population using in three months ending in June). IRI data for the total fish oil market for the 52 weeks ended October 28, 2001 places the market at 2.8 million in unit sales and $18.5 million, a 19.8% and 13.9% change respectively from the prior year.

Yet, there is still a huge gap between awareness and understanding. While the Natural Marketing Institute reports a 100% increase in omega 3 use, this only represents a jump from 2.7% of consumers to 5.4%. According to Olav Sandnes, president, Marine Nutriceutical, Mt. Bethel, PA, a supplier of a variety of marine oils, "While 55% of the population are aware of the benefits of omega 3's, only 7% take supplements. This is a tremendous dichotomy and a great opportunity for us," he said.

"We must recognize why this is," he continued. "We believe firmly that people don't like taking fish oil and companies have been selling based on the content of the fatty acids, not on quality. Customers don't care about that."

Mary Ann Siciliano, national sales manager at supplier Arista Industries, Wilton, CT, also stressed quality. "There are many manufacturers not manufacturing to quality standards and customers and consumers don't always know what to look for. Education and quality are the key. The answer is knowing your suppliers and knowing what you're buying."

Another issue in terms of awareness is educating people about the difference between marine source omega 3's and omega 3's from flax, which has certainly gained in popularity recently as well. Ms. Todd commented on the issue, "You need a huge amount of flax to equal the amount of omega 3's in fish oil," a fact that consumers just don't understand. "The educational arm will be a huge thrust," she added. "We are working on bringing awareness to health professionals, who are still not specific about marine sources versus flax."

Awareness numbers fall lower when the discussion turns to individual fatty acids. For DHA, the figure is about 22%. Yet suppliers are optimistic about improvement. According to Claire Packer, business development manager, Croda Oleochemicals, Healthcare, Goole, U.K., manufacturer of Incromega omega 3 oils, "The awareness of the importance of individual fatty acids is growing within the industry as more and more products are being launched that contain specific PUFAs to target specific conditions."

In terms of DHA in particular, Ms. McClure predicted that once infant formula with DHA in it comes out that number will go through the roof.

The Infant Formula Issue
Speaking of infant formula, that segment of the market has long been a target for omega 3's-specifically DHA-enhancement in the U.S. Other countries have had DHA-enriched formulas on the market for many years and the U.S. has notably lagged behind. That is poised to change now, with the announcement last summer that Martek Biosciences, Columbia, MD, manufacturer of Neuromins¨ DHA, has achieved generally recognized as safe (GRAS) status for infant formula applications. "This effectively opened the door for the formula manufacturers to pursue label and ingredient changes with FDA," said Ethan Leonard, marketing manager at Martek. "Our hope is that sometime in 2002 we will see product on the market from at least one, if not more, manufacturers. Of course it has to go through the FDA process so we're not sure when it will happen, but we have seen broadening interest, as well as continued interest outside the U.S."

While suppliers are enthusiastic about the possibilities, they also remain cautious. BASF's Mr. Woolf commented, "We believe it will be in select market introductions, not across the board and not a quick roll out. There is just not a great deal of enthusiasm for doing this immediately," he said, predicting that pre-term formulas would be first.

Once the ball starts rolling, though, the momentum should carry a lot of weight. Bjorn Rene, sales and marketing director, Pronova, Lysaker, Norway-which manufactures omega 3 fatty acids such as Triomar¨-commented, "Once one company goes to market, others will follow. We will hopefully see DHA in infant formula early this year."

And Omega Tech's Ms. McClure took the next step, "Once it's in infant formula, the logic seems to be if it's good for the baby, it must be good for me too, at which time we should see a big upsurge."
Food Vs. Supplement

Infant formula notwithstanding, the discussion about adding omega 3 fatty acids to food products usually revolves around one main issue: taste. Right or wrong, there is still a perception that these products will taste or smell fishy, which consumers are simply not willing to accept, regardless of the health benefits attached. "What I hear from the industry is that consumers are not satisfied with the quality of fish oils on the market," said Gregory Drew, marketing manager, cosmetic & food at omega 3 supplier Fuji Chemical Industries (USA), Inc., Robbinsville, NJ. "You're seeing a lot of initial purchases, but not repeat sales." Yet suppliers say that they have mastered this problem and many are extremely optimistic about the future of the functional food industry. Gerhard Schmid, PhD, president & CEO at Wacker, commented, "Our expectation is that the functional food market will open fast; we are getting a lot of requests for samples and doing lots of trials." Wacker's Dr. Reuscher added, "We are optimistic about the functional food area and we will see more of these fortified foods in the future. Although we are still at the beginning of the market and we feel like mainstream acceptance in foods will probably take some time, we think there is huge potential."

"I think the push will be in functional foods," Martek's Mr. Leonard concurred. "There has been a buzz related to the GRAS notification and there's a lot of awareness among consumers. Functional food offers the best opportunity. For example bars offer a multitude of nutritional elements and can reach a much broader segment of the population."

Cost is another issue, of course. "In the food area, it has to be cost effective or a multinational food company won't even consider adding it to the food," said Don McGimpsey, vice president-sales, Bioriginal Food & Science Corporation, Saskatoon, Canada, which supplies both powders and oils. "They are not looking at incremental cost increases; if Kraft puts something in, what are they going to take out?"

Several suppliers compared opportunities in the food versus supplement business. "Fish oil in the food industry in America is still in its infancy," said Fuji's Mr. Drew. "In the short term the supplement industry seems to have more potential, but food fortification is definitely the big picture. The reason, I believe, is because of technological hurdles in the development of a dry oil powder with good physical and sensory characteristics. Sure, there are good powders on the market, but if better powdered fish oils were available, we would see a lot more products in development and on retail shelves." He added that consumer awareness will also grow once this problem is solved.

David Lewis, director of sales and marketing, Lipid Nutrition, a division of Loders Croklaan, Channahon, IL, supplier of Marinolª omega 3's, agreed. "Right now, it appears supplements are growing faster than foods, although the potential for future growth and opportunity may be greater in foods. There is almost limitless potential for the types of foods appropriate for fortification."

"Supplements have always been the route for individuals who want to take a proactive approach to nutrition," explained Mr. Woolf. "But the average consumer will try to consume foods for a good long term dietary lifestyle. Making good choices of fortified foods will alter their omega 3 intake."

One supplier had an ominous comment: "If we don't do more in the way of self regulation on the supplement side, consumers will continue to lose trust in the business and they'll be less apt to stop in the supplement aisle. We will be better off in functional foods."

Summing it up, Mr. Rene said, "The major volume growth potential is in the functional food area, but you need to be able to do good formulations. I think both food and supplements will continue to grow, however; it will give people different opportunities to get omega 3's in their diet.


Food Processing Issues
Speaking of formulations, there are certainly considerations when adding omega 3's to food products. Wacker's Dr. Schmid commented, "Process technology is crucial. If the product is not stabilized properly, it will degrade and actually create free radicals, which of course is the opposite of what you want."

"Oxidation is a constant problem," agreed Mr. Sandnes, "and 'stable' is a relative term."

Expounding on this issue was Fuji's Mr. Drew. "I believe it is terribly irresponsible for marketers to recommend supplemental doses of long chain omega products without also recommending an increase in dietary antioxidant intake." he explained. "Long chain fatty acids are very reactive to oxygen and free radicals. Increasing the intake of antioxidants, especially the lipid soluble antioxidants, is the best way to maintain biodefenses against excess lipid peroxidation from omega oil supplementation."

Despite processing concerns, omega 3's are actually easy to work with, report suppliers. Mr. Leonard of GCI said, "Formulations that are not fishy have been developed; there is strong scientific support and it's easy to work with."

Dr. Schmid added, "There are clear health benefits to be incorporated, very easily, into many different foods, with no additional processing necessary."

Loders' Mr. Lewis also said, "As breakthrough technologies surface, the ability to add omega 3 to foods will be improved. Tackling the issues of taste and mouthfeel will open whole categories to fortification."

The supplement business has processing issues as well. "Omega 3 capsules are huge, so you can't get them into a multivitamin," said Roche's Ms. Todd. "We need to figure out a more concentrated form or make them tablet-able; these are some of our initiatives," she said.

And both sides of the industry have ongoing contamination issues to contend with. However, this problem is fading as customers become more educated and quality controls are put in place. "In terms of contamination issues, the consumer should feel satisfied with the fact that the oils are Proposition 65 compliant and are made with a high quality operation," said Mr. McGimpsey of Bioriginal. "We run well established efficient operations and compliance is checked throughout the process."

Croda's Ms. Packer added, "Recently we have seen the industry moving towards higher potency products manufactured to higher standards, i.e. minimizing pesticides and heavy metals."


The International Market
While the U.S. market is certainly growing, many international markets are way beyond the state of the American market. In Scandinavia, about 65% of consumers consume some type of omega 3 fatty acid, compared to about 3% in North America, according to one supplier. But countries like Italy, France and Spain still have low levels of awareness.

Product categories also differ internationally. In Italy, for example, Parmalat sells an omega 3 milk. In Norway, said Mr. Thomassen of Denofa, "We have omega 3 bread and in other European countries we find long chain omega 3's in foods such as cookies, spreads for bread and dairy products."
Omega Tech has rolled out its Gold Circle Farms concept on a worldwide basis, mainly through technology licensing. Ms. McClure said, "We have had great success putting together prototype products and we have had a great deal of interest." There are three new egg brands around the world," she said "and in Israel one entrepreneur is manufacturing DHA-enriched chicken nuggets and chicken salads, while in Japan they're putting it in table spreads and breads."

Mr. Lewis of Loders concluded, "In terms of comparison between the U.S. and internationally, the international markets, specifically in Asia and Europe, are more mature and established and have higher consumption rates of concentrates. The U.S. market, by comparison, is underdeveloped and offers more opportunities for expansion."


Health Benefits Overview
Omega 3 fatty acids truly are ingredients that have so many different indications. The connection between omega 3's and cardiovascular disease is hands down the most recognized link in the adult market. However, there are specific areas within the cardiovascular market that are specifically being targeted and there are additional areas of development as well.

In the cardiovascular arena, reduction of triglycerides is a top benefit, while cholesterol and blood pressure lowering are also primary benefits. Beyond cardiovascular, infant and maternal nutrition rank high on the list. Mr. Woolf said, "In general, one of the top areas of future interest will be in perinatal nutrition, spilling over into pediatric/toddler foods. However," he added, "The most frequent association right now is between fish oils and cardio health, with cognition falling in second."

Also touting the prenatal/infant area was Fuji's Mr. Drew. "I think the biggest potential for long-chain omega 3's is in the areas of prenatal, maternal, infant and child nutrition," he said. "This is an area where consumers will spend more money for premium products." He also predicted that pet food fortification will also be a large market, void of taste-related issues as in the human nutrition market.

In the children's market, DHA in particular is widely recognized in connection with brain function and studies on the use of omega 3's in combating ADD and ADHD are underway. Possibly connected to this is the link to depression, which is also the source of ongoing research. Likewise omega 3's have shown potential in connection with Alzheimer's disease, while joint health and vision improvement are also up and coming markets.

Larry Nowakowski, director of refined oil sales, Omega Protein, Houston, TX, manufacturer of OmegaDry¨, commented on the challenges of having an ingredient for so many categories. "The challenge is deciding how to market the product. Do you go after the cardiovascular condition or inflammation, for example? What do you put on the label?" You have to pick your spot, he said, "You're not going to go into every product."

Building The Science
While omega 3's definitely have a good amount of science behind them already, there are many avenues to explore and research is ongoing. For instance, a study using Triomar¨ omega 3 fatty acids from Pronova is being done on postpartum depression. The study, sponsored by NIH, will include 50 pregnant women with previous postpartum depression; for two months the women will receive three capsules/day of 60% omega 3 fatty acids or placebo. The study is being run by Dr. Marlene Freeman, who started the Women's Mental Health Program in Tucson, AZ, and is expected to be completed this summer.

Dr. Freeman also co-authored a study that examined the role of EPA and DHA in treating manic depression (bipolar disease). High doses of omega 3's were given to manic-depressive patients. The authors concluded that those treated with omega 3's remained symptom free to a larger extent than the patients who were given an olive oil placebo. In fact, the improvement was so pronounced (omega 3: 64% vs. placebo: 19%), investigators terminated the nine-month trial after only four months.

Another trial on postpartum depression and omega 3 fatty acids was recently published in the Journal of Affective Disorders (October 2001). The study analyzed 14,532 subjects and found that higher omega 3 fatty acid content in mother's milk and higher seafood consumption were associated with lower rates of postpartum depression. Omega Tech is also planning a study on postpartum depression; the study, which will use a DHA-enriched snack bar, is under development and should commence in 2002.

In the prenatal area, Omega Tech is just completing a study of 600 pregnant women; this study duplicates another smaller study where it was determined that taking DHA increases the length of gestation and length and weight of the baby at birth. Omega Tech also has several studies underway testing DHA and improved pregnancy outcomes.

On the cardiovascular side, Omega Tech has three clinical trials finishing this month on its DHA Gold product; the results show that the product lowered triglycerides, raised HDL and reduced blood pressure. Roche is also sponsoring research on heart arrhythmias, triglyceride levels and synergy with vitamin E.

New studies are also going on analyzing omega 3's and reduced depression, dementia and Alzheimer's disease, while infant cognition is also the focus of research. An OmegaTech-sponsored trial is following 100 male and female infants from birth to 18 months of age to assess the influence of the maternal diet on infant cognitive/visual development. Results are due later this year.

DHA and improved vision is another area being investigated. One study published last year showed that infants who were breast fed had better visual development at 31/2 years than those who were fed infant formula (without DHA). And importantly, children whose mothers ate oily fish during pregnancy were more likely to have better visual development at 31/2 years. In adults, a large population study showed that a high intake of fish lowered the risk of age-related macular degeneration.

Finally, clinicals are being done on the connection between EPA and reducing sun damage, opening up the possibility of putting a highly concentrated EPA in a suntan lotion. NW